Drug Safety Matters

#46 Protecting the health ecosystem – Valentina Giunchi & Joe Mitchell 04.06.2026 35dk

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...

#45 How to perform better disproportionality analyses – Michele Fusaroli & Eugene van Puijenbroek 26.03.2026 47dk

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...

#44 Rethinking medical device safety, part 2 – Omar Aimer 26.02.2026 21dk

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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.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...

#43 Rethinking medical device safety, part 1 – Omar Aimer 28.01.2026 22dk

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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.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...

#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal 16.12.2025 18dk

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...

#41 How to use artificial intelligence in pharmacovigilance, part 2 – Niklas Norén 21.11.2025 29dk

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...

#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén 17.10.2025 29dk

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...

#39 Putting children first on Patient Safety Day – Angela Caro-Rojas 29.08.2025 26dk

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...

#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium 19.06.2025 35dk

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...

#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa 28.05.2025 39dk

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...

#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin 27.03.2025 37dk

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...

#35 Veterinary pharmacovigilance, part 2 – James Mount 28.01.2025 42dk

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 ...

#34 Veterinary pharmacovigilance, part 1 – James Mount 17.12.2024 48dk

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...

#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias 29.11.2024 39dk

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 ...

#32 Pharmacovigilance in older adults – Giovanni Furlan 25.10.2024 48dk

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...

#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori 30.09.2024 43dk

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...

Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects 26.08.2024 25dk

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...

Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance 27.06.2024 30dk

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...

#30 Preventing and reporting medication errors – Rabat CC & UMC 15.05.2024 34dk

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 ...

#29 When medicines change our behaviour – Michele Fusaroli 23.04.2024 31dk

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...