Community is the future of pharmacovigilance

Perspective / 22 October 2019

Participants in the 21st international pharmacovigilance course. Photo: UMC

A pharmacoepidemiologist reflects on two decades of international pharmacovigilance training and sees the future in a strengthening global community of practitioners.


In June 2019, UMC held its 21st inter-national pharmaco­vigilance training course. From all parts of the world, pharmaco­vigilance professionals assembled in Uppsala to take part  in the lectures, group work, and case studies in the methods and practice of signal detection, causality assessment, and pharmacoepidemiology. It’s a unique and, for many, unforgettable experience of engaging in high-quality discussions and lessons on how to improve drug safety for both populations and individual patients.

The systematic analysis of spontaneous case reports has been the impetus for many formal scientific inquiries, regulatory inter-ventions, or changes in the practice of medicine. Therefore, training about vigilance methods, scientific inquiry, and implementing and communicating results remains important. Over the past two decades, I’ve had the privilege, together with Toine Egberts from our Utrecht group, to be one of the lecturers in the UMC pharmaco-vigilance course. This year, I delivered my final contribution. It’s sad, yes, but professional retirement is ahead and it’s good to see new people take up the torch. 

Pharmacovigilance has changed dramatically during my two-decade tenure at the UMC course. I want to take this opportunity to briefly reflect on a few of these changes – and this is a personal selection.

First, getting meaningful numerical information based on the analysis of the spontaneous reports (for example, disproportionality analysis, machine learning, and time trends) has become a critical asset in the field. Contrasting the number of observed reports against an estimated number of the expected has always been part of the intellectual logic of pharmacovigilance, but with the new statistical and digital advances, making sense out of these comparisons has become increasingly sophisticated.

This development was also an important part of creating intellectual and productive bridges between pharmacovigilance and pharmacoepidemiology. Although both fields have their own historical antecedents, their own scientific and clinical culture, their own societies (ISoP and ISPE), they have also many features in common. Ultimately, sound and informed evidence is what can make a difference in ensuring and managing drug safety. And many people are members of both communities, fuelling mutual work and beneficial collaborations to protect public health around the globe.

By gathering and fostering expertise and experiences from different geographic regions, reaching out with the most recent pharmaco­vigilance methods and practices, and engaging with many international experts, UMC has made it clear that drug safety has no borders.

Second, whereas drug licensing and reimbursement are often connected to national or regional jurisdictions, drug safety is by definition global, affecting all exposed individuals and communities. International collaboration to meet global challenges is a must. Here, UMC – together with national pharmacovigilance centres and regionally – has contributed tremendously.

By gathering and fostering expertise and experiences from different geographic regions, reaching out with the most recent pharmacovigilance methods and practices, and engaging with many international experts, UMC has made it clear that drug safety has no borders. In this context, I was very pleased to see how topics such as communication skills, patient engagement, and stakeholder interactions have become more visible in the UMC course over the years. Pharmacovigilance involves informed story building, where choosing the right language, information channel, and forum – and being transparent about relevant interests – have become more critical. Where pharmacovigilance of the past was more or less a closed shop, nowadays social media and speedy interactive web forums make any conversation or debate about a drug safety issue “real life” everywhere. The safety debates about new malaria regimens in Africa or pharmacogenomic modifiers of adverse reactions of tamoxifen in Asia happened locally yet, at the same moment, were everywhere. 

My third reflection relates to the intriguing and sometimes complex relationship between the practice of pharmacovigilance – dealing with more or less well-documented, spontaneous case reports from vigilant individual doctors, pharmacists, or nurses who observed something unexpected – and the legally enforced regulatory systems of pharmacovigilance, wherein governments and industry are bound to act according to legal rules and directives.

In many regions, pharmacovigilance has been professionalised and formalised with the best intentions, but often at the expense of the necessary involvement of a clinical perspective. Compliance with procedures does not always go hand-in-hand with digging into an individual report for a couple of days, calling the reporting physician at the ward and having a conversation over a coffee on the likelihood of causality or possible alternative explanations of the observed association. Achieving a smart blend of efficient and transparent procedures with the human touch of medical practice still seems to be a challenge. Providing the best of both worlds has always been a strength of the UMC course. Participants have been stimulated to bring in their individual case stories – the conversations over a coffee, or the patient who visited the clinic on Monday with an intriguing story. Part of pharmacovigilance is making sense of these personal stories, and over the years, I met many UMC course participants with a strong dedication to working along such lines.

Finally, UMC courses have contributed in many ways to capacity building in pharmacovigilance – probably one of the most relevant investments in the future. There remain many challenges, such as lack of resources, lack of vision or ambition, and erratic political will. But UMC courses have shown that capacity building should, and does, go hand-in-hand with community building.

I observed that many UMC course participants have stayed in touch with each other after the course, building learning communities, continuing to exchange notable experiences, or embarking on extended scientific training and pharmaco-vigilance research. Interestingly, many course participants learnt that for good practice of pharmacovigilance, advanced thinking can be even more important than advanced databases or record linkage systems. We in Utrecht had the privilege to host a number of international pharmacovigilance PhD students over the last decade, virtually all former participants of UMC courses. That type of community building, with major regional spin-offs, really delivers. Not only in terms of capacity building and scientific output, but far beyond.

The UMC course is the hub, and the spokes make the connections to the national centres and the regions. I send a big thank you to all UMC colleagues and course participants for allowing me to be part of that learning system for many years.

Tags: education, CapacityBuilding, training

Bert Leufkens
Professor of Pharmaceutical Policy and Regulatory Science, Utrecht University

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