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Drug Safety Matters

Uppsala Monitoring Centre

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.

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.

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Thursday · 39 min
#47 Viewing global pharmacovigilance through the local lens – Salvador Alvarado & Matthew Barwick
Send us a voicemail! Global pharmacovigilance requires harmonised methods, but solutions must be tailored to the local context. We sat down with Salvador Alvarado and Matthew Barwick from Uppsala Monitoring Centre to explore how local constraints affect drug safety and how a new film series by UMC can inspire PV professionals across borders. Tune in to find out: How the thalidomide tragedy triggered a global pharmacovigilance collaboration How UMC supports members of the WHO Programme for International Drug Monitoring How to communicate science effectively on camera Want to know more? Watch The WHO PIDM in Focus film series on YouTube. Read about the benefits of the WHO PIDM, its members and UMC’s role in the programme. Revisit these related episodes from the Drug Safety Matters archive: Unpacking the WHO Global Smart Pharmacovigilance Strategy Communicating science through film Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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June 4 · 34 min
#46 Protecting the health ecosystem – Valentina Giunchi & Joe Mitchell
Send us a voicemail! 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 are turning up, and why this should be on every pharmacovigilance scientist's radar How the dramatic collapse of India's vulture populations in the early 2000s speaks to the importance of the One Health approach Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution. Want to know more? 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: The revised Erice declaration for the inclusion of environmental issues in pharmacovigilance A book chapter on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editors A paper summarising the main concepts in ecopharmacovigilance and pharmaceutical pollution A paper with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use. A recent paper with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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March 26 · 46 min
#45 How to perform better disproportionality analyses – Michele Fusaroli & Eugene van Puijenbroek
Send us a voicemail! 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 verdicts How poorly performed analyses affect scientists, regulators and patients How to avoid the most common sources of bias Want to know more? Michele and Eugene’s paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis. In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis. Michele also reviewed the method’s limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’. Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers. Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses. In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis. UMC’s guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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February 26 · 20 min
#44 Rethinking medical device safety, part 2 – Omar Aimer
Send us a voicemail! 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 medical devices differs from medicines and vaccines How AI may be used for predictive safety monitoring Why regulatory and data harmonisation remains the key to improving medical device safety Want to know more? Listen to the first part of the interview here. 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 paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports. 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 Nature paper. Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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January 28 · 22 min
#43 Rethinking medical device safety, part 1 – Omar Aimer
Send us a voicemail! 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 defines a medical device and how prevalent they are in our society Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short How global initiatives aim to strengthen safety monitoring standards Want to know more? Listen to the second part of the interview here. 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 paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports. 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 Nature paper. Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Dec 16, 2025 · 18 min
#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal
Send us a voicemail! 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. 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. Want to know more? Read WHO’s “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025). Explore WHO’s work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team. Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines. Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member. Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Nov 21, 2025 · 29 min
#41 How to use artificial intelligence in pharmacovigilance, part 2 – Niklas Norén
Send us a voicemail! 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 and where it should – or shouldn’t – go next. Tune in to find out: How to keep up with rapid developments in AI technology Why model and performance transparency both matter How to protect sensitive patient data when using AI Want to know more? Listen to the first part of the interview here. The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025. For a summary of the report's guiding principles and examples of how they can be applied, check out this article in Drug Safety. Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare. Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. Other recent UMC publications cited in the interview or relevant to the topic include: a pre-print on the revised vigiMatch algorithm for duplicate detection an article on the pitfalls of disproportionality analysis a pre-print on critically appraising AI applications for rare-event recognition For more on the ‘black box’ issue and maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Oct 17, 2025 · 29 min
#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén
