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.
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#46 Protecting the health ecosystem – Valentina Giunchi & Joe Mitchell
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 en
#45 How to perform better disproportionality analyses – Michele Fusaroli & Eugene van Puijenbroek
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 dispro
#44 Rethinking medical device safety, part 2 – Omar Aimer
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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.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 monitorin
#43 Rethinking medical device safety, part 1 – Omar Aimer
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 Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.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 mon
#42 Unpacking the WHO Global Smart Pharmacovigilance Strategy – Shanthi Pal
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 focu
#41 How to use artificial intelligence in pharmacovigilance, part 2 – Niklas Norén
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 Up
#40 How to use artificial intelligence in pharmacovigilance, part 1 – Niklas Norén
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 Res
#39 Putting children first on Patient Safety Day – Angela Caro-Rojas
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 co
#38 Patient perspectives in PV: a fireside chat at the ISoP mid-year symposium
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 Härm
#37 Beyond numbers: quality in ADR reporting – Henry Zakumumpa
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 introd
#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin
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 profe
#35 Veterinary pharmacovigilance, part 2 – James Mount
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 ch
#34 Veterinary pharmacovigilance, part 1 – James Mount
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 electe
#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias
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 n
#32 Pharmacovigilance in older adults – Giovanni Furlan
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 us
#31 A guide to reporting disproportionality analyses – Michele Fusaroli and Daniele Sartori
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 pharmacovigil
Uppsala Reports Long Reads – Weeding out duplicates to better detect side effects
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.
Uppsala Reports Long Reads – Ensuring trust in AI/ML when used in pharmacovigilance
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
#30 Preventing and reporting medication errors – Rabat CC & UMC
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
#29 When medicines change our behaviour – Michele Fusaroli
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 k
#28 Catching black swans – François Montastruc
Send a message to the show!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’ th
#27 When drugs damage the liver – Rita Baião
Send a message to the show!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 condit
#26 What's trending in pharmacovigilance? – Angela Caro-Rojas
Send a message to the show!What 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 t
#25 A week in the name of medicines safety – part 2
Send a message to the show!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
#24 A week in the name of medicines safety – part 1
Send a message to the show!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.
Uppsala Reports Long Reads – The colour of signals
Send a message to the show!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
Uppsala Reports Long Reads – Empowering patients as partners
Send a message to the show!A patient's perspective can ensure safe medical care and lead to new insights that traditional research may overlook. But how do we best harness that perspective to improve patient outcomes?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
#23 Assessing safety in clinical trials – Marianne Lunzer & Sanja Prpić
Send a message to the show!Medicines safety monitoring is a continuous process that begins with pre-marketing clinical trials and continues with post-marketing studies to fill any gaps in knowledge. With Marianne Lunzer from AGES and Sanja Prpić from HALMED, we review the pros and cons of various study types and the importance of testing medicines on diverse populations.Tune in to find out:How pre
#22 Reforming pharmacovigilance education – Michael Reumerman
Send a message to the show!Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.Tune in to find out:How real-life education can benefit healthcare studentsWhich educational
#21 Unlocking the power of real-world data – Patrick Ryan
Send a message to the show!The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety.Tune in to find out:How real-world data is co
#20 The evidence for signals – Daniele Sartori
Send a message to the show!Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.Tune in to find out: Which features of case reports are most often used to assess
Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era
Send a message to the show!Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?This episode is part of the Uppsala Reports Long Reads se
#19 Lessons in pandemic pharmacovigilance – Elena Rocca
Send a message to the show!The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.Tune in to find out:How to handle uncertain eviden
#18 The IDMP standards explained – Malin Fladvad & Olle Lagerlund
Send a message to the show!The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standar
#17 Why we need vaccine surveillance systems – Madhava Balakrishnan
Send a message to the show!Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur.Tune
#16 How drug safety can help fight resistant bugs – Jean Marie Vianney Habarugira & Albert Figueras
Send a message to the show!Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.Tune in to find out:How to code adverse drug
#15 Safety of HIV medications – Henry Zakumumpa
Send a message to the show!With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.
