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  <description><![CDATA[<p>Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.&nbsp;</p><p><br></p><p>The views and opinions expressed in the podcast are those of the hosts and guests respectively and, unless otherwise stated, do not represent the position of any institution to which they are affiliated.</p>]]></description>
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    <itunes:title>#46 Protecting the health ecosystem – Valentina Giunchi &amp; Joe Mitchell</itunes:title>
    <title>#46 Protecting the health ecosystem – Valentina Giunchi &amp; Joe Mitchell</title>
    <itunes:summary><![CDATA[Send a message to the show! Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems.  Tune in to find out: Where in the environment pharmaceutical residues...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems.<b> </b></p><p><b>Tune in to find out:</b></p><ul><li>Where in the environment pharmaceutical residues are turning up, and why this should be on every pharmacovigilance scientist&apos;s radar</li><li>How the dramatic collapse of India&apos;s vulture populations in the early 2000s speaks to the importance of the One Health approach </li><li>Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution.</li></ul><p><b>Want to know more?</b></p><p>For a deep dive into ecopharmacovigilance, the following references provide foundational information on the topic in pharmacovigilance, most of them penned by Professor Giampaolo Velo, who coined the term:</p><ul><li>The revised <a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC2817447/'>Erice declaration</a> for the inclusion of environmental issues in pharmacovigilance</li><li>A <a href='https://link.springer.com/chapter/10.1007/978-3-319-40400-4_18'>book chapter</a> on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editors</li><li>A <a href='https://link.springer.com/article/10.2165/11539380-000000000-00000'>paper</a> summarising the main concepts in ecopharmacovigilance and pharmaceutical pollution</li></ul><p>A <a href='https://academic.oup.com/ijpp/article/33/1/102/7935481'>paper</a> with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use.</p><p>A <a href='https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2026.1799220/full'>recent paper</a> with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance. </p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems.<b> </b></p><p><b>Tune in to find out:</b></p><ul><li>Where in the environment pharmaceutical residues are turning up, and why this should be on every pharmacovigilance scientist&apos;s radar</li><li>How the dramatic collapse of India&apos;s vulture populations in the early 2000s speaks to the importance of the One Health approach </li><li>Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution.</li></ul><p><b>Want to know more?</b></p><p>For a deep dive into ecopharmacovigilance, the following references provide foundational information on the topic in pharmacovigilance, most of them penned by Professor Giampaolo Velo, who coined the term:</p><ul><li>The revised <a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC2817447/'>Erice declaration</a> for the inclusion of environmental issues in pharmacovigilance</li><li>A <a href='https://link.springer.com/chapter/10.1007/978-3-319-40400-4_18'>book chapter</a> on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editors</li><li>A <a href='https://link.springer.com/article/10.2165/11539380-000000000-00000'>paper</a> summarising the main concepts in ecopharmacovigilance and pharmaceutical pollution</li></ul><p>A <a href='https://academic.oup.com/ijpp/article/33/1/102/7935481'>paper</a> with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use.</p><p>A <a href='https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2026.1799220/full'>recent paper</a> with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance. </p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <pubDate>Thu, 04 Jun 2026 09:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; Introduction" />
  <psc:chapter start="3:37" title="Where medicines show up in nature and why it matters" />
  <psc:chapter start="5:09" title="Diclofenac and vulture population collapse" />
  <psc:chapter start="7:28" title="What is ecopharmacovigilance?" />
  <psc:chapter start="9:32" title="One Health and its connection to ecopharmacovigilance" />
  <psc:chapter start="11:27" title="The One Health approach and AMR" />
  <psc:chapter start="14:17" title="The One Health approach to drug utilisation and other therapeutic groups" />
  <psc:chapter start="18:23" title="Challenges to studying long-term environmental effects of drugs" />
  <psc:chapter start="25:41" title="Solutions for reducing the impact of medicines on the environment" />
  <psc:chapter start="29:26" title="How the public can help" />
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    <itunes:title>#45 How to perform better disproportionality analyses – Michele Fusaroli &amp; Eugene van Puijenbroek</itunes:title>
    <title>#45 How to perform better disproportionality analyses – Michele Fusaroli &amp; Eugene van Puijenbroek</title>
    <itunes:summary><![CDATA[Send a message to the show! For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool. Tune in to find out: Why we should never treat disproportionality signals as verdictsHow poorly performed analyses affect scientists, regulators an...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.</p><p><b>Tune in to find out:</b></p><ul><li>Why we should never treat disproportionality signals as verdicts</li><li>How poorly performed analyses affect scientists, regulators and patients</li><li>How to avoid the most common sources of bias<b> </b></li></ul><p><b>Want to know more?</b></p><ul><li>Michele and Eugene’s paper in Drug Safety is a concrete guide to <a href='https://link.springer.com/article/10.1007/s40264-025-01604-y'>charting and sidestepping the pitfalls</a> of disproportionality analysis.</li><li>In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help <a href='https://link.springer.com/article/10.1007/s40264-025-01628-4'>map and address biases</a> in disproportionality analysis.</li><li>Michele also reviewed the <a href='https://uppsalareports.org/articles/disproportionality-analysis-fast-but-fragile-and-easy-to-misuse/'>method’s limitations</a> in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.</li><li>Last year, Retraction Watch covered the <a href='https://retractionwatch.com/2025/09/16/exclusive-journal-bans-drug-safety-database-papers-as-they-flood-the-literature/'>spike in pharmacovigilance studies</a> in the literature and why some journals decided to ban drug safety database papers.</li><li>Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV <a href='https://www.drugsafetymatterspod.org/618871/episodes/15786391-31-a-guide-to-reporting-disproportionality-analyses-michele-fusaroli-and-daniele-sartori'>guidelines for reporting disproportionality analyses</a>.</li><li>In 2016, the IMI PROTECT project published <a href='https://link.springer.com/article/10.1007/s40264-016-0405-1'>recommendations to improve signal detection practices</a>, especially for quantitative methods like disproportionality analysis.</li><li>UMC’s guidebook on <a href='https://view.publitas.com/uppsala-monitoring-centre/signal-detection-for-national-pharmacovigilance-centres-with-small-data-sets/page/1'>signal detection in small datasets</a> offers step-by-step advice for qualitative methods and manual case review.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.</p><p><b>Tune in to find out:</b></p><ul><li>Why we should never treat disproportionality signals as verdicts</li><li>How poorly performed analyses affect scientists, regulators and patients</li><li>How to avoid the most common sources of bias<b> </b></li></ul><p><b>Want to know more?</b></p><ul><li>Michele and Eugene’s paper in Drug Safety is a concrete guide to <a href='https://link.springer.com/article/10.1007/s40264-025-01604-y'>charting and sidestepping the pitfalls</a> of disproportionality analysis.</li><li>In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help <a href='https://link.springer.com/article/10.1007/s40264-025-01628-4'>map and address biases</a> in disproportionality analysis.</li><li>Michele also reviewed the <a href='https://uppsalareports.org/articles/disproportionality-analysis-fast-but-fragile-and-easy-to-misuse/'>method’s limitations</a> in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.</li><li>Last year, Retraction Watch covered the <a href='https://retractionwatch.com/2025/09/16/exclusive-journal-bans-drug-safety-database-papers-as-they-flood-the-literature/'>spike in pharmacovigilance studies</a> in the literature and why some journals decided to ban drug safety database papers.</li><li>Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV <a href='https://www.drugsafetymatterspod.org/618871/episodes/15786391-31-a-guide-to-reporting-disproportionality-analyses-michele-fusaroli-and-daniele-sartori'>guidelines for reporting disproportionality analyses</a>.</li><li>In 2016, the IMI PROTECT project published <a href='https://link.springer.com/article/10.1007/s40264-016-0405-1'>recommendations to improve signal detection practices</a>, especially for quantitative methods like disproportionality analysis.</li><li>UMC’s guidebook on <a href='https://view.publitas.com/uppsala-monitoring-centre/signal-detection-for-national-pharmacovigilance-centres-with-small-data-sets/page/1'>signal detection in small datasets</a> offers step-by-step advice for qualitative methods and manual case review.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <pubDate>Thu, 26 Mar 2026 17:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; introduction" />
  <psc:chapter start="2:23" title="What is disproportionality analysis?" />
  <psc:chapter start="4:57" title="Easy to use – and misuse" />
  <psc:chapter start="8:19" title="False alarms create fear and fatigue" />
  <psc:chapter start="12:48" title="Should we ditch the method?" />
  <psc:chapter start="14:44" title="A practical guide to disproportionality" />
  <psc:chapter start="17:49" title="How to avoid common mistakes" />
  <psc:chapter start="21:46" title="Why journal bans won&#39;t work" />
  <psc:chapter start="26:15" title="Designing effective training" />
  <psc:chapter start="29:52" title="Why guidelines alone do not fix misuse" />
  <psc:chapter start="34:46" title="Listener question: database size" />
  <psc:chapter start="37:37" title="Listener question: method sensitivity" />
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  <psc:chapter start="45:24" title="Closing, resources &amp; credits" />
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    <itunes:duration>2840</itunes:duration>
    <itunes:keywords>disproportionality analysis, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science, signal detection, signal assessment</itunes:keywords>
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    <itunes:title>#44 Rethinking medical device safety, part 2 – Omar Aimer</itunes:title>
    <title>#44 Rethinking medical device safety, part 2 – Omar Aimer</title>
    <itunes:summary><![CDATA[Send a message to the show! Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.  In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. Tune in to find out: How reporting for m...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. </p><p>In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.</p><p><b>Tune in to find out:</b></p><ul><li>How reporting for medical devices differs from medicines and vaccines</li><li>How AI may be used for predictive safety monitoring</li><li>Why regulatory and data harmonisation remains the key to improving medical device safety</li></ul><p><b>Want to know more?</b></p><p>Listen to the first part of the interview <a href='https://www.drugsafetymatterspod.org/618871/episodes/18577832-43-rethinking-medical-device-safety-part-1-omar-aimer'>here</a>.</p><p>If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a <a href='https://link.springer.com/article/10.1007/s40264-025-01599-6'>paper on the topic</a> in the journal Drug Safety, as well as an <a href='https://uppsalareports.org/articles/rethinking-medical-device-safety-in-a-drug-centric-world/'>article for Uppsala Reports</a>.</p><p>Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic <em>et al.</em> in their <a href='https://www.nature.com/articles/s41746-025-01717-9'>Nature paper</a>.</p><p>Founded in 2018, <a href='https://isoponline.org/special-interest-groups/medical-devices-group/'>ISoP’s Medical Device Safety Special Interest Group</a> works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. </p><p>In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.</p><p><b>Tune in to find out:</b></p><ul><li>How reporting for medical devices differs from medicines and vaccines</li><li>How AI may be used for predictive safety monitoring</li><li>Why regulatory and data harmonisation remains the key to improving medical device safety</li></ul><p><b>Want to know more?</b></p><p>Listen to the first part of the interview <a href='https://www.drugsafetymatterspod.org/618871/episodes/18577832-43-rethinking-medical-device-safety-part-1-omar-aimer'>here</a>.</p><p>If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a <a href='https://link.springer.com/article/10.1007/s40264-025-01599-6'>paper on the topic</a> in the journal Drug Safety, as well as an <a href='https://uppsalareports.org/articles/rethinking-medical-device-safety-in-a-drug-centric-world/'>article for Uppsala Reports</a>.</p><p>Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic <em>et al.</em> in their <a href='https://www.nature.com/articles/s41746-025-01717-9'>Nature paper</a>.</p><p>Founded in 2018, <a href='https://isoponline.org/special-interest-groups/medical-devices-group/'>ISoP’s Medical Device Safety Special Interest Group</a> works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 26 Feb 2026 11:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; introduction" />
  <psc:chapter start="2:02" title="How reporting for medical devices differs to reporting for drugs" />
  <psc:chapter start="4:44" title="The importance of product quality for medical device safety" />
  <psc:chapter start="6:03" title="The prevalence of underreporting in the pharmacovigilance of medical devices" />
  <psc:chapter start="7:40" title="Improving reporting rates" />
  <psc:chapter start="9:19" title="Follow up loops and positive side-effects" />
  <psc:chapter start="11:49" title="Patients play a crucial role in medical device safety" />
  <psc:chapter start="14:13" title="Tech futures: Blockchain and AI" />
  <psc:chapter start="15:53" title="Tech futures: Implementing in practice" />
  <psc:chapter start="17:06" title="Can AI speed harmonisation?" />
  <psc:chapter start="17:57" title="A global device database and the key to device safety" />
  <psc:chapter start="19:45" title="Closing And Where To Learn More" />
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    <itunes:title>#43 Rethinking medical device safety, part 1 – Omar Aimer</itunes:title>
    <title>#43 Rethinking medical device safety, part 1 – Omar Aimer</title>
    <itunes:summary><![CDATA[Send a message to the show! Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.   In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.  Tune in to find out: What de...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.  </p><p>In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. </p><p><b>Tune in to find out:</b></p><ul><li>What defines a medical device and how prevalent they are in our society</li><li>Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short</li><li>How global initiatives aim to strengthen safety monitoring standards</li></ul><p><b>Want to know more?</b></p><p>Listen to the second part of the interview <a href='https://www.drugsafetymatterspod.org/618871/episodes/18751261-44-rethinking-medical-device-safety-part-2-omar-aimer'>here</a>.<b> </b></p><p>If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a <a href='https://link.springer.com/article/10.1007/s40264-025-01599-6'>paper on the topic</a> in the journal Drug Safety, as well as an <a href='https://uppsalareports.org/articles/rethinking-medical-device-safety-in-a-drug-centric-world/'>article for Uppsala Reports</a>.</p><p>Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their <a href='https://www.nature.com/articles/s41746-025-01717-9'>Nature paper</a>.</p><p>Founded in 2018, <a href='https://isoponline.org/special-interest-groups/medical-devices-group/'>ISoP’s Medical Device Safety Special Interest Group</a> works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.  </p><p>In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. </p><p><b>Tune in to find out:</b></p><ul><li>What defines a medical device and how prevalent they are in our society</li><li>Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short</li><li>How global initiatives aim to strengthen safety monitoring standards</li></ul><p><b>Want to know more?</b></p><p>Listen to the second part of the interview <a href='https://www.drugsafetymatterspod.org/618871/episodes/18751261-44-rethinking-medical-device-safety-part-2-omar-aimer'>here</a>.<b> </b></p><p>If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a <a href='https://link.springer.com/article/10.1007/s40264-025-01599-6'>paper on the topic</a> in the journal Drug Safety, as well as an <a href='https://uppsalareports.org/articles/rethinking-medical-device-safety-in-a-drug-centric-world/'>article for Uppsala Reports</a>.</p><p>Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their <a href='https://www.nature.com/articles/s41746-025-01717-9'>Nature paper</a>.</p><p>Founded in 2018, <a href='https://isoponline.org/special-interest-groups/medical-devices-group/'>ISoP’s Medical Device Safety Special Interest Group</a> works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 28 Jan 2026 08:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; introduction" />
  <psc:chapter start="1:56" title="Hello, Omar!" />
  <psc:chapter start="2:16" title="Defining medical devices and key examples" />
  <psc:chapter start="4:46" title="The status of medical device safety monitoring" />
  <psc:chapter start="5:55" title="Post‑market surveillance landscape for medical devices" />
  <psc:chapter start="7:17" title="What makes medical device safety monitoring different to medicines and vaccines" />
  <psc:chapter start="10:44" title="Barriers to effective medical device vigilance" />
  <psc:chapter start="12:28" title="AI, software, and performance drift" />
  <psc:chapter start="16:14" title="Drug device combination products pose dual safety challenges" />
  <psc:chapter start="19:08" title="How the IMDRF and single audit program improves medical device global safety standards" />
  <psc:chapter start="21:27" title=" Closing, resources &amp; credits" />
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    <itunes:duration>1364</itunes:duration>
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    <itunes:title>#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal</itunes:title>
    <title>#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal</title>
    <itunes:summary><![CDATA[Send a message to the show! This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of W...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy. </p><p>In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.</p><p><b>Want to know more?</b></p><ul><li>Read WHO’s “<a href='https://www.who.int/publications/i/item/9789240116757'>Global smart pharmacovigilance strategy</a>” (Geneva: World Health Organization; 2025). </li><li>Explore WHO’s work on pharmacovigilance through the <a href='https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance'>Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team</a>.</li><li>Learn more about regulatory systems strengthening and the <a href='https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss'>WHO Global Benchmarking Tool (GBT)</a> for medicines and vaccines.</li><li>Discover the WHO network for regulatory systems strengthening – the <a href='https://www.who.int/initiatives/coalition-of-interested-parties'>Coalition of Interested Parties (CIP)</a>, of which UMC is a member.</li><li>Visit the <a href='https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/'>UMC website</a> to find out more about the WHO PIDM and UMC’s role in it.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy. </p><p>In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.</p><p><b>Want to know more?</b></p><ul><li>Read WHO’s “<a href='https://www.who.int/publications/i/item/9789240116757'>Global smart pharmacovigilance strategy</a>” (Geneva: World Health Organization; 2025). </li><li>Explore WHO’s work on pharmacovigilance through the <a href='https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance'>Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team</a>.</li><li>Learn more about regulatory systems strengthening and the <a href='https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss'>WHO Global Benchmarking Tool (GBT)</a> for medicines and vaccines.</li><li>Discover the WHO network for regulatory systems strengthening – the <a href='https://www.who.int/initiatives/coalition-of-interested-parties'>Coalition of Interested Parties (CIP)</a>, of which UMC is a member.</li><li>Visit the <a href='https://who-umc.org/about-the-who-programme-for-international-drug-monitoring/'>UMC website</a> to find out more about the WHO PIDM and UMC’s role in it.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 16 Dec 2025 07:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:44" title="What&#39;s the thinking behind the strategy?" />
  <psc:chapter start="4:26" title="The four pillars of the strategy" />
  <psc:chapter start="4:37" title="The first pillar: Leaning on learnings and existent infrastructure" />
  <psc:chapter start="5:01" title="The second pillar: Risk-based prioritisations" />
  <psc:chapter start="5:40" title="The third pillar: Reliance and work-sharing" />
  <psc:chapter start="8:49" title="The fourth pillar: Being part of a regulatory system-strengthening" />
  <psc:chapter start="10:09" title="Putting the strategy into practice" />
  <psc:chapter start="12:25" title="Measuring the success of the strategy" />
  <psc:chapter start="13:58" title="UMC’s role" />
  <psc:chapter start="17:30" title="Outro, resources and links" />
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    <itunes:title>#41 How to use artificial intelligence in pharmacovigilance, part 2 – Niklas Norén</itunes:title>
    <title>#41 How to use artificial intelligence in pharmacovigilance, part 2 – Niklas Norén</title>
    <itunes:summary><![CDATA[Send a message to the show! Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits? In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?</p><p>In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.</p><p><b>Tune in to find out:</b></p><ul><li>How to keep up with rapid developments in AI technology</li><li>Why model and performance transparency both matter</li><li>How to protect sensitive patient data when using AI</li></ul><p><b>Want to know more?</b></p><p>Listen to the first part of the interview <a href='https://www.buzzsprout.com/618871/episodes/18022607'>here</a>.</p><p>The <a href='https://cioms.ch/working_groups/working-group-xiv-artificial-intelligence-in-pharmacovigilance/'>CIOMS Working Group XIV</a> published its <a href='https://cioms.ch/artificial-intelligence-inpv/'>recommendations for the use of AI in pharmacovigilance</a> in December 2025.</p><p>Earlier this year, the World Health Organization issued <a href='https://www.who.int/publications/i/item/9789240084759'>guidance on large multi-modal models</a> – a type of generative AI – when used in healthcare.</p><p>Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in <a href='https://univr.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=6f0bb70e-856b-46b7-b57b-b15700a28106'>this presentation at the University of Verona</a> and in <a href='https://uppsalareports.org/articles/artificial-intelligence-in-pharmacovigilance-harnessing-potential-navigating-risks/'>this Uppsala Reports article</a>.</p><p>Other recent UMC publications cited in the interview or relevant to the topic include:</p><ul><li>a pre-print on the <a href='https://arxiv.org/abs/2504.03729'>revised vigiMatch algorithm</a> for duplicate detection</li><li>an article on the <a href='https://link.springer.com/article/10.1007/s40264-025-01604-y'>pitfalls of disproportionality analysis</a></li><li>a pre-print on <a href='https://arxiv.org/abs/2510.04341'>critically appraising AI applications</a> for rare-event recognition</li></ul><p>For more on the ‘black box’ issue and maintaining trust in AI, revisit <a href='https://www.drugsafetymatterspod.org/618871/episodes/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>this interview with GSK’s Michael Glaser</a> from the Drug Safety Matters archive.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?</p><p>In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.</p><p><b>Tune in to find out:</b></p><ul><li>How to keep up with rapid developments in AI technology</li><li>Why model and performance transparency both matter</li><li>How to protect sensitive patient data when using AI</li></ul><p><b>Want to know more?</b></p><p>Listen to the first part of the interview <a href='https://www.buzzsprout.com/618871/episodes/18022607'>here</a>.</p><p>The <a href='https://cioms.ch/working_groups/working-group-xiv-artificial-intelligence-in-pharmacovigilance/'>CIOMS Working Group XIV</a> published its <a href='https://cioms.ch/artificial-intelligence-inpv/'>recommendations for the use of AI in pharmacovigilance</a> in December 2025.</p><p>Earlier this year, the World Health Organization issued <a href='https://www.who.int/publications/i/item/9789240084759'>guidance on large multi-modal models</a> – a type of generative AI – when used in healthcare.</p><p>Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in <a href='https://univr.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=6f0bb70e-856b-46b7-b57b-b15700a28106'>this presentation at the University of Verona</a> and in <a href='https://uppsalareports.org/articles/artificial-intelligence-in-pharmacovigilance-harnessing-potential-navigating-risks/'>this Uppsala Reports article</a>.</p><p>Other recent UMC publications cited in the interview or relevant to the topic include:</p><ul><li>a pre-print on the <a href='https://arxiv.org/abs/2504.03729'>revised vigiMatch algorithm</a> for duplicate detection</li><li>an article on the <a href='https://link.springer.com/article/10.1007/s40264-025-01604-y'>pitfalls of disproportionality analysis</a></li><li>a pre-print on <a href='https://arxiv.org/abs/2510.04341'>critically appraising AI applications</a> for rare-event recognition</li></ul><p>For more on the ‘black box’ issue and maintaining trust in AI, revisit <a href='https://www.drugsafetymatterspod.org/618871/episodes/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>this interview with GSK’s Michael Glaser</a> from the Drug Safety Matters archive.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 21 Nov 2025 13:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; introduction" />
  <psc:chapter start="2:22" title="The &#39;black box&#39; issue and transparency" />
  <psc:chapter start="7:57" title="Managing fast-changing models" />
  <psc:chapter start="11:16" title="Future-proofing guideline principles" />
  <psc:chapter start="13:39" title="Data privacy and prompt risks" />
  <psc:chapter start="16:13" title="Bias in safety data: risks and opportunities" />
  <psc:chapter start="18:21" title="Avoiding hype and fear" />
  <psc:chapter start="20:57" title="Hallucinations and persuasive outputs" />
  <psc:chapter start="22:51" title="Evolving roles and new skills" />
  <psc:chapter start="26:04" title="What’s next for CIOMS guidelines" />
  <psc:chapter start="28:19" title="Closing, resources &amp; credits" />
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    <itunes:duration>1788</itunes:duration>
    <itunes:keywords>AI, artificial intelligence, CIOMS, GenAI, generative AI, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén</itunes:title>
    <title>#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén</title>
    <itunes:summary><![CDATA[Send a message to the show! Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits? In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharma...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?</p><p>In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.</p><p><b>Tune in to find out:</b></p><ul><li>Why pharmacovigilance needs specific AI guidelines</li><li>How a risk-based approach to AI regulation works</li><li>Where in the PV cycle is human oversight most needed</li></ul><p><b>Want to know more?</b></p><p>Listen to the second part of the interview <a href='https://www.buzzsprout.com/618871/episodes/18217823'>here</a>.</p><p>The <a href='https://cioms.ch/working_groups/working-group-xiv-artificial-intelligence-in-pharmacovigilance/'>CIOMS Working Group XIV</a> published its <a href='https://cioms.ch/artificial-intelligence-inpv/'>recommendations for the use of AI in pharmacovigilance</a> in December 2025.</p><p>Earlier this year, the World Health Organization issued <a href='https://www.who.int/publications/i/item/9789240084759'>guidance on large multi-modal models</a> – a type of generative AI – when used in healthcare.</p><p>Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in <a href='https://univr.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=6f0bb70e-856b-46b7-b57b-b15700a28106'>this presentation at the University of Verona</a> and in <a href='https://uppsalareports.org/articles/artificial-intelligence-in-pharmacovigilance-harnessing-potential-navigating-risks/'>this Uppsala Reports article</a>. His favourite definition of AI remains the one proposed by <a href='https://link.springer.com/article/10.1007/s40264-022-01156-5'>Jeffrey Aronson in Drug Safety</a>.</p><p>For more on maintaining trust in AI, revisit <a href='https://www.drugsafetymatterspod.org/618871/episodes/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>this interview with GSK’s Michael Glaser</a> from the Drug Safety Matters archive.</p><p>The AI methods developed by UMC and cited in the interview include: </p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/episodes/15414766-uppsala-reports-long-reads-weeding-out-duplicates-to-better-detect-side-effects'>vigiMatch</a> for duplicate detection</li><li><a href='https://www.drugsafetymatterspod.org/618871/episodes/9731548-12-improving-signal-detection-with-vigigroup-jim-barrett-joe-mitchell'>vigiGroup</a> for clustering</li><li><a href='https://view.publitas.com/uppsala-monitoring-centre/uppsala-reports-78/page/22'>vigiRank</a> for signal detection</li><li><a href='https://link.springer.com/article/10.1007/s40264-013-0131-x'>vigiGrade</a> for case report completeness scoring</li><li><a href='https://who-umc.org/whodrug/whodrug-koda/'>WHODrug Koda</a> for automated coding</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?</p><p>In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.</p><p><b>Tune in to find out:</b></p><ul><li>Why pharmacovigilance needs specific AI guidelines</li><li>How a risk-based approach to AI regulation works</li><li>Where in the PV cycle is human oversight most needed</li></ul><p><b>Want to know more?</b></p><p>Listen to the second part of the interview <a href='https://www.buzzsprout.com/618871/episodes/18217823'>here</a>.</p><p>The <a href='https://cioms.ch/working_groups/working-group-xiv-artificial-intelligence-in-pharmacovigilance/'>CIOMS Working Group XIV</a> published its <a href='https://cioms.ch/artificial-intelligence-inpv/'>recommendations for the use of AI in pharmacovigilance</a> in December 2025.</p><p>Earlier this year, the World Health Organization issued <a href='https://www.who.int/publications/i/item/9789240084759'>guidance on large multi-modal models</a> – a type of generative AI – when used in healthcare.</p><p>Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in <a href='https://univr.cloud.panopto.eu/Panopto/Pages/Viewer.aspx?id=6f0bb70e-856b-46b7-b57b-b15700a28106'>this presentation at the University of Verona</a> and in <a href='https://uppsalareports.org/articles/artificial-intelligence-in-pharmacovigilance-harnessing-potential-navigating-risks/'>this Uppsala Reports article</a>. His favourite definition of AI remains the one proposed by <a href='https://link.springer.com/article/10.1007/s40264-022-01156-5'>Jeffrey Aronson in Drug Safety</a>.</p><p>For more on maintaining trust in AI, revisit <a href='https://www.drugsafetymatterspod.org/618871/episodes/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>this interview with GSK’s Michael Glaser</a> from the Drug Safety Matters archive.</p><p>The AI methods developed by UMC and cited in the interview include: </p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/episodes/15414766-uppsala-reports-long-reads-weeding-out-duplicates-to-better-detect-side-effects'>vigiMatch</a> for duplicate detection</li><li><a href='https://www.drugsafetymatterspod.org/618871/episodes/9731548-12-improving-signal-detection-with-vigigroup-jim-barrett-joe-mitchell'>vigiGroup</a> for clustering</li><li><a href='https://view.publitas.com/uppsala-monitoring-centre/uppsala-reports-78/page/22'>vigiRank</a> for signal detection</li><li><a href='https://link.springer.com/article/10.1007/s40264-013-0131-x'>vigiGrade</a> for case report completeness scoring</li><li><a href='https://who-umc.org/whodrug/whodrug-koda/'>WHODrug Koda</a> for automated coding</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 17 Oct 2025 16:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="Welcome &amp; introduction" />
  <psc:chapter start="2:15" title="Hello, Niklas!" />
  <psc:chapter start="2:36" title="What counts as AI in pharmacovigilance?" />
  <psc:chapter start="6:19" title="What&#39;s so special about generative AI" />
  <psc:chapter start="8:09" title="Why pharmacovigilance needs AI guidelines" />
  <psc:chapter start="11:15" title="Risk-based approach explained" />
  <psc:chapter start="11:49" title="Examples of low- and high-risk situations" />
  <psc:chapter start="14:32" title="Human in the loop versus on the loop" />
  <psc:chapter start="17:02" title="Where AI works in PV today" />
  <psc:chapter start="20:08" title="Listener question: Monitoring signals with AI" />
  <psc:chapter start="21:50" title="What AI might do next" />
  <psc:chapter start="24:01" title="What AI shouldn’t decide" />
  <psc:chapter start="25:27" title="Will AI reshape the PV cycle?" />
  <psc:chapter start="28:11" title="Closing, resources &amp; credits" />
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    <itunes:duration>1780</itunes:duration>
    <itunes:keywords>AI, artificial intelligence, CIOMS, GenAI, generative AI, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#39 Putting children first on Patient Safety Day – Angela Caro-Rojas</itunes:title>
    <title>#39 Putting children first on Patient Safety Day – Angela Caro-Rojas</title>
    <itunes:summary><![CDATA[Send a message to the show! Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas. Tune in to find out: Why we need a Patient Safety DayHow to prevent common medication errors in childrenHow to build child-friendly healthcare environmentsWant to k...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.</p><p><b>Tune in to find out:</b></p><ul><li>Why we need a Patient Safety Day</li><li>How to prevent common medication errors in children</li><li>How to build child-friendly healthcare environments</li></ul><p><b>Want to know more?</b></p><p>Visit the World Health Organization’s <a href='https://www.who.int/campaigns/world-patient-safety-day'>campaign website</a> to learn more about World Patient Safety Day and download campaign materials.</p><p>You can also show support for the campaign by joining <a href='https://isoponline.org/training/patient-safety-day/'>ISoP&apos;s free virtual event</a> on September 18 and 19, or visit <a href='https://www.youtube.com/channel/UCo-jtROXZbiDk_1GLxzThzQ/videos'>ISoP&apos;s YouTube channel</a> to access recordings from previous Patient Safety Day events.</p><p>For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.buzzsprout.com/admin/618871/episodes/9313838-uppsala-reports-long-reads-the-kids-list'>The KIDs List</a></li><li><a href='https://www.buzzsprout.com/admin/618871/episodes/14166982-26-what-s-trending-in-pharmacovigilance-angela-caro'>What’s trending in pharmacovigilance?</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.</p><p><b>Tune in to find out:</b></p><ul><li>Why we need a Patient Safety Day</li><li>How to prevent common medication errors in children</li><li>How to build child-friendly healthcare environments</li></ul><p><b>Want to know more?</b></p><p>Visit the World Health Organization’s <a href='https://www.who.int/campaigns/world-patient-safety-day'>campaign website</a> to learn more about World Patient Safety Day and download campaign materials.</p><p>You can also show support for the campaign by joining <a href='https://isoponline.org/training/patient-safety-day/'>ISoP&apos;s free virtual event</a> on September 18 and 19, or visit <a href='https://www.youtube.com/channel/UCo-jtROXZbiDk_1GLxzThzQ/videos'>ISoP&apos;s YouTube channel</a> to access recordings from previous Patient Safety Day events.</p><p>For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.buzzsprout.com/admin/618871/episodes/9313838-uppsala-reports-long-reads-the-kids-list'>The KIDs List</a></li><li><a href='https://www.buzzsprout.com/admin/618871/episodes/14166982-26-what-s-trending-in-pharmacovigilance-angela-caro'>What’s trending in pharmacovigilance?</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 29 Aug 2025 16:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="Welcome and introduction" />
