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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:

• The evidence for signals
• Unlocking the power of real-world data

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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.

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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.

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

• The evidence for signals
• Assessing safety in clinical trials

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

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Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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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 causality 
• Why pharmacovigilance experts should report clinical assessments clearly 
• How to shorten the time between signal detection and communication 

Want to know more?

Check out the full scoping review that inspired this episode.

In 2002, Meyboom and colleagues discussed criteria to select and follow up on signals.

In the first chapter of Uncertainty in Pharmacology, Aronson explains the difference between evidence for a mechanism and evidence from a mechanism.

In 2018, Murad and colleagues published a method to evaluate the quality of evidence in a series of case reports.

UMC scientists have shown how chemical information can support timely signal detection.

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

• Unlocking the power of real-world data
• Assessing safety in clinical trials

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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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 pharmacovigilance magazine, brought to you in audio format. Find the original article here.

After the read, we speak to data scientist Sara Vidlin, who authored the article, to learn more about masking and how to deal with it.

Tune in to find out: 

• How masking evolves with the data 
• Which methods can be used to unmask data 
• What other pitfalls to watch out for when performing quantitative analyses

Want to know more?

In the very beginning of the vaccine rollout, the USA FDA observed how early signals for COVID-19 vaccines were delayed because of other drugs masking them, highlighting how masking is not a static phenomenon.

In 2013, Uppsala Monitoring Centre developed a simple strategy to uncover masking by identifying and removing influential outliers.

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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 evidence
• Why clinical expertise matters in the age of big data
• Why pharmacovigilance requires interdisciplinary thinking 

Want to know more?

In the article that inspired this episode, Elena Rocca and Birgitta Grundmark describe the practical, conceptual, and ethical challenges pharmacovigilance experts were faced with during the pandemic.

See also this review by Annette Rudolph and colleagues at Uppsala Monitoring Centre on the unique challenges of a global vaccination campaign.

Elena’s reflections on big data pharmacovigilance and its ethical implications were inspired by Sabina Leonelli’s work on big data biology and mathematician Cathy O’Neil’s Weapons of Math Destruction.

The CauseHealth Pharmacovigilance project, a collaboration between UMC and the NMBU Centre for Applied Philosophy of Science in Norway, ran between 2018 and 2021.

For more philosophical inspiration, revisit this interview with Eugene van Puijenbroek on intuition in pharmacovigilance or this Uppsala Reports Long Read on new approaches to causality.

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Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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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.

Tune in to find out:

• What the IDMP standards cover
• How Uppsala Monitoring Centre will help create and maintain them
• What is expected of other key stakeholders

Want to know more?

UNICOM’s ‘IDMP in a capsule’ explains how the IDMP standards work throughout the life cycle of a medicinal product and is available as a handbook and video tutorial.

Healthcare consultant Christian Hay discusses how IDMP will improve medication safety worldwide in Uppsala Reports.

Development and implementation of the standards are led by the International Organization for Standardization (ISO), who described the key benefits of the project in this article from 2016.

The IDMP standards for dose form and characteristics will be provided by the European Directorate for the Quality of Medicines & HealthCare (EDQM), and those for units by the Unified Code for Units of Measure (UCUM).

You can learn more about Uppsala Monitoring Centre’s role in the IDMP project and how the standards will affect the WHODrug Global drug dictionary on our website.

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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 in to find out:

• How safety surveillance differs between vaccines and drugs
• What the most common side effects of vaccines are
• How to address the public’s concerns on vaccine safety

Want to know more?

The World Health Organization offers free manuals on surveillance and causality assessment of adverse events following immunisation (AEFI).

They also maintain an AEFI causality assessment software where you can practice on real or sample cases, and an online course on the principles and processes of AEFI causality assessment.

In the BMJ Global Health, Madhava Balakrishnan and colleagues review how online communication affects immunisation stress-related responses and how to address public anxieties around vaccine safety.

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

• How to talk about risks
• Talking about vaccine safety
• Convincing the vaccine hesitant
• Keeping vaccines safe

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We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

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Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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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 reactions for optimal AMR surveillance
• How to use pharmacovigilance networks to track resistant pathogens and falsified antimicrobials
• Why collaborating with AMR specialists will benefit the drug safety community

Want to know more?

• In their study, Jean Marie and Albert shortlisted 17 MedDRA codes used to report AMR-related adverse drug reactions in a global and a national pharmacovigilance database.
• Pharmacovigilance tools could be especially useful in estimating the burden of AMR in low-resource communities that lack diagnostic lab capacity.
• Jean Marie’s research was inspired by this article in Uppsala Reports, which defined antimicrobial resistance as an overlooked adverse event.
• Since 2015, the World Health Organization’s GLASS (Global Antimicrobial Resistance and Use Surveillance System) has been used to collect, analyse, and share AMR data around the world.

Interested in AMR from a social perspective? Then don’t miss this Drug Safety Matters episode on behaviour change communication.

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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.

Tune in to find out:

• How dolutegravir-based HIV therapies compare to earlier regimens
• How pharmacovigilance data can help shape HIV treatment guidelines 
• Why we should empower patients to share concerns about their healthcare

Want to know more?

Hyperglycemia, insomnia and reduced libido were the most common side effects observed by Ugandan clinicians in patients taking dolutegravir.

Nurses are the backbone of HIV disease management in Uganda and could play an important role in pharmacovigilance activities as well.

Henry Zakumumpa’s research was supported by Uppsala Monitoring Centre in collaboration with CARTA, the Consortium for Advanced Research Training in Africa, which is working to build up research capacity in public health.

The World Health Organization’s resources on HIV/AIDS include easily digestible information for patients, epidemiological data on disease spread, and current guidelines for prevention and treatment.

For more on African and patient-centred pharmacovigilance, check out these episodes from the Drug Safety Matters archive:

• Advancing pharmacovigilance in Africa
• Why we should listen to patients

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.