Send us a voicemail! 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 pharmacovigilance and where it should – or shouldn’t – go next. Tune in to find out: Why pharmacovigilance needs specific AI guidelines How a risk-based approach to AI regulation works Where in the PV cycle is human oversight most needed Want to know more? Listen to the second part of the interview here. The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025. For a summary of the report's guiding principles and examples of how they can be applied, check out this article in Drug Safety. Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare. Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety. For more on maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive. The AI methods developed by UMC and cited in the interview include: vigiMatch for duplicate detection vigiGroup for clustering vigiRank for signal detection vigiGrade for case report completeness scoring WHODrug Koda for automated coding Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Aug 29, 2025 · 25 min
#39 Putting children first on Patient Safety Day – Angela Caro-Rojas
Send us a voicemail! 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 Day How to prevent common medication errors in children How to build child-friendly healthcare environments Want to know more? Visit the World Health Organization’s campaign website to learn more about World Patient Safety Day and download campaign materials. You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events. For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive: The KIDs List What’s trending in pharmacovigilance? Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Jun 19, 2025 · 34 min
#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium
Send us a voicemail! 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 pharmacovigilance centre of Morocco, member of the IsoP advisory board), and Daniele Sartori (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance. The symposium was a collaboration between ISoP and UMC. Want to know more? Visit the official website of the 2025 ISoP Mid-Year Symposium to learn more about its sessions, speakers and chairs. Not patient but im-patient – read about Sara Riggare’s research on patient engagement and other topics. Listen to Henry Zakumumpa talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters. Read about the PhD project of Tommy Emil Dzus, Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies, at Oslo Metropolitan University, Norway. Sabine Koch is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm. Details on Mikael Hoffman's research can be found on his profile page on ResearchGate. Take a look at what’s in store for participants at the 24th Annual Meeting of ISoP in Cairo, on October 24–27, 2025. Visit the websites of the Drug Safety Research Unit (DSRU), ISoP, Centre Anti Poison et Pharmacovigilance du Maroc, and Uppsala Monitoring Centre, to find out more about their work. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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May 28, 2025 · 38 min
#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa
Send us a voicemail! 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. Tune in to find out: Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers? What are the challenges with reporting via WhatsApp? How can regulators and PV centres foster better quality in incoming adverse event reports? Want to know more? Listen to Henry talk about the safety of HIV medications in this 2022 episode of Drug Safety Matters. Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about Henry’s research. Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews (British Journal of Clinical Pharmacology, 2023) Improving adverse drug event reporting by healthcare professionals (Cochrane Database Systematic Review, 2024) Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Mar 27, 2025 · 36 min
#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin
Send us a voicemail! 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 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. Tune in to find out Why is the world still behind when it comes to pregnancy-related PV? What are the challenges faced by PV assessors wanting to look at pregnancy cases? How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events? How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases? How to use the VigiBase pregnancy algorithm Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches. In the qualitative view in VigiLyze, click on “Filter” -> “Patient” -> “Pregnancy” to apply the filter. Want to know more? Read about the VigiBase pregnancy algorithm in this Uppsala Reports article and in this scientific paper, published in Drug Safety in 2025. EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. EURAP - International Registry of Antiepileptic Drugs and Pregnancy The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files The IMI-concePTION project Medical Dictionary for Regulatory Activities (MedDRA) support documentation Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. Drug Safety. 2024 Sakai T, Mori C, Koshiba H, et al. Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases. Drugs Real World Outcomes. 2022 Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Jan 28, 2025 · 41 min
#35 Veterinary pharmacovigilance, part 2 – James Mount
Send us a voicemail! 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. Tune in to find out How the types of ADRs reported for animals and humans differ How the many species and breeds included in veterinary PV affect the ADR coding What the Veterinary Big Data Strategy is ... and much more! Want to know more? The public portal of the European Union Veterinary Pharmacovigilance Database. One Health – an integrated approach to the well-being of people, animals and the environment. A survey of veterinary professionals in Sweden, about practices and attitudes in relation to ADR reporting. A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicines. The EMA Big Data strategy for veterinary medicines and Data quality framework for medicines regulation Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool VetCompass - Royal Veterinary College, RVC Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA) Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA) Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Dec 17, 2024 · 47 min
#34 Veterinary pharmacovigilance, part 1 – James Mount
