Drug Safety Matters

• #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 poster, presented at the International Society of Pharmacoepidemiology (ISPE) 2024 annual meeting. 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 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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• #35 Veterinary pharmacovigilance, part 2 – James Mount

  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 outHow the types of ADRs reported for animals and humans differHow 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 regulationSmall Animal Veterinary Surveillance Network (SAVSNET) - University of LiverpoolVetCompass - Royal Veterinary College, RVCVeterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA) 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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