  <psc:chapter start="2:20" title="Hello, Angela!" />
  <psc:chapter start="3:14" title="Why we need Patient Safety Day" />
  <psc:chapter start="3:55" title="Safe care for every newborn and every child" />
  <psc:chapter start="5:04" title="Challenges in paediatric pharmacovigilance" />
  <psc:chapter start="7:20" title="Common medication errors in children" />
  <psc:chapter start="10:28" title="Preventing medication harm in children" />
  <psc:chapter start="13:27" title="Prioritising safety in resource-limited settings" />
  <psc:chapter start="16:11" title="Ensuring children&#39;s voices are heard" />
  <psc:chapter start="20:44" title="ISoP&#39;s Patient Safety Day event" />
  <psc:chapter start="22:35" title="How to participate in the campaign" />
  <psc:chapter start="24:06" title="Final remarks and goodbye" />
  <psc:chapter start="24:58" title="Outro" />
</psc:chapters>
    <itunes:duration>1576</itunes:duration>
    <itunes:keywords>drug safety, ISoP, medicine, medicines safety, paediatrics, patient safety, Patient Safety Day, pediatrics, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium</itunes:title>
    <title>#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium</title>
    <itunes:summary><![CDATA[Send a message to the show! This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro-Rojas (president of ISoP), Linda Härmark (director of the Drug Safety Research Unit in the UK), Ghita Benabdallah (national pharmacov...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was <em>Improving information capture for safer use of medicines</em>. The episode is an abridged recording of the concluding fireside chat, where <b>Angela Caro-Rojas</b> (president of ISoP), <b>Linda Härmark </b>(director of the Drug Safety Research Unit in the UK), <b>Ghita Benabdallah</b> (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and <b>Daniele Sartori</b> (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance.</p><p>The symposium was a collaboration between ISoP and UMC.</p><p> </p><p><b>Want to know more?</b></p><ul><li>Visit the official website of the <a href='https://isoponline.org/training/symposium/uppsala/'>2025 ISoP Mid-Year Symposium</a> to learn more about its sessions, speakers and chairs. </li><li><a href='https://www.riggare.se/'>Not patient but im-patient</a> – read about Sara Riggare’s research on patient engagement and other topics.</li><li>Listen to <a href='https://www.drugsafetymatterspod.org/618871/episodes/17239148-37-beyond-numbers-quality-in-adr-reporting-henry-zakumumpa'>Henry Zakumumpa</a> talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.</li><li>Read about the PhD project of Tommy Emil Dzus, <a href='https://www.oslomet.no/en/about/employee/todzu9985/'>Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies</a>, at Oslo Metropolitan University, Norway.</li><li><a href='https://ki.se/en/people/sabine-koch#about-me'>Sabine Koch</a> is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.</li><li>Details on Mikael Hoffman&apos;s research can be found on his profile page on <a href='https://www.researchgate.net/profile/Mikael-Hoffmann'>ResearchGate</a>.</li><li>Take a look at what’s in store for participants at the <a href='https://isop2025cairo.org/'>24th Annual Meeting of ISoP in Cairo</a>, on October 24–27, 2025.</li><li>Visit the websites of the <a href='https://www.dsru.org/'>Drug Safety Research Unit (DSRU)</a>, <a href='https://isoponline.org/'>ISoP</a>, <a href='https://www.capm-sante.ma/'>Centre Anti Poison et Pharmacovigilance du Maroc</a>, and <a href='https://who-umc.org/'>Uppsala Monitoring Centre</a>, to find out more about their work.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was <em>Improving information capture for safer use of medicines</em>. The episode is an abridged recording of the concluding fireside chat, where <b>Angela Caro-Rojas</b> (president of ISoP), <b>Linda Härmark </b>(director of the Drug Safety Research Unit in the UK), <b>Ghita Benabdallah</b> (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and <b>Daniele Sartori</b> (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance.</p><p>The symposium was a collaboration between ISoP and UMC.</p><p> </p><p><b>Want to know more?</b></p><ul><li>Visit the official website of the <a href='https://isoponline.org/training/symposium/uppsala/'>2025 ISoP Mid-Year Symposium</a> to learn more about its sessions, speakers and chairs. </li><li><a href='https://www.riggare.se/'>Not patient but im-patient</a> – read about Sara Riggare’s research on patient engagement and other topics.</li><li>Listen to <a href='https://www.drugsafetymatterspod.org/618871/episodes/17239148-37-beyond-numbers-quality-in-adr-reporting-henry-zakumumpa'>Henry Zakumumpa</a> talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.</li><li>Read about the PhD project of Tommy Emil Dzus, <a href='https://www.oslomet.no/en/about/employee/todzu9985/'>Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies</a>, at Oslo Metropolitan University, Norway.</li><li><a href='https://ki.se/en/people/sabine-koch#about-me'>Sabine Koch</a> is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.</li><li>Details on Mikael Hoffman&apos;s research can be found on his profile page on <a href='https://www.researchgate.net/profile/Mikael-Hoffmann'>ResearchGate</a>.</li><li>Take a look at what’s in store for participants at the <a href='https://isop2025cairo.org/'>24th Annual Meeting of ISoP in Cairo</a>, on October 24–27, 2025.</li><li>Visit the websites of the <a href='https://www.dsru.org/'>Drug Safety Research Unit (DSRU)</a>, <a href='https://isoponline.org/'>ISoP</a>, <a href='https://www.capm-sante.ma/'>Centre Anti Poison et Pharmacovigilance du Maroc</a>, and <a href='https://who-umc.org/'>Uppsala Monitoring Centre</a>, to find out more about their work.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 19 Jun 2025 11:00:00 +0200</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="Introduction to the ISOP Symposium" />
  <psc:chapter start="2:26" title="Personal takeaways from the two-day conference" />
  <psc:chapter start="7:44" title="Patient Perspective in Pharmacovigilance" />
  <psc:chapter start="18:44" title="Different kinds of patient engagement in pharmacovigilance" />
  <psc:chapter start="23:30" title="Patient reporting of adverse events" />
  <psc:chapter start="28:15" title="A look into the future of pharmacovigilance" />
  <psc:chapter start="34:30" title="Final Thoughts and Closing" />
</psc:chapters>
    <itunes:duration>2123</itunes:duration>
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    <itunes:title>#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa</itunes:title>
    <title>#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa</title>
    <itunes:summary><![CDATA[Send a message to the show! Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsAp...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsApp and the Med Safety smartphone app. Henry Zakumumpa is a researcher at Makerere University in Kampala, Uganda. He has recently performed a qualitative study to learn more about drivers and obstacles for quality in adverse event reporting from patients and healthcare professionals in Uganda. He joins the Drug Safety Matters studio to help us get a more nuanced picture of challenges and opportunities around the issue.<br/> <br/> </p><p><b>Tune in to find out:</b></p><ul><li>Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers?</li><li>What are the challenges with reporting via WhatsApp?</li><li>How can regulators and PV centres foster better quality in incoming adverse event reports?</li></ul><p> </p><p><b>Want to know more?</b></p><ul><li>Listen to Henry talk about <a href='https://www.drugsafetymatterspod.org/618871/episodes/10526666-15-safety-of-hiv-medications-henry-zakumumpa'>the safety of HIV medications</a> in this 2022 episode of Drug Safety Matters.</li><li>Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about <a href='https://carta-evidence.org/author/1000167592/'>Henry’s research</a>.</li><li><a href='https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15791'>Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews</a> (British Journal of Clinical Pharmacology, 2023)</li><li><a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC11520514/'>Improving adverse drug event reporting by healthcare professionals</a> (Cochrane Database Systematic Review, 2024)</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsApp and the Med Safety smartphone app. Henry Zakumumpa is a researcher at Makerere University in Kampala, Uganda. He has recently performed a qualitative study to learn more about drivers and obstacles for quality in adverse event reporting from patients and healthcare professionals in Uganda. He joins the Drug Safety Matters studio to help us get a more nuanced picture of challenges and opportunities around the issue.<br/> <br/> </p><p><b>Tune in to find out:</b></p><ul><li>Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers?</li><li>What are the challenges with reporting via WhatsApp?</li><li>How can regulators and PV centres foster better quality in incoming adverse event reports?</li></ul><p> </p><p><b>Want to know more?</b></p><ul><li>Listen to Henry talk about <a href='https://www.drugsafetymatterspod.org/618871/episodes/10526666-15-safety-of-hiv-medications-henry-zakumumpa'>the safety of HIV medications</a> in this 2022 episode of Drug Safety Matters.</li><li>Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about <a href='https://carta-evidence.org/author/1000167592/'>Henry’s research</a>.</li><li><a href='https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15791'>Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews</a> (British Journal of Clinical Pharmacology, 2023)</li><li><a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC11520514/'>Improving adverse drug event reporting by healthcare professionals</a> (Cochrane Database Systematic Review, 2024)</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 28 May 2025 18:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="Welcome and introduction" />
  <psc:chapter start="2:52" title="What drives you, as a researcher?" />
  <psc:chapter start="3:30" title="What got you into pharmacovigilance?" />
  <psc:chapter start="5:33" title="The quality challenge" />
  <psc:chapter start="7:20" title="A qualitative study on ADR reporting quality" />
  <psc:chapter start="8:58" title="The patient side of the quality issue" />
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  <psc:chapter start="21:43" title="WhatsApp reporting – how does it work?" />
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  <psc:chapter start="27:46" title="What can be done to foster quality (and quantity) of ADR reporting" />
  <psc:chapter start="30:19" title="Challenges after disrupted funding" />
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  <psc:chapter start="36:25" title="A dream project?" />
  <psc:chapter start="38:21" title="Outro" />
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    <itunes:title>#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg &amp; Sara Vidlin</itunes:title>
    <title>#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg &amp; Sara Vidlin</title>
    <itunes:summary><![CDATA[Send a message to the show! There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions. The Research section at Uppsala Monitoring Centre has a tea...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.</p><p>The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges. </p><p><b>Tune in to find out</b></p><ul><li>Why is the world still behind when it comes to pregnancy-related PV?</li><li>What are the challenges faced by PV assessors wanting to look at pregnancy cases?</li><li>How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?</li><li>How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?</li></ul><p><b>How to use the VigiBase pregnancy algorithm</b></p><ul><li>Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. </li><li>In the qualitative view in VigiLyze, click on “Filter” -&gt; “Patient” -&gt; “Pregnancy” to apply the filter.</li></ul><p><b>Want to know more?</b></p><ul><li>Read about the VigiBase pregnancy algorithm <a href='https://uppsalareports.org/articles/uncovering-pregnancy-cases-in-vigibase/'>in this Uppsala Reports article</a> and in <a href='https://link.springer.com/article/10.1007/s40264-025-01559-0'>this scientific paper, published in Drug Safety</a> in 2025. </li><li>EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. <a href='https://eurapinternational.org/'>EURAP - International Registry of Antiepileptic Drugs and Pregnancy</a></li><li>The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - <a href='https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files'>E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files</a></li><li>The IMI-<a href='https://www.imi-conception.eu/'>concePTION</a> project</li><li>Medical Dictionary for Regulatory Activities (MedDRA) <a href='https://www.meddra.org/how-to-use/support-documentation/english'>support documentation</a></li><li>Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. I<a href='https://doi.org/10.1007/s40264-024-01448-y'>dentification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance.</a> Drug Safety. 2024</li><li>Sakai T, Mori C, Koshiba H, et al. <a href='https://doi.org/10.1007/s40801-021-00287-y'>Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases.</a> Drugs Real World Outcomes. 2022</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.</p><p>The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges. </p><p><b>Tune in to find out</b></p><ul><li>Why is the world still behind when it comes to pregnancy-related PV?</li><li>What are the challenges faced by PV assessors wanting to look at pregnancy cases?</li><li>How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?</li><li>How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?</li></ul><p><b>How to use the VigiBase pregnancy algorithm</b></p><ul><li>Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. </li><li>In the qualitative view in VigiLyze, click on “Filter” -&gt; “Patient” -&gt; “Pregnancy” to apply the filter.</li></ul><p><b>Want to know more?</b></p><ul><li>Read about the VigiBase pregnancy algorithm <a href='https://uppsalareports.org/articles/uncovering-pregnancy-cases-in-vigibase/'>in this Uppsala Reports article</a> and in <a href='https://link.springer.com/article/10.1007/s40264-025-01559-0'>this scientific paper, published in Drug Safety</a> in 2025. </li><li>EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. <a href='https://eurapinternational.org/'>EURAP - International Registry of Antiepileptic Drugs and Pregnancy</a></li><li>The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - <a href='https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files'>E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files</a></li><li>The IMI-<a href='https://www.imi-conception.eu/'>concePTION</a> project</li><li>Medical Dictionary for Regulatory Activities (MedDRA) <a href='https://www.meddra.org/how-to-use/support-documentation/english'>support documentation</a></li><li>Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. I<a href='https://doi.org/10.1007/s40264-024-01448-y'>dentification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance.</a> Drug Safety. 2024</li><li>Sakai T, Mori C, Koshiba H, et al. <a href='https://doi.org/10.1007/s40801-021-00287-y'>Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases.</a> Drugs Real World Outcomes. 2022</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 27 Mar 2025 10:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg &amp; Sara Vidlin" />
  <psc:chapter start="0:50" title="Intro/Welcome" />
  <psc:chapter start="2:33" title="Pregnancy-related pharmacovigilance – a definition" />
  <psc:chapter start="3:22" title="The thalidomide tragedy" />
  <psc:chapter start="5:05" title="Pregnant persons – a special patient group" />
  <psc:chapter start="11:33" title="Challenges in assessing pregnancy cases (1)" />
  <psc:chapter start="16:12" title="The VigiBase pregnancy algorithm" />
  <psc:chapter start="23:21" title="Challenges in assessing pregnancy cases (2)" />
  <psc:chapter start="24:33" title="Other pregnancy algorithms" />
  <psc:chapter start="26:40" title="Tips on how to report pregnancy cases" />
  <psc:chapter start="32:55" title="Other data sources for pregnancy-related pharmacovigilance" />
  <psc:chapter start="33:36" title="What&#39;s next?" />
  <psc:chapter start="36:19" title="Outro/Goodbye" />
</psc:chapters>
    <itunes:duration>2243</itunes:duration>
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    <itunes:title>#35 Veterinary pharmacovigilance, part 2 – James Mount</itunes:title>
    <title>#35 Veterinary pharmacovigilance, part 2 – James Mount</title>
    <itunes:summary><![CDATA[Send a message to the show! Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. </p><p><b>Tune in to find out</b></p><ul><li>How the types of ADRs reported for animals and humans differ</li><li>How the many species and breeds included in veterinary PV affect the ADR coding </li><li>What the Veterinary Big Data Strategy is</li></ul><p><b>... and much more!</b></p><p><b>Want to know more?</b></p><ul><li>The public portal of the <a href='https://www.adrreports.eu/vet/en/index.html'>European Union Veterinary Pharmacovigilance Database</a>.</li><li><a href='https://www.who.int/health-topics/one-health#tab=tab_1'>One Health</a> – an integrated approach to the well-being of people, animals and the environment.</li><li>A <a href='https://doi.org/10.1002/vro2.18'>survey of veterinary professionals in Sweden</a>, about practices and attitudes in relation to ADR reporting.</li><li>A <a href='https://doi.org/10.1002/vro2.48'>review of adverse events in animals and children</a> after secondary exposure to transdermal hormone-containing medicines. </li><li>The EMA <a href='https://www.ema.europa.eu/en/news/big-data-strategy-veterinary-medicines-eu'>Big Data strategy for veterinary medicines</a> and <a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-quality-framework-medicines-regulation'>Data quality framework for medicines regulation</a></li><li><a href='https://www.liverpool.ac.uk/savsnet/'>Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool</a></li><li><a href='https://www.rvc.ac.uk/vetcompass'>VetCompass - Royal Veterinary College, RVC</a></li><li><a href='https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/veterinary-good-pharmacovigilance-practices-vgvp#vgvp-modules-10210'>Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)</a></li><li><a href='https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/eudravigilance-veterinary#veterinary-dictionary-for-drug-regulatory-activities-veddra-11398'>Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA)</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. </p><p><b>Tune in to find out</b></p><ul><li>How the types of ADRs reported for animals and humans differ</li><li>How the many species and breeds included in veterinary PV affect the ADR coding </li><li>What the Veterinary Big Data Strategy is</li></ul><p><b>... and much more!</b></p><p><b>Want to know more?</b></p><ul><li>The public portal of the <a href='https://www.adrreports.eu/vet/en/index.html'>European Union Veterinary Pharmacovigilance Database</a>.</li><li><a href='https://www.who.int/health-topics/one-health#tab=tab_1'>One Health</a> – an integrated approach to the well-being of people, animals and the environment.</li><li>A <a href='https://doi.org/10.1002/vro2.18'>survey of veterinary professionals in Sweden</a>, about practices and attitudes in relation to ADR reporting.</li><li>A <a href='https://doi.org/10.1002/vro2.48'>review of adverse events in animals and children</a> after secondary exposure to transdermal hormone-containing medicines. </li><li>The EMA <a href='https://www.ema.europa.eu/en/news/big-data-strategy-veterinary-medicines-eu'>Big Data strategy for veterinary medicines</a> and <a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-quality-framework-medicines-regulation'>Data quality framework for medicines regulation</a></li><li><a href='https://www.liverpool.ac.uk/savsnet/'>Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool</a></li><li><a href='https://www.rvc.ac.uk/vetcompass'>VetCompass - Royal Veterinary College, RVC</a></li><li><a href='https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/veterinary-good-pharmacovigilance-practices-vgvp#vgvp-modules-10210'>Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)</a></li><li><a href='https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/eudravigilance-veterinary#veterinary-dictionary-for-drug-regulatory-activities-veddra-11398'>Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA)</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 28 Jan 2025 12:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="#35 Veterinary pharmacovigilance, part 2 – James Mount" />
  <psc:chapter start="0:53" title="Intro" />
  <psc:chapter start="1:39" title="Welcome" />
  <psc:chapter start="1:57" title="Types of ADRs reported in veterinary vs human PV" />
  <psc:chapter start="3:20" title="User safety – when humans are accidentally exposed to veterinary medicines" />
  <psc:chapter start="7:12" title="When animals are accidentally exposed to human medicines" />
  <psc:chapter start="9:25" title="Gentamicin – an illustrative example of the overlap between human and veterinary PV" />
  <psc:chapter start="10:42" title="Differences in ADR reporting between the veterinary and human side" />
  <psc:chapter start="14:06" title="Environmental aspects in veterinary PV" />
  <psc:chapter start="16:57" title="Vet PV&#39;s diversity in stakeholders, target groups and patients (species, breeds)" />
  <psc:chapter start="19:43" title="Listener question: differences in susceptibility to certain ADRs between different breeds (and species)" />
  <psc:chapter start="24:31" title="Technological solutions for discovering ADRs in animals?" />
  <psc:chapter start="27:23" title="Signal detection in veterinary PV practice" />
  <psc:chapter start="30:33" title="The EU Veterinary Big Data Strategy" />
  <psc:chapter start="36:23" title="AI in PV in the near future" />
  <psc:chapter start="40:54" title="Outro" />
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    <itunes:title>#34 Veterinary pharmacovigilance, part 1 – James Mount </itunes:title>
    <title>#34 Veterinary pharmacovigilance, part 1 – James Mount </title>
    <itunes:summary><![CDATA[Send a message to the show! Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. <br/> </p><p><b>Tune in to find out:</b></p><ul><li>What are the similarities and differences between veterinary and human pharmacovigilance?</li><li>How is animal health connected to public health? </li><li>What types of adverse events are reported on the veterinary side compared with the human side? </li><li>What can be found in the EU veterinary pharmacovigilance database? </li></ul><p> </p><p><b>Want to know more?</b></p><ul><li>The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found <a href='https://eur-lex.europa.eu/eli/reg/2019/6/oj'>here</a>. </li><li>The public portal of the <a href='https://www.adrreports.eu/vet/en/index.html'>European Union Veterinary Pharmacovigilance Database</a>.</li><li>WHO&apos;s information page on <a href='https://www.who.int/health-topics/one-health#tab=tab_1'>One Health</a>, an integrated approach to the well-being of people, animals and the environment.</li><li>A <a href='https://doi.org/10.1002/vro2.18'>survey of veterinary professionals in Sweden</a>, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.</li><li>A <a href='https://doi.org/10.1002/vro2.48'>review of adverse events in animals and children</a> after secondary exposure to transdermal hormone-containing medicinal products. </li><li>A study looking at suspected adverse drug reaction reporting in <a href='https://doi.org/10.1111/jsap.13721'>veterinary free‐text clinical narratives</a>.</li><li>The EMA <a href='https://www.ema.europa.eu/en/news/big-data-strategy-veterinary-medicines-eu'>Big Data strategy for veterinary medicines</a> in the EU. </li><li><a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-quality-framework-medicines-regulation'>Data quality framework for medicines regulation | European Medicines Agency (EMA)</a></li><li><a href='https://www.liverpool.ac.uk/savsnet/'>Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool</a></li><li><a href='https://www.rvc.ac.uk/vetcompass'>VetCompass - Royal Veterinary College, RVC</a></li><li><a href='https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines'>Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)</a></li><li>The Swedish Medical Products Agency&apos;s <a href='https://www.lakemedelsverket.se/sv/lakemedel-for-djur/biverkningsrapportering#hmainbody1'>online reporting form</a> for suspected adverse drug reactions in animals (In Swedish).  </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV. <br/> </p><p><b>Tune in to find out:</b></p><ul><li>What are the similarities and differences between veterinary and human pharmacovigilance?</li><li>How is animal health connected to public health? </li><li>What types of adverse events are reported on the veterinary side compared with the human side? </li><li>What can be found in the EU veterinary pharmacovigilance database? </li></ul><p> </p><p><b>Want to know more?</b></p><ul><li>The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found <a href='https://eur-lex.europa.eu/eli/reg/2019/6/oj'>here</a>. </li><li>The public portal of the <a href='https://www.adrreports.eu/vet/en/index.html'>European Union Veterinary Pharmacovigilance Database</a>.</li><li>WHO&apos;s information page on <a href='https://www.who.int/health-topics/one-health#tab=tab_1'>One Health</a>, an integrated approach to the well-being of people, animals and the environment.</li><li>A <a href='https://doi.org/10.1002/vro2.18'>survey of veterinary professionals in Sweden</a>, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.</li><li>A <a href='https://doi.org/10.1002/vro2.48'>review of adverse events in animals and children</a> after secondary exposure to transdermal hormone-containing medicinal products. </li><li>A study looking at suspected adverse drug reaction reporting in <a href='https://doi.org/10.1111/jsap.13721'>veterinary free‐text clinical narratives</a>.</li><li>The EMA <a href='https://www.ema.europa.eu/en/news/big-data-strategy-veterinary-medicines-eu'>Big Data strategy for veterinary medicines</a> in the EU. </li><li><a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-quality-framework-medicines-regulation'>Data quality framework for medicines regulation | European Medicines Agency (EMA)</a></li><li><a href='https://www.liverpool.ac.uk/savsnet/'>Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool</a></li><li><a href='https://www.rvc.ac.uk/vetcompass'>VetCompass - Royal Veterinary College, RVC</a></li><li><a href='https://www.ema.europa.eu/en/news/reflection-paper-use-artificial-intelligence-lifecycle-medicines'>Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)</a></li><li>The Swedish Medical Products Agency&apos;s <a href='https://www.lakemedelsverket.se/sv/lakemedel-for-djur/biverkningsrapportering#hmainbody1'>online reporting form</a> for suspected adverse drug reactions in animals (In Swedish).  </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/16292963-34-veterinary-pharmacovigilance-part-1-james-mount.mp3" length="34586501" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 17 Dec 2024 12:00:00 +0100</pubDate>
    <podcast:transcript url="https://www.buzzsprout.com/618871/16292963/transcript" type="text/html" />
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    <psc:chapters>
  <psc:chapter start="0:00" title="#34 Veterinary pharmacovigilance, part 1 – James Mount " />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:15" title="How similar is veterinary pharmacovigilance to human pharmacovigliance?" />
  <psc:chapter start="7:10" title="The connection between animal and public health" />
  <psc:chapter start="10:39" title="Side effects in animals, detection and (under-) reporting" />
  <psc:chapter start="14:59" title="Proportion of ADR reports from pet owners vs professionals" />
  <psc:chapter start="15:35" title="Detection and reporting of side effects in production animals" />
  <psc:chapter start="17:10" title="Initiatives and innovations to stimulate more reporting on the veterinary side" />
  <psc:chapter start="26:02" title="Are we tolerating more side effects from veterinary medicinal products?" />
  <psc:chapter start="28:13" title="Are animal protection regulations reflected in national veterinary PV practices?" />
  <psc:chapter start="30:17" title="Why, and how, are veterinarians using both human and veterinary medicinal products in their practice?" />
  <psc:chapter start="36:59" title="The EU database for veterinary suspected adverse drug reactions" />
  <psc:chapter start="40:47" title="Differences in ADR reporting of individuals (pets) vs masses (production animals)s" />
  <psc:chapter start="43:31" title="More on veterinary pharmacovigilance databases, VeDDRA, etc." />
  <psc:chapter start="45:51" title="Thanks and goodbye" />
</psc:chapters>
    <itunes:duration>2880</itunes:duration>
    <itunes:keywords></itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias</itunes:title>
    <title>#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias</title>
    <itunes:summary><![CDATA[Send a message to the show! While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.  <br/><br/><b>Tune in to find out:</b></p><ul><li>What challenges are PV assessors faced with, when working with narratives? </li><li>How could automation of certain tasks help streamline narrative analyses in the future?</li><li>How can reporters craft narratives that effectively document adverse events? </li></ul><p><br/><b>Want to know more?</b></p><ul><li><a href='https://who-umc.org/media/fbfhgnn4/narrative_poster_digital.pdf'>Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study</a> – poster presented at the 23rd ISoP Annual Meeting <a href='https://link.springer.com/article/10.1007/s40264-024-01477-7'>“Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”</a>, 1–5 October 2024 Montreal, Canada.</li><li><a href='https://cioms.ch/wp-content/uploads/2017/01/Group5_Pharmacovigilance.pdf'>Current Challenges in Pharmacovigilance: Pragmatic Approaches</a>, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.  <br/><br/><b>Tune in to find out:</b></p><ul><li>What challenges are PV assessors faced with, when working with narratives? </li><li>How could automation of certain tasks help streamline narrative analyses in the future?</li><li>How can reporters craft narratives that effectively document adverse events? </li></ul><p><br/><b>Want to know more?</b></p><ul><li><a href='https://who-umc.org/media/fbfhgnn4/narrative_poster_digital.pdf'>Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study</a> – poster presented at the 23rd ISoP Annual Meeting <a href='https://link.springer.com/article/10.1007/s40264-024-01477-7'>“Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”</a>, 1–5 October 2024 Montreal, Canada.</li><li><a href='https://cioms.ch/wp-content/uploads/2017/01/Group5_Pharmacovigilance.pdf'>Current Challenges in Pharmacovigilance: Pragmatic Approaches</a>, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/16191067-33-narrative-fields-and-signal-assessors-an-exploratory-study-joana-felix-and-alem-zekarias.mp3" length="28368825" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 29 Nov 2024 15:00:00 +0100</pubDate>
    <podcast:transcript url="https://www.buzzsprout.com/618871/16191067/transcript" type="text/html" />
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    <psc:chapters>
  <psc:chapter start="0:00" title="#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias" />
  <psc:chapter start="0:49" title="Intro" />
  <psc:chapter start="2:22" title="What are &quot;narrative fields&quot;?" />
  <psc:chapter start="4:32" title="Why this study?" />
  <psc:chapter start="5:39" title="How was the study performed?" />
  <psc:chapter start="9:01" title="Theme 1: Content and Value" />
  <psc:chapter start="13:17" title="Theme 2: Processes" />
  <psc:chapter start="17:08" title="Theme 3: Challenges" />
  <psc:chapter start="27:12" title="Theme 4: Needs" />
  <psc:chapter start="32:51" title="Takeaways" />
  <psc:chapter start="38:17" title="Outro" />
</psc:chapters>
    <itunes:duration>2362</itunes:duration>
    <itunes:keywords>ICSR, adverse drug reactions, signal detection, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#32 Pharmacovigilance in older adults – Giovanni Furlan</itunes:title>
    <title>#32 Pharmacovigilance in older adults – Giovanni Furlan</title>
    <itunes:summary><![CDATA[Send a message to the show! Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in moni...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients.</p><p> <b>Tune in to find out:</b></p><ul><li>What makes older adults especially at risk of experiencing adverse drug reactions and medication errors</li><li>Why frailty is far more useful than age in predicting adverse drug reaction risk</li><li>How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.</li></ul><p><br/><b>Want to know more?</b></p><p>This interview all started with Giovanni&apos;s Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it <a href='https://uppsalareports.org/articles/looking-beyond-age-to-understand-adverse-reaction-risk-in-older-patients/'>here</a>.<br/><b><br/></b>For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of <a href='https://link.springer.com/article/10.1007/s40264-020-00949-w'>drug safety in geriatric patients</a>.</p><p>If our discussion of frailty piqued your interest, read <a href='https://www.sciencedirect.com/science/article/abs/pii/S0047637419300387?via%3Dihub'>this paper</a> on the biology of frailty and how this impacts clinical pharmacology, <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8966695/'>this multi-centre cohort study</a> that shows frailty is significantly correlated with MRH, and <a href='https://academic.oup.com/ageing/article/49/1/7/5607678?login=false'>this commentary</a> advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such. <br/><br/>As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his <a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC3688067/'>paper</a>.</p><p>For more on prescribing cascades, their prevention, detection, and reversal, read <a href='https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.15543'>this paper</a> by Brath and colleagues.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients.</p><p> <b>Tune in to find out:</b></p><ul><li>What makes older adults especially at risk of experiencing adverse drug reactions and medication errors</li><li>Why frailty is far more useful than age in predicting adverse drug reaction risk</li><li>How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.</li></ul><p><br/><b>Want to know more?</b></p><p>This interview all started with Giovanni&apos;s Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it <a href='https://uppsalareports.org/articles/looking-beyond-age-to-understand-adverse-reaction-risk-in-older-patients/'>here</a>.<br/><b><br/></b>For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of <a href='https://link.springer.com/article/10.1007/s40264-020-00949-w'>drug safety in geriatric patients</a>.</p><p>If our discussion of frailty piqued your interest, read <a href='https://www.sciencedirect.com/science/article/abs/pii/S0047637419300387?via%3Dihub'>this paper</a> on the biology of frailty and how this impacts clinical pharmacology, <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8966695/'>this multi-centre cohort study</a> that shows frailty is significantly correlated with MRH, and <a href='https://academic.oup.com/ageing/article/49/1/7/5607678?login=false'>this commentary</a> advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such. <br/><br/>As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his <a href='https://pmc.ncbi.nlm.nih.gov/articles/PMC3688067/'>paper</a>.</p><p>For more on prescribing cascades, their prevention, detection, and reversal, read <a href='https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.15543'>this paper</a> by Brath and colleagues.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/15988988-32-pharmacovigilance-in-older-adults-giovanni-furlan.mp3" length="34943654" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-15988988</guid>
    <pubDate>Fri, 25 Oct 2024 15:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="#32 Pharmacovigilance in older adults – Giovanni Furlan" />
  <psc:chapter start="0:54" title="Introduction" />
  <psc:chapter start="2:01" title="Welcome Giovanni!" />
  <psc:chapter start="3:19" title="Why older adults are more at risk of experiencing adverse reactions to medicines" />
  <psc:chapter start="12:50" title="Why age alone should not be used as the defining characteristic in this patient group" />
  <psc:chapter start="16:37" title="Older adults are underrepresented in clinical trials and its impact on pharmacovigilance" />
  <psc:chapter start="25:00" title="Post-hospital syndrome in older patients" />
