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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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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 sho...
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 He...
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, ...
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 smartph...
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 focussin...
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 pra...
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...
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 ...
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 ...
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 disprop...
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 detec...
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 pharma...
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 t...
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 more? This review by Daniel Wei...
Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the unpredictable. Tune in to find out: What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilanceWhat makes an adverse drug reaction a black, white, or grey swan Why flexibility...
The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI). Tune in to find out: Who is most at risk of developing DILIHow to diagnose the condition and control the damageHow to assess case reports of DILIWant to know more? This infographic in Nature Reviews nicely ...
1What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro-Rojas, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance. Tune in to find out: Why patient engagement is a growing priorityWhat challenges exist in the Latin American regionWhich topics will be in the spotlight next yearWant to know more? ISoP is a non-profit society ope...
To mark #MedSafetyWeek, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign. Tune in to find out: Why you s...
To mark #MedSafetyWeek, which takes place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this first part, we speak to Mitul Jadeja from the Medicines and Healthcare products Regulatory Agency in the UK about under-reporting and how initiatives like #MedSafetyWeek can help draw attention to medicines safety. Tune in to find out: Why under-reporting plagues all pharmacovigilance systemsWhat regulators can do to encourage people to...
Herbal remedies have been used for thousands of years to treat what ails us. Yet why do we still know so little about their potential side effects compared to modern medicines? 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 Daniele Sartori to learn more about the challenges in herbal pharmacovigilance. Tune in t...
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