Send us a voicemail! 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. Tune in to find out: What are the similarities and differences between veterinary and human pharmacovigilance? How is animal health connected to public health? What types of adverse events are reported on the veterinary side compared with the human side? What can be found in the EU veterinary pharmacovigilance database? Want to know more? The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found here. The public portal of the European Union Veterinary Pharmacovigilance Database. WHO's information page on One Health, an integrated approach to the well-being of people, animals and the environment. A survey of veterinary professionals in Sweden, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information. A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal products. A study looking at suspected adverse drug reaction reporting in veterinary free‐text clinical narratives. The EMA Big Data strategy for veterinary medicines in the EU. Data quality framework for medicines regulation | European Medicines Agency (EMA) Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool VetCompass - Royal Veterinary College, RVC Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA) The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish). Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Nov 29, 2024 · 38 min
#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias
Send us a voicemail! 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. Tune in to find out: What challenges are PV assessors faced with, when working with narratives? How could automation of certain tasks help streamline narrative analyses in the future? How can reporters craft narratives that effectively document adverse events? Want to know more? Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada. Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Oct 25, 2024 · 47 min
#32 Pharmacovigilance in older adults – Giovanni Furlan
Send us a voicemail! 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. Tune in to find out: What makes older adults especially at risk of experiencing adverse drug reactions and medication errors Why frailty is far more useful than age in predicting adverse drug reaction risk How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials. Want to know more? This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here. For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of drug safety in geriatric patients. If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such. As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper. For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Sep 30, 2024 · 42 min
#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori
Send us a voicemail! 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 in the publication of disproportionality analyses in recent years and what this means for their reliability What it means to publish “good” pharmacovigilance science Want to know more? Read the READUS-PV guidelines, why they were created, and why they are important. In 2021, Khouri and colleagues showed that current methods and models used for disproportionality analyses are unreliable, and Mouffak and colleagues found that there is a tendency to overstate results in published disproportionality analyses. A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this exponential increase in disproportionality analyses. This paper elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Aug 26, 2024 · 25 min
Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects
Send us a voicemail! 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 more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance. Tune in to find out: How the new algorithm handles duplicates in VigiBase About different approaches for developing algorithms Why it can be challenging to evaluate the performance of an algorithm Want to know more? Listen to the Drug Safety Matters interview with Michael Glaser 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. Artificial intelligence in pharmacovigilance – value proposition and the need for critical appraisal, a presentation by Niklas Norén, Head of Research at UMC, given at University of Verona in April 2024. Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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Jun 27, 2024 · 30 min
Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance
Send us a voicemail! 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 and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field. Tune in to find out: ● How AI and ML are being used today in pharmacovigilance processes ● Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance ● How we may best move forward to implement AI/ML into healthcare. Want to know more? To know more about how AI and ML are being used in pharmacovigilance currently, read this scoping review. To know more about future trends of the use of AI in Biopharma, read this Accenture survey. Despite there being major interest in ML and AI to do more than task automation, there are a number of barriers to its implementation in healthcare. Check out this future-focused paper on the use of AI/ML in pharmacovigilance that details how to utilise it to its fullest potential. A mindset shift 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. A validation framework must be developed for AI-based pharmacovigilance systems. One suggestion is to do so using a risk-based approach. While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies like this one suggest that the technology has a ways to go to be useful in pharmacovigilance. The World Health Organization have published an extensive guideline on the ethics and governance of AI for health. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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May 15, 2024 · 33 min
#30 Preventing and reporting medication errors – Rabat CC & UMC
Send us a voicemail! 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. Tune in to find out: What are the most common causes for medication errors? How should strategies for preventing medication errors be devised? How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment? What can be done to encourage healthcare professionals to report medication errors? Want to know more? In March 2024, WHO published this systematic review of the global burden of preventable medication-related harm in healthcare. According to this 2021 article in BMJ, 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. This 2012 meta-analysis confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden. The European Medicines Agency (EMA) has a dedicated webpage with recommendations, guidelines, legal requirements and a good practice guide on medication errors. Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch! About UMC Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
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