  <psc:chapter start="35:39" title="How pharmaceutical practice is being tailored to older patients" />
  <psc:chapter start="41:29" title="What more can be done to improve pharmacovigilance in elderly patients" />
  <psc:chapter start="47:22" title="Outro" />
</psc:chapters>
    <itunes:duration>2910</itunes:duration>
    <itunes:keywords>drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori</itunes:title>
    <title>#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori</title>
    <itunes:summary><![CDATA[Send a message to the show! Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible.   Tune in to find out:  The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created Why there has been a spike i...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible.  </p><p><b>Tune in to find out:</b> </p><ul><li>The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created </li><li>Why there has been a spike in the publication of disproportionality analyses in recent years and what this means for their reliability </li><li>What it means to publish “good” pharmacovigilance science  </li></ul><p><br/></p><p><b>Want to know more?</b> </p><ul><li>Read the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11116264/'>READUS-PV guidelines</a>, <a href='https://pubmed.ncbi.nlm.nih.gov/38713346/'>why they were created</a>, and <a href='https://link.springer.com/article/10.1007/s40264-024-01441-5'>why they are important</a>. </li><li>In 2021, Khouri and colleagues showed that <a href='https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.668765/full'>current methods and models used for disproportionality analyses are unreliable</a>, and Mouffak and colleagues found that there is a <a href='https://www.sciencedirect.com/science/article/abs/pii/S0895435621002006'>tendency to overstate results in published disproportionality analyses</a>. </li><li>A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this <a href='https://www.intechopen.com/chapters/38579'>exponential increase in disproportionality analyses</a>.  </li><li><a href='https://openpublishing.library.umass.edu/pare/article/id/1418/'>This paper</a> elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible.  </p><p><b>Tune in to find out:</b> </p><ul><li>The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created </li><li>Why there has been a spike in the publication of disproportionality analyses in recent years and what this means for their reliability </li><li>What it means to publish “good” pharmacovigilance science  </li></ul><p><br/></p><p><b>Want to know more?</b> </p><ul><li>Read the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11116264/'>READUS-PV guidelines</a>, <a href='https://pubmed.ncbi.nlm.nih.gov/38713346/'>why they were created</a>, and <a href='https://link.springer.com/article/10.1007/s40264-024-01441-5'>why they are important</a>. </li><li>In 2021, Khouri and colleagues showed that <a href='https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2021.668765/full'>current methods and models used for disproportionality analyses are unreliable</a>, and Mouffak and colleagues found that there is a <a href='https://www.sciencedirect.com/science/article/abs/pii/S0895435621002006'>tendency to overstate results in published disproportionality analyses</a>. </li><li>A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this <a href='https://www.intechopen.com/chapters/38579'>exponential increase in disproportionality analyses</a>.  </li><li><a href='https://openpublishing.library.umass.edu/pare/article/id/1418/'>This paper</a> elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Mon, 30 Sep 2024 10:00:00 +0200</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="Intro" />
  <psc:chapter start="2:05" title="Welcome" />
  <psc:chapter start="2:36" title="What is disproportionality analysis?" />
  <psc:chapter start="4:37" title="A reporting problem in PV science" />
  <psc:chapter start="10:28" title="What is the READUS-PV project?" />
  <psc:chapter start="15:37" title="Why the recent spike in disproportionality reporting?" />
  <psc:chapter start="19:13" title="Effects of the reporting spike" />
  <psc:chapter start="22:06" title="What has prevented a more widespread support of previous guidelines?" />
  <psc:chapter start="23:10" title="Patterns in the publication of disproportionality analyses" />
  <psc:chapter start="24:59" title="What is the Delphi method?" />
  <psc:chapter start="32:38" title="Transparency, replicability and reproducibility in PV research - what impact will the READUS-PV have?" />
  <psc:chapter start="37:09" title="What are the next steps to ensure uptake and integration of READUS-PV into the community?" />
  <psc:chapter start="38:18" title="Listener question: How does READUS-PV apply to disproportionality analyses on medication errors?" />
  <psc:chapter start="39:59" title="Final comments" />
  <psc:chapter start="42:11" title="Outro" />
</psc:chapters>
    <itunes:duration>2604</itunes:duration>
    <itunes:keywords></itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects</itunes:title>
    <title>Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects</title>
    <itunes:summary><![CDATA[Send a message to the show! Duplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here. After the read, we speak to author Jim Barrett, Senior Data Scientist at UMC, to learn mo...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Duplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them. </p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://uppsalareports.org/articles/weeding-out-duplicates-to-better-detect-side-effects/'>original article here</a>.</p><p>After the read, we speak to author Jim Barrett, Senior Data Scientist at UMC, to learn more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance.<br/><br/></p><p><b>Tune in to find out:</b></p><ul><li>How the new algorithm handles duplicates in VigiBase</li><li>About different approaches for developing algorithms</li><li>Why it can be challenging to evaluate the performance of an algorithm</li></ul><p><br/><b>Want to know more?</b></p><ul><li>Listen to the Drug Safety Matters <a href='https://www.drugsafetymatterspod.org/618871/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>interview with Michael Glaser</a> about his Uppsala Reports article “Ensuring trust in AI/ML when used in pharmacovigilance” and check out the episode’s extensive list of links for more on AI in pharmacovigilance. </li><li><a href='https://bit.ly/4aIREVR'><em>Artificial intelligence in pharmacovigilance – value proposition and the need for critical appraisal</em></a>, a presentation by Niklas Norén, Head of Research at UMC, given at University of Verona in April 2024.  </li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Duplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them. </p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://uppsalareports.org/articles/weeding-out-duplicates-to-better-detect-side-effects/'>original article here</a>.</p><p>After the read, we speak to author Jim Barrett, Senior Data Scientist at UMC, to learn more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance.<br/><br/></p><p><b>Tune in to find out:</b></p><ul><li>How the new algorithm handles duplicates in VigiBase</li><li>About different approaches for developing algorithms</li><li>Why it can be challenging to evaluate the performance of an algorithm</li></ul><p><br/><b>Want to know more?</b></p><ul><li>Listen to the Drug Safety Matters <a href='https://www.drugsafetymatterspod.org/618871/15300461-uppsala-reports-long-reads-ensuring-trust-in-ai-ml-when-used-in-pharmacovigilance'>interview with Michael Glaser</a> about his Uppsala Reports article “Ensuring trust in AI/ML when used in pharmacovigilance” and check out the episode’s extensive list of links for more on AI in pharmacovigilance. </li><li><a href='https://bit.ly/4aIREVR'><em>Artificial intelligence in pharmacovigilance – value proposition and the need for critical appraisal</em></a>, a presentation by Niklas Norén, Head of Research at UMC, given at University of Verona in April 2024.  </li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author></itunes:author>
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    <pubDate>Mon, 26 Aug 2024 10:00:00 +0200</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects" />
  <psc:chapter start="0:48" title="Intro" />
  <psc:chapter start="1:51" title="Article read" />
  <psc:chapter start="6:36" title="Welcome, Jim!" />
  <psc:chapter start="7:58" title="Definitions of AI, machine learning and algorithms" />
  <psc:chapter start="9:26" title="How do we develop algorithms at UMC?" />
  <psc:chapter start="10:52" title="Evaluating the performance of algorithms" />
  <psc:chapter start="13:48" title="How many algorithms has UMC developed?" />
  <psc:chapter start="14:24" title="How many duplicates in VigiBase?" />
  <psc:chapter start="16:08" title="Which duplicate to keep, and which to weed out?" />
  <psc:chapter start="18:49" title="Other examples of algorithms used in pharmacovigilance" />
  <psc:chapter start="20:57" title="Where will we be in a couple of years?" />
  <psc:chapter start="22:26" title="Pitfalls to be mindful of, heading into the future" />
  <psc:chapter start="23:11" title="A dream algorithm?" />
  <psc:chapter start="24:35" title="Thank you and goodbye" />
  <psc:chapter start="24:48" title="Outro" />
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    <itunes:duration>1542</itunes:duration>
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    <itunes:title>Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance</itunes:title>
    <title>Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance</title>
    <itunes:summary><![CDATA[Send a message to the show! Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity? This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here. After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI an...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?</p><p>This episode is part of the <a href='https://uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://uppsalareports.org/articles/how-do-we-ensure-trust-in-aiml-when-used-in-pharmacovigilance/'>original article here</a>.</p><p>After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field.<br/><br/><b>Tune in to find out:</b></p><p>●      How AI and ML are being used today in pharmacovigilance processes</p><p>●     Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance</p><p>●      How we may best move forward to implement AI/ML into healthcare.</p><p><b> Want to know more?</b></p><p> To know more about how AI and ML are being used in pharmacovigilance currently, read <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9883349/'>this scoping review</a>.</p><p>To know more about future trends of the use of AI in Biopharma, read this <a href='https://www.accenture.com/us-en/insights/life-sciences/biopharma-technology-trends-2023'>Accenture survey</a>.</p><ul><li>Despite there being major interest in ML and AI to do more than task automation, there are a <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10623210/'>number of barriers</a> to its implementation in healthcare. Check out this future-focused paper on the <a href='https://www.sciencedirect.com/science/article/pii/S2211883723000217'>use of AI/ML in pharmacovigilance</a> that details how to utilise it to its fullest potential.</li><li>A <a href='https://www.sciencedirect.com/science/article/pii/S2211883723000217'>mindset shift</a> is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.</li><li>A validation framework must be <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892696/'>developed for AI-based pharmacovigilance systems</a>. One suggestion is to do so using a <a href='https://www.nature.com/articles/s41573-023-00769-4#ref-CR1'>risk-based approach</a>.</li><li>While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies <a href='https://link.springer.com/article/10.1007/s40264-023-01315-2'>like this one</a> suggest that the technology has a ways to go to be useful in pharmacovigilance.</li><li>The World Health Organization have published an <a href='https://www.who.int/publications/i/item/9789240084759'>extensive guideline</a> on the ethics and governance of AI for health.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?</p><p>This episode is part of the <a href='https://uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://uppsalareports.org/articles/how-do-we-ensure-trust-in-aiml-when-used-in-pharmacovigilance/'>original article here</a>.</p><p>After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field.<br/><br/><b>Tune in to find out:</b></p><p>●      How AI and ML are being used today in pharmacovigilance processes</p><p>●     Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance</p><p>●      How we may best move forward to implement AI/ML into healthcare.</p><p><b> Want to know more?</b></p><p> To know more about how AI and ML are being used in pharmacovigilance currently, read <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9883349/'>this scoping review</a>.</p><p>To know more about future trends of the use of AI in Biopharma, read this <a href='https://www.accenture.com/us-en/insights/life-sciences/biopharma-technology-trends-2023'>Accenture survey</a>.</p><ul><li>Despite there being major interest in ML and AI to do more than task automation, there are a <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10623210/'>number of barriers</a> to its implementation in healthcare. Check out this future-focused paper on the <a href='https://www.sciencedirect.com/science/article/pii/S2211883723000217'>use of AI/ML in pharmacovigilance</a> that details how to utilise it to its fullest potential.</li><li>A <a href='https://www.sciencedirect.com/science/article/pii/S2211883723000217'>mindset shift</a> is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.</li><li>A validation framework must be <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7892696/'>developed for AI-based pharmacovigilance systems</a>. One suggestion is to do so using a <a href='https://www.nature.com/articles/s41573-023-00769-4#ref-CR1'>risk-based approach</a>.</li><li>While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies <a href='https://link.springer.com/article/10.1007/s40264-023-01315-2'>like this one</a> suggest that the technology has a ways to go to be useful in pharmacovigilance.</li><li>The World Health Organization have published an <a href='https://www.who.int/publications/i/item/9789240084759'>extensive guideline</a> on the ethics and governance of AI for health.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 27 Jun 2024 09:00:00 +0200</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance" />
  <psc:chapter start="0:48" title="Intro" />
  <psc:chapter start="1:49" title="Article read" />
  <psc:chapter start="10:25" title="Welcome, Michael!" />
  <psc:chapter start="10:31" title="Where AI and ML are being used in pharmacovigilance processes today" />
  <psc:chapter start="12:13" title="We need to change the way we think about AI to harness its full potential" />
  <psc:chapter start="15:32" title="How to handle patient data to ensure patient safety while making data available for training AI models" />
  <psc:chapter start="18:12" title="Achieving harmonisation in AI regulations across industry and organisations" />
  <psc:chapter start="20:30" title="What is a risk-based framework and how can it be used to ensure trust in AI when used for pharmacovigilance" />
  <psc:chapter start="26:16" title="How healthcare organisations may utilise these risk-based frameworks" />
  <psc:chapter start="29:45" title="Outro" />
</psc:chapters>
    <itunes:duration>1857</itunes:duration>
    <itunes:keywords>drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science, AI, machine learning</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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  </item>
  <item>
    <itunes:title>#30 Preventing and reporting medication errors – Rabat CC &amp; UMC</itunes:title>
    <title>#30 Preventing and reporting medication errors – Rabat CC &amp; UMC</title>
    <itunes:summary><![CDATA[Send a message to the show! Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors from occurring – and, when they do occur, make sure that they are reported as such. <br/><br/></p><p><b>Tune in to find out:</b></p><ul><li>What are the most common causes for medication errors?</li><li>How should strategies for preventing medication errors be devised? </li><li>How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment?</li><li>What can be done to encourage healthcare professionals to report medication errors?</li></ul><p><br/><b>Want to know more?</b></p><ul><li>In March 2024, WHO published <a href='https://www.who.int/publications/i/item/9789240088887'>this systematic review</a> of the global burden of preventable medication-related harm in healthcare.</li><li>According to this <a href='https://qualitysafety.bmj.com/content/30/2/96.long'>2021 article in BMJ</a>, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. </li><li>This <a href='https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0033236'>2012 meta-analysis</a> confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.</li><li>The European Medicines Agency (EMA) has a <a href='https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors'>dedicated webpage</a> with recommendations, guidelines, legal requirements and a <em>good practice</em> guide on medication errors. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors from occurring – and, when they do occur, make sure that they are reported as such. <br/><br/></p><p><b>Tune in to find out:</b></p><ul><li>What are the most common causes for medication errors?</li><li>How should strategies for preventing medication errors be devised? </li><li>How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment?</li><li>What can be done to encourage healthcare professionals to report medication errors?</li></ul><p><br/><b>Want to know more?</b></p><ul><li>In March 2024, WHO published <a href='https://www.who.int/publications/i/item/9789240088887'>this systematic review</a> of the global burden of preventable medication-related harm in healthcare.</li><li>According to this <a href='https://qualitysafety.bmj.com/content/30/2/96.long'>2021 article in BMJ</a>, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. </li><li>This <a href='https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0033236'>2012 meta-analysis</a> confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.</li><li>The European Medicines Agency (EMA) has a <a href='https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors'>dedicated webpage</a> with recommendations, guidelines, legal requirements and a <em>good practice</em> guide on medication errors. </li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 15 May 2024 13:00:00 +0200</pubDate>
    <podcast:transcript url="https://www.buzzsprout.com/618871/15072807/transcript" type="text/html" />
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    <psc:chapters>
  <psc:chapter start="0:00" title="#30 Preventing and reporting medication errors – Rabat CC &amp; UMC" />
  <psc:chapter start="0:55" title="Intro" />
  <psc:chapter start="1:47" title="Welcome" />
  <psc:chapter start="2:03" title="What is a medication error?" />
  <psc:chapter start="3:41" title="Common causes" />
  <psc:chapter start="6:30" title="Frequency of medication errors" />
  <psc:chapter start="8:25" title="Impact on patients, healthcare and communities" />
  <psc:chapter start="9:29" title="Data collection and analysis" />
  <psc:chapter start="11:33" title="Listener question: Efficiency of P-method" />
  <psc:chapter start="12:31" title="Listener question: Facilitating patient reporting" />
  <psc:chapter start="15:04" title="Reasons for under-reporting" />
  <psc:chapter start="16:07" title="&quot;Errors&quot; - a blaming name?" />
  <psc:chapter start="17:35" title="Coding medication errors" />
  <psc:chapter start="19:15" title="Signal detection and assessment" />
  <psc:chapter start="21:24" title="The VigiBase global perspective" />
  <psc:chapter start="23:11" title="Strategies for prevention" />
  <psc:chapter start="25:49" title="Listener question: Technological innovations" />
  <psc:chapter start="27:01" title="Listener question: AI" />
  <psc:chapter start="29:03" title="Reflections on a UMC course on medication errors" />
  <psc:chapter start="33:24" title="Outro" />
</psc:chapters>
    <itunes:duration>2077</itunes:duration>
    <itunes:keywords>Medication errors, preventable adverse drug reactions, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#29 When medicines change our behaviour – Michele Fusaroli</itunes:title>
    <title>#29 When medicines change our behaviour – Michele Fusaroli</title>
    <itunes:summary><![CDATA[Send a message to the show! Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders. Tune in to find out: Which medicines may cause impulsivityWhat the ‘four knights’ of impulsivity areHow patient stories can help detect these conditionsWant to know mor...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders.</p><p><b>Tune in to find out:</b></p><ul><li>Which medicines may cause impulsivity</li><li>What the ‘four knights’ of impulsivity are</li><li>How patient stories can help detect these conditions</li></ul><p><b>Want to know more?</b></p><p><a href='https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.27668'>This review by Daniel Weintraub</a> summarises twenty years of research on impulse control disorders in Parkinson’s disease.<br/><br/>In 2003, Driver-Dunckley and colleagues in the US published the <a href='https://www.neurology.org/doi/10.1212/01.WNL.0000076478.45005.EC'>first case series linking pathological gambling to dopamine agonists</a>.<br/><br/>In 2016, the US Food and Drug Administration warned about <a href='https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-new-impulse-control-problems-associated-mental-health'>impulse-control problems associated with the antipsychotic drug aripiprazole</a>.<br/><br/>Michele and colleagues in Italy have investigated the <a href='https://onlinelibrary.wiley.com/doi/10.1111/pcn.13511'>mechanisms</a> and <a href='https://www.medrxiv.org/content/10.1101/2023.11.17.23298635v2'>burden</a> of drug-induced impulsivity.<br/><br/>In their 2024 <a href='https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29700'>guidelines for managing impulsivity</a> in Parkinson&apos;s disease, an expert consensus group highlighted the pivotal role of caregivers and of psychosocial interventions.<br/><br/>Finally, these are the Drug Safety Matters episodes cited in the interview:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/14599616-28-catching-black-swans-francois-montastruc'>Catching black swans</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/14405046-27-when-drugs-damage-the-liver-rita-baiao'>When drugs damage the liver</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13531660-uppsala-reports-long-reads-empowering-patients-as-partners'>Empowering patients as partners</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders.</p><p><b>Tune in to find out:</b></p><ul><li>Which medicines may cause impulsivity</li><li>What the ‘four knights’ of impulsivity are</li><li>How patient stories can help detect these conditions</li></ul><p><b>Want to know more?</b></p><p><a href='https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.27668'>This review by Daniel Weintraub</a> summarises twenty years of research on impulse control disorders in Parkinson’s disease.<br/><br/>In 2003, Driver-Dunckley and colleagues in the US published the <a href='https://www.neurology.org/doi/10.1212/01.WNL.0000076478.45005.EC'>first case series linking pathological gambling to dopamine agonists</a>.<br/><br/>In 2016, the US Food and Drug Administration warned about <a href='https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-new-impulse-control-problems-associated-mental-health'>impulse-control problems associated with the antipsychotic drug aripiprazole</a>.<br/><br/>Michele and colleagues in Italy have investigated the <a href='https://onlinelibrary.wiley.com/doi/10.1111/pcn.13511'>mechanisms</a> and <a href='https://www.medrxiv.org/content/10.1101/2023.11.17.23298635v2'>burden</a> of drug-induced impulsivity.<br/><br/>In their 2024 <a href='https://movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29700'>guidelines for managing impulsivity</a> in Parkinson&apos;s disease, an expert consensus group highlighted the pivotal role of caregivers and of psychosocial interventions.<br/><br/>Finally, these are the Drug Safety Matters episodes cited in the interview:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/14599616-28-catching-black-swans-francois-montastruc'>Catching black swans</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/14405046-27-when-drugs-damage-the-liver-rita-baiao'>When drugs damage the liver</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13531660-uppsala-reports-long-reads-empowering-patients-as-partners'>Empowering patients as partners</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <pubDate>Tue, 23 Apr 2024 11:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="#29 When medicines change our behaviour – Michele Fusaroli" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:32" title="Welcome, Michele!" />
  <psc:chapter start="3:26" title="Body versus mind" />
  <psc:chapter start="6:17" title="Tamoxifen and brain fog" />
  <psc:chapter start="7:15" title="Drug-induced impulse control disorders" />
  <psc:chapter start="9:25" title="Drugs and mechanisms" />
  <psc:chapter start="10:37" title="Frequency of impulse control disorders" />
  <psc:chapter start="11:46" title="Risk factors" />
  <psc:chapter start="12:24" title="Impact on quality of life" />
  <psc:chapter start="14:55" title="First identification" />
  <psc:chapter start="16:41" title="Third-generation antipsychotics" />
  <psc:chapter start="19:39" title="Diagnosis" />
  <psc:chapter start="21:24" title="Coping strategies" />
  <psc:chapter start="24:31" title="Assessing impulsivity reports" />
  <psc:chapter start="27:19" title="Final advice" />
  <psc:chapter start="29:40" title="Outro" />
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    <itunes:duration>1869</itunes:duration>
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    <itunes:title>#28 Catching black swans – François Montastruc</itunes:title>
    <title>#28 Catching black swans – François Montastruc</title>
    <itunes:summary><![CDATA[Send a message to the show! Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable. Tune in to find out: What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilanceWhat makes an adverse drug reaction a black, white, or gr...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable.</p><p><b>Tune in to find out:</b></p><ul><li>What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilance</li><li>What makes an adverse drug reaction a black, white, or grey swan</li><li> Why flexibility and communication are key to patient safety</li></ul><p><b>Want to know more?<br/><br/></b>Here are the research articles cited in the episode:</p><ul><li><a href='https://bmjmedicine.bmj.com/content/2/1/e000352'>Quality of reporting of adverse events in clinical trials</a> of COVID-19 drugs: systematic review</li><li><a href='https://link.springer.com/article/10.1007/s40264-020-01013-3'>Psychiatric disorders and hydroxychloroquine</a> for COVID-19: a VigiBase study</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S1542356520310600?via%3Dihub'>Hepatic disorders with the use of remdesivir</a> for COVID-19</li><li><a href='https://www.sciencedirect.com/science/article/pii/S1198743X2100094X?via%3Dihub'>Serious bradycardia and remdesivir</a> for COVID-19: a new safety concern</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S235255682100093X?via%3Dihub'>Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia:</a> a missed opportunity for a rapid return of experience</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S004059572100130X?via%3Dihub'>Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine:</a> data from the French network of regional pharmacovigilance centres</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S0040595724000015?via%3Dihub'>Teaching pharmacovigilance to French medical students</a> during the COVID-19 pandemic: interest of distance learning clinical reasoning sessions</li></ul><p>If you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12805441'>Reforming pharmacovigilance education</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/11863934'>Lessons in pandemic pharmacovigilance</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6839950'>Intuition in pharmacovigilance</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable.</p><p><b>Tune in to find out:</b></p><ul><li>What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilance</li><li>What makes an adverse drug reaction a black, white, or grey swan</li><li> Why flexibility and communication are key to patient safety</li></ul><p><b>Want to know more?<br/><br/></b>Here are the research articles cited in the episode:</p><ul><li><a href='https://bmjmedicine.bmj.com/content/2/1/e000352'>Quality of reporting of adverse events in clinical trials</a> of COVID-19 drugs: systematic review</li><li><a href='https://link.springer.com/article/10.1007/s40264-020-01013-3'>Psychiatric disorders and hydroxychloroquine</a> for COVID-19: a VigiBase study</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S1542356520310600?via%3Dihub'>Hepatic disorders with the use of remdesivir</a> for COVID-19</li><li><a href='https://www.sciencedirect.com/science/article/pii/S1198743X2100094X?via%3Dihub'>Serious bradycardia and remdesivir</a> for COVID-19: a new safety concern</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S235255682100093X?via%3Dihub'>Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia:</a> a missed opportunity for a rapid return of experience</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S004059572100130X?via%3Dihub'>Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine:</a> data from the French network of regional pharmacovigilance centres</li><li><a href='https://www.sciencedirect.com/science/article/abs/pii/S0040595724000015?via%3Dihub'>Teaching pharmacovigilance to French medical students</a> during the COVID-19 pandemic: interest of distance learning clinical reasoning sessions</li></ul><p>If you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12805441'>Reforming pharmacovigilance education</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/11863934'>Lessons in pandemic pharmacovigilance</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6839950'>Intuition in pharmacovigilance</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 29 Feb 2024 09:00:00 +0100</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="#28 Catching black swans – François Montastruc" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:38" title="Black swan theory" />
  <psc:chapter start="5:28" title="Relevance to pharmacovigilance" />
  <psc:chapter start="9:12" title="Black swan events" />
  <psc:chapter start="11:30" title="White swan events" />
  <psc:chapter start="14:32" title="Grey swan events" />
  <psc:chapter start="17:39" title="The pharmacovigilance &#39;oiseleur&#39;" />
  <psc:chapter start="20:27" title="Teaching bird-catching" />
  <psc:chapter start="23:28" title="Collaboration is crucial" />
  <psc:chapter start="26:35" title="Outro" />
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    <itunes:duration>1680</itunes:duration>
    <itunes:keywords>COVID-19, drug safety, medicine, medicines safety, pandemic, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#27 When drugs damage the liver – Rita Baião</itunes:title>
    <title>#27 When drugs damage the liver – Rita Baião</title>
    <itunes:summary><![CDATA[Send a message to the show! The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).  Tune in to find out: Who is most at risk of developing DILIHow to diagnose the condition and control the damageHow to assess case reports of DILIWant to know more? This infograph...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).<br/><br/><b>Tune in to find out:</b></p><ul><li>Who is most at risk of developing DILI</li><li>How to diagnose the condition and control the damage</li><li>How to assess case reports of DILI</li></ul><p><b>Want to know more?</b></p><ul><li><a href='https://proeurodilinet.eu/wp-content/uploads/2019/10/2019-Andrade-Lucena-PrimeView-summary-DILI.jpg'>This infographic</a> in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.</li><li>In <a href='https://cioms.ch/wp-content/uploads/2020/06/CIOMS_DILI_Web_16Jun2020.pdf'>this report</a>, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.</li><li>In <a href='https://link.springer.com/article/10.1007/s40264-023-01360-x'>this Drug Safety article</a>, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development. </li><li>The <a href='https://proeurodilinet.eu/'>PRO-EURO DILI NETWORK</a> coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the <a href='https://www.spanishdili.uma.es/'>Spanish DILI Registry</a> and the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6465791/'>Latin American DILI Network</a>.</li><li>The free online tool <a href='https://www.ncbi.nlm.nih.gov/books/NBK547852/'>LiverTox</a> contains up-to-date information on drug-induced liver injury for medicines and herbal products.</li></ul><p>To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre’s <a href='https://learning.who-umc.org/visitor_catalog_class/show/40535'>free online course</a> on the topic.<br/><br/>For more on the clustering algorithm vigiGroup, revisit <a href='https://www.drugsafetymatterspod.org/618871/9731548-12-improving-signal-detection-with-vigigroup-jim-barrett-joe-mitchell'>this interview</a> with UMC scientists Jim Barrett and Joe Mitchell.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).<br/><br/><b>Tune in to find out:</b></p><ul><li>Who is most at risk of developing DILI</li><li>How to diagnose the condition and control the damage</li><li>How to assess case reports of DILI</li></ul><p><b>Want to know more?</b></p><ul><li><a href='https://proeurodilinet.eu/wp-content/uploads/2019/10/2019-Andrade-Lucena-PrimeView-summary-DILI.jpg'>This infographic</a> in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.</li><li>In <a href='https://cioms.ch/wp-content/uploads/2020/06/CIOMS_DILI_Web_16Jun2020.pdf'>this report</a>, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.</li><li>In <a href='https://link.springer.com/article/10.1007/s40264-023-01360-x'>this Drug Safety article</a>, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development. </li><li>The <a href='https://proeurodilinet.eu/'>PRO-EURO DILI NETWORK</a> coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the <a href='https://www.spanishdili.uma.es/'>Spanish DILI Registry</a> and the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6465791/'>Latin American DILI Network</a>.</li><li>The free online tool <a href='https://www.ncbi.nlm.nih.gov/books/NBK547852/'>LiverTox</a> contains up-to-date information on drug-induced liver injury for medicines and herbal products.</li></ul><p>To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre’s <a href='https://learning.who-umc.org/visitor_catalog_class/show/40535'>free online course</a> on the topic.<br/><br/>For more on the clustering algorithm vigiGroup, revisit <a href='https://www.drugsafetymatterspod.org/618871/9731548-12-improving-signal-detection-with-vigigroup-jim-barrett-joe-mitchell'>this interview</a> with UMC scientists Jim Barrett and Joe Mitchell.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/14405046-27-when-drugs-damage-the-liver-rita-baiao.mp3" length="21015175" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 01 Feb 2024 10:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="#27 When drugs damage the liver – Rita Baião" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:36" title="Welcome, Rita!" />
  <psc:chapter start="3:05" title="Frequency of DILI" />
  <psc:chapter start="4:15" title="Pre- and post-marketing" />
  <psc:chapter start="6:00" title="Mechanisms of injury" />
  <psc:chapter start="7:56" title="Risk factors" />
  <psc:chapter start="10:11" title="Diagnosis" />
  <psc:chapter start="12:22" title="Controlling the damage" />
  <psc:chapter start="13:42" title="Impact on adherence" />
  <psc:chapter start="17:53" title="Analysing DILI reports" />
  <psc:chapter start="20:21" title="Patient registries" />
  <psc:chapter start="23:22" title="Clustering DILI reports with vigiGroup" />
  <psc:chapter start="25:36" title="Benefits of vigiGroup" />
  <psc:chapter start="27:44" title="Outro" />
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    <itunes:duration>1749</itunes:duration>
    <itunes:keywords>DILI, drug-induced liver injury, drug safety, liver, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#26 What&#39;s trending in pharmacovigilance? – Angela Caro-Rojas</itunes:title>
    <title>#26 What&#39;s trending in pharmacovigilance? – Angela Caro-Rojas</title>
