#28 Catching black swans – François Montastruc

enFebruary 29, 2024

Drug Safety Matters

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What was the main topic of the podcast episode?

Summarise the key points discussed in the episode?

Were there any notable quotes or insights from the speakers?

Which popular books were mentioned in this episode?

Were there any points particularly controversial or thought-provoking discussed in the episode?

Were any current events or trending topics addressed in the episode?

About this Episode

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 pharmacovigilance
What makes an adverse drug reaction a black, white, or grey swan
Why flexibility and communication are key to patient safety

Want to know more?

Here are the research articles cited in the episode:

Quality of reporting of adverse events in clinical trials of COVID-19 drugs: systematic review
Psychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase study
Hepatic disorders with the use of remdesivir for COVID-19
Serious bradycardia and remdesivir for COVID-19: a new safety concern
Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experience
Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centres
Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessions

If you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:

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Recent Episodes from Drug Safety Matters

#28 Catching black swans – François Montastruc

Tune in to find out:

What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilance
What makes an adverse drug reaction a black, white, or grey swan
Why flexibility and communication are key to patient safety

Want to know more?

Here are the research articles cited in the episode:

Quality of reporting of adverse events in clinical trials of COVID-19 drugs: systematic review
Psychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase study
Hepatic disorders with the use of remdesivir for COVID-19
Serious bradycardia and remdesivir for COVID-19: a new safety concern
Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experience
Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centres
Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessions

If you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:

enFebruary 29, 2024

#27 When drugs damage the liver – Rita Baião

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 DILI
How to diagnose the condition and control the damage
How to assess case reports of DILI

Want to know more?

This infographic in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.
In this report, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.
In this Drug Safety article, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development.
The PRO-EURO DILI NETWORK coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the Spanish DILI Registry and the Latin American DILI Network.
The free online tool LiverTox contains up-to-date information on drug-induced liver injury for medicines and herbal products.

To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre’s free online course on the topic.

For more on the clustering algorithm vigiGroup, revisit this interview with UMC scientists Jim Barrett and Joe Mitchell.

enFebruary 01, 2024

#26 What's trending in pharmacovigilance? – Angela Caro

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, 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 priority
What challenges exist in the Latin American region
Which topics will be in the spotlight next year

Want to know more?

ISoP is a non-profit society open to anyone with an interest in pharmacovigilance.

Through 14 chapters and 13 special interest groups, the society works to enhance the safe and proper use of medicines across countries.

Their latest annual meeting took place in Bali, Indonesia in November 2023, while the next one will take place in Montreal, Canada in October 2024.

To learn more about ISoP’s activities in patient engagement and pharmacogenomics, listen to these episodes from the Drug Safety Matters archive:

Drug Safety Matters

enDecember 20, 2023

#25 A week in the name of medicines safety – part 2

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 should always tailor your communication strategy to your setting
How to deal with the financial, cultural, and logistical challenges of campaign planning
What to keep in mind if you are new to #MedSafetyWeek

Want to know more?

You can read a summary of this episode on the Uppsala Reports news site.

To learn more about #MedSafetyWeek, check out the hashtag online and visit the campaign website, where you will also find free social media materials in several languages.

This is the second of a two-part episode on pharmacovigilance communication campaigns. Listen to the first part here.

enNovember 13, 2023

#24 A week in the name of medicines safety – part 1

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 systems
What regulators can do to encourage people to report side effects
Why we need reports from both patients and healthcare professionals

Want to know more?

Here are the studies cited in the episode:

A BMJ study in 2022 measured the burden and associated cost of adverse drug reactions, polypharmacy and multimorbidity at a hospital in the UK.
In 1976, Inman proposed a theoretical model, known as the ‘seven deadly sins’, to explain why healthcare professionals fail to report adverse drug reactions. This recent systematic review in Drug Safety expands on that.
The SCOPE Joint Action project aimed to enhance pharmacovigilance in the EU and delivered practical guidance for regulators.
The first UK study to compare Yellow Card reports from patients and healthcare professionals was published in 2012.

To join the #MedSafetyWeek campaign next week, follow the hashtag online and check out the campaign website for free social media materials.

Finally, don’t forget to tune in on 13 November for part 2 of this podcast, where we’ll hear from #MedSafetyWeek advocates in Iraq, Luxembourg, and Namibia about their experience with the campaign. Read a preview of the conversation on Uppsala Reports.

enNovember 02, 2023

Uppsala Reports Long Reads – The colour of signals

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 to find out:

Why the risks of herbals are rarely discussed
How to encourage safety data collection for herbals
How to improve herbal nomenclature and regulation

Want to know more?

