Drug Safety Matters

• #40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén

  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 guidelinesHow a risk-based approach to AI regulation worksWhere in the PV cycle is human oversight most neededWant to know more?In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.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 detectionvigiGroup for clusteringvigiRank for signal detectionvigiGrade for case report completeness scoringWHODrug Koda for automated coding Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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• #39 Putting children first on Patient Safety Day – Angela Caro-Rojas

  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 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 ListWhat’s trending in pharmacovigilance? Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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• #38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium

  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. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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• #37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa

  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) Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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• #36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin

  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 outWhy 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 algorithmUsers 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 PregnancyThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related FilesThe IMI-concePTION projectMedical Dictionary for Regulatory Activities (MedDRA) support documentationZaccaria 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. 2024Sakai T, Mori C, Koshiba H, et al. Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Dispro Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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