    <itunes:summary><![CDATA[Send a message to the show! What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro-Rojas, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance. Tune in to find out: Why patient engagement is a growing priorityWhat challenges exist in the Latin American regionWhich topics will be in the spotlight next yearWant to know more? ISoP...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro-Rojas, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance.</p><p><b>Tune in to find out:</b></p><ul><li>Why patient engagement is a growing priority</li><li>What challenges exist in the Latin American region</li><li>Which topics will be in the spotlight next year</li></ul><p><b>Want to know more?</b></p><p><a href='https://isoponline.org/'>ISoP</a> is a non-profit society open to anyone with an interest in pharmacovigilance.<br/><br/>Through <a href='https://isoponline.org/chapters/chapters-overview/'>14 chapters</a> and <a href='https://isoponline.org/special-interest-groups/sigs-overview/'>13 special interest groups</a>, the society works to enhance the safe and proper use of medicines across countries.<br/> <br/>Their latest annual meeting took place in <a href='https://isop2023bali.org'>Bali, Indonesia</a> in November 2023, while the next one will take place in <a href='https://isop2024montreal.org/'>Montreal, Canada</a> in October 2024.<br/> <br/>To learn more about ISoP’s activities in patient engagement and pharmacogenomics, listen to these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/13531660-uppsala-reports-long-reads-empowering-patients-as-partners'>Empowering patients as partners</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8795485-10-tailoring-drug-therapy-to-your-genes-qun-ying-yue'>Tailoring drug therapy to your genes</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro-Rojas, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance.</p><p><b>Tune in to find out:</b></p><ul><li>Why patient engagement is a growing priority</li><li>What challenges exist in the Latin American region</li><li>Which topics will be in the spotlight next year</li></ul><p><b>Want to know more?</b></p><p><a href='https://isoponline.org/'>ISoP</a> is a non-profit society open to anyone with an interest in pharmacovigilance.<br/><br/>Through <a href='https://isoponline.org/chapters/chapters-overview/'>14 chapters</a> and <a href='https://isoponline.org/special-interest-groups/sigs-overview/'>13 special interest groups</a>, the society works to enhance the safe and proper use of medicines across countries.<br/> <br/>Their latest annual meeting took place in <a href='https://isop2023bali.org'>Bali, Indonesia</a> in November 2023, while the next one will take place in <a href='https://isop2024montreal.org/'>Montreal, Canada</a> in October 2024.<br/> <br/>To learn more about ISoP’s activities in patient engagement and pharmacogenomics, listen to these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/13531660-uppsala-reports-long-reads-empowering-patients-as-partners'>Empowering patients as partners</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8795485-10-tailoring-drug-therapy-to-your-genes-qun-ying-yue'>Tailoring drug therapy to your genes</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/14166982-26-what-s-trending-in-pharmacovigilance-angela-caro-rojas.mp3" length="20724079" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 20 Dec 2023 09:00:00 +0100</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="#26 What&#39;s trending in pharmacovigilance? – Angela Caro-Rojas" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:22" title="Welcome, Angela!" />
  <psc:chapter start="2:35" title="The Bali meeting" />
  <psc:chapter start="3:27" title="Putting patients first" />
  <psc:chapter start="6:39" title="Unconventional topics" />
  <psc:chapter start="9:20" title="This year&#39;s trends" />
  <psc:chapter start="11:09" title="Impact of COVID vaccines" />
  <psc:chapter start="13:22" title="Common challenges" />
  <psc:chapter start="17:24" title="Latin American challenges" />
  <psc:chapter start="21:24" title="Highlights of 2023" />
  <psc:chapter start="23:46" title="Trends for 2024" />
  <psc:chapter start="27:06" title="Outro" />
</psc:chapters>
    <itunes:duration>1725</itunes:duration>
    <itunes:keywords></itunes:keywords>
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  <item>
    <itunes:title>#25 A week in the name of medicines safety – part 2</itunes:title>
    <title>#25 A week in the name of medicines safety – part 2</title>
    <itunes:summary><![CDATA[Send a message to the show! To mark #MedSafetyWeek, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign. Tu...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>To mark <a href='https://who-umc.org/medsafetyweek/'>#MedSafetyWeek</a>, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign.</p><p><b>Tune in to find out:</b></p><ul><li>Why you should always tailor your communication strategy to your setting</li><li>How to deal with the financial, cultural, and logistical challenges of campaign planning</li><li>What to keep in mind if you are new to #MedSafetyWeek</li></ul><p><b>Want to know more?</b></p><p>You can read a <a href='https://www.uppsalareports.org/articles/start-small-but-think-big-trials-and-triumphs-of-medsafetyweek-campaigners/'>summary of this episode</a> on the Uppsala Reports news site.<br/><br/>To learn more about #MedSafetyWeek, check out the hashtag online and visit the <a href='https://who-umc.org/medsafetyweek/'>campaign website</a>, where you will also find free social media materials in several languages.<br/><br/>This is the second of a two-part episode on pharmacovigilance communication campaigns. Listen to the first part <a href='https://www.drugsafetymatterspod.org/618871/13895097-24-a-week-in-the-name-of-medicines-safety-part-1'>here</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>To mark <a href='https://who-umc.org/medsafetyweek/'>#MedSafetyWeek</a>, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign.</p><p><b>Tune in to find out:</b></p><ul><li>Why you should always tailor your communication strategy to your setting</li><li>How to deal with the financial, cultural, and logistical challenges of campaign planning</li><li>What to keep in mind if you are new to #MedSafetyWeek</li></ul><p><b>Want to know more?</b></p><p>You can read a <a href='https://www.uppsalareports.org/articles/start-small-but-think-big-trials-and-triumphs-of-medsafetyweek-campaigners/'>summary of this episode</a> on the Uppsala Reports news site.<br/><br/>To learn more about #MedSafetyWeek, check out the hashtag online and visit the <a href='https://who-umc.org/medsafetyweek/'>campaign website</a>, where you will also find free social media materials in several languages.<br/><br/>This is the second of a two-part episode on pharmacovigilance communication campaigns. Listen to the first part <a href='https://www.drugsafetymatterspod.org/618871/13895097-24-a-week-in-the-name-of-medicines-safety-part-1'>here</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/13959809-25-a-week-in-the-name-of-medicines-safety-part-2.mp3" length="24411072" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-13959809</guid>
    <pubDate>Mon, 13 Nov 2023 11:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="#25 A week in the name of medicines safety – part 2" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:02" title="Pharmacists as ambassadors" />
  <psc:chapter start="6:08" title="Regional pharmacovigilance centres" />
  <psc:chapter start="7:39" title="Public relations partners" />
  <psc:chapter start="9:40" title="Simple but effective materials" />
  <psc:chapter start="10:46" title="Dealing with trolls" />
  <psc:chapter start="11:40" title="Measuring impact" />
  <psc:chapter start="13:39" title="Gaining internal support" />
  <psc:chapter start="15:11" title="Finding external sponsors" />
  <psc:chapter start="16:30" title="Engaging doctors" />
  <psc:chapter start="17:28" title="Picking the right language" />
  <psc:chapter start="19:37" title="Adapting to different cultures" />
  <psc:chapter start="20:48" title="Reaching remote communities" />
  <psc:chapter start="22:15" title="Complementary perspectives" />
  <psc:chapter start="24:07" title="Motivating healthcare professionals" />
  <psc:chapter start="25:35" title="Plan early" />
  <psc:chapter start="27:05" title="Start simple" />
  <psc:chapter start="29:26" title="Focus on what you have" />
  <psc:chapter start="32:04" title="Outro" />
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    <itunes:duration>2032</itunes:duration>
    <itunes:keywords>campaign, communication, drug safety, medicine, medicines safety, #MedSafetyWeek, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>#24 A week in the name of medicines safety – part 1</itunes:title>
    <title>#24 A week in the name of medicines safety – part 1</title>
    <itunes:summary><![CDATA[Send a message to the show! To mark #MedSafetyWeek, which takes place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety. Tune in to find out: Why under-reporting plagues all pharmacovigilance systemsWhat regulators c...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>To mark <a href='https://who-umc.org/medsafetyweek/'>#MedSafetyWeek</a>, which takes place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety.</p><p><b>Tune in to find out:</b></p><ul><li>Why under-reporting plagues all pharmacovigilance systems</li><li>What regulators can do to encourage people to report side effects</li><li>Why we need reports from both patients and healthcare professionals</li></ul><p><b>Want to know more?</b></p><p><b> </b>Here are the studies cited in the episode:</p><ul><li>A BMJ study in 2022 measured the <a href='https://bmjopen.bmj.com/content/12/7/e055551'>burden and associated cost of adverse drug reactions</a>, polypharmacy and multimorbidity at a hospital in the UK.</li><li>In 1976, Inman proposed a theoretical model, known as the ‘seven deadly sins’, to explain why healthcare professionals fail to report adverse drug reactions. <a href='https://link.springer.com/article/10.1007/s40264-023-01302-7'>This recent systematic review</a> in Drug Safety expands on that. </li><li>The <a href='https://link.springer.com/article/10.1007/s40264-018-0708-5'>SCOPE Joint Action project</a> aimed to enhance pharmacovigilance in the EU and delivered practical guidance for regulators.</li><li>The <a href='https://link.springer.com/article/10.2165/11536510-000000000-00000'>first UK study</a> to compare Yellow Card reports from patients and healthcare professionals was published in 2012.</li></ul><p>To join the #MedSafetyWeek campaign next week, follow the hashtag online and check out the <a href='https://who-umc.org/medsafetyweek/'>campaign website</a> for free social media materials.</p><p>Finally, don’t forget to tune in on 13 November for part 2 of this podcast, where we’ll hear from #MedSafetyWeek advocates in Iraq, Luxembourg, and Namibia about their experience with the campaign. Read a preview of the conversation on <a href='https://www.uppsalareports.org/articles/start-small-but-think-big-trials-and-triumphs-of-medsafetyweek-campaigners/'>Uppsala Reports</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>To mark <a href='https://who-umc.org/medsafetyweek/'>#MedSafetyWeek</a>, which takes place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety.</p><p><b>Tune in to find out:</b></p><ul><li>Why under-reporting plagues all pharmacovigilance systems</li><li>What regulators can do to encourage people to report side effects</li><li>Why we need reports from both patients and healthcare professionals</li></ul><p><b>Want to know more?</b></p><p><b> </b>Here are the studies cited in the episode:</p><ul><li>A BMJ study in 2022 measured the <a href='https://bmjopen.bmj.com/content/12/7/e055551'>burden and associated cost of adverse drug reactions</a>, polypharmacy and multimorbidity at a hospital in the UK.</li><li>In 1976, Inman proposed a theoretical model, known as the ‘seven deadly sins’, to explain why healthcare professionals fail to report adverse drug reactions. <a href='https://link.springer.com/article/10.1007/s40264-023-01302-7'>This recent systematic review</a> in Drug Safety expands on that. </li><li>The <a href='https://link.springer.com/article/10.1007/s40264-018-0708-5'>SCOPE Joint Action project</a> aimed to enhance pharmacovigilance in the EU and delivered practical guidance for regulators.</li><li>The <a href='https://link.springer.com/article/10.2165/11536510-000000000-00000'>first UK study</a> to compare Yellow Card reports from patients and healthcare professionals was published in 2012.</li></ul><p>To join the #MedSafetyWeek campaign next week, follow the hashtag online and check out the <a href='https://who-umc.org/medsafetyweek/'>campaign website</a> for free social media materials.</p><p>Finally, don’t forget to tune in on 13 November for part 2 of this podcast, where we’ll hear from #MedSafetyWeek advocates in Iraq, Luxembourg, and Namibia about their experience with the campaign. Read a preview of the conversation on <a href='https://www.uppsalareports.org/articles/start-small-but-think-big-trials-and-triumphs-of-medsafetyweek-campaigners/'>Uppsala Reports</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 02 Nov 2023 14:00:00 +0100</pubDate>
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  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:28" title="Welcome, Mitul!" />
  <psc:chapter start="2:37" title="Why we need communications campaigns" />
  <psc:chapter start="6:46" title="Barriers to reporting" />
  <psc:chapter start="10:24" title="Different reporters, different perspectives" />
  <psc:chapter start="15:02" title="Other interventions to prompt reporting" />
  <psc:chapter start="19:47" title="Global versus local" />
  <psc:chapter start="23:34" title="Future of #MedSafetyWeek" />
  <psc:chapter start="25:58" title="Outro" />
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    <itunes:duration>1668</itunes:duration>
    <itunes:keywords>campaign, communication, drug safety, medicine, medicines safety, #MedSafetyWeek, patient safety, pharmacovigilance, science</itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – The colour of signals</itunes:title>
    <title>Uppsala Reports Long Reads – The colour of signals</title>
    <itunes:summary><![CDATA[Send a message to the show! Herbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines?  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.  After the read, we speak to author Daniele Sartori to learn more about the challenges in herbal p...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Herbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/the-colour-of-signals/'>original article here</a>.<br/><br/>After the read, we speak to author Daniele Sartori to learn more about the challenges in herbal pharmacovigilance.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why the risks of herbals are rarely discussed</li><li>How to encourage safety data collection for herbals</li><li>How to improve herbal nomenclature and regulation</li></ul><p><b>Want to know more?<br/><br/></b>Here are some of the resources cited in the episode:</p><ul><li>Underreporting of adverse reactions to herbal remedies is driven by <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1873549/'>our attitude towards herbals themselves</a>, but also by a <a href='https://onlinelibrary.wiley.com/doi/10.1111/j.2042-7174.2011.00150.x'>lack of training</a> on herbal medicines in healthcare curricula.</li><li>It is possible to safely use herbal medicines together with other medicines, but we must keep in mind some <a href='https://www.who.int/publications/i/item/9789240019140'>critical issues related to their interaction</a>.</li><li>Simple videos can <a href='https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14726'>dramatically increase public awareness</a> of ADR reporting schemes.</li><li>Kew Gardens’ <a href='https://mpns.science.kew.org/mpns-portal/'>Medicinal Plant Names Services</a> offers a systematic overview of medicinal plants and their accepted scientific names.</li><li>The American Botanical Council suggests methods to <a href='https://pubs.acs.org/doi/10.1021/acs.jnatprod.2c00929'>uncover attempts to adulterate plant extracts</a>.</li></ul><p>For a comprehensive overview of herbal pharmacovigilance, check out <a href='https://link.springer.com/book/10.1007/978-3-031-07275-8'>this recent book by Joanne Barnes and colleagues</a> covering advances, challenges, and international perspectives in the field.<br/><br/>For more on Daniele’s scoping review of signals or the thorny nomenclature of medicinal plants, listen to these episodes from the Drug Safety Matters archive:</p><ul><li> <a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.buzzsprout.com/618871/4302125'>Navigating the plant names jungle</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Herbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/the-colour-of-signals/'>original article here</a>.<br/><br/>After the read, we speak to author Daniele Sartori to learn more about the challenges in herbal pharmacovigilance.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why the risks of herbals are rarely discussed</li><li>How to encourage safety data collection for herbals</li><li>How to improve herbal nomenclature and regulation</li></ul><p><b>Want to know more?<br/><br/></b>Here are some of the resources cited in the episode:</p><ul><li>Underreporting of adverse reactions to herbal remedies is driven by <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1873549/'>our attitude towards herbals themselves</a>, but also by a <a href='https://onlinelibrary.wiley.com/doi/10.1111/j.2042-7174.2011.00150.x'>lack of training</a> on herbal medicines in healthcare curricula.</li><li>It is possible to safely use herbal medicines together with other medicines, but we must keep in mind some <a href='https://www.who.int/publications/i/item/9789240019140'>critical issues related to their interaction</a>.</li><li>Simple videos can <a href='https://bpspubs.onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14726'>dramatically increase public awareness</a> of ADR reporting schemes.</li><li>Kew Gardens’ <a href='https://mpns.science.kew.org/mpns-portal/'>Medicinal Plant Names Services</a> offers a systematic overview of medicinal plants and their accepted scientific names.</li><li>The American Botanical Council suggests methods to <a href='https://pubs.acs.org/doi/10.1021/acs.jnatprod.2c00929'>uncover attempts to adulterate plant extracts</a>.</li></ul><p>For a comprehensive overview of herbal pharmacovigilance, check out <a href='https://link.springer.com/book/10.1007/978-3-031-07275-8'>this recent book by Joanne Barnes and colleagues</a> covering advances, challenges, and international perspectives in the field.<br/><br/>For more on Daniele’s scoping review of signals or the thorny nomenclature of medicinal plants, listen to these episodes from the Drug Safety Matters archive:</p><ul><li> <a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.buzzsprout.com/618871/4302125'>Navigating the plant names jungle</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <pubDate>Fri, 29 Sep 2023 16:00:00 +0200</pubDate>
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  <psc:chapter start="9:48" title="Welcome, Daniele!" />
  <psc:chapter start="10:22" title="Why we don&#39;t talk about harms" />
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    <itunes:keywords>drug safety, herbal, herbal medicine, medicinal plant, medicine, medicines safety, patient safety, pharmacovigilance, science, traditional medicine, Uppsala Reports</itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – Empowering patients as partners</itunes:title>
    <title>Uppsala Reports Long Reads – Empowering patients as partners</title>
    <itunes:summary><![CDATA[Send a message to the show! A patient's perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes?  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.  After the read, we speak to Manal Younus, who authored the article, to learn more a...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>A patient&apos;s perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/empowering-patients-as-partners-patient-engagement-in-healthcare/'>original article here</a>.<br/><br/>After the read, we speak to Manal Younus, who authored the article, to learn more about patient engagement and its benefits for medicines safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How regulators and healthcare professionals can effectively engage patients</li><li>How patients can get involved in drug safety monitoring</li><li>What the pharmacovigilance community learned from the valproate case</li></ul><p><b>Want to know more?</b></p><p>In 2022, the Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on <a href='https://cioms.ch/publications/product/patient-involvement/'>patient involvement in the development, regulation and safe use of medicines</a>. They also recorded a <a href='https://www.youtube.com/watch?v=pOjIMrPOVRA'>webinar</a> to summarise the report’s main conclusions.<br/><br/>The International Society of Pharmacovigilance (ISoP) runs a <a href='https://isoponline.org/special-interest-groups/patient-engagement-group/'>patient engagement group</a> to advance patient involvement in the safety monitoring of medicines.<br/><br/>The <a href='https://www.gov.uk/guidance/valproate-use-by-women-and-girls'>Valproate toolkit</a>, developed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), supports healthcare professionals in advising women of childbearing age about the risks and benefits of valproate therapy.<br/><br/><a href='https://www.patientslikeme.com/'>PatientsLikeMe</a> is a digital platform where patients can share personal health stories, connect to peers, and learn about different conditions and treatments.<br/><br/>For more on patient engagement and communication, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8013525-7-the-challenge-of-rare-diseases-christina-strom-moller'>The challenge of rare diseases</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/10092641-13-how-to-talk-about-risks-alexandra-freeman'>How to talk about risks</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>A patient&apos;s perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/empowering-patients-as-partners-patient-engagement-in-healthcare/'>original article here</a>.<br/><br/>After the read, we speak to Manal Younus, who authored the article, to learn more about patient engagement and its benefits for medicines safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How regulators and healthcare professionals can effectively engage patients</li><li>How patients can get involved in drug safety monitoring</li><li>What the pharmacovigilance community learned from the valproate case</li></ul><p><b>Want to know more?</b></p><p>In 2022, the Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on <a href='https://cioms.ch/publications/product/patient-involvement/'>patient involvement in the development, regulation and safe use of medicines</a>. They also recorded a <a href='https://www.youtube.com/watch?v=pOjIMrPOVRA'>webinar</a> to summarise the report’s main conclusions.<br/><br/>The International Society of Pharmacovigilance (ISoP) runs a <a href='https://isoponline.org/special-interest-groups/patient-engagement-group/'>patient engagement group</a> to advance patient involvement in the safety monitoring of medicines.<br/><br/>The <a href='https://www.gov.uk/guidance/valproate-use-by-women-and-girls'>Valproate toolkit</a>, developed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), supports healthcare professionals in advising women of childbearing age about the risks and benefits of valproate therapy.<br/><br/><a href='https://www.patientslikeme.com/'>PatientsLikeMe</a> is a digital platform where patients can share personal health stories, connect to peers, and learn about different conditions and treatments.<br/><br/>For more on patient engagement and communication, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8013525-7-the-challenge-of-rare-diseases-christina-strom-moller'>The challenge of rare diseases</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/10092641-13-how-to-talk-about-risks-alexandra-freeman'>How to talk about risks</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 05 Sep 2023 14:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="Uppsala Reports Long Reads – Empowering patients as partners" />
  <psc:chapter start="0:48" title="Intro" />
  <psc:chapter start="2:06" title="Article read" />
  <psc:chapter start="9:29" title="Welcome, Manal!" />
  <psc:chapter start="10:50" title="History of patient engagement" />
  <psc:chapter start="13:35" title="Benefits for drug safety monitoring" />
  <psc:chapter start="17:04" title="Lessons from valproate" />
  <psc:chapter start="20:49" title="Overcoming obstacles" />
  <psc:chapter start="25:47" title="First steps" />
  <psc:chapter start="30:27" title="How to talk to patients" />
  <psc:chapter start="34:56" title="Patient and Consumers Working Party" />
  <psc:chapter start="36:57" title="Beyond the European Union" />
  <psc:chapter start="39:05" title="Starting the conversation" />
  <psc:chapter start="41:58" title="Outro" />
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    <itunes:duration>2602</itunes:duration>
    <itunes:keywords>communication, drug safety, medicine, medicines safety, patient engagement, patient safety, pharmacovigilance, science, Uppsala Reports</itunes:keywords>
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    <itunes:title>#23 Assessing safety in clinical trials – Marianne Lunzer &amp; Sanja Prpić</itunes:title>
    <title>#23 Assessing safety in clinical trials – Marianne Lunzer &amp; Sanja Prpić</title>
    <itunes:summary><![CDATA[Send a message to the show! Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations.  Tune in to find out: How pre- and post-approval safety studies are connectedWhy safety assessors can request studies in u...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations.<br/><br/><b>Tune in to find out:</b></p><ul><li>How pre- and post-approval safety studies are connected</li><li>Why safety assessors can request studies in underrepresented populations</li><li>How new regulations are impacting safety assessments in the EU</li></ul><p><b>Want to know more?<br/><br/></b><a href='https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-138'>This review in Trials</a> summarises the methodological challenges of assessing drug safety in clinical trials, while <a href='https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13513'>this study in Clinical and Translational Science</a> reviews how sex, racial, and ethnic diversity in clinical trials have changed in recent years. <br/><br/>Post-authorisation safety studies can be imposed or voluntary and can be carried out as clinical trials or as non-interventional studies. Read about the differences on <a href='https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass'>the European Medicines Agency’s website.</a><br/><br/>Large simple trials can control for biases in observational research while still providing results that are generalisable to real-world use. <a href='https://link.springer.com/article/10.2165/11593820-000000000-00000'>This review in Drug Safety</a> explains why.<br/><br/>The new <a href='https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation'>Clinical Trials Regulation</a> harmonises how EU trials are assessed and supervised for increased safety and transparency. As part of these efforts, the <a href='https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2023_01_CTCG_SAFE_CT.pdf'>SAFE CT project</a> aims to facilitate clinical trial coordination and safety assessments in the EU.<br/><br/>For more on clinical trials, revisit <a href='https://www.drugsafetymatterspod.org/618871/5676835-5-restoring-invisible-and-abandoned-trials-peter-doshi'>this conversation with Peter Doshi</a> on restoring invisible and abandoned trials.</p><p>This episode is the last of a three-part series on sources of evidence in pharmacovigilance. Listen to the first two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/12547412-21-unlocking-the-power-of-real-world-data-patrick-ryan'>Unlocking the power of real-world data</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations.<br/><br/><b>Tune in to find out:</b></p><ul><li>How pre- and post-approval safety studies are connected</li><li>Why safety assessors can request studies in underrepresented populations</li><li>How new regulations are impacting safety assessments in the EU</li></ul><p><b>Want to know more?<br/><br/></b><a href='https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-13-138'>This review in Trials</a> summarises the methodological challenges of assessing drug safety in clinical trials, while <a href='https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13513'>this study in Clinical and Translational Science</a> reviews how sex, racial, and ethnic diversity in clinical trials have changed in recent years. <br/><br/>Post-authorisation safety studies can be imposed or voluntary and can be carried out as clinical trials or as non-interventional studies. Read about the differences on <a href='https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/post-authorisation-safety-studies-pass'>the European Medicines Agency’s website.</a><br/><br/>Large simple trials can control for biases in observational research while still providing results that are generalisable to real-world use. <a href='https://link.springer.com/article/10.2165/11593820-000000000-00000'>This review in Drug Safety</a> explains why.<br/><br/>The new <a href='https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation'>Clinical Trials Regulation</a> harmonises how EU trials are assessed and supervised for increased safety and transparency. As part of these efforts, the <a href='https://www.hma.eu/fileadmin/dateien/HMA_joint/00-_About_HMA/03-Working_Groups/CTCG/2023_01_CTCG_SAFE_CT.pdf'>SAFE CT project</a> aims to facilitate clinical trial coordination and safety assessments in the EU.<br/><br/>For more on clinical trials, revisit <a href='https://www.drugsafetymatterspod.org/618871/5676835-5-restoring-invisible-and-abandoned-trials-peter-doshi'>this conversation with Peter Doshi</a> on restoring invisible and abandoned trials.</p><p>This episode is the last of a three-part series on sources of evidence in pharmacovigilance. Listen to the first two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/12547412-21-unlocking-the-power-of-real-world-data-patrick-ryan'>Unlocking the power of real-world data</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 27 Jun 2023 16:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="#23 Assessing safety in clinical trials – Marianne Lunzer &amp; Sanja Prpić" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:28" title="Welcome, Marianne and Sanja!" />
  <psc:chapter start="2:43" title="How is safety studied in clinical trials?" />
  <psc:chapter start="5:01" title="Strengths and limitations of clinical trials" />
  <psc:chapter start="7:56" title="Connecting pre- and post-approval studies" />
  <psc:chapter start="9:52" title="Large simple trials" />
  <psc:chapter start="11:36" title="Strengths and limitations of post-authorisation safety studies" />
  <psc:chapter start="13:26" title="Diversity in clinical trial populations" />
  <psc:chapter start="17:49" title="International cooperation" />
  <psc:chapter start="20:21" title="Clinical Trials Regulation" />
  <psc:chapter start="23:28" title="Lessons from the COVID pandemic" />
  <psc:chapter start="26:29" title="Integrating multiple sources of evidence" />
  <psc:chapter start="30:23" title="Outro" />
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    <itunes:duration>1905</itunes:duration>
    <itunes:keywords>clinical trials, drug safety, evidence, medicine, medicines safety, non-interventional studies, patient safety, pharmacovigilance, post-authorisation safety studies, science</itunes:keywords>
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    <itunes:title>#22 Reforming pharmacovigilance education – Michael Reumerman</itunes:title>
    <title>#22 Reforming pharmacovigilance education – Michael Reumerman</title>
    <itunes:summary><![CDATA[Send a message to the show! Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.  Tune in to find out: How real-life education can benefit healthcare studentsWhich educational intervention can be most impactfulHow adverse drug event managers can improve pharmacovigilan...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.<br/><br/><b>Tune in to find out:</b></p><ul><li>How real-life education can benefit healthcare students</li><li>Which educational intervention can be most impactful</li><li>How adverse drug event managers can improve pharmacovigilance</li></ul><p><br/><b>Want to know more?</b></p><p><a href='https://research.vu.nl/ws/portalfiles/portal/202743404/577946-bw-reumerman1+-+63bbe975f1865.pdf'>In his PhD thesis</a>, Michael details the current state of pharmacovigilance education and all the real-life interventions he and his colleagues have tested in the Netherlands so far.<br/><br/>As part of an <a href='https://pubmed.ncbi.nlm.nih.gov/33624120/'>international collaboration</a>, staff at Amsterdam UMC have helped set up the <a href='https://www.prescribingeducation.eu/'>European Open Platform for Prescribing Education (EurOP2E)</a>, an online collection of problem-based, <a href='https://pubmed.ncbi.nlm.nih.gov/36180446/'>open teaching resources</a> to improve clinical pharmacology and therapeutics education.<br/><br/>The World Health Organization’s <a href='https://apps.who.int/iris/bitstream/handle/10665/59001/WHO_DAP_94.11.pdf'>Guide to Good Prescribing</a> provides a six-step guide for students to the process of rational prescribing – but the time has come to <a href='https://pubmed.ncbi.nlm.nih.gov/31938856/'>update both its content and form</a>.<br/><br/>In 2018, the Netherlands Pharmacovigilance Centre Lareb developed a <a href='https://uppsalareports.org/articles/putting-pharmacovigilance-on-the-curriculum/'>core curriculum for pharmacovigilance education</a> in universities.<br/><br/>Whether you’re a healthcare professional or not, check out Uppsala Monitoring Centre’s growing collection of <a href='https://who-umc.org/education-and-training/'>self-paced e-learning courses</a> to learn about different aspects of pharmacovigilance.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.<br/><br/><b>Tune in to find out:</b></p><ul><li>How real-life education can benefit healthcare students</li><li>Which educational intervention can be most impactful</li><li>How adverse drug event managers can improve pharmacovigilance</li></ul><p><br/><b>Want to know more?</b></p><p><a href='https://research.vu.nl/ws/portalfiles/portal/202743404/577946-bw-reumerman1+-+63bbe975f1865.pdf'>In his PhD thesis</a>, Michael details the current state of pharmacovigilance education and all the real-life interventions he and his colleagues have tested in the Netherlands so far.<br/><br/>As part of an <a href='https://pubmed.ncbi.nlm.nih.gov/33624120/'>international collaboration</a>, staff at Amsterdam UMC have helped set up the <a href='https://www.prescribingeducation.eu/'>European Open Platform for Prescribing Education (EurOP2E)</a>, an online collection of problem-based, <a href='https://pubmed.ncbi.nlm.nih.gov/36180446/'>open teaching resources</a> to improve clinical pharmacology and therapeutics education.<br/><br/>The World Health Organization’s <a href='https://apps.who.int/iris/bitstream/handle/10665/59001/WHO_DAP_94.11.pdf'>Guide to Good Prescribing</a> provides a six-step guide for students to the process of rational prescribing – but the time has come to <a href='https://pubmed.ncbi.nlm.nih.gov/31938856/'>update both its content and form</a>.<br/><br/>In 2018, the Netherlands Pharmacovigilance Centre Lareb developed a <a href='https://uppsalareports.org/articles/putting-pharmacovigilance-on-the-curriculum/'>core curriculum for pharmacovigilance education</a> in universities.<br/><br/>Whether you’re a healthcare professional or not, check out Uppsala Monitoring Centre’s growing collection of <a href='https://who-umc.org/education-and-training/'>self-paced e-learning courses</a> to learn about different aspects of pharmacovigilance.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/12805441-22-reforming-pharmacovigilance-education-michael-reumerman.mp3" length="24184102" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Mon, 08 May 2023 14:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="#22 Reforming pharmacovigilance education – Michael Reumerman" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:19" title="Welcome, Michael!" />
  <psc:chapter start="2:36" title="Reporting barriers" />
  <psc:chapter start="4:18" title="One-size-fits-all solutions" />
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  <psc:chapter start="12:57" title="Adverse drug event managers" />
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  <psc:chapter start="16:43" title="Unique perspectives" />
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    <itunes:duration>2013</itunes:duration>
    <itunes:keywords>clinical education, drug safety, education, healthcare professionals, medicine, medicines safety, patient safety, pharmacovigilance, real-life education, science, teaching</itunes:keywords>
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    <itunes:title>#21 Unlocking the power of real-world data – Patrick Ryan</itunes:title>
    <title>#21 Unlocking the power of real-world data – Patrick Ryan</title>