Here are some of the resources cited in the episode:

Underreporting of adverse reactions to herbal remedies is driven by our attitude towards herbals themselves, but also by a lack of training on herbal medicines in healthcare curricula.
It is possible to safely use herbal medicines together with other medicines, but we must keep in mind some critical issues related to their interaction.
Simple videos can dramatically increase public awareness of ADR reporting schemes.
Kew Gardens’ Medicinal Plant Names Services offers a systematic overview of medicinal plants and their accepted scientific names.
The American Botanical Council suggests methods to uncover attempts to adulterate plant extracts.

For a comprehensive overview of herbal pharmacovigilance, check out this recent book by Joanne Barnes and colleagues covering advances, challenges, and international perspectives in the field.

For more on Daniele’s scoping review of signals or the thorny nomenclature of medicinal plants, listen to these episodes from the Drug Safety Matters archive:

Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.

enSeptember 29, 2023

Uppsala Reports Long Reads – Empowering patients as partners

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 article here.

After the read, we speak to Manal Younus, who authored the article, to learn more about patient engagement and its benefits for medicines safety.

Tune in to find out:

How regulators and healthcare professionals can effectively engage patients
How patients can get involved in drug safety monitoring
What the pharmacovigilance community learned from the valproate case

Want to know more?

In 2022, the Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on patient involvement in the development, regulation and safe use of medicines. They also recorded a webinar to summarise the report’s main conclusions.

The International Society of Pharmacovigilance (ISoP) runs a patient engagement group to advance patient involvement in the safety monitoring of medicines.

The Valproate toolkit, developed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), supports healthcare professionals in advising women of childbearing age about the risks and benefits of valproate therapy.

PatientsLikeMe is a digital platform where patients can share personal health stories, connect to peers, and learn about different conditions and treatments.

For more on patient engagement and communication, check out these episodes from the Drug Safety Matters archive:

Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.

enSeptember 05, 2023

#23 Assessing safety in clinical trials – Marianne Lunzer & Sanja Prpić

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- and post-approval safety studies are connected
Why safety assessors can request studies in underrepresented populations
How new regulations are impacting safety assessments in the EU

Want to know more?

This review in Trials summarises the methodological challenges of assessing drug safety in clinical trials, while this study in Clinical and Translational Science reviews how sex, racial, and ethnic diversity in clinical trials have changed in recent years.

Post-authorisation safety studies can be imposed or voluntary and can be carried out as clinical trials or as non-interventional studies. Read about the differences on the European Medicines Agency’s website.

Large simple trials can control for biases in observational research while still providing results that are generalisable to real-world use. This review in Drug Safety explains why.

The new Clinical Trials Regulation harmonises how EU trials are assessed and supervised for increased safety and transparency. As part of these efforts, the SAFE CT project aims to facilitate clinical trial coordination and safety assessments in the EU.

For more on clinical trials, revisit this conversation with Peter Doshi on restoring invisible and abandoned trials.

This episode is the last of a three-part series on sources of evidence in pharmacovigilance. Listen to the first two episodes here:

enJune 27, 2023

#22 Reforming pharmacovigilance education – Michael Reumerman

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 students
Which educational intervention can be most impactful
How adverse drug event managers can improve pharmacovigilance

Want to know more?

In his PhD thesis, Michael details the current state of pharmacovigilance education and all the real-life interventions he and his colleagues have tested in the Netherlands so far.

As part of an international collaboration, staff at Amsterdam UMC have helped set up the European Open Platform for Prescribing Education (EurOP2E), an online collection of problem-based, open teaching resources to improve clinical pharmacology and therapeutics education.

The World Health Organization’s Guide to Good Prescribing provides a six-step guide for students to the process of rational prescribing – but the time has come to update both its content and form.

In 2018, the Netherlands Pharmacovigilance Centre Lareb developed a core curriculum for pharmacovigilance education in universities.

Whether you’re a healthcare professional or not, check out Uppsala Monitoring Centre’s growing collection of self-paced e-learning courses to learn about different aspects of pharmacovigilance.

enMay 08, 2023

healthcare professionals

#21 Unlocking the power of real-world data – Patrick Ryan

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 collected and analysed
Which pharmacovigilance processes will benefit most from it
How to make data accessible without infringing patient privacy

Want to know more?

Review the basics of real-world data and its use in the medicines life cycle in Pharmaceutical Medicine, or read up on the opportunities and challenges for pharmacovigilance in Clinical Pharmacology & Therapeutics.

In partnership with the Observational Health Data Sciences and Informatics (OHDSI) and the European Health Data & Evidence Network (EHDEN) consortia, UMC researchers are exploring how real-world data can help prioritise and validate signals in pharmacovigilance. Read about their latest collaboration on Uppsala Reports.

Another important player in the real-world data space is the Data Analysis and Real World Interrogation Network (DARWIN), which aims to provide timely and reliable evidence from real-world healthcare databases in the EU to improve the safety and effectiveness of medicines.

For more on real-world evidence and the challenges of working with big data, don’t miss the Voice of EHDEN podcast or this conversation with Elena Rocca from the Drug Safety Matters archive.