Drug Safety Matters

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.

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• How pre- and post-approval safety studies are connected
• ...

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.

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• How real-life education can benefit healthcare students
• Which educational intervention can be most impactful
• How adverse dr...

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.

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• How real-world data is collected and analysed
• Which pharmacovigilance proc...

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.

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• Which features of case reports are most often used to assess causality 
• Why pharmacovigilance experts should r...

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 series – the most topical stories from UMC’s pharmacov...

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.

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• How to handle uncertain evidence
• Why clinical expertise matters in the age of b...

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 standardisation effort.

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• What the IDMP standard...

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.

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• How safety surveillance differs between va...

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.

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• How to code adverse drug reactions for optimal AMR surveillance
• How to us...

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.

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• How dolutegravir-based HIV t...

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 within public health programmes.

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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.

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• Why people perceive risks so differently
• Wh...

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 reduce medication errors and improve reporting practices.

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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.

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• What the limits of traditional disproportionality analysis are
• How clustering algorithms...

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 responsible vaccine safety communication.

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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 episode is part of the Uppsala Reports Long Reads ser...

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 hesitancy.

This episode is part of the Uppsala Reports Lon...

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.

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• How genetic biomarkers can guide medicine use and dosing recommendations
• What we need...

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.

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• How suspected side effects are reported and studied around the world
• Why a...