    <itunes:summary><![CDATA[Send a message to the show! The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson &amp; Johnson discusses how to harness real-world data for patient safety.  Tune in to find out: How real-world data is collected and analysedWhich pharmacovigilance processes will benefit most from itHow to make da...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson &amp; Johnson discusses how to harness real-world data for patient safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How real-world data is collected and analysed</li><li>Which pharmacovigilance processes will benefit most from it</li><li>How to make data accessible without infringing patient privacy</li></ul><p> <br/><b>Want to know more?<br/><br/></b>Review the basics of real-world data and its use in the medicines life cycle <a href='https://link.springer.com/article/10.1007/s40290-022-00456-6'>in Pharmaceutical Medicine</a>, or read up on the opportunities and challenges for pharmacovigilance <a href='https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.2172'>in Clinical Pharmacology &amp; Therapeutics</a>.<br/><br/>In partnership with the <a href='https://ohdsi.org/'>Observational Health Data Sciences and Informatics (OHDSI)</a> and the <a href='https://www.ehden.eu/'>European Health Data &amp; Evidence Network (EHDEN)</a> consortia, UMC researchers are exploring how real-world data can help prioritise and validate signals in pharmacovigilance. Read about their latest collaboration on <a href='https://uppsalareports.org/articles/fruitful-start-for-ehden-powered-signal-discovery/'>Uppsala Reports</a>.<br/><br/>Another important player in the real-world data space is the <a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu'>Data Analysis and Real World Interrogation Network (DARWIN)</a>, which aims to provide timely and reliable evidence from real-world healthcare databases in the EU to improve the safety and effectiveness of medicines.<br/><br/>For more on real-world evidence and the challenges of working with big data, don’t miss the <a href='https://www.ehden.eu/webinars-and-podcasts/'>Voice of EHDEN</a> podcast or <a href='https://www.drugsafetymatterspod.org/618871/11863934-19-lessons-in-pandemic-pharmacovigilance-elena-rocca'>this conversation with Elena Rocca</a> from the Drug Safety Matters archive.</p><p>This episode is the second of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13116788-23-assessing-safety-in-clinical-trials-marianne-lunzer-sanja-prpic'>Assessing safety in clinical trials</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson &amp; Johnson discusses how to harness real-world data for patient safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How real-world data is collected and analysed</li><li>Which pharmacovigilance processes will benefit most from it</li><li>How to make data accessible without infringing patient privacy</li></ul><p> <br/><b>Want to know more?<br/><br/></b>Review the basics of real-world data and its use in the medicines life cycle <a href='https://link.springer.com/article/10.1007/s40290-022-00456-6'>in Pharmaceutical Medicine</a>, or read up on the opportunities and challenges for pharmacovigilance <a href='https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.2172'>in Clinical Pharmacology &amp; Therapeutics</a>.<br/><br/>In partnership with the <a href='https://ohdsi.org/'>Observational Health Data Sciences and Informatics (OHDSI)</a> and the <a href='https://www.ehden.eu/'>European Health Data &amp; Evidence Network (EHDEN)</a> consortia, UMC researchers are exploring how real-world data can help prioritise and validate signals in pharmacovigilance. Read about their latest collaboration on <a href='https://uppsalareports.org/articles/fruitful-start-for-ehden-powered-signal-discovery/'>Uppsala Reports</a>.<br/><br/>Another important player in the real-world data space is the <a href='https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu'>Data Analysis and Real World Interrogation Network (DARWIN)</a>, which aims to provide timely and reliable evidence from real-world healthcare databases in the EU to improve the safety and effectiveness of medicines.<br/><br/>For more on real-world evidence and the challenges of working with big data, don’t miss the <a href='https://www.ehden.eu/webinars-and-podcasts/'>Voice of EHDEN</a> podcast or <a href='https://www.drugsafetymatterspod.org/618871/11863934-19-lessons-in-pandemic-pharmacovigilance-elena-rocca'>this conversation with Elena Rocca</a> from the Drug Safety Matters archive.</p><p>This episode is the second of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12297094-20-the-evidence-for-signals-daniele-sartori'>The evidence for signals</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13116788-23-assessing-safety-in-clinical-trials-marianne-lunzer-sanja-prpic'>Assessing safety in clinical trials</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/12547412-21-unlocking-the-power-of-real-world-data-patrick-ryan.mp3" length="24760350" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 30 Mar 2023 11:00:00 +0200</pubDate>
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  <psc:chapter start="0:00" title="#21 Unlocking the power of real-world data – Patrick Ryan" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:17" title="Welcome, Patrick!" />
  <psc:chapter start="2:25" title="What is real-world data?" />
  <psc:chapter start="4:54" title="Sources of real-world data" />
  <psc:chapter start="7:22" title="Value for pharmacovigilance" />
  <psc:chapter start="9:58" title="Signal detection or assessment?" />
  <psc:chapter start="12:10" title="Post-authorisation safety studies" />
  <psc:chapter start="13:34" title="OHDSI and EHDEN" />
  <psc:chapter start="16:10" title="Study-a-thon" />
  <psc:chapter start="20:02" title="Challenges" />
  <psc:chapter start="22:37" title="Data privacy" />
  <psc:chapter start="24:34" title="Data quality" />
  <psc:chapter start="26:34" title="Quantity vs quality" />
  <psc:chapter start="29:30" title="Using real-world data more" />
  <psc:chapter start="32:42" title="Outro" />
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    <itunes:duration>2061</itunes:duration>
    <itunes:keywords>drug safety, EHDEN, evidence, health data, medicine, medicines safety, OHDSI, patient safety, pharmacovigilance, real world data, science</itunes:keywords>
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    <itunes:title>#20 The evidence for signals – Daniele Sartori</itunes:title>
    <title>#20 The evidence for signals – Daniele Sartori</title>
    <itunes:summary><![CDATA[Send a message to the show! Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.  Tune in to find out:  Which features of case reports are most often used to assess causality Why pharmacovigilance experts should report clinical assessments clearly&...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.<br/><br/><b>Tune in to find out:</b> </p><ul><li>Which features of case reports are most often used to assess causality </li><li>Why pharmacovigilance experts should report clinical assessments clearly </li><li>How to shorten the time between signal detection and communication </li></ul><p><br/><b>Want to know more?</b> <br/><br/>Check out the <a href='https://link.springer.com/article/10.1007/s40264-022-01258-0'>full scoping review</a> that inspired this episode.<br/><br/>In 2002, Meyboom and colleagues discussed criteria to <a href='https://pubmed.ncbi.nlm.nih.gov/12071784/'>select and follow up</a> on signals.<br/><br/>In the first chapter of <a href='https://link.springer.com/book/10.1007/978-3-030-29179-2'>Uncertainty in Pharmacology</a>, Aronson explains the difference between evidence <em>for </em>a mechanism and evidence <em>from </em>a mechanism.<br/><br/>In 2018, Murad and colleagues published a method to evaluate the <a href='https://ebm.bmj.com/content/ebmed/23/2/60.full.pdf'>quality of evidence</a> in a series of case reports.<br/><br/>UMC scientists have shown how <a href='https://who-umc.org/media/alzhmc0f/machine-learning-to-predict-safety-signals-using-molecular-similarity-and-disproportionality_quirant-poster.pdf'>chemical information</a> can support timely signal detection.<br/><br/>This episode is the first of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12547412-21-unlocking-the-power-of-real-world-data-patrick-ryan'>Unlocking the power of real-world data</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13116788-23-assessing-safety-in-clinical-trials-marianne-lunzer-sanja-prpic'>Assessing safety in clinical trials</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.<br/><br/><b>Tune in to find out:</b> </p><ul><li>Which features of case reports are most often used to assess causality </li><li>Why pharmacovigilance experts should report clinical assessments clearly </li><li>How to shorten the time between signal detection and communication </li></ul><p><br/><b>Want to know more?</b> <br/><br/>Check out the <a href='https://link.springer.com/article/10.1007/s40264-022-01258-0'>full scoping review</a> that inspired this episode.<br/><br/>In 2002, Meyboom and colleagues discussed criteria to <a href='https://pubmed.ncbi.nlm.nih.gov/12071784/'>select and follow up</a> on signals.<br/><br/>In the first chapter of <a href='https://link.springer.com/book/10.1007/978-3-030-29179-2'>Uncertainty in Pharmacology</a>, Aronson explains the difference between evidence <em>for </em>a mechanism and evidence <em>from </em>a mechanism.<br/><br/>In 2018, Murad and colleagues published a method to evaluate the <a href='https://ebm.bmj.com/content/ebmed/23/2/60.full.pdf'>quality of evidence</a> in a series of case reports.<br/><br/>UMC scientists have shown how <a href='https://who-umc.org/media/alzhmc0f/machine-learning-to-predict-safety-signals-using-molecular-similarity-and-disproportionality_quirant-poster.pdf'>chemical information</a> can support timely signal detection.<br/><br/>This episode is the first of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/12547412-21-unlocking-the-power-of-real-world-data-patrick-ryan'>Unlocking the power of real-world data</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/13116788-23-assessing-safety-in-clinical-trials-marianne-lunzer-sanja-prpic'>Assessing safety in clinical trials</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/12297094-20-the-evidence-for-signals-daniele-sartori.mp3" length="33382638" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-12297094</guid>
    <pubDate>Thu, 23 Feb 2023 09:00:00 +0100</pubDate>
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    <psc:chapters>
  <psc:chapter start="0:00" title="#20 The evidence for signals – Daniele Sartori" />
  <psc:chapter start="0:54" title="Intro" />
  <psc:chapter start="2:22" title="Welcome, Daniele!" />
  <psc:chapter start="2:52" title="What is a signal?" />
  <psc:chapter start="5:06" title="Sources of evidence" />
  <psc:chapter start="6:53" title="Why did you research this?" />
  <psc:chapter start="8:14" title="Scoping review" />
  <psc:chapter start="11:10" title="Signals based on case reports" />
  <psc:chapter start="13:32" title="Features of causality" />
  <psc:chapter start="15:23" title="Experimental evidence" />
  <psc:chapter start="18:00" title="Reporting clinical assessments" />
  <psc:chapter start="20:15" title="Case-by-case assessment" />
  <psc:chapter start="22:31" title="Unexpected findings" />
  <psc:chapter start="24:47" title="Value of other types of evidence" />
  <psc:chapter start="27:17" title="Pharmacological reasoning" />
  <psc:chapter start="33:04" title="Time to communication" />
  <psc:chapter start="36:41" title="Using signal information" />
  <psc:chapter start="40:12" title="Is artificial intelligence a threat?" />
  <psc:chapter start="42:05" title="Impact of the study" />
  <psc:chapter start="43:22" title="Future research" />
  <psc:chapter start="44:40" title="Outro" />
</psc:chapters>
    <itunes:duration>2780</itunes:duration>
    <itunes:keywords>case reports, drug safety, evidence, medicine, medicines safety, patient safety, pharmacovigilance, science, signal detection, spontaneous reports</itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era</itunes:title>
    <title>Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era</title>
    <itunes:summary><![CDATA[Send a message to the show! Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/unmasking-data-in-the-covid-19-vaccine-era/'>original article here</a>. <br/><br/>After the read, we speak to data scientist Sara Vidlin, who authored the article, to learn more about masking and how to deal with it.<br/><br/><b>Tune in to find out:</b> </p><ul><li>How masking evolves with the data </li><li>Which methods can be used to unmask data </li><li>What other pitfalls to watch out for when performing quantitative analyses</li></ul><p><b>Want to know more?<br/><br/></b>In the very beginning of the vaccine rollout, the USA FDA observed how <a href='https://link.springer.com/article/10.1007/s40264-022-01186-z'>early signals for COVID-19 vaccines were delayed because of other drugs</a> masking them, highlighting how masking is not a static phenomenon.<br/><br/>In 2013, Uppsala Monitoring Centre developed a <a href='https://onlinelibrary.wiley.com/doi/10.1002/pds.3474'>simple strategy to uncover masking</a> by identifying and removing influential outliers.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/unmasking-data-in-the-covid-19-vaccine-era/'>original article here</a>. <br/><br/>After the read, we speak to data scientist Sara Vidlin, who authored the article, to learn more about masking and how to deal with it.<br/><br/><b>Tune in to find out:</b> </p><ul><li>How masking evolves with the data </li><li>Which methods can be used to unmask data </li><li>What other pitfalls to watch out for when performing quantitative analyses</li></ul><p><b>Want to know more?<br/><br/></b>In the very beginning of the vaccine rollout, the USA FDA observed how <a href='https://link.springer.com/article/10.1007/s40264-022-01186-z'>early signals for COVID-19 vaccines were delayed because of other drugs</a> masking them, highlighting how masking is not a static phenomenon.<br/><br/>In 2013, Uppsala Monitoring Centre developed a <a href='https://onlinelibrary.wiley.com/doi/10.1002/pds.3474'>simple strategy to uncover masking</a> by identifying and removing influential outliers.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/12117074-uppsala-reports-long-reads-unmasking-data-in-the-covid-19-vaccine-era.mp3" length="15846156" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 26 Jan 2023 13:00:00 +0100</pubDate>
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  <psc:chapter start="0:00" title="Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era" />
  <psc:chapter start="0:47" title="Intro" />
  <psc:chapter start="2:04" title="Article read" />
  <psc:chapter start="8:25" title="Welcome, Sara!" />
  <psc:chapter start="8:38" title="Causes of masking" />
  <psc:chapter start="9:32" title="Masking by COVID-19 vaccine reports" />
  <psc:chapter start="12:52" title="Masking by other vaccine reports" />
  <psc:chapter start="14:19" title="Solutions" />
  <psc:chapter start="15:27" title="Raising awareness" />
  <psc:chapter start="16:39" title="Other pitfalls of quantitative analyses" />
  <psc:chapter start="20:01" title="Value of quantitative analyses" />
  <psc:chapter start="20:53" title="Outro" />
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    <itunes:duration>1319</itunes:duration>
    <itunes:keywords>data science, disproportionality, drug safety, masking, medicine, medicines safety, patient safety, pharmacovigilance, science, signal detection, Uppsala Reports</itunes:keywords>
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    <itunes:title>#19 Lessons in pandemic pharmacovigilance – Elena Rocca</itunes:title>
    <title>#19 Lessons in pandemic pharmacovigilance – Elena Rocca</title>
    <itunes:summary><![CDATA[Send a message to the show! The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.  Tune in to find out: How to handle uncertain evidenceWhy clinical expertise matters in the age of big dataWhy pharmacovigilance requires interdi...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How to handle uncertain evidence</li><li>Why clinical expertise matters in the age of big data</li><li>Why pharmacovigilance requires interdisciplinary thinking </li></ul><p><b>Want to know more?<br/><br/></b>In the article that inspired this episode, Elena Rocca and Birgitta Grundmark describe the <a href='https://www.argumenta.org/article/monitoring-safety-medicines-vaccines-times-pandemic-practical-conceptual-ethical-challenges-pharmacovigilance-special-issue/'>practical, conceptual, and ethical challenges</a> pharmacovigilance experts were faced with during the pandemic.<br/> <br/>See also <a href='https://journals.sagepub.com/doi/10.1177/20420986221118972'>this review by Annette Rudolph and colleagues at Uppsala Monitoring Centre</a> on the unique challenges of a global vaccination campaign.<br/><br/>Elena’s reflections on big data pharmacovigilance and its ethical implications were inspired by Sabina Leonelli’s work on <a href='https://elifesciences.org/articles/47381'>big data biology</a> and mathematician Cathy O’Neil’s <a href='https://en.wikipedia.org/wiki/Weapons_of_Math_Destruction'>Weapons of Math Destruction</a>.<br/><br/>The <a href='https://causehealthpharmacovigilance.wordpress.com/'>CauseHealth Pharmacovigilance</a> project, a collaboration between UMC and the NMBU Centre for Applied Philosophy of Science in Norway, ran between 2018 and 2021.<br/><br/>For more philosophical inspiration, revisit <a href='https://www.drugsafetymatterspod.org/618871/6839950'>this interview</a> with Eugene van Puijenbroek on intuition in pharmacovigilance or <a href='https://www.drugsafetymatterspod.org/618871/3726209'>this Uppsala Reports Long Read</a> on new approaches to causality.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How to handle uncertain evidence</li><li>Why clinical expertise matters in the age of big data</li><li>Why pharmacovigilance requires interdisciplinary thinking </li></ul><p><b>Want to know more?<br/><br/></b>In the article that inspired this episode, Elena Rocca and Birgitta Grundmark describe the <a href='https://www.argumenta.org/article/monitoring-safety-medicines-vaccines-times-pandemic-practical-conceptual-ethical-challenges-pharmacovigilance-special-issue/'>practical, conceptual, and ethical challenges</a> pharmacovigilance experts were faced with during the pandemic.<br/> <br/>See also <a href='https://journals.sagepub.com/doi/10.1177/20420986221118972'>this review by Annette Rudolph and colleagues at Uppsala Monitoring Centre</a> on the unique challenges of a global vaccination campaign.<br/><br/>Elena’s reflections on big data pharmacovigilance and its ethical implications were inspired by Sabina Leonelli’s work on <a href='https://elifesciences.org/articles/47381'>big data biology</a> and mathematician Cathy O’Neil’s <a href='https://en.wikipedia.org/wiki/Weapons_of_Math_Destruction'>Weapons of Math Destruction</a>.<br/><br/>The <a href='https://causehealthpharmacovigilance.wordpress.com/'>CauseHealth Pharmacovigilance</a> project, a collaboration between UMC and the NMBU Centre for Applied Philosophy of Science in Norway, ran between 2018 and 2021.<br/><br/>For more philosophical inspiration, revisit <a href='https://www.drugsafetymatterspod.org/618871/6839950'>this interview</a> with Eugene van Puijenbroek on intuition in pharmacovigilance or <a href='https://www.drugsafetymatterspod.org/618871/3726209'>this Uppsala Reports Long Read</a> on new approaches to causality.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/11863934-19-lessons-in-pandemic-pharmacovigilance-elena-rocca.mp3" length="24388200" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-11863934</guid>
    <pubDate>Thu, 15 Dec 2022 09:00:00 +0100</pubDate>
    <itunes:duration>2031</itunes:duration>
    <itunes:keywords>big data, COVID-19, drug safety, medicine, medicines safety, pandemic, patient safety, pharmacovigilance, philosophy, science, vaccine safety</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>#18 The IDMP standards explained – Malin Fladvad &amp; Olle Lagerlund</itunes:title>
    <title>#18 The IDMP standards explained – Malin Fladvad &amp; Olle Lagerlund</title>
    <itunes:summary><![CDATA[Send a message to the show! The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort. Tune in to find out: What the IDMP standards coverHow Uppsala Monitoring Centre...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort.</p><p><b>Tune in to find out:</b></p><ul><li>What the IDMP standards cover</li><li>How Uppsala Monitoring Centre will help create and maintain them</li><li>What is expected of other key stakeholders</li></ul><p><b>Want to know more?</b></p><p>UNICOM’s ‘IDMP in a capsule’ explains how the IDMP standards work throughout the life cycle of a medicinal product and is available as a <a href='https://unicom-project.eu/wp-content/uploads/2021/10/UNICOM-handboek_A4_04.pdf'>handbook</a> and <a href='https://www.youtube.com/watch?v=OfctZZoBRkk'>video tutorial.</a><br/><br/>Healthcare consultant Christian Hay discusses how IDMP will improve medication safety worldwide <a href='https://www.uppsalareports.org/articles/stamping-out-drug-adversity/'>in Uppsala Reports.</a><br/><br/>Development and implementation of the standards are led by the International Organization for Standardization (ISO), who described the key benefits of the project <a href='https://www.iso.org/news/2016/03/Ref2056.html'>in this article from 2016.</a><br/><br/>The IDMP standards for dose form and characteristics will be provided by the <a href='https://www.edqm.eu/en/'>European Directorate for the Quality of Medicines &amp; HealthCare (EDQM)</a>, and those for units by the <a href='https://ucum.org/'>Unified Code for Units of Measure (UCUM)</a>.<br/><br/>You can learn more about Uppsala Monitoring Centre’s role in the IDMP project and how the standards will affect the WHODrug Global drug dictionary <a href='https://who-umc.org/idmp/'>on our website</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort.</p><p><b>Tune in to find out:</b></p><ul><li>What the IDMP standards cover</li><li>How Uppsala Monitoring Centre will help create and maintain them</li><li>What is expected of other key stakeholders</li></ul><p><b>Want to know more?</b></p><p>UNICOM’s ‘IDMP in a capsule’ explains how the IDMP standards work throughout the life cycle of a medicinal product and is available as a <a href='https://unicom-project.eu/wp-content/uploads/2021/10/UNICOM-handboek_A4_04.pdf'>handbook</a> and <a href='https://www.youtube.com/watch?v=OfctZZoBRkk'>video tutorial.</a><br/><br/>Healthcare consultant Christian Hay discusses how IDMP will improve medication safety worldwide <a href='https://www.uppsalareports.org/articles/stamping-out-drug-adversity/'>in Uppsala Reports.</a><br/><br/>Development and implementation of the standards are led by the International Organization for Standardization (ISO), who described the key benefits of the project <a href='https://www.iso.org/news/2016/03/Ref2056.html'>in this article from 2016.</a><br/><br/>The IDMP standards for dose form and characteristics will be provided by the <a href='https://www.edqm.eu/en/'>European Directorate for the Quality of Medicines &amp; HealthCare (EDQM)</a>, and those for units by the <a href='https://ucum.org/'>Unified Code for Units of Measure (UCUM)</a>.<br/><br/>You can learn more about Uppsala Monitoring Centre’s role in the IDMP project and how the standards will affect the WHODrug Global drug dictionary <a href='https://who-umc.org/idmp/'>on our website</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/11372280-18-the-idmp-standards-explained-malin-fladvad-olle-lagerlund.mp3" length="17117611" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-11372280</guid>
    <pubDate>Thu, 29 Sep 2022 10:00:00 +0200</pubDate>
    <itunes:duration>1425</itunes:duration>
    <itunes:keywords>drug safety, IDMP, ISO, medicine, medicines safety, patient safety, pharmacovigilance, science, standards</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>#17 Why we need vaccine surveillance systems – Madhava Balakrishnan</itunes:title>
    <title>#17 Why we need vaccine surveillance systems – Madhava Balakrishnan</title>
    <itunes:summary><![CDATA[Send a message to the show! Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur. Tune in to find out: How safety surveillance differs between vaccines and drugsWhat the most common...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur.</p><p><b>Tune in to find out:</b></p><ul><li>How safety surveillance differs between vaccines and drugs</li><li>What the most common side effects of vaccines are</li><li>How to address the public’s concerns on vaccine safety</li></ul><p><b>Want to know more?<br/><br/></b>The World Health Organization offers free manuals on <a href='https://www.who.int/publications/i/item/10665206144'>surveillance</a> and <a href='https://www.who.int/publications/i/item/9789241516990'>causality assessment</a> of adverse events following immunisation (AEFI).<br/><br/>They also maintain an <a href='https://gvsi-aefi-tools.org/'>AEFI causality assessment software</a> where you can practice on real or sample cases, and an <a href='https://gvsi-aefi-tools.org/elearning.html'>online course on the principles and processes of AEFI causality assessment</a>.<br/><br/>In the BMJ Global Health, Madhava Balakrishnan and colleagues review <a href='https://gh.bmj.com/content/6/Suppl_2/e003908'>how online communication affects immunisation stress-related responses</a> and how to address public anxieties around vaccine safety.<br/><br/>For more on vaccines and risk communication, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/10092641'>How to talk about risks</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/9482726'>Talking about vaccine safety</a></li><li><a href='https://www.buzzsprout.com/618871/episodes/9108454'>Convincing the vaccine hesitant</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur.</p><p><b>Tune in to find out:</b></p><ul><li>How safety surveillance differs between vaccines and drugs</li><li>What the most common side effects of vaccines are</li><li>How to address the public’s concerns on vaccine safety</li></ul><p><b>Want to know more?<br/><br/></b>The World Health Organization offers free manuals on <a href='https://www.who.int/publications/i/item/10665206144'>surveillance</a> and <a href='https://www.who.int/publications/i/item/9789241516990'>causality assessment</a> of adverse events following immunisation (AEFI).<br/><br/>They also maintain an <a href='https://gvsi-aefi-tools.org/'>AEFI causality assessment software</a> where you can practice on real or sample cases, and an <a href='https://gvsi-aefi-tools.org/elearning.html'>online course on the principles and processes of AEFI causality assessment</a>.<br/><br/>In the BMJ Global Health, Madhava Balakrishnan and colleagues review <a href='https://gh.bmj.com/content/6/Suppl_2/e003908'>how online communication affects immunisation stress-related responses</a> and how to address public anxieties around vaccine safety.<br/><br/>For more on vaccines and risk communication, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/10092641'>How to talk about risks</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/9482726'>Talking about vaccine safety</a></li><li><a href='https://www.buzzsprout.com/618871/episodes/9108454'>Convincing the vaccine hesitant</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/11195673-17-why-we-need-vaccine-surveillance-systems-madhava-balakrishnan.mp3" length="20287104" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-11195673</guid>
    <pubDate>Wed, 24 Aug 2022 14:00:00 +0200</pubDate>
    <itunes:duration>1689</itunes:duration>
    <itunes:keywords>drug safety, medicine, medicines safety, patient safety, pharmacovigilance, safety surveillance, science, side effects, vaccine, vaccine safety, vaccine surveillance</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>#16 How drug safety can help fight resistant bugs – Jean Marie Vianney Habarugira &amp; Albert Figueras</itunes:title>
    <title>#16 How drug safety can help fight resistant bugs – Jean Marie Vianney Habarugira &amp; Albert Figueras</title>
    <itunes:summary><![CDATA[Send a message to the show! Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.  Tune in to find out: How to code adverse drug reactions for optimal AMR surveillanceHow to use pharmacovigilance networks to track resista...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.<br/><br/><b>Tune in to find out:</b></p><ul><li>How to code adverse drug reactions for optimal AMR surveillance</li><li>How to use pharmacovigilance networks to track resistant pathogens and falsified antimicrobials</li><li>Why collaborating with AMR specialists will benefit the drug safety community</li></ul><p><b>Want to know more?</b></p><ul><li>In their study, Jean Marie and Albert shortlisted <a href='https://onlinelibrary.wiley.com/doi/10.1002/pds.5249'>17 MedDRA codes</a> used to report AMR-related adverse drug reactions in a global and a <a href='https://www.mdpi.com/2079-6382/10/12/1512'>national pharmacovigilance database</a>.</li><li>Pharmacovigilance tools could be especially useful in <a href='https://link.springer.com/article/10.1007/s00228-020-03035-3'>estimating the burden of AMR in low-resource communities</a> that lack diagnostic lab capacity.</li><li>Jean Marie’s research was inspired by <a href='https://view.publitas.com/uppsala-monitoring-centre/web_uppsalareports_issue74/page/8-9'>this article in Uppsala Reports</a>, which defined antimicrobial resistance as an overlooked adverse event.</li><li>Since 2015, <a href='https://www.who.int/initiatives/glass'>the World Health Organization’s GLASS</a> (Global Antimicrobial Resistance and Use Surveillance System) has been used to collect, analyse, and share AMR data around the world.</li></ul><p>Interested in AMR from a social perspective? Then don’t miss <a href='https://www.drugsafetymatterspod.org/618871/8406336'>this Drug Safety Matters episode</a> on behaviour change communication.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.<br/><br/><b>Tune in to find out:</b></p><ul><li>How to code adverse drug reactions for optimal AMR surveillance</li><li>How to use pharmacovigilance networks to track resistant pathogens and falsified antimicrobials</li><li>Why collaborating with AMR specialists will benefit the drug safety community</li></ul><p><b>Want to know more?</b></p><ul><li>In their study, Jean Marie and Albert shortlisted <a href='https://onlinelibrary.wiley.com/doi/10.1002/pds.5249'>17 MedDRA codes</a> used to report AMR-related adverse drug reactions in a global and a <a href='https://www.mdpi.com/2079-6382/10/12/1512'>national pharmacovigilance database</a>.</li><li>Pharmacovigilance tools could be especially useful in <a href='https://link.springer.com/article/10.1007/s00228-020-03035-3'>estimating the burden of AMR in low-resource communities</a> that lack diagnostic lab capacity.</li><li>Jean Marie’s research was inspired by <a href='https://view.publitas.com/uppsala-monitoring-centre/web_uppsalareports_issue74/page/8-9'>this article in Uppsala Reports</a>, which defined antimicrobial resistance as an overlooked adverse event.</li><li>Since 2015, <a href='https://www.who.int/initiatives/glass'>the World Health Organization’s GLASS</a> (Global Antimicrobial Resistance and Use Surveillance System) has been used to collect, analyse, and share AMR data around the world.</li></ul><p>Interested in AMR from a social perspective? Then don’t miss <a href='https://www.drugsafetymatterspod.org/618871/8406336'>this Drug Safety Matters episode</a> on behaviour change communication.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/10867845-16-how-drug-safety-can-help-fight-resistant-bugs-jean-marie-vianney-habarugira-albert-figueras.mp3" length="24756301" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-10867845</guid>
    <pubDate>Thu, 30 Jun 2022 09:00:00 +0200</pubDate>
    <itunes:duration>2061</itunes:duration>
    <itunes:keywords>AMR, antibiotics, antibiotic resistance, antimicrobial resistance, antimicrobial stewardship, drug safety, EDCTP, medicine, medicines safety, patient safety, pharmacovigilance, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#15 Safety of HIV medications – Henry Zakumumpa</itunes:title>
    <title>#15 Safety of HIV medications – Henry Zakumumpa</title>
    <itunes:summary><![CDATA[Send a message to the show! With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.  Tune in to find out: How dolutegravir-based HIV therapies compare to earlier regimensHow pharm...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.<br/><br/><b>Tune in to find out:</b></p><ul><li>How dolutegravir-based HIV therapies compare to earlier regimens</li><li>How pharmacovigilance data can help shape HIV treatment guidelines </li><li>Why we should empower patients to share concerns about their healthcare</li></ul><p><b>Want to know more?<br/><br/></b><a href='https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06933-8'>Hyperglycemia, insomnia and reduced libido</a> were the most common side effects observed by Ugandan clinicians in patients taking dolutegravir.<br/><br/><a href='https://human-resources-health.biomedcentral.com/articles/10.1186/s12960-020-00479-7'>Nurses</a> are the backbone of HIV disease management in Uganda and could play an important role in pharmacovigilance activities as well.<br/><br/>Henry Zakumumpa’s research was supported by Uppsala Monitoring Centre in collaboration with <a href='https://cartafrica.org/'>CARTA, the Consortium for Advanced Research Training in Africa</a>, which is working to build up research capacity in public health.<br/><br/>The <a href='https://www.who.int/health-topics/hiv-aids#tab=tab_1'>World Health Organization’s resources on HIV/AIDS</a> include easily digestible information for patients, epidemiological data on disease spread, and current guidelines for prevention and treatment.</p><p>For more on African and patient-centred pharmacovigilance, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/10302499-14-advancing-pharmacovigilance-in-africa-eleni-aklillu-abbie-barry'>Advancing pharmacovigilance in Africa</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.<br/><br/><b>Tune in to find out:</b></p><ul><li>How dolutegravir-based HIV therapies compare to earlier regimens</li><li>How pharmacovigilance data can help shape HIV treatment guidelines </li><li>Why we should empower patients to share concerns about their healthcare</li></ul><p><b>Want to know more?<br/><br/></b><a href='https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-06933-8'>Hyperglycemia, insomnia and reduced libido</a> were the most common side effects observed by Ugandan clinicians in patients taking dolutegravir.<br/><br/><a href='https://human-resources-health.biomedcentral.com/articles/10.1186/s12960-020-00479-7'>Nurses</a> are the backbone of HIV disease management in Uganda and could play an important role in pharmacovigilance activities as well.<br/><br/>Henry Zakumumpa’s research was supported by Uppsala Monitoring Centre in collaboration with <a href='https://cartafrica.org/'>CARTA, the Consortium for Advanced Research Training in Africa</a>, which is working to build up research capacity in public health.<br/><br/>The <a href='https://www.who.int/health-topics/hiv-aids#tab=tab_1'>World Health Organization’s resources on HIV/AIDS</a> include easily digestible information for patients, epidemiological data on disease spread, and current guidelines for prevention and treatment.</p><p>For more on African and patient-centred pharmacovigilance, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/10302499-14-advancing-pharmacovigilance-in-africa-eleni-aklillu-abbie-barry'>Advancing pharmacovigilance in Africa</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>Why we should listen to patients</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/10526666-15-safety-of-hiv-medications-henry-zakumumpa.mp3" length="24479090" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-10526666</guid>
    <pubDate>Fri, 29 Apr 2022 15:00:00 +0200</pubDate>
    <itunes:duration>2038</itunes:duration>
    <itunes:keywords>Africa, AIDS, CARTA, drug safety, HIV, medicine, medicines safety, patient safety, pharmacovigilance, public health programme, science, Uganda</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#14 Advancing pharmacovigilance in Africa – Eleni Aklillu &amp; Abbie Barry</itunes:title>
    <title>#14 Advancing pharmacovigilance in Africa – Eleni Aklillu &amp; Abbie Barry</title>
