Drug Safety Matters
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.
Episodes
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...
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 v...
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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.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 ...
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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.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 chan...
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 pharmacovigila...
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 ho...
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,...
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 child...
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 Saf...
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 pa...
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...
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 Workin...
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 Wo...
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 repo...
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 adult...
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 READ...
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...
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 th...
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 Upps...
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 impulsivity
- What the ‘four knights’ of impulsiv...
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