#14 Advancing pharmacovigilance in Africa – Eleni Aklillu & Abbie Barry
Send a message to the show!Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in East Africa – especially
#13 How to talk about risks – Alexandra Freeman
Send a message to the show!People’s perception of risk can vary greatly from person to person, making it challenging for healthcare professionals to communicate benefits and harms of medicines in a balanced fashion. Alexandra Freeman from the Winton Centre for Risk and Evidence Communication discusses how to give patients the information they need to decide what's best for them.Tune in to fin
Uppsala Reports Long Reads – Safety issues faced by refugee communities
Send a message to the show!The loss of vital health records is a universal problem for refugees. When their medical information goes missing, patients are less likely to receive the care they need and more likely to be prescribed the wrong treatments. Thankfully, the International Society of Pharmacovigilance Egypt Chapter and the Palestine Red Crescent Society are taking on this problem, to reduc
#12 Improving signal detection with vigiGroup – Jim Barrett & Joe Mitchell
Send a message to the show!Statistical tools can not only cut through the noise in large pharmacovigilance databases. They can also help identify more clinically meaningful patterns in the data. Uppsala Monitoring Centre’s Jim Barrett and Joe Mitchell explain how vigiGroup, a novel clustering algorithm, can bring value to signal detection.Tune in to find out:What the limits of traditional dispropo
#11 Talking about vaccine safety – Anthony Cox & Daniel Salmon
Send a message to the show!With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best advice for balanced and r
Uppsala Reports Long Reads – The KIDs List
Send a message to the show!It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribing for the better.This e
Uppsala Reports Long Reads – Convincing the vaccine hesitant
Send a message to the show!Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination belief and vaccine hesit
#10 Tailoring drug therapy to your genes – Qun-Ying Yue
Send a message to the show!Genetic variation is one of the reasons people differ in their response to medicines. Understanding that variation can inform more refined choices of drugs and doses – ultimately preventing undesired side effects. Join us as we discuss past, present and future of pharmacogenomics with Uppsala Monitoring Centre’s Qun-Ying Yue.Tune in to find out:How genetic biomarkers can
#9 Keeping vaccines safe – Helena Sköld & Annette Rudolph
Send a message to the show!With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.Tune in to find out:How suspected side effect
Uppsala Reports Long Reads – Substandard and falsified COVID-19 vaccines in the Americas
Send a message to the show!While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait – and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably arou
#8 How do we change behaviour around antimicrobial resistance?
Send a message to the show!Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance through behaviour change” ta
Uppsala Reports Long Reads – Into the infodemic
Send a message to the show!As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original a
#7 The challenge of rare diseases – Christina Ström Möller
Send a message to the show!By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commerc
Uppsala Reports Long Reads – Africa integral to evolution of pharmacogenomics research
Send a message to the show!As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 1
#6 Intuition in pharmacovigilance – Eugene van Puijenbroek
Send a message to the show!In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, witho
Uppsala Reports Long Reads – Patient's advocate
Send a message to the show!In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her
Uppsala Reports Long Reads – Vaccination errors risk harm and damage trust
Send a message to the show!Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.Thi
#5 Restoring invisible and abandoned trials – Peter Doshi
Send a message to the show!Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission
#4 Communicating science through film – Matthew Barwick
Send a message to the show!Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Ta
Uppsala Reports Long Reads – Found in space
Send a message to the show!When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.This episode is part of the Uppsala Reports Long Reads
Uppsala Reports Long Reads – 10 critical steps for patient safety
Send a message to the show!How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio f
#3 Navigating the plant names jungle – Bob Allkin
Send a message to the show!Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it's not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it.Tune in
#2 Why we should listen to patients – Linda Härmark
Send a message to the show!As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more
Uppsala Reports Long Reads – Philosophy of science meets patient safety
Send a message to the show!Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering
Uppsala Reports Long Reads – Ending the pregnant pause
Send a message to the show!Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilanc
#1 Fighting the fakes – Aline Plançon
Send a message to the show!Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. S