    <itunes:summary><![CDATA[Send a message to the show! Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in East Africa – especially within public health programmes.  Tune in to find out: How comorbidities and genetic variation ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in East Africa – especially within public health programmes.<br/><br/><b>Tune in to find out:</b></p><ul><li>How comorbidities and genetic variation affect drug safety monitoring</li><li>Why pharmacovigilance centres should strengthen their ties with academia</li><li>How to apply the PROFORMA model elsewhere </li></ul><p><b>Want to know more?</b></p><ul><li>Low- and middle-income countries like the PROFORMA target nations face unique challenges in establishing robust pharmacovigilance systems, as described in <a href='https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15193'>this comprehensive review</a>.</li><li>PROFORMA’s <a href='https://link.springer.com/article/10.1007/s40264-019-00898-z'>baseline assessment</a> of national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania identified gaps and laid the groundwork for targeted interventions.</li><li>Their subsequent assessment of <a href='https://www.mdpi.com/1660-4601/18/4/1941'>pharmacovigilance capacity within the neglected tropical diseases programmes</a> highlighted the urgent need for collaboration between those programmes and the national pharmacovigilance centres.</li><li>You can read about PROFORMA’s accomplishments in more detail on <a href='https://www.uppsalareports.org/articles/proforma-project-promoting-medicines-safety-in-africa/'>Uppsala Reports</a> and on the <a href='https://proforma.ki.se/'>PROFORMA website</a>, which also lists the consortium’s publications and upcoming events.</li></ul><p>For more on the influence of genetic factors on drug response, revisit <a href='https://www.drugsafetymatterspod.org/618871/8795485-10-tailoring-drug-therapy-to-your-genes-qun-ying-yue'>this interview</a> with UMC’s pharmacogenetics specialist Qun-Ying Yue or <a href='https://www.drugsafetymatterspod.org/618871/7648585-uppsala-reports-long-reads-africa-integral-to-evolution-of-pharmacogenomics-research'>this Uppsala Reports Long Read</a> on pharmacogenomics research in Africa.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in East Africa – especially within public health programmes.<br/><br/><b>Tune in to find out:</b></p><ul><li>How comorbidities and genetic variation affect drug safety monitoring</li><li>Why pharmacovigilance centres should strengthen their ties with academia</li><li>How to apply the PROFORMA model elsewhere </li></ul><p><b>Want to know more?</b></p><ul><li>Low- and middle-income countries like the PROFORMA target nations face unique challenges in establishing robust pharmacovigilance systems, as described in <a href='https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/bcp.15193'>this comprehensive review</a>.</li><li>PROFORMA’s <a href='https://link.springer.com/article/10.1007/s40264-019-00898-z'>baseline assessment</a> of national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania identified gaps and laid the groundwork for targeted interventions.</li><li>Their subsequent assessment of <a href='https://www.mdpi.com/1660-4601/18/4/1941'>pharmacovigilance capacity within the neglected tropical diseases programmes</a> highlighted the urgent need for collaboration between those programmes and the national pharmacovigilance centres.</li><li>You can read about PROFORMA’s accomplishments in more detail on <a href='https://www.uppsalareports.org/articles/proforma-project-promoting-medicines-safety-in-africa/'>Uppsala Reports</a> and on the <a href='https://proforma.ki.se/'>PROFORMA website</a>, which also lists the consortium’s publications and upcoming events.</li></ul><p>For more on the influence of genetic factors on drug response, revisit <a href='https://www.drugsafetymatterspod.org/618871/8795485-10-tailoring-drug-therapy-to-your-genes-qun-ying-yue'>this interview</a> with UMC’s pharmacogenetics specialist Qun-Ying Yue or <a href='https://www.drugsafetymatterspod.org/618871/7648585-uppsala-reports-long-reads-africa-integral-to-evolution-of-pharmacogenomics-research'>this Uppsala Reports Long Read</a> on pharmacogenomics research in Africa.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/10302499-14-advancing-pharmacovigilance-in-africa-eleni-aklillu-abbie-barry.mp3" length="27373714" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-10302499</guid>
    <pubDate>Thu, 24 Mar 2022 09:00:00 +0100</pubDate>
    <itunes:duration>2279</itunes:duration>
    <itunes:keywords>Africa, drug safety, mass drug administration, mass immunisation, medicine, medicines safety, patient safety, pharmacovigilance, pharmacogenomics, public health programme, PROFORMA, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#13 How to talk about risks – Alexandra Freeman</itunes:title>
    <title>#13 How to talk about risks – Alexandra Freeman</title>
    <itunes:summary><![CDATA[Send a message to the show! People’s perception of risk can vary greatly from person to person, making it challenging for healthcare professionals to communicate benefits and harms of medicines in a balanced fashion. Alexandra Freeman from the Winton Centre for Risk and Evidence Communication discusses how to give patients the information they need to decide what's best for them.  Tune in to find out: Why people perceive risks so differentlyWhy medical communicators should strive to inform ra...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>People’s perception of risk can vary greatly from person to person, making it challenging for healthcare professionals to communicate benefits and harms of medicines in a balanced fashion. Alexandra Freeman from the Winton Centre for Risk and Evidence Communication discusses how to give patients the information they need to decide what&apos;s best for them.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why people perceive risks so differently</li><li>Why medical communicators should strive to inform rather than persuade</li><li>How to communicate in a trustworthy fashion</li></ul><p><b>Want to know more?</b></p><ul><li>There is no right way to communicate evidence to patients, but there are a few <a href='https://dtb.bmj.com/content/57/8/119'>things you can do</a> to avoid getting it wrong.</li><li>Conventional communication techniques are good for persuading people – but when the aim is to inform, the <a href='https://www.nature.com/articles/d41586-020-03189-1'>principles of evidence communication</a> should be applied instead.</li><li>Graphics can help people translate abstract numbers into <a href='https://blogs.bmj.com/bmj/2020/11/18/alexandra-freeman-the-strange-world-of-risk-perception-and-communicating-risks/'>contextualised risks</a> they can relate to, like <a href='https://wintoncentre.maths.cam.ac.uk/news/latest-data-mhra-blood-clots-associated-astra-zeneca-covid-19-vaccine/'>these visuals</a> that illustrate the risk of blood clots with the AstraZeneca COVID-19 vaccine.</li><li><a href='https://royalsocietypublishing.org/doi/10.1098/rsos.201721'>These evidence-based guidelines</a> can help professional communicators illustrate the personalised risk of dying from COVID-19.</li><li>The Winton Centre offers plenty of resources on risk and evidence communication, including <a href='https://moodle.wintoncentre.uk/'>free e-learning courses</a> for healthcare professionals, the <a href='https://riskytalk.libsyn.com/about'>Risky Talk podcast</a> with statistician David Spiegelhalter, and the <a href='https://realrisk.wintoncentre.uk/'>RealRisk tool</a> to help healthcare professionals and communicators extract the right statistics from academic papers.</li></ul><p>For more on communicating benefits and harms in pharmacovigilance, revisit <a href='https://www.drugsafetymatterspod.org/618871/9482726-11-talking-about-vaccine-safety-anthony-cox-daniel-salmon'>this Drug Safety Matters episode</a> on vaccine safety communication.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>People’s perception of risk can vary greatly from person to person, making it challenging for healthcare professionals to communicate benefits and harms of medicines in a balanced fashion. Alexandra Freeman from the Winton Centre for Risk and Evidence Communication discusses how to give patients the information they need to decide what&apos;s best for them.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why people perceive risks so differently</li><li>Why medical communicators should strive to inform rather than persuade</li><li>How to communicate in a trustworthy fashion</li></ul><p><b>Want to know more?</b></p><ul><li>There is no right way to communicate evidence to patients, but there are a few <a href='https://dtb.bmj.com/content/57/8/119'>things you can do</a> to avoid getting it wrong.</li><li>Conventional communication techniques are good for persuading people – but when the aim is to inform, the <a href='https://www.nature.com/articles/d41586-020-03189-1'>principles of evidence communication</a> should be applied instead.</li><li>Graphics can help people translate abstract numbers into <a href='https://blogs.bmj.com/bmj/2020/11/18/alexandra-freeman-the-strange-world-of-risk-perception-and-communicating-risks/'>contextualised risks</a> they can relate to, like <a href='https://wintoncentre.maths.cam.ac.uk/news/latest-data-mhra-blood-clots-associated-astra-zeneca-covid-19-vaccine/'>these visuals</a> that illustrate the risk of blood clots with the AstraZeneca COVID-19 vaccine.</li><li><a href='https://royalsocietypublishing.org/doi/10.1098/rsos.201721'>These evidence-based guidelines</a> can help professional communicators illustrate the personalised risk of dying from COVID-19.</li><li>The Winton Centre offers plenty of resources on risk and evidence communication, including <a href='https://moodle.wintoncentre.uk/'>free e-learning courses</a> for healthcare professionals, the <a href='https://riskytalk.libsyn.com/about'>Risky Talk podcast</a> with statistician David Spiegelhalter, and the <a href='https://realrisk.wintoncentre.uk/'>RealRisk tool</a> to help healthcare professionals and communicators extract the right statistics from academic papers.</li></ul><p>For more on communicating benefits and harms in pharmacovigilance, revisit <a href='https://www.drugsafetymatterspod.org/618871/9482726-11-talking-about-vaccine-safety-anthony-cox-daniel-salmon'>this Drug Safety Matters episode</a> on vaccine safety communication.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/10092641-13-how-to-talk-about-risks-alexandra-freeman.mp3" length="28046685" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 24 Feb 2022 09:00:00 +0100</pubDate>
    <itunes:duration>2335</itunes:duration>
    <itunes:keywords>evidence communication, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, risk, risk communication, risk perception, science, Winton Centre</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>Uppsala Reports Long Reads – Safety issues faced by refugee communities</itunes:title>
    <title>Uppsala Reports Long Reads – Safety issues faced by refugee communities</title>
    <itunes:summary><![CDATA[Send a message to the show! The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt Chapter and the Palestine Red Crescent Society are taking on this problem, to reduce medication errors and improve reporting practices.  This episode is part of the Uppsala Report...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt Chapter and the Palestine Red Crescent Society are taking on this problem, to reduce medication errors and improve reporting practices.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/egypt-addresses-safety-issues-faced-by-refugee-community/'>original article here</a>.<br/><br/>After the read, we speak to Mohamed Elhawary and Hadir Rostom, who co-authored the article, to learn more about their work and the overall challenge of ensuring medicines safety in vulnerable communities.<br/><br/><b>Tune in to find out:</b></p><ul><li>What the most frequent causes of medication errors in refugee communities are</li><li>How electronic health records can help prevent harm to patients </li><li>Why safety monitoring is crucial when there is a shortage of medicines</li></ul><p><b>Want to know more?<br/><br/></b>The International Society of Pharmacovigilance runs a <a href='https://link.springer.com/article/10.1007/s40264-021-01145-0'>Special Interest Group on medication errors</a> to promote the implementation of best safety practices around the world. They also organise a range of <a href='https://isoponline.org/'>networking and training activities for pharmacovigilance professionals</a> on different aspects of medicines safety.<br/><br/>The United Nations High Commissioner for Refugees (UNHCR) has practical advice for healthcare workers to <a href='https://www.unhcr.org/5cd962bc7.pdf'>promote treatment adherence in refugee settings</a>. <br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt Chapter and the Palestine Red Crescent Society are taking on this problem, to reduce medication errors and improve reporting practices.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/egypt-addresses-safety-issues-faced-by-refugee-community/'>original article here</a>.<br/><br/>After the read, we speak to Mohamed Elhawary and Hadir Rostom, who co-authored the article, to learn more about their work and the overall challenge of ensuring medicines safety in vulnerable communities.<br/><br/><b>Tune in to find out:</b></p><ul><li>What the most frequent causes of medication errors in refugee communities are</li><li>How electronic health records can help prevent harm to patients </li><li>Why safety monitoring is crucial when there is a shortage of medicines</li></ul><p><b>Want to know more?<br/><br/></b>The International Society of Pharmacovigilance runs a <a href='https://link.springer.com/article/10.1007/s40264-021-01145-0'>Special Interest Group on medication errors</a> to promote the implementation of best safety practices around the world. They also organise a range of <a href='https://isoponline.org/'>networking and training activities for pharmacovigilance professionals</a> on different aspects of medicines safety.<br/><br/>The United Nations High Commissioner for Refugees (UNHCR) has practical advice for healthcare workers to <a href='https://www.unhcr.org/5cd962bc7.pdf'>promote treatment adherence in refugee settings</a>. <br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/9961913-uppsala-reports-long-reads-safety-issues-faced-by-refugee-communities.mp3" length="18587794" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-9961913</guid>
    <pubDate>Thu, 27 Jan 2022 11:00:00 +0100</pubDate>
    <itunes:duration>1547</itunes:duration>
    <itunes:keywords>drug safety, Egypt, electronic health record, ISoP, medicine, medicines safety, patient safety, pharmacovigilance, refugee, science, Uppsala Reports</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>#12 Improving signal detection with vigiGroup – Jim Barrett &amp; Joe Mitchell</itunes:title>
    <title>#12 Improving signal detection with vigiGroup – Jim Barrett &amp; Joe Mitchell</title>
    <itunes:summary><![CDATA[Send a message to the show! Statistical tools can not only cut through the noise in large pharmacovigilance databases. They can also help identify more clinically meaningful patterns in the data. Uppsala Monitoring Centre’s Jim Barrett and Joe Mitchell explain how vigiGroup, a novel clustering algorithm, can bring value to signal detection.  Tune in to find out: What the limits of traditional disproportionality analysis areHow clustering algorithms can improve current signal detection practic...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Statistical tools can not only cut through the noise in large pharmacovigilance databases. They can also help identify more clinically meaningful patterns in the data. Uppsala Monitoring Centre’s Jim Barrett and Joe Mitchell explain how vigiGroup, a novel clustering algorithm, can bring value to signal detection.<br/><br/><b>Tune in to find out:</b></p><ul><li>What the limits of traditional disproportionality analysis are</li><li>How clustering algorithms can improve current signal detection practices</li><li>How vigiGroup has helped monitor the safety of COVID-19 vaccines so far</li></ul><p><b>Want to know more?</b></p><ul><li>By applying vigiGroup to COVID-19 vaccine reports in VigiBase, our Research team was able to identify a number of potential safety signals. Find out more in <a href='https://who-umc.org/media/tv1mwujk/exploring-the-safety-profiles-of-the-covid19-vaccines-in-vigibase-using-vigigroup-isop.pdf'>this poster</a> or in <a href='https://www.youtube.com/watch?v=Fht9MrGiR-U'>this presentation</a>. </li><li>Details on how the vigiGroup method was developed and tested can be found in the <a href='https://www.sciencedirect.com/science/article/pii/S0933365721001925'>original publication in Artificial Intelligence in Medicine</a>.</li><li><a href='https://www.sciencedirect.com/science/article/pii/S2590136221000395'>Appendicitis</a> was one of the possible safety signals for the COVID-19 vaccines identified with vigiGroup.</li></ul><p>For more on signal detection at Uppsala Monitoring Centre, visit the <a href='https://who-umc.org/signal-work/'>Signal Work section on our website</a> or listen to <a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>this interview with Helena Sköld and Annette Rudolph</a> on vaccine pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Statistical tools can not only cut through the noise in large pharmacovigilance databases. They can also help identify more clinically meaningful patterns in the data. Uppsala Monitoring Centre’s Jim Barrett and Joe Mitchell explain how vigiGroup, a novel clustering algorithm, can bring value to signal detection.<br/><br/><b>Tune in to find out:</b></p><ul><li>What the limits of traditional disproportionality analysis are</li><li>How clustering algorithms can improve current signal detection practices</li><li>How vigiGroup has helped monitor the safety of COVID-19 vaccines so far</li></ul><p><b>Want to know more?</b></p><ul><li>By applying vigiGroup to COVID-19 vaccine reports in VigiBase, our Research team was able to identify a number of potential safety signals. Find out more in <a href='https://who-umc.org/media/tv1mwujk/exploring-the-safety-profiles-of-the-covid19-vaccines-in-vigibase-using-vigigroup-isop.pdf'>this poster</a> or in <a href='https://www.youtube.com/watch?v=Fht9MrGiR-U'>this presentation</a>. </li><li>Details on how the vigiGroup method was developed and tested can be found in the <a href='https://www.sciencedirect.com/science/article/pii/S0933365721001925'>original publication in Artificial Intelligence in Medicine</a>.</li><li><a href='https://www.sciencedirect.com/science/article/pii/S2590136221000395'>Appendicitis</a> was one of the possible safety signals for the COVID-19 vaccines identified with vigiGroup.</li></ul><p>For more on signal detection at Uppsala Monitoring Centre, visit the <a href='https://who-umc.org/signal-work/'>Signal Work section on our website</a> or listen to <a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>this interview with Helena Sköld and Annette Rudolph</a> on vaccine pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/9731548-12-improving-signal-detection-with-vigigroup-jim-barrett-joe-mitchell.mp3" length="17299755" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-9731548</guid>
    <pubDate>Thu, 16 Dec 2021 16:00:00 +0100</pubDate>
    <itunes:duration>1440</itunes:duration>
    <itunes:keywords>data science, drug safety, medicine, medicines safety, patient safety, pharmacovigilance, science, signal detection, vigiGroup</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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    <itunes:title>#11 Talking about vaccine safety – Anthony Cox &amp; Daniel Salmon</itunes:title>
    <title>#11 Talking about vaccine safety – Anthony Cox &amp; Daniel Salmon</title>
    <itunes:summary><![CDATA[Send a message to the show! With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best advice for balanced and responsible vaccine safety communication.  Tune in to find out: Why we can’t allow bad actors to ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best advice for balanced and responsible vaccine safety communication.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why we can’t allow bad actors to damage the drive for openness in research and data</li><li>Why we should be open about uncertainty and always frame risks in the context of benefits</li><li>How to prevent public health advocacy from biasing the science of vaccine safety</li></ul><p><b>Want to know more?<br/><br/></b>The <a href='https://ohei.med.umich.edu/sites/default/files/files/downloads/FINAL%20COVID19VaccineHandbook%204%20production.pdf'>COVID-19 Vaccine Communication Handbook</a> is a practical guide for anyone who wishes to improve their vaccine communication and challenge misinformation.<br/><br/>The <a href='https://cioms.ch/wp-content/uploads/2019/05/WEB-CIOMS-Communication-Guide-2018.pdf'>CIOMS Guide to Vaccine Safety Communication</a> helps medicine regulators communicate the uncertainties, risks and safety of vaccines.<br/><br/>The World Health Organization provides resources on <a href='https://www.who.int/news-room/feature-stories/detail/how-to-talk-about-vaccines'>vaccine communication</a> and a series of illustrated articles on <a href='https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/explainers'>vaccine development and distribution</a>.<br/><br/>In his <a href='https://anthonycox.substack.com/'>Is it Safe?</a> newsletter, Anthony Cox discusses the science, practice, and practicalities of medicine safety – including the latest developments with COVID-19 vaccines.<br/><br/>For more on vaccines, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/9108454-uppsala-reports-long-reads-convincing-the-vaccine-hesitant'>Convincing the vaccine hesitant</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8591012-uppsala-reports-long-reads-substandard-and-falsified-covid-19-vaccines-in-the-americas'>Substandard and falsified COVID-19 vaccines in the Americas</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6027052-uppsala-reports-long-reads-vaccination-errors-risk-harm-and-damage-trust'>Vaccination errors risk harm and damage trust</a></li></ul><p>Finally, we featured these interviews with Anthony Cox and Daniel Salmon as an article in <a href='https://www.uppsalareports.org/articles/talking-about-vaccine-safety/'>Uppsala Reports</a>, too.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best advice for balanced and responsible vaccine safety communication.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why we can’t allow bad actors to damage the drive for openness in research and data</li><li>Why we should be open about uncertainty and always frame risks in the context of benefits</li><li>How to prevent public health advocacy from biasing the science of vaccine safety</li></ul><p><b>Want to know more?<br/><br/></b>The <a href='https://ohei.med.umich.edu/sites/default/files/files/downloads/FINAL%20COVID19VaccineHandbook%204%20production.pdf'>COVID-19 Vaccine Communication Handbook</a> is a practical guide for anyone who wishes to improve their vaccine communication and challenge misinformation.<br/><br/>The <a href='https://cioms.ch/wp-content/uploads/2019/05/WEB-CIOMS-Communication-Guide-2018.pdf'>CIOMS Guide to Vaccine Safety Communication</a> helps medicine regulators communicate the uncertainties, risks and safety of vaccines.<br/><br/>The World Health Organization provides resources on <a href='https://www.who.int/news-room/feature-stories/detail/how-to-talk-about-vaccines'>vaccine communication</a> and a series of illustrated articles on <a href='https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/explainers'>vaccine development and distribution</a>.<br/><br/>In his <a href='https://anthonycox.substack.com/'>Is it Safe?</a> newsletter, Anthony Cox discusses the science, practice, and practicalities of medicine safety – including the latest developments with COVID-19 vaccines.<br/><br/>For more on vaccines, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/9108454-uppsala-reports-long-reads-convincing-the-vaccine-hesitant'>Convincing the vaccine hesitant</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8591012-uppsala-reports-long-reads-substandard-and-falsified-covid-19-vaccines-in-the-americas'>Substandard and falsified COVID-19 vaccines in the Americas</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6027052-uppsala-reports-long-reads-vaccination-errors-risk-harm-and-damage-trust'>Vaccination errors risk harm and damage trust</a></li></ul><p>Finally, we featured these interviews with Anthony Cox and Daniel Salmon as an article in <a href='https://www.uppsalareports.org/articles/talking-about-vaccine-safety/'>Uppsala Reports</a>, too.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/9482726-11-talking-about-vaccine-safety-anthony-cox-daniel-salmon.mp3" length="21277344" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-9482726</guid>
    <pubDate>Wed, 03 Nov 2021 13:00:00 +0100</pubDate>
    <itunes:duration>1771</itunes:duration>
    <itunes:keywords>communication, medicine, patient safety, pharmacovigilance, science, side effect, vaccines, vaccine hesitancy, vaccine safety</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – The KIDs List</itunes:title>
    <title>Uppsala Reports Long Reads – The KIDs List</title>
    <itunes:summary><![CDATA[Send a message to the show! It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribing for the better.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribing for the better.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/improving-medication-safety-for-children-the-kids-list/'>original article here</a>.<br/><br/>After the read, we speak to Rachel Meyers and David Hoff, who co-authored the KIDs List, to learn more about their work and the overall challenges of medicines safety in children.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why adverse drug reactions tend to occur more often in the paediatric population</li><li>How the KIDs List can improve prescribing for children </li><li>How to collect even better safety information on paediatric drugs in the future</li></ul><p><b>Want to know more?<br/><br/></b>The KIDs List was first published in <a href='https://meridian.allenpress.com/jppt/article/25/3/175/433697/Key-Potentially-Inappropriate-Drugs-in-Pediatrics'>The Journal of Pediatric Pharmacology and Therapeutics</a>, where you can find more information on how the list was compiled and how it is meant to be used.<br/><br/>In an earlier commentary for the <a href='https://www.sciencedirect.com/science/article/pii/S0022354919306665?via%3Dihub'>Journal of Pharmaceutical Sciences</a>, Rachel Meyers reflects on the changes she’d like to see in how paediatric drugs are developed.<br/><br/>In Europe, the <a href='https://www.imi.europa.eu/projects-results/project-factsheets/c4c'>conect4children (c4c) project</a> aims to speed up and facilitate high-quality clinical trials in children while ensuring that the voices of young patients and their families are heard.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribing for the better.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/improving-medication-safety-for-children-the-kids-list/'>original article here</a>.<br/><br/>After the read, we speak to Rachel Meyers and David Hoff, who co-authored the KIDs List, to learn more about their work and the overall challenges of medicines safety in children.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why adverse drug reactions tend to occur more often in the paediatric population</li><li>How the KIDs List can improve prescribing for children </li><li>How to collect even better safety information on paediatric drugs in the future</li></ul><p><b>Want to know more?<br/><br/></b>The KIDs List was first published in <a href='https://meridian.allenpress.com/jppt/article/25/3/175/433697/Key-Potentially-Inappropriate-Drugs-in-Pediatrics'>The Journal of Pediatric Pharmacology and Therapeutics</a>, where you can find more information on how the list was compiled and how it is meant to be used.<br/><br/>In an earlier commentary for the <a href='https://www.sciencedirect.com/science/article/pii/S0022354919306665?via%3Dihub'>Journal of Pharmaceutical Sciences</a>, Rachel Meyers reflects on the changes she’d like to see in how paediatric drugs are developed.<br/><br/>In Europe, the <a href='https://www.imi.europa.eu/projects-results/project-factsheets/c4c'>conect4children (c4c) project</a> aims to speed up and facilitate high-quality clinical trials in children while ensuring that the voices of young patients and their families are heard.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/9313838-uppsala-reports-long-reads-the-kids-list.mp3" length="22910166" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-9313838</guid>
    <pubDate>Tue, 05 Oct 2021 16:00:00 +0200</pubDate>
    <itunes:duration>1907</itunes:duration>
    <itunes:keywords>KIDs List, medicine, medicine safety, paediatrics, patient safety, pediatrics, pharmacovigilance, science, Uppsala Reports</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>Uppsala Reports Long Reads – Convincing the vaccine hesitant</itunes:title>
    <title>Uppsala Reports Long Reads – Convincing the vaccine hesitant</title>
    <itunes:summary><![CDATA[Send a message to the show! Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination belief and vaccine hesitancy.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination belief and vaccine hesitancy.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/countering-narratives-of-distrust-key-to-convincing-the-vaccine-hesitant/'>original article here</a>.<br/><br/>After the read, we speak to Uppsala Reports editor Gerard Ross about the dangers of polarising the conversation on vaccines, the role of social media, and how it all boils down to trust.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why having questions or worries about vaccines is not the same thing as being anti-vaccination</li><li>Why directing appropriate communication at the vaccine hesitant is more effective than attacking the vaccine deniers</li><li>How cultural sensitivity and emotional intelligence can benefit pro-vaccine communication</li></ul><p><b>Want to know more?</b></p><p>The World Health Organization provides resources on <a href='https://www.who.int/news-room/feature-stories/detail/how-to-talk-about-vaccines'>vaccine communication in general</a> and <a href='https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice'>COVID-19 vaccines</a> in particular.<br/><br/>The University of Queensland’s online course on <a href='https://www.edx.org/course/antivaccination-and-vaccine-hesitancy?index=undefined&amp;position=1'>Antivaccination and Vaccine Hesitancy</a> is available to people anywhere in the world.<br/><br/>For more on vaccine safety and confidence, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8591012-uppsala-reports-long-reads-substandard-and-falsified-covid-19-vaccines-in-the-americas'>Substandard and falsified COVID-19 vaccines in the Americas</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6027052-uppsala-reports-long-reads-vaccination-errors-risk-harm-and-damage-trust'>Vaccination errors risk harm and damage trust</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination belief and vaccine hesitancy.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/countering-narratives-of-distrust-key-to-convincing-the-vaccine-hesitant/'>original article here</a>.<br/><br/>After the read, we speak to Uppsala Reports editor Gerard Ross about the dangers of polarising the conversation on vaccines, the role of social media, and how it all boils down to trust.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why having questions or worries about vaccines is not the same thing as being anti-vaccination</li><li>Why directing appropriate communication at the vaccine hesitant is more effective than attacking the vaccine deniers</li><li>How cultural sensitivity and emotional intelligence can benefit pro-vaccine communication</li></ul><p><b>Want to know more?</b></p><p>The World Health Organization provides resources on <a href='https://www.who.int/news-room/feature-stories/detail/how-to-talk-about-vaccines'>vaccine communication in general</a> and <a href='https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines/advice'>COVID-19 vaccines</a> in particular.<br/><br/>The University of Queensland’s online course on <a href='https://www.edx.org/course/antivaccination-and-vaccine-hesitancy?index=undefined&amp;position=1'>Antivaccination and Vaccine Hesitancy</a> is available to people anywhere in the world.<br/><br/>For more on vaccine safety and confidence, check out these episodes from the Drug Safety Matters archive:</p><ul><li><a href='https://www.drugsafetymatterspod.org/618871/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph'>Keeping vaccines safe</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/8591012-uppsala-reports-long-reads-substandard-and-falsified-covid-19-vaccines-in-the-americas'>Substandard and falsified COVID-19 vaccines in the Americas</a></li><li><a href='https://www.drugsafetymatterspod.org/618871/6027052-uppsala-reports-long-reads-vaccination-errors-risk-harm-and-damage-trust'>Vaccination errors risk harm and damage trust</a></li></ul><p>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/9108454-uppsala-reports-long-reads-convincing-the-vaccine-hesitant.mp3" length="25598202" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-9108454</guid>
    <pubDate>Mon, 30 Aug 2021 13:00:00 +0200</pubDate>
    <itunes:duration>2131</itunes:duration>
    <itunes:keywords>anti-vaccination, COVID-19, Tom Aechtner, medicine, patient safety, pandemic, pharmacovigilance, science, Uppsala Reports, vaccines, vaccine hesitancy</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#10 Tailoring drug therapy to your genes – Qun-Ying Yue</itunes:title>
    <title>#10 Tailoring drug therapy to your genes – Qun-Ying Yue</title>
    <itunes:summary><![CDATA[Send a message to the show! Genetic variation is one of the reasons people differ in their response to medicines. Understanding that variation can inform more refined choices of drugs and doses – ultimately preventing undesired side effects. Join us as we discuss past, present and future of pharmacogenomics with Uppsala Monitoring Centre’s Qun-Ying Yue. Tune in to find out: How genetic biomarkers can guide medicine use and dosing recommendationsWhat we need to effectively implement genetic-ba...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Genetic variation is one of the reasons people differ in their response to medicines. Understanding that variation can inform more refined choices of drugs and doses – ultimately preventing undesired side effects. Join us as we discuss past, present and future of pharmacogenomics with Uppsala Monitoring Centre’s Qun-Ying Yue.</p><p><b>Tune in to find out:</b></p><ul><li>How genetic biomarkers can guide medicine use and dosing recommendations</li><li>What we need to effectively implement genetic-based prescribing in clinical practice</li><li>How increasing diversity in clinical trials can aid pharmacogenomics research </li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li><a href='https://www.nature.com/articles/s41397-020-0148-3'>SWEDEGENE</a> is a Swedish nation-wide DNA sample collection established to facilitate pharmacogenomic studies of serious adverse drug reactions.</li><li>The African continent, with its genetically diverse populations, is a treasure trove of pharmacogenomics data – as long as African patients are included in drug studies, as we discussed in <a href='https://www.drugsafetymatterspod.org/618871/7648585-uppsala-reports-long-reads-africa-integral-to-evolution-of-pharmacogenomics-research'>this Uppsala Reports Long Read episode.</a></li><li>As a past member of the European Medicines Agency’s <a href='https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/pharmacogenomics-working-party'>Pharmacogenomics Working Party</a>, Ying contributed to the <a href='https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal_en.pdf'>“Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products”</a>.</li><li>Ying also chairs <a href='https://isoponline.org/special-interest-groups/pharmacogenomics/'>ISoP’s Pharmacogenomics Special Interest Group</a>, whose work and objectives have been described in <a href='https://www.uppsalareports.org/articles/pharmacogenomics-group-aims-to-refine-patient-safety-options/'>Uppsala Reports</a> and <a href='https://link.springer.com/article/10.1007/s40264-021-01068-w?wt_mc=Internal.Event.1.SEM.ArticleAuthorOnlineFirst&amp;utm_source=ArticleAuthorOnlineFirst&amp;utm_medium=email&amp;utm_content=AA_en_06082018&amp;ArticleAuthorOnlineFirst_20210509'>Drug Safety</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Genetic variation is one of the reasons people differ in their response to medicines. Understanding that variation can inform more refined choices of drugs and doses – ultimately preventing undesired side effects. Join us as we discuss past, present and future of pharmacogenomics with Uppsala Monitoring Centre’s Qun-Ying Yue.</p><p><b>Tune in to find out:</b></p><ul><li>How genetic biomarkers can guide medicine use and dosing recommendations</li><li>What we need to effectively implement genetic-based prescribing in clinical practice</li><li>How increasing diversity in clinical trials can aid pharmacogenomics research </li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li><a href='https://www.nature.com/articles/s41397-020-0148-3'>SWEDEGENE</a> is a Swedish nation-wide DNA sample collection established to facilitate pharmacogenomic studies of serious adverse drug reactions.</li><li>The African continent, with its genetically diverse populations, is a treasure trove of pharmacogenomics data – as long as African patients are included in drug studies, as we discussed in <a href='https://www.drugsafetymatterspod.org/618871/7648585-uppsala-reports-long-reads-africa-integral-to-evolution-of-pharmacogenomics-research'>this Uppsala Reports Long Read episode.</a></li><li>As a past member of the European Medicines Agency’s <a href='https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/pharmacogenomics-working-party'>Pharmacogenomics Working Party</a>, Ying contributed to the <a href='https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal_en.pdf'>“Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products”</a>.</li><li>Ying also chairs <a href='https://isoponline.org/special-interest-groups/pharmacogenomics/'>ISoP’s Pharmacogenomics Special Interest Group</a>, whose work and objectives have been described in <a href='https://www.uppsalareports.org/articles/pharmacogenomics-group-aims-to-refine-patient-safety-options/'>Uppsala Reports</a> and <a href='https://link.springer.com/article/10.1007/s40264-021-01068-w?wt_mc=Internal.Event.1.SEM.ArticleAuthorOnlineFirst&amp;utm_source=ArticleAuthorOnlineFirst&amp;utm_medium=email&amp;utm_content=AA_en_06082018&amp;ArticleAuthorOnlineFirst_20210509'>Drug Safety</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/8795485-10-tailoring-drug-therapy-to-your-genes-qun-ying-yue.mp3" length="21810228" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-8795485</guid>
    <pubDate>Thu, 29 Jul 2021 09:00:00 +0200</pubDate>
    <itunes:duration>1816</itunes:duration>
    <itunes:keywords>DNA, gene, genetic screening, medicine, patient safety, pharmacogenomics, pharmacovigilance, science, side effect</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#9 Keeping vaccines safe – Helena Sköld &amp; Annette Rudolph</itunes:title>
    <title>#9 Keeping vaccines safe – Helena Sköld &amp; Annette Rudolph</title>
    <itunes:summary><![CDATA[Send a message to the show! With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.  Tune in to find out: How suspected side effects are reported and studied around the worldWhy a mere list of reported side effects says litt...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.<br/><br/><b>Tune in to find out:</b></p><ul><li>How suspected side effects are reported and studied around the world</li><li>Why a mere list of reported side effects says little about a vaccine’s safety profile</li><li>How a global database like VigiBase can help spot unexpected safety issues</li></ul><p><b>Want to know more?<br/><br/></b>Media coverage can greatly affect the rate at which side effects of medicines and vaccines are reported, as shown by <a href='https://bmjopen.bmj.com/content/2/4/e001607.long'>this study by the New Zealand Centre for Adverse Reactions Monitoring</a>.<br/><br/>When talking about side effects of any medicine or vaccine, it’s important <a href='https://www.dsru.org/reporting-rate-of-spontaneous-adverse-drug-reactions-adrs-is-not-incidence/'>not to confuse reporting rates with incidence</a>.<br/><br/>In its <a href='https://www.who.int/publications/i/item/10665338400'>COVID-19 vaccine safety surveillance manual</a>, the World Health Organization (WHO) outlines how countries should prepare for the introduction of COVID-19 vaccines. <br/><br/>Uppsala Monitoring Centre (UMC) has developed guidelines for <a href='https://www.who-umc.org/global-pharmacovigilance/covid-19/'>carrying out pharmacovigilance work</a> during the COVID-19 pandemic and a list of <a href='https://www.who-umc.org/global-pharmacovigilance/covid-19/how-to-understand-data-on-side-effects/'>frequently asked questions</a> on suspected side effects of COVID-19 vaccines.<br/><br/>Among other things, UMC has been supporting members of the <a href='https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/'>WHO Programme for International Drug Monitoring</a> in their vaccine safety surveillance efforts by improving the <a href='https://www.who-umc.org/vigibase/vigilyze/quantitative-covid-19-vaccine-safety-surveillance-with-vigilyze-in-near-real-time/'>VigiLyze</a> and <a href='https://www.who-umc.org/global-pharmacovigilance/vigiflow/vaccine-surveillance-in-vigiflow/'>VigiFlow</a> tools.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.<br/><br/><b>Tune in to find out:</b></p><ul><li>How suspected side effects are reported and studied around the world</li><li>Why a mere list of reported side effects says little about a vaccine’s safety profile</li><li>How a global database like VigiBase can help spot unexpected safety issues</li></ul><p><b>Want to know more?<br/><br/></b>Media coverage can greatly affect the rate at which side effects of medicines and vaccines are reported, as shown by <a href='https://bmjopen.bmj.com/content/2/4/e001607.long'>this study by the New Zealand Centre for Adverse Reactions Monitoring</a>.<br/><br/>When talking about side effects of any medicine or vaccine, it’s important <a href='https://www.dsru.org/reporting-rate-of-spontaneous-adverse-drug-reactions-adrs-is-not-incidence/'>not to confuse reporting rates with incidence</a>.<br/><br/>In its <a href='https://www.who.int/publications/i/item/10665338400'>COVID-19 vaccine safety surveillance manual</a>, the World Health Organization (WHO) outlines how countries should prepare for the introduction of COVID-19 vaccines. <br/><br/>Uppsala Monitoring Centre (UMC) has developed guidelines for <a href='https://www.who-umc.org/global-pharmacovigilance/covid-19/'>carrying out pharmacovigilance work</a> during the COVID-19 pandemic and a list of <a href='https://www.who-umc.org/global-pharmacovigilance/covid-19/how-to-understand-data-on-side-effects/'>frequently asked questions</a> on suspected side effects of COVID-19 vaccines.<br/><br/>Among other things, UMC has been supporting members of the <a href='https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/'>WHO Programme for International Drug Monitoring</a> in their vaccine safety surveillance efforts by improving the <a href='https://www.who-umc.org/vigibase/vigilyze/quantitative-covid-19-vaccine-safety-surveillance-with-vigilyze-in-near-real-time/'>VigiLyze</a> and <a href='https://www.who-umc.org/global-pharmacovigilance/vigiflow/vaccine-surveillance-in-vigiflow/'>VigiFlow</a> tools.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/8745388-9-keeping-vaccines-safe-helena-skold-annette-rudolph.mp3" length="19743528" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-8745388</guid>
    <pubDate>Thu, 24 Jun 2021 09:00:00 +0200</pubDate>
    <itunes:duration>1643</itunes:duration>
    <itunes:keywords>COVID-19, medicine, patient safety, pharmacovigilance, science, side effect, vaccine, VigiBase</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>Uppsala Reports Long Reads – Substandard and falsified COVID-19 vaccines in the Americas</itunes:title>
    <title>Uppsala Reports Long Reads – Substandard and falsified COVID-19 vaccines in the Americas</title>
    <itunes:summary><![CDATA[Send a message to the show! While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait ­– and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably around the world.  This episode is part of the Uppsala Reports Long Reads series – the most topical ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait ­– and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably around the world.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/substandard-and-falsified-covid-19-vaccines-in-the-americas-can-vaccine-equity-help/'>original article here</a>.<br/><br/>After the read, we talk to Danini about the COVAX programme, organised crime, and trust in vaccinations.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why COVID-19 vaccine delivery to low- and middle-income countries has been inadequate so far</li><li>What threats substandard and falsified vaccines pose to people and countries</li><li>How you can help mitigate the spread of compromised products</li></ul><p><b>Want to know more?<br/><br/></b>Tune into our <a href='https://www.drugsafetymatterspod.org/618871/2586265-1-fighting-the-fakes-aline-plancon'>first episode</a> to learn about the deadly trade of fake medicines from former Interpol officer Aline Plançon.<br/><br/>The <a href='https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines'>US Food and Drug Administration</a> has more information on the COVID-19 vaccines authorised for emergency use in the country, plus other useful resources on vaccines.<br/><br/>In March 2021, the <a href='https://www.iddo.org/document/medical-product-quality-report-covid-19-vaccine-issues-march-2021'>Infectious Disease Data Observatory</a> reported 54 incidents of COVID-19 vaccines being substandard, falsified, or diverted from the legal supply chain.<br/><br/>In the same month, <a href='https://www.interpol.int/en/News-and-Events/News/2021/Online-vaccine-scams-INTERPOL-and-Homeland-Security-Investigations-issue-public-warning'>Interpol and the US’s Homeland Security Investigations</a> warned the public against purchasing alleged COVID-19 vaccines online, while the <a href='https://www.who.int/news/item/26-03-2021-medical-product-alert-n-2-2021-falsified-covid-19-vaccine-bnt162b2'>World Health Organization</a> issued a medical product alert on a falsified COVID-19 vaccine detected in Mexico.<br/><br/>WHO also curates a database on <a href='https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines'>COVID-19 vaccine candidates</a> in development around the world.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait ­– and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably around the world.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/substandard-and-falsified-covid-19-vaccines-in-the-americas-can-vaccine-equity-help/'>original article here</a>.<br/><br/>After the read, we talk to Danini about the COVAX programme, organised crime, and trust in vaccinations.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why COVID-19 vaccine delivery to low- and middle-income countries has been inadequate so far</li><li>What threats substandard and falsified vaccines pose to people and countries</li><li>How you can help mitigate the spread of compromised products</li></ul><p><b>Want to know more?<br/><br/></b>Tune into our <a href='https://www.drugsafetymatterspod.org/618871/2586265-1-fighting-the-fakes-aline-plancon'>first episode</a> to learn about the deadly trade of fake medicines from former Interpol officer Aline Plançon.<br/><br/>The <a href='https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines'>US Food and Drug Administration</a> has more information on the COVID-19 vaccines authorised for emergency use in the country, plus other useful resources on vaccines.<br/><br/>In March 2021, the <a href='https://www.iddo.org/document/medical-product-quality-report-covid-19-vaccine-issues-march-2021'>Infectious Disease Data Observatory</a> reported 54 incidents of COVID-19 vaccines being substandard, falsified, or diverted from the legal supply chain.<br/><br/>In the same month, <a href='https://www.interpol.int/en/News-and-Events/News/2021/Online-vaccine-scams-INTERPOL-and-Homeland-Security-Investigations-issue-public-warning'>Interpol and the US’s Homeland Security Investigations</a> warned the public against purchasing alleged COVID-19 vaccines online, while the <a href='https://www.who.int/news/item/26-03-2021-medical-product-alert-n-2-2021-falsified-covid-19-vaccine-bnt162b2'>World Health Organization</a> issued a medical product alert on a falsified COVID-19 vaccine detected in Mexico.<br/><br/>WHO also curates a database on <a href='https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines'>COVID-19 vaccine candidates</a> in development around the world.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/8591012-uppsala-reports-long-reads-substandard-and-falsified-covid-19-vaccines-in-the-americas.mp3" length="15687923" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-8591012</guid>
    <pubDate>Thu, 27 May 2021 08:00:00 +0200</pubDate>
    <podcast:soundbite startTime="0.0" duration="30.0" />
    <itunes:duration>1305</itunes:duration>
    <itunes:keywords>Americas, COVID-19, Danini Marin, fake medicine, falsified medicine, medicine, patient safety, pandemic, pharmacovigilance, science, substandard medicine, Uppsala Reports, vaccines, vaccine safety</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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  <item>
    <itunes:title>#8 How do we change behaviour around antimicrobial resistance?</itunes:title>
    <title>#8 How do we change behaviour around antimicrobial resistance?</title>
    <itunes:summary><![CDATA[Send a message to the show! Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance through behaviour change” tackled this very problem. We spoke to three key participants – Otto Cars, Eldar Shafir and Vaness...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance through behaviour change” tackled this very problem. We spoke to three key participants – Otto Cars, Eldar Shafir and Vanessa Carter – to learn more.<br/><br/><b>Tune in to find out:</b></p><ul><li>How the COVID-19 pandemic might affect AMR globally</li><li>How the context around us influences the decisions we make</li><li>How patients’ stories can help communicate the urgency of AMR</li></ul><p><b>Want to know more?<br/><br/></b>The <a href='https://www.uppsalahealthsummit.se/'>Uppsala Health Summit</a> is a recurring international policy arena for dialogue on healthcare challenges and how we can overcome them.<br/><br/><a href='https://www.who.int/antimicrobial-resistance/interagency-coordination-group/otto_cars_bio/en/'>Otto Cars</a> is founder and now senior advisor to <a href='https://www.reactgroup.org/'>ReACT (Action on Antibiotic Resistance)</a>. He set the scene at Uppsala Health Summit 2021 with a lecture on the <a href='https://www.youtube.com/watch?v=5N6JdBI4LUk'>current status of AMR globally</a>. In a <a href='https://www.uppsalahealthsummit.se/news/News-detail/?tarContentId=893516'>recent interview</a>, he described how to make the most of the COVID-19 momentum to spur much-needed action in the AMR sphere.<br/><br/><a href='https://psych.princeton.edu/person/eldar-shafir'>Eldar Shafir</a> is professor of behavioural science and public policy at Princeton University, with a special interest in the<a href='https://behavioralscientist.org/scarcity-excerpt-mullainathan-shafir/'> effect of poverty on decision-making</a>. In his keynote lecture at the summit, he commented on the <a href='https://www.youtube.com/watch?v=YReyDikZOcw'>AMR problem from a behavioural perspective</a>. He points us to a 2016 research paper on the <a href='https://jamanetwork.com/journals/jama/article-abstract/2488307'>effect of behavioural interventions on inappropriate antibiotic prescribing</a>.<br/><br/><a href='http://www.vanessacarter.co.za/'>Vanessa Carter</a> is a South Africa-based patient advocate for AMR and e-patient scholar at Stanford University Medicine X. She suggests reading Tom Ferguson’s white paper on <a href='https://participatorymedicine.org/e-Patient_White_Paper_with_Afterword.pdf'>e-patients and their contribution to healthcare</a>.<br/><br/>This episode was produced in collaboration with <a href='https://www.uac.uu.se/the-amr-studio/'>The AMR Studio podcast</a> at <a href='https://www.uac.uu.se'>Uppsala Antibiotic Center</a>. Tune into their show for more stories on antimicrobial resistance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance through behaviour change” tackled this very problem. We spoke to three key participants – Otto Cars, Eldar Shafir and Vanessa Carter – to learn more.<br/><br/><b>Tune in to find out:</b></p><ul><li>How the COVID-19 pandemic might affect AMR globally</li><li>How the context around us influences the decisions we make</li><li>How patients’ stories can help communicate the urgency of AMR</li></ul><p><b>Want to know more?<br/><br/></b>The <a href='https://www.uppsalahealthsummit.se/'>Uppsala Health Summit</a> is a recurring international policy arena for dialogue on healthcare challenges and how we can overcome them.<br/><br/><a href='https://www.who.int/antimicrobial-resistance/interagency-coordination-group/otto_cars_bio/en/'>Otto Cars</a> is founder and now senior advisor to <a href='https://www.reactgroup.org/'>ReACT (Action on Antibiotic Resistance)</a>. He set the scene at Uppsala Health Summit 2021 with a lecture on the <a href='https://www.youtube.com/watch?v=5N6JdBI4LUk'>current status of AMR globally</a>. In a <a href='https://www.uppsalahealthsummit.se/news/News-detail/?tarContentId=893516'>recent interview</a>, he described how to make the most of the COVID-19 momentum to spur much-needed action in the AMR sphere.<br/><br/><a href='https://psych.princeton.edu/person/eldar-shafir'>Eldar Shafir</a> is professor of behavioural science and public policy at Princeton University, with a special interest in the<a href='https://behavioralscientist.org/scarcity-excerpt-mullainathan-shafir/'> effect of poverty on decision-making</a>. In his keynote lecture at the summit, he commented on the <a href='https://www.youtube.com/watch?v=YReyDikZOcw'>AMR problem from a behavioural perspective</a>. He points us to a 2016 research paper on the <a href='https://jamanetwork.com/journals/jama/article-abstract/2488307'>effect of behavioural interventions on inappropriate antibiotic prescribing</a>.<br/><br/><a href='http://www.vanessacarter.co.za/'>Vanessa Carter</a> is a South Africa-based patient advocate for AMR and e-patient scholar at Stanford University Medicine X. She suggests reading Tom Ferguson’s white paper on <a href='https://participatorymedicine.org/e-Patient_White_Paper_with_Afterword.pdf'>e-patients and their contribution to healthcare</a>.<br/><br/>This episode was produced in collaboration with <a href='https://www.uac.uu.se/the-amr-studio/'>The AMR Studio podcast</a> at <a href='https://www.uac.uu.se'>Uppsala Antibiotic Center</a>. Tune into their show for more stories on antimicrobial resistance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Tue, 27 Apr 2021 08:00:00 +0200</pubDate>
    <itunes:duration>2898</itunes:duration>
    <itunes:keywords>AMR, antibiotics, antimicrobial resistance, antibiotic resistance, behaviour change, communication, Eldar Shafir, medicine, Otto Cars, ReACT, Vanessa Carter, patient safety, science</itunes:keywords>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – Into the infodemic</itunes:title>
    <title>Uppsala Reports Long Reads – Into the infodemic</title>
    <itunes:summary><![CDATA[Send a message to the show! As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.  After the read, Marco tells us how the pandemic has affected his work at the Uni...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/into-the-infodemic-countering-covid-s-medicine-myths/'>original article here</a>.<br/><br/>After the read, Marco tells us how the pandemic has affected his work at the University Hospital of Pisa, Italy – and what are the most pressing challenges in pharmacovigilance communication today. <br/><br/><b>Tune in to find out:</b></p><ul><li>What consequences the infodemic had on the use of medicines</li><li>How the pharmacovigilance community has fought the infodemic so far</li><li>Why empathy can be a powerful tool to counteract misinformation</li></ul><p><b>Want to know more?<br/><br/></b>Marco Tuccori’s piece in Uppsala Reports was inspired by an article that he and his colleagues wrote for Drug Safety, on the <a href='https://link.springer.com/article/10.1007%2Fs40264-020-00965-w'>impact of the infodemic on drug-utilisation behaviours</a>.  <br/><br/>Don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/into-the-infodemic-countering-covid-s-medicine-myths/'>original article here</a>.<br/><br/>After the read, Marco tells us how the pandemic has affected his work at the University Hospital of Pisa, Italy – and what are the most pressing challenges in pharmacovigilance communication today. <br/><br/><b>Tune in to find out:</b></p><ul><li>What consequences the infodemic had on the use of medicines</li><li>How the pharmacovigilance community has fought the infodemic so far</li><li>Why empathy can be a powerful tool to counteract misinformation</li></ul><p><b>Want to know more?<br/><br/></b>Marco Tuccori’s piece in Uppsala Reports was inspired by an article that he and his colleagues wrote for Drug Safety, on the <a href='https://link.springer.com/article/10.1007%2Fs40264-020-00965-w'>impact of the infodemic on drug-utilisation behaviours</a>.  <br/><br/>Don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/8216763-uppsala-reports-long-reads-into-the-infodemic.mp3" length="20141301" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-8216763</guid>
    <pubDate>Fri, 26 Mar 2021 16:00:00 +0100</pubDate>
    <itunes:duration>1677</itunes:duration>
    <itunes:keywords>communications, COVID-19, infodemic, Marco Tuccori, medicine, patient safety, pandemic, pharmacovigilance, science, Uppsala Reports</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#7 The challenge of rare diseases – Christina Ström Möller</itunes:title>
    <title>#7 The challenge of rare diseases – Christina Ström Möller</title>
    <itunes:summary><![CDATA[Send a message to the show! By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commercial and human challenges of the rare disease landscape. Tune in to find out: What drug developme...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commercial and human challenges of the rare disease landscape.</p><p><b>Tune in to find out:</b></p><ul><li>What drug development, testing and distribution look like when patients are few and far apart </li><li>Why patient narratives are especially important when monitoring the safety of rare disease drugs</li><li>How patient organisations work to support rare disease patients and raise awareness of their condition</li></ul><p><b>Want to know more?</b></p><p>Read the <a href='https://www.sobi.com/en/stories'>stories of patients living with rare diseases</a> on the Sobi website.<br/><br/>Show your support for <a href='https://www.rarediseaseday.org/'>Rare Disease Day</a> on 28 February by sharing campaign materials online with the hashtag #RareDiseaseDay or joining one of the many events planned around the world.<br/><br/>Rare Disease Day is organised by <a href='https://www.eurordis.org/'>EURORDIS-Rare Diseases Europe</a>, a non-profit alliance of rare disease patient organisations from 73 countries.<br/><br/>When <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6243425/'>assessing the safety of rare disease medicines</a>, also known as orphan drugs, it is important to include all available sources of data.<br/><br/>A recent <a href='https://www.sciencedirect.com/science/article/pii/S1098301520344132?via%3Dihub'>review of orphan drug policies</a> found that several low- and middle-income countries had developed such policies in the last decade ­– although disparities between countries with different income levels still remain.<br/><br/>A <a href='https://download2.eurordis.org/rbv/covid19survey/covid_infographics_final.pdf'>survey conducted by EURORDIS in 2020</a> found that the COVID-19 pandemic exacerbated the many challenges that people living with a rare disease face.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commercial and human challenges of the rare disease landscape.</p><p><b>Tune in to find out:</b></p><ul><li>What drug development, testing and distribution look like when patients are few and far apart </li><li>Why patient narratives are especially important when monitoring the safety of rare disease drugs</li><li>How patient organisations work to support rare disease patients and raise awareness of their condition</li></ul><p><b>Want to know more?</b></p><p>Read the <a href='https://www.sobi.com/en/stories'>stories of patients living with rare diseases</a> on the Sobi website.<br/><br/>Show your support for <a href='https://www.rarediseaseday.org/'>Rare Disease Day</a> on 28 February by sharing campaign materials online with the hashtag #RareDiseaseDay or joining one of the many events planned around the world.<br/><br/>Rare Disease Day is organised by <a href='https://www.eurordis.org/'>EURORDIS-Rare Diseases Europe</a>, a non-profit alliance of rare disease patient organisations from 73 countries.<br/><br/>When <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6243425/'>assessing the safety of rare disease medicines</a>, also known as orphan drugs, it is important to include all available sources of data.<br/><br/>A recent <a href='https://www.sciencedirect.com/science/article/pii/S1098301520344132?via%3Dihub'>review of orphan drug policies</a> found that several low- and middle-income countries had developed such policies in the last decade ­– although disparities between countries with different income levels still remain.<br/><br/>A <a href='https://download2.eurordis.org/rbv/covid19survey/covid_infographics_final.pdf'>survey conducted by EURORDIS in 2020</a> found that the COVID-19 pandemic exacerbated the many challenges that people living with a rare disease face.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 26 Feb 2021 09:00:00 +0100</pubDate>
    <itunes:duration>1494</itunes:duration>
    <itunes:keywords>Christina Ström Möller, EURORDIS, medicine, orphan drugs, patient safety, pharmacovigilance, rare diseases, Rare Disease Day, science, Sobi</itunes:keywords>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – Africa integral to evolution of pharmacogenomics research</itunes:title>
    <title>Uppsala Reports Long Reads – Africa integral to evolution of pharmacogenomics research</title>
    <itunes:summary><![CDATA[Send a message to the show! As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 15 have been studied in African populations. Thankfully efforts to boost pharmacogenomics researc...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 15 have been studied in African populations. Thankfully efforts to boost pharmacogenomics research in Africa are now underway.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/africa-integral-to-evolution-of-pharmacogenomics-research/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>How drug metabolism is affected by genetic variation</li><li>Why African patients urgently need genotype-guided drug dosing </li><li>How different research initiatives are trying to fill the knowledge gap</li></ul><p><b>Want to know more?<br/><br/></b>A <a href='https://pubmed.ncbi.nlm.nih.gov/29868213/'>review of the disease burden in Africa</a> concluded that a pharmacogenomics-based healthcare approach – where drug choices and doses are optimised for each patient ­– would benefit the genetically diverse African population.<br/><br/><a href='https://pubmed.ncbi.nlm.nih.gov/32125935/'>Clinical pharmacogenetics studies conducted in African populations</a> have so far highlighted several pharmacogenetics associations ­– but also gaps in knowledge.<br/><br/>The <a href='https://www.researchgate.net/publication/333612236_African_Pharmacogenomics_Consortium_Consolidating_pharmacogenomics_knowledge_capacity_development_and_translation_in_Africa'>African Pharmacogenomics Consortium</a> drives pharmacogenomics research in Africa and aims to improve the safety of drugs for use in African populations.<br/><br/>The <a href='https://www.ga4gh.org/about-us/'>Global Alliance for Genomics and Health</a> aims to enable the safe and effective sharing of genomic and health-related data between different research and healthcare institutions.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 15 have been studied in African populations. Thankfully efforts to boost pharmacogenomics research in Africa are now underway.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/africa-integral-to-evolution-of-pharmacogenomics-research/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>How drug metabolism is affected by genetic variation</li><li>Why African patients urgently need genotype-guided drug dosing </li><li>How different research initiatives are trying to fill the knowledge gap</li></ul><p><b>Want to know more?<br/><br/></b>A <a href='https://pubmed.ncbi.nlm.nih.gov/29868213/'>review of the disease burden in Africa</a> concluded that a pharmacogenomics-based healthcare approach – where drug choices and doses are optimised for each patient ­– would benefit the genetically diverse African population.<br/><br/><a href='https://pubmed.ncbi.nlm.nih.gov/32125935/'>Clinical pharmacogenetics studies conducted in African populations</a> have so far highlighted several pharmacogenetics associations ­– but also gaps in knowledge.<br/><br/>The <a href='https://www.researchgate.net/publication/333612236_African_Pharmacogenomics_Consortium_Consolidating_pharmacogenomics_knowledge_capacity_development_and_translation_in_Africa'>African Pharmacogenomics Consortium</a> drives pharmacogenomics research in Africa and aims to improve the safety of drugs for use in African populations.<br/><br/>The <a href='https://www.ga4gh.org/about-us/'>Global Alliance for Genomics and Health</a> aims to enable the safe and effective sharing of genomic and health-related data between different research and healthcare institutions.<br/><br/>Finally, don’t forget to ­subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a> for free regular updates from the world of pharmacovigilance.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 03 Feb 2021 13:00:00 +0100</pubDate>
    <itunes:duration>778</itunes:duration>
    <itunes:keywords>Africa, medicine, patient safety, pharmacogenomics, pharmacovigilance</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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  <item>
    <itunes:title>#6 Intuition in pharmacovigilance – Eugene van Puijenbroek</itunes:title>
    <title>#6 Intuition in pharmacovigilance – Eugene van Puijenbroek</title>
    <itunes:summary><![CDATA[Send a message to the show! In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses. Together with Eugene van Puijenbroek ...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses.</p><p>Together with Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb, we explore the role of intuitive reasoning in the science of drug safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How clinical and intuitive reasoning complement each other for optimal decision-making</li><li>How adverse drug reaction reporting forms could be improved to detect intuitive reasoning</li><li>How pharmacovigilance professionals can train their intuition</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>A <a href='https://pubmed.ncbi.nlm.nih.gov/23319507/'>study on real cases of intuition</a> in family medicine concluded that automatic, non-analytical processes in clinical judgment extend beyond first impressions.</li><li>The <a href='https://pubmed.ncbi.nlm.nih.gov/21430797/'>dual-process theory</a> highlights the importance of physicians’ intuition and the high level of interaction between analytical and non-analytical processes in clinical reasoning.</li><li><a href='https://pubmed.ncbi.nlm.nih.gov/20967509/'>Gut feelings</a> may help general practitioners efficiently navigate the often complex and uncertain diagnostic situations of general practice.</li><li>In a <a href='https://pubmed.ncbi.nlm.nih.gov/12014539/'>discussion paper on intuition and evidence</a>, professor Trisha Greenhalgh suggests that the experienced practitioner should follow clinical hunches as well as applying the deductive principles of evidence-based medicine.</li></ul><p>If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out <a href='http://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>this interview with Linda Härmark</a> on patient reporting.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses.</p><p>Together with Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb, we explore the role of intuitive reasoning in the science of drug safety.<br/><br/><b>Tune in to find out:</b></p><ul><li>How clinical and intuitive reasoning complement each other for optimal decision-making</li><li>How adverse drug reaction reporting forms could be improved to detect intuitive reasoning</li><li>How pharmacovigilance professionals can train their intuition</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>A <a href='https://pubmed.ncbi.nlm.nih.gov/23319507/'>study on real cases of intuition</a> in family medicine concluded that automatic, non-analytical processes in clinical judgment extend beyond first impressions.</li><li>The <a href='https://pubmed.ncbi.nlm.nih.gov/21430797/'>dual-process theory</a> highlights the importance of physicians’ intuition and the high level of interaction between analytical and non-analytical processes in clinical reasoning.</li><li><a href='https://pubmed.ncbi.nlm.nih.gov/20967509/'>Gut feelings</a> may help general practitioners efficiently navigate the often complex and uncertain diagnostic situations of general practice.</li><li>In a <a href='https://pubmed.ncbi.nlm.nih.gov/12014539/'>discussion paper on intuition and evidence</a>, professor Trisha Greenhalgh suggests that the experienced practitioner should follow clinical hunches as well as applying the deductive principles of evidence-based medicine.</li></ul><p>If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out <a href='http://www.drugsafetymatterspod.org/618871/3844829-2-why-we-should-listen-to-patients-linda-harmark'>this interview with Linda Härmark</a> on patient reporting.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/6839950-6-intuition-in-pharmacovigilance-eugene-van-puijenbroek.mp3" length="18543883" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-6839950</guid>
    <pubDate>Thu, 17 Dec 2020 09:00:00 +0100</pubDate>
    <itunes:duration>1543</itunes:duration>
    <itunes:keywords>clinical reasoning, dual-process theory, intuition, Lareb, medicine, patient safety, pharmacovigilance, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – Patient&#39;s advocate</itunes:title>
    <title>Uppsala Reports Long Reads – Patient&#39;s advocate</title>
    <itunes:summary><![CDATA[Send a message to the show! In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her into one of the world’s leading advocates for patient safety.  This episode is part of the Upps...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her into one of the world’s leading advocates for patient safety.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/patient-s-advocate/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why monitoring the safety of medicines and vaccines matters more than ever during the COVID-19 pandemic</li><li>How UMC’s methods and tools have advanced the science of pharmacovigilance </li><li>Why it’s important to see the patient behind the data</li></ul><p><b>Want to know more?<br/></b>Uppsala Monitoring Centre has been leading a <a href='https://www.who-umc.org/global-pharmacovigilance/global-pharmacovigilance/'>global effort</a> to improve the science of pharmacovigilance for <a href='https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/the-story-of-umc-and-the-who-programme/'>more than 40 years.</a><br/><br/>You can read a comprehensive history of the organisation in the book <a href='https://view.publitas.com/uppsala-monitoring-centre/making-medicines-safer/page/1'>Making Medicines Safer</a>.<br/><br/>If you’d like free regular updates from the world of pharmacovigilance, subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her into one of the world’s leading advocates for patient safety.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/patient-s-advocate/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why monitoring the safety of medicines and vaccines matters more than ever during the COVID-19 pandemic</li><li>How UMC’s methods and tools have advanced the science of pharmacovigilance </li><li>Why it’s important to see the patient behind the data</li></ul><p><b>Want to know more?<br/></b>Uppsala Monitoring Centre has been leading a <a href='https://www.who-umc.org/global-pharmacovigilance/global-pharmacovigilance/'>global effort</a> to improve the science of pharmacovigilance for <a href='https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/the-story-of-umc-and-the-who-programme/'>more than 40 years.</a><br/><br/>You can read a comprehensive history of the organisation in the book <a href='https://view.publitas.com/uppsala-monitoring-centre/making-medicines-safer/page/1'>Making Medicines Safer</a>.<br/><br/>If you’d like free regular updates from the world of pharmacovigilance, subscribe to the monthly <a href='https://uppsalareports.org/Subscribe'>Uppsala Reports newsletter</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/6564580-uppsala-reports-long-reads-patient-s-advocate.mp3" length="7582777" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 26 Nov 2020 09:00:00 +0100</pubDate>
    <itunes:duration>630</itunes:duration>
    <itunes:keywords>COVID-19, leadership, Marie Lindquist, medicine, milestones, patient safety, pharmacovigilance</itunes:keywords>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – Vaccination errors risk harm and damage trust</itunes:title>
    <title>Uppsala Reports Long Reads – Vaccination errors risk harm and damage trust</title>
    <itunes:summary><![CDATA[Send a message to the show! Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/serious-errors-with-two-component-vaccines-risk-harm-and-damage-trust/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Which errors can occur in the vaccination process</li><li>Why two-component vaccines are especially susceptible to administration errors</li><li>How vaccine packaging and labelling can be improved to prevent errors</li></ul><p><b>Want to know more?</b></p><p>The <a href='https://www.ismp.org/'>Institute for Safe Medication Practices</a> has repeatedly warned about the <a href='https://www.ismp.org/resources/administering-just-diluent-or-one-two-vaccine-components-leaves-patients-unprotected'>risks with two-component vaccines</a>. In 2015, they issued a position statement calling for <a href='https://www.intmedsafe.net/wp-content/uploads/2014/07/IMSN-Position-Statement-Vaccines-packaginglabelling-2015112.pdf'>safer design of vaccine packaging and labelling</a>.<br/><br/>Tragic errors can occur when dangerous substances are accidentally used instead of the vaccine diluent, like the incident that occurred <a href='https://www.aljazeera.com/news/middleeast/2014/10/un-vaccine-mistake-killed-syrian-children-2014101192556950498.html'>in Syria in 2014</a>.<br/><br/>The <a href='https://www.washingtonpost.com/opinions/global-opinions/the-measles-outbreak-in-samoa-must-be-a-lesson-for-the-rest-of-the-world/2019/12/08/df0d9274-183a-11ea-9110-3b34ce1d92b1_story.html'>measles outbreak</a> that took root in Samoa as a consequence of vaccine hesitancy – which in turn stemmed from an earlier, tragic vaccination error – holds <a href='https://onlinelibrary.wiley.com/doi/pdf/10.1111/jpc.14752'>important lessons</a> for the rest of the world.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/serious-errors-with-two-component-vaccines-risk-harm-and-damage-trust/'>original article here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Which errors can occur in the vaccination process</li><li>Why two-component vaccines are especially susceptible to administration errors</li><li>How vaccine packaging and labelling can be improved to prevent errors</li></ul><p><b>Want to know more?</b></p><p>The <a href='https://www.ismp.org/'>Institute for Safe Medication Practices</a> has repeatedly warned about the <a href='https://www.ismp.org/resources/administering-just-diluent-or-one-two-vaccine-components-leaves-patients-unprotected'>risks with two-component vaccines</a>. In 2015, they issued a position statement calling for <a href='https://www.intmedsafe.net/wp-content/uploads/2014/07/IMSN-Position-Statement-Vaccines-packaginglabelling-2015112.pdf'>safer design of vaccine packaging and labelling</a>.<br/><br/>Tragic errors can occur when dangerous substances are accidentally used instead of the vaccine diluent, like the incident that occurred <a href='https://www.aljazeera.com/news/middleeast/2014/10/un-vaccine-mistake-killed-syrian-children-2014101192556950498.html'>in Syria in 2014</a>.<br/><br/>The <a href='https://www.washingtonpost.com/opinions/global-opinions/the-measles-outbreak-in-samoa-must-be-a-lesson-for-the-rest-of-the-world/2019/12/08/df0d9274-183a-11ea-9110-3b34ce1d92b1_story.html'>measles outbreak</a> that took root in Samoa as a consequence of vaccine hesitancy – which in turn stemmed from an earlier, tragic vaccination error – holds <a href='https://onlinelibrary.wiley.com/doi/pdf/10.1111/jpc.14752'>important lessons</a> for the rest of the world.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 23 Oct 2020 11:00:00 +0200</pubDate>
    <itunes:duration>600</itunes:duration>
    <itunes:keywords>medication errors, medicine, patient safety, pharmacovigilance, vaccines</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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  <item>
    <itunes:title>#5 Restoring invisible and abandoned trials – Peter Doshi</itunes:title>
    <title>#5 Restoring invisible and abandoned trials – Peter Doshi</title>
    <itunes:summary><![CDATA[Send a message to the show! Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission to fix the problem and improve data transparency for good. Tune in to find out: How publication...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission to fix the problem and improve data transparency for good.</p><p><b>Tune in to find out:</b></p><ul><li>How publication and reporting biases affect our understanding of trial results</li><li>How an investigation into anti-influenza drugs helped galvanise a general movement towards greater data transparency </li><li>How the RIAT Support Center is facilitating the correction of the scientific record</li></ul><p><b>Want to know more?</b></p><p>The <a href='https://restoringtrials.org/'>Restoring Invisible &amp; Abandoned Trials (RIAT) Support Center</a> offers free support to researchers anywhere in the world that would like to <a href='https://www.bmj.com/content/346/bmj.f2865'>publish an unpublished trial or correct a misreported trial</a>.<br/><br/>The <a href='https://www.alltrials.net/'>AllTrials campaign</a> calls for all past and present clinical trials to be registered and their results reported.<br/><br/>The <a href='https://www.bmj.com/tamiflu'>Tamiflu campaign</a> highlighted important discrepancies between journal publications and the underlying clinical study reports, and increased awareness of the importance of independent access to underlying trial data.<br/><br/>A 2016 systematic review found that <a href='https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002127'>much of the information on adverse events remains unpublished</a> and that the number and range of adverse events is higher in unpublished than in published versions of the same study. <br/><br/>Authors from the European Medicines Agency debate whether <a href='https://www.ejinme.com/article/S0953-6205(19)30425-X/fulltext'>clinical trial publications are a sufficient basis for healthcare decisions</a>.<br/><br/>Peter Doshi and David Healy argue that <a href='https://www.bmj.com/content/370/bmj.m3260'>doctors should not recommend COVID-19 treatments and vaccines when full data are not publicly available</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission to fix the problem and improve data transparency for good.</p><p><b>Tune in to find out:</b></p><ul><li>How publication and reporting biases affect our understanding of trial results</li><li>How an investigation into anti-influenza drugs helped galvanise a general movement towards greater data transparency </li><li>How the RIAT Support Center is facilitating the correction of the scientific record</li></ul><p><b>Want to know more?</b></p><p>The <a href='https://restoringtrials.org/'>Restoring Invisible &amp; Abandoned Trials (RIAT) Support Center</a> offers free support to researchers anywhere in the world that would like to <a href='https://www.bmj.com/content/346/bmj.f2865'>publish an unpublished trial or correct a misreported trial</a>.<br/><br/>The <a href='https://www.alltrials.net/'>AllTrials campaign</a> calls for all past and present clinical trials to be registered and their results reported.<br/><br/>The <a href='https://www.bmj.com/tamiflu'>Tamiflu campaign</a> highlighted important discrepancies between journal publications and the underlying clinical study reports, and increased awareness of the importance of independent access to underlying trial data.<br/><br/>A 2016 systematic review found that <a href='https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002127'>much of the information on adverse events remains unpublished</a> and that the number and range of adverse events is higher in unpublished than in published versions of the same study. <br/><br/>Authors from the European Medicines Agency debate whether <a href='https://www.ejinme.com/article/S0953-6205(19)30425-X/fulltext'>clinical trial publications are a sufficient basis for healthcare decisions</a>.<br/><br/>Peter Doshi and David Healy argue that <a href='https://www.bmj.com/content/370/bmj.m3260'>doctors should not recommend COVID-19 treatments and vaccines when full data are not publicly available</a>.<br/><br/></p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
    <guid isPermaLink="false">Buzzsprout-5676835</guid>
    <pubDate>Wed, 30 Sep 2020 17:00:00 +0200</pubDate>
    <itunes:duration>2107</itunes:duration>
    <itunes:keywords>clinical trials, data access, medicine, open access, patient safety, pharmacovigilance, RIAT, science</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
    <itunes:explicit>false</itunes:explicit>
  </item>
  <item>
    <itunes:title>#4 Communicating science through film – Matthew Barwick </itunes:title>
    <title>#4 Communicating science through film – Matthew Barwick </title>
    <itunes:summary><![CDATA[Send a message to the show! Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Tag along to learn their best tips for effective science communication and how to harness the powe...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Tag along to learn their best tips for effective science communication and how to harness the power of film to tell stories in science.</p><p><b>Tune in to find out:</b></p><ul><li>What scientists can gain from communicating their work</li><li>Why passion and emotions are an important element of science communication </li><li>Why a two-way dialogue between scientist and audience is better than traditional one-way forms of communication</li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li><a href='https://www.frontiersin.org/articles/10.3389/fcomm.2019.00055/full'>Why Science Communication, and Does It Work?</a> reviews the main aims of science communication efforts and their success.</li><li>Good science communication should stir AEIOU in an audience: <a href='http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.556.4469&amp;rep=rep1&amp;type=pdf'>Awareness, Enjoyment, Interest, Opinions, and Understanding.</a></li><li>In <a href='https://www.youtube.com/watch?v=mIT5KNtRs08'>“Talking Science”</a>, a free YouTube course in science communication, BBC presenter Greg Foot shares tips and techniques to help scientists talk to the public.</li><li>The <a href='https://www.sciencefilm.ch/'>Global Science Film Festival</a> offers scientists the opportunity to learn basic communication and filmmaking skills, and showcase their work. The two films mentioned in the episode are <a href='https://thewomanwholovesgiraffes.com/'>“The woman who loves giraffes”</a> (best film, Global Science Film Festival 2019) and <a href='https://www.sonyclassics.com/aquarela/'>“Aquarela”</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Tag along to learn their best tips for effective science communication and how to harness the power of film to tell stories in science.</p><p><b>Tune in to find out:</b></p><ul><li>What scientists can gain from communicating their work</li><li>Why passion and emotions are an important element of science communication </li><li>Why a two-way dialogue between scientist and audience is better than traditional one-way forms of communication</li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li><a href='https://www.frontiersin.org/articles/10.3389/fcomm.2019.00055/full'>Why Science Communication, and Does It Work?</a> reviews the main aims of science communication efforts and their success.</li><li>Good science communication should stir AEIOU in an audience: <a href='http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.556.4469&amp;rep=rep1&amp;type=pdf'>Awareness, Enjoyment, Interest, Opinions, and Understanding.</a></li><li>In <a href='https://www.youtube.com/watch?v=mIT5KNtRs08'>“Talking Science”</a>, a free YouTube course in science communication, BBC presenter Greg Foot shares tips and techniques to help scientists talk to the public.</li><li>The <a href='https://www.sciencefilm.ch/'>Global Science Film Festival</a> offers scientists the opportunity to learn basic communication and filmmaking skills, and showcase their work. The two films mentioned in the episode are <a href='https://thewomanwholovesgiraffes.com/'>“The woman who loves giraffes”</a> (best film, Global Science Film Festival 2019) and <a href='https://www.sonyclassics.com/aquarela/'>“Aquarela”</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
    <enclosure url="https://www.buzzsprout.com/618871/episodes/5171818-4-communicating-science-through-film-matthew-barwick.mp3" length="21130315" type="audio/mpeg" />
    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 27 Aug 2020 14:00:00 +0200</pubDate>
    <itunes:duration>1759</itunes:duration>
    <itunes:keywords>communication, film, Global Science Film Festival, science, science communication, storytelling</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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  <item>
    <itunes:title>Uppsala Reports Long Reads – Found in space</itunes:title>
    <title>Uppsala Reports Long Reads – Found in space</title>
    <itunes:summary><![CDATA[Send a message to the show! When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in aud...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/found-in-space-new-method-reveals-related-drug-and-reaction-terms/'>original article here</a>.<br/><br/>After the read, Uppsala Reports editor Gerard Ross interviews Lucie on her work behind the scenes and the broader implications of her research for the pharmacovigilance field. <br/><br/><b>Tune in to find out:</b></p><ul><li>How natural language processing can help connect related drug and adverse reaction terms</li><li>What advantages the new method offers over MedDRA classifications</li><li>Which pharmacovigilance tasks could benefit from this new research</li></ul><p><b>Want to know more?<br/></b>Lucie presented her work on vector representations for pharmacovigilance at the <a href='https://ieeexplore.ieee.org/document/8904551'>IEEE International Conference on Healthcare Informatics in 2019</a>. And here’s some background reading on <a href='https://papers.nips.cc/paper/5021-distributed-representations-of-words-and-phrases-and-their-compositionality.pdf'>distributed representations of words and phrases</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/found-in-space-new-method-reveals-related-drug-and-reaction-terms/'>original article here</a>.<br/><br/>After the read, Uppsala Reports editor Gerard Ross interviews Lucie on her work behind the scenes and the broader implications of her research for the pharmacovigilance field. <br/><br/><b>Tune in to find out:</b></p><ul><li>How natural language processing can help connect related drug and adverse reaction terms</li><li>What advantages the new method offers over MedDRA classifications</li><li>Which pharmacovigilance tasks could benefit from this new research</li></ul><p><b>Want to know more?<br/></b>Lucie presented her work on vector representations for pharmacovigilance at the <a href='https://ieeexplore.ieee.org/document/8904551'>IEEE International Conference on Healthcare Informatics in 2019</a>. And here’s some background reading on <a href='https://papers.nips.cc/paper/5021-distributed-representations-of-words-and-phrases-and-their-compositionality.pdf'>distributed representations of words and phrases</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 06 Aug 2020 12:00:00 +0200</pubDate>
    <itunes:duration>1394</itunes:duration>
    <itunes:keywords>case safety reports, data science, medicine, natural language processing, pharmacovigilance</itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – 10 critical steps for patient safety</itunes:title>
    <title>Uppsala Reports Long Reads – 10 critical steps for patient safety</title>
    <itunes:summary><![CDATA[Send a message to the show! How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.  This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here. After the read, we reach UMC director Marie Lindquist i...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/10-critical-steps-to-improve-patient-safety-worldwide/'>original article here</a>.</p><p>After the read, we reach UMC director Marie Lindquist in her home in Gothenburg, Sweden to discuss the relevance of the Erice statement, as the world copes with the COVID-19 pandemic.<br/><br/><b>Tune in to find out:</b></p><ul><li>What actions we should be taking to protect patients from medicine-related harm</li><li>Why collaboration between evidence-based medicine and pharmacovigilance is crucial</li><li>Why transparency is of the essence when communicating uncertainty</li></ul><p><b>Want to know more?<br/><br/></b>The full statement produced by the Erice group is entitled <a href='https://www.cebm.net/wp-content/uploads/2019/12/The-Erice-Statement.pdf'>“Improving the detection, analysis, and reporting of harms in medicines and devices”</a>.<br/><br/>The original <a href='https://prescrire.org/docus/ericeEn.pdf'>Erice Declaration of 1997</a> laid the groundwork for good communication practices in the pharmacovigilance field and was updated in <a href='https://pubmed.ncbi.nlm.nih.gov/16454537/'>2006</a> and in <a href='https://pubmed.ncbi.nlm.nih.gov/28815462/'>2017</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.<br/><br/>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/10-critical-steps-to-improve-patient-safety-worldwide/'>original article here</a>.</p><p>After the read, we reach UMC director Marie Lindquist in her home in Gothenburg, Sweden to discuss the relevance of the Erice statement, as the world copes with the COVID-19 pandemic.<br/><br/><b>Tune in to find out:</b></p><ul><li>What actions we should be taking to protect patients from medicine-related harm</li><li>Why collaboration between evidence-based medicine and pharmacovigilance is crucial</li><li>Why transparency is of the essence when communicating uncertainty</li></ul><p><b>Want to know more?<br/><br/></b>The full statement produced by the Erice group is entitled <a href='https://www.cebm.net/wp-content/uploads/2019/12/The-Erice-Statement.pdf'>“Improving the detection, analysis, and reporting of harms in medicines and devices”</a>.<br/><br/>The original <a href='https://prescrire.org/docus/ericeEn.pdf'>Erice Declaration of 1997</a> laid the groundwork for good communication practices in the pharmacovigilance field and was updated in <a href='https://pubmed.ncbi.nlm.nih.gov/16454537/'>2006</a> and in <a href='https://pubmed.ncbi.nlm.nih.gov/28815462/'>2017</a>.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 16 Jul 2020 12:00:00 +0200</pubDate>
    <itunes:duration>1098</itunes:duration>
    <itunes:keywords>communication, COVID-19, medicine, pharmacovigilance, patient safety, Erice declaration, regulation</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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    <itunes:title>#3 Navigating the plant names jungle – Bob Allkin</itunes:title>
    <title>#3 Navigating the plant names jungle – Bob Allkin</title>
    <itunes:summary><![CDATA[Send a message to the show! Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it's not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it. Tune in to find out: How common, scientific and pharmaceutical plant names differHow Kew’s Medicinal Plant N...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it&apos;s not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it.</p><p><b>Tune in to find out:</b></p><ul><li>How common, scientific and pharmaceutical plant names differ</li><li>How Kew’s Medicinal Plant Names Services works</li><li>How healthcare and pharmacovigilance professionals working with herbal medicines can avoid mistakes</li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li>Bob Allkin discusses the regulation of medicinal plant names in UMC’s magazine <a href='https://www.uppsalareports.org/articles/navigating-the-plant-names-jungle/'>Uppsala Reports</a></li><li>Kew’s <a href='https://stateoftheworldsplants.org/'>“State of the World’s Plants 2017”</a> report includes a chapter on use and regulation of medicinal plants around the world</li><li>These are the <a href='https://www.sciencedirect.com/science/article/pii/S1876382016303547'>most common mistakes</a> when using plant names – and how to avoid them</li><li><a href='https://www.iso.org/news/ref2234.html'>IDMP standards</a> improve the description of medicinal products worldwide</li><li>Kew’s <a href='https://www.kew.org/science/our-science/science-services/medicinal-plant-names-services'>Medicinal Plant Names Services</a> is freely accessible online – start browsing!</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it&apos;s not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it.</p><p><b>Tune in to find out:</b></p><ul><li>How common, scientific and pharmaceutical plant names differ</li><li>How Kew’s Medicinal Plant Names Services works</li><li>How healthcare and pharmacovigilance professionals working with herbal medicines can avoid mistakes</li></ul><p><b>Want to know more?</b></p><p>Here are a few resources to get you started:</p><ul><li>Bob Allkin discusses the regulation of medicinal plant names in UMC’s magazine <a href='https://www.uppsalareports.org/articles/navigating-the-plant-names-jungle/'>Uppsala Reports</a></li><li>Kew’s <a href='https://stateoftheworldsplants.org/'>“State of the World’s Plants 2017”</a> report includes a chapter on use and regulation of medicinal plants around the world</li><li>These are the <a href='https://www.sciencedirect.com/science/article/pii/S1876382016303547'>most common mistakes</a> when using plant names – and how to avoid them</li><li><a href='https://www.iso.org/news/ref2234.html'>IDMP standards</a> improve the description of medicinal products worldwide</li><li>Kew’s <a href='https://www.kew.org/science/our-science/science-services/medicinal-plant-names-services'>Medicinal Plant Names Services</a> is freely accessible online – start browsing!</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Thu, 25 Jun 2020 10:00:00 +0200</pubDate>
    <itunes:duration>2456</itunes:duration>
    <itunes:keywords>herbal medicines, Kew Gardens, medicine, medicinal plants, patient safety, pharmacovigilance, traditional medicines</itunes:keywords>
    <itunes:episodeType>full</itunes:episodeType>
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    <itunes:title>#2 Why we should listen to patients – Linda Härmark </itunes:title>
    <title>#2 Why we should listen to patients – Linda Härmark </title>
    <itunes:summary><![CDATA[Send a message to the show! As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more. Tune in to find out: What patient reports reveal about people’s use of medicinesHow to make be...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more.</p><p><b>Tune in to find out:</b></p><ul><li>What patient reports reveal about people’s use of medicines</li><li>How to make best use of the information relayed by patients</li><li>What to consider when setting up a patient reporting system</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>After <a href='https://www.uppsalareports.org/articles/fifteen-years-of-patient-reporting/'>fifteen years in the business</a>, Lareb has lessons to share on implementing and running patient reporting systems.</li><li>Pharmacovigilance pioneer Sten Olsson argues that patient reporting is the <a href='https://www.uppsalareports.org/articles/patient-reporting-is-the-future-of-pharmacovigilance/'>future of pharmacovigilance</a>.</li><li>Collaborating with patient organizations can help pharmacovigilance centres <a href='https://link.springer.com/epdf/10.1007/s40264-020-00932-5?sharing_token=UymSCfwYQtbwpAvoGlMCyve4RwlQNchNByi7wbcMAY46wYhhX3aGTBFEy2HpjUH9T1soB0JUyEz1yQozCMuVZd61kDrkvOvh7C43JVZJ85SCE7bHCQJIdXkewtLnKYrZSqjn1DLQazctI3hY8sL8vHo1j7ZJJL2tO3-EnJqThlo%3D'>deliver medicine safety updates to the right audiences</a> and <a href='https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1591366'>understand how patients use medicines</a>.</li><li>Patient reports can help identify previously unrecognized side effects, like in the case of <a href='https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.13617'>panic attacks with the contraceptive desogestrel</a>.</li><li>A collaborative <a href='https://link.springer.com/article/10.1007/s40264-017-0594-2'>signal detection workshop on patient reports</a> taught Lareb and Uppsala Monitoring Centre staff some valuable lessons.</li><li>Every year, the <a href='https://www.who-umc.org/medsafetyweek/'>#MedSafetyWeek campaign</a> raises awareness of medicine side effects and pharmacovigilance reporting systems – join in!</li></ul><p>If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out <a href='https://www.buzzsprout.com/618871/6839950'>this interview with Eugene van Puijenbroek</a> on intuitive and clinical reasoning.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more.</p><p><b>Tune in to find out:</b></p><ul><li>What patient reports reveal about people’s use of medicines</li><li>How to make best use of the information relayed by patients</li><li>What to consider when setting up a patient reporting system</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>After <a href='https://www.uppsalareports.org/articles/fifteen-years-of-patient-reporting/'>fifteen years in the business</a>, Lareb has lessons to share on implementing and running patient reporting systems.</li><li>Pharmacovigilance pioneer Sten Olsson argues that patient reporting is the <a href='https://www.uppsalareports.org/articles/patient-reporting-is-the-future-of-pharmacovigilance/'>future of pharmacovigilance</a>.</li><li>Collaborating with patient organizations can help pharmacovigilance centres <a href='https://link.springer.com/epdf/10.1007/s40264-020-00932-5?sharing_token=UymSCfwYQtbwpAvoGlMCyve4RwlQNchNByi7wbcMAY46wYhhX3aGTBFEy2HpjUH9T1soB0JUyEz1yQozCMuVZd61kDrkvOvh7C43JVZJ85SCE7bHCQJIdXkewtLnKYrZSqjn1DLQazctI3hY8sL8vHo1j7ZJJL2tO3-EnJqThlo%3D'>deliver medicine safety updates to the right audiences</a> and <a href='https://www.tandfonline.com/doi/full/10.1080/14740338.2019.1591366'>understand how patients use medicines</a>.</li><li>Patient reports can help identify previously unrecognized side effects, like in the case of <a href='https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.13617'>panic attacks with the contraceptive desogestrel</a>.</li><li>A collaborative <a href='https://link.springer.com/article/10.1007/s40264-017-0594-2'>signal detection workshop on patient reports</a> taught Lareb and Uppsala Monitoring Centre staff some valuable lessons.</li><li>Every year, the <a href='https://www.who-umc.org/medsafetyweek/'>#MedSafetyWeek campaign</a> raises awareness of medicine side effects and pharmacovigilance reporting systems – join in!</li></ul><p>If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out <a href='https://www.buzzsprout.com/618871/6839950'>this interview with Eugene van Puijenbroek</a> on intuitive and clinical reasoning.</p><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Wed, 20 May 2020 17:00:00 +0200</pubDate>
    <itunes:duration>1755</itunes:duration>
    <itunes:keywords>Lareb, medicine, patient reporting, patient safety, pharmacovigilance</itunes:keywords>
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    <itunes:title>Uppsala Reports Long Reads – Philosophy of science meets patient safety</itunes:title>
    <title>Uppsala Reports Long Reads – Philosophy of science meets patient safety</title>
    <itunes:summary><![CDATA[Send a message to the show! Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances­, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering a more nuanced understanding of patient safety. This episode is part of the Uppsala Reports Lon...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances­, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering a more nuanced understanding of patient safety.</p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/causehealth-risk-and-safety-philosophy-of-science-meets-patient-safety/'>text version here</a>. <br/><br/><b>Tune in to find out:</b></p><ul><li>What causal dispositions are</li><li>Why pharmacovigilance would benefit from a new approach to causality</li><li>How to promote trans-disciplinary approaches to medical inquiry</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>The <a href='https://causehealthpharmacovigilance.wordpress.com/'>CauseHealth Risk and Safety</a> project is bridging pharmacovigilance and philosophy of science</li><li><a href='https://www.mdpi.com/1660-4601/17/6/1813'>Causal evidence and dispositions</a> can improve our understanding of causality in medicine and public health</li><li>Medical scientists and philosophers worldwide <a href='https://ebm.bmj.com/content/25/1/6'>appeal</a> to expand the notion of “evidence”</li><li>Patient experiences can enhance the quality and safety of healthcare, say the authors of the <a href='https://pubmed.ncbi.nlm.nih.gov/32297160/'>Erice Call for Change</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances­, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering a more nuanced understanding of patient safety.</p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/causehealth-risk-and-safety-philosophy-of-science-meets-patient-safety/'>text version here</a>. <br/><br/><b>Tune in to find out:</b></p><ul><li>What causal dispositions are</li><li>Why pharmacovigilance would benefit from a new approach to causality</li><li>How to promote trans-disciplinary approaches to medical inquiry</li></ul><p><b>Want to know more?</b></p><p>Here are a few reading resources to get you started:</p><ul><li>The <a href='https://causehealthpharmacovigilance.wordpress.com/'>CauseHealth Risk and Safety</a> project is bridging pharmacovigilance and philosophy of science</li><li><a href='https://www.mdpi.com/1660-4601/17/6/1813'>Causal evidence and dispositions</a> can improve our understanding of causality in medicine and public health</li><li>Medical scientists and philosophers worldwide <a href='https://ebm.bmj.com/content/25/1/6'>appeal</a> to expand the notion of “evidence”</li><li>Patient experiences can enhance the quality and safety of healthcare, say the authors of the <a href='https://pubmed.ncbi.nlm.nih.gov/32297160/'>Erice Call for Change</a></li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <pubDate>Wed, 13 May 2020 09:00:00 +0200</pubDate>
    <itunes:duration>791</itunes:duration>
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    <itunes:title>Uppsala Reports Long Reads – Ending the pregnant pause</itunes:title>
    <title>Uppsala Reports Long Reads – Ending the pregnant pause</title>
    <itunes:summary><![CDATA[Send a message to the show! Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap. This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the text version here.  Tune in to find out: W...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap.</p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/ending-the-pregnant-pause/'>text version here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why clinical trials often fail to include pregnant and breastfeeding women</li><li>What the lack of safety information means for women who need medicines during pregnancy and breastfeeding</li><li>How new multi-disciplinary initiatives are planning to boost pharmacovigilance activities related to pregnancy and lactation</li></ul><p><b>Want to know more?</b></p><p>Read how <a href='http://euromedicat.eu/'>EUROmediCAT</a> plans to evaluate the safety of medicines in pregnancy in relation to the risk of congenital anomalies. </p><p>Find out how <a href='https://www.imi-conception.eu/'>ConcePTION</a> wants to help women make informed decisions about the medications they need before, during and after pregnancy.</p><p>Read about:</p><ul><li><a href='https://link.springer.com/article/10.1007/s40264-018-0729-0'>Lareb’s survey</a> of pregnancy-related pharmacovigilance activities</li><li>the history of <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800017/'>women’s involvement</a> in clinical trials</li><li>the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747530/'>ethical debate</a> surrounding the inclusion of pregnant women in research</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap.</p><p>This episode is part of the <a href='https://www.uppsalareports.org/'>Uppsala Reports</a> Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the <a href='https://www.uppsalareports.org/articles/ending-the-pregnant-pause/'>text version here</a>.<br/><br/><b>Tune in to find out:</b></p><ul><li>Why clinical trials often fail to include pregnant and breastfeeding women</li><li>What the lack of safety information means for women who need medicines during pregnancy and breastfeeding</li><li>How new multi-disciplinary initiatives are planning to boost pharmacovigilance activities related to pregnancy and lactation</li></ul><p><b>Want to know more?</b></p><p>Read how <a href='http://euromedicat.eu/'>EUROmediCAT</a> plans to evaluate the safety of medicines in pregnancy in relation to the risk of congenital anomalies. </p><p>Find out how <a href='https://www.imi-conception.eu/'>ConcePTION</a> wants to help women make informed decisions about the medications they need before, during and after pregnancy.</p><p>Read about:</p><ul><li><a href='https://link.springer.com/article/10.1007/s40264-018-0729-0'>Lareb’s survey</a> of pregnancy-related pharmacovigilance activities</li><li>the history of <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800017/'>women’s involvement</a> in clinical trials</li><li>the <a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2747530/'>ethical debate</a> surrounding the inclusion of pregnant women in research</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Fri, 24 Apr 2020 10:00:00 +0200</pubDate>
    <itunes:duration>1560</itunes:duration>
    <itunes:keywords>clinical trials, medicine, pharmacovigilance, patient registries, patient safety, pregnancy</itunes:keywords>
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    <itunes:title>#1 Fighting the fakes – Aline Plançon</itunes:title>
    <title>#1 Fighting the fakes – Aline Plançon</title>
    <itunes:summary><![CDATA[Send a message to the show! Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. So how do we put a stop to this deadly trade? Drug Safety Matters investigates with former Interp...]]></itunes:summary>
    <description><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. So how do we put a stop to this deadly trade? Drug Safety Matters investigates with former Interpol officer and PMEDS program founder Aline Plançon.<br/><br/><b>Tune in to find out:</b></p><ul><li>How widespread and dangerous fake medicines are</li><li>What makes pharmaceutical crime so successful</li><li>What action is being taken to curb the problem</li><li>How modern tracking technology can help</li><li>What we can do to raise awareness</li></ul><p><b>Want to know more?</b></p><ul><li>Read Aline Plançon’s book on fake medicines, <a href='https://www.babelio.com/livres/Plancon-Faux-medicaments-un-crime-silencieux/1198625'>Faux Médicaments: Un Crime Silencieux</a> (in French).</li><li>Find out how the World Health Organization is fighting falsified and substandard medicines in <a href='https://view.publitas.com/uppsala-monitoring-centre/uppsala-reports-80/page/6'>UMC’s magazine Uppsala Reports.</a></li><li>Teach your children about falsified medicines with <a href='https://www.who-umc.org/global-pharmacovigilance/pharmacovigilance-communications/annie-mac-s-adventures/'>UMC’s comic book Annie &amp; Mac’s Adventures</a>: Lord Fake Strikes Again. It’s available in <a href='https://www.who-umc.org/media/164310/draft2_anniemac2_low_3-final.pdf'>English</a> and <a href='https://www.who-umc.org/media/165213/umc_comicbook-1__spanish_latin_america_final_web.pdf'>Spanish</a>.</li><li>Help raise awareness of the problem by joining the <a href='http://fightthefakes.org/'>Fight the Fakes campaign</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></description>
    <content:encoded><![CDATA[<p><a target="_blank" href="https://www.buzzsprout.com/618871/fan_mail/new">Send a message to the show!</a></p><p>Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. So how do we put a stop to this deadly trade? Drug Safety Matters investigates with former Interpol officer and PMEDS program founder Aline Plançon.<br/><br/><b>Tune in to find out:</b></p><ul><li>How widespread and dangerous fake medicines are</li><li>What makes pharmaceutical crime so successful</li><li>What action is being taken to curb the problem</li><li>How modern tracking technology can help</li><li>What we can do to raise awareness</li></ul><p><b>Want to know more?</b></p><ul><li>Read Aline Plançon’s book on fake medicines, <a href='https://www.babelio.com/livres/Plancon-Faux-medicaments-un-crime-silencieux/1198625'>Faux Médicaments: Un Crime Silencieux</a> (in French).</li><li>Find out how the World Health Organization is fighting falsified and substandard medicines in <a href='https://view.publitas.com/uppsala-monitoring-centre/uppsala-reports-80/page/6'>UMC’s magazine Uppsala Reports.</a></li><li>Teach your children about falsified medicines with <a href='https://www.who-umc.org/global-pharmacovigilance/pharmacovigilance-communications/annie-mac-s-adventures/'>UMC’s comic book Annie &amp; Mac’s Adventures</a>: Lord Fake Strikes Again. It’s available in <a href='https://www.who-umc.org/media/164310/draft2_anniemac2_low_3-final.pdf'>English</a> and <a href='https://www.who-umc.org/media/165213/umc_comicbook-1__spanish_latin_america_final_web.pdf'>Spanish</a>.</li><li>Help raise awareness of the problem by joining the <a href='http://fightthefakes.org/'>Fight the Fakes campaign</a>.</li></ul><p><b>Got a story to share?<br/></b>We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, <a href='https://www.buzzsprout.com/twilio/text_messages/618871/open_sms'>get in touch</a>!<br/><br/><b>About UMC<br/></b><a href='https://www.who-umc.org/'>Uppsala Monitoring Centre</a> promotes safer use of medicines and vaccines for everyone everywhere. Follow us on <a href='https://www.facebook.com/UppsalaMonitoringCentre'>Facebook</a>, <a href='https://www.linkedin.com/company/109057/'>LinkedIn</a>, <a href='https://twitter.com/UMCGlobalSafety'>X</a><em>, </em>and <a href='https://bsky.app/profile/umc-pv.bsky.social'>Bluesky</a>.</p>]]></content:encoded>
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    <itunes:author>Uppsala Monitoring Centre</itunes:author>
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    <pubDate>Mon, 27 Jan 2020 11:00:00 +0100</pubDate>
    <itunes:duration>1760</itunes:duration>
    <itunes:keywords>medicine, fake medicine, falsified medicine, substandard medicine, Interpol, pharmacovigilance, patient safety</itunes:keywords>
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