Drug Safety Matters

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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

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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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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.

Tune in to find out:

• How comorbidities and genetic variation affect drug safety monitoring
• Why pharmacovigilance centres should strengthen their ties with academia
• How to apply the PROFORMA model elsewhere 

Want to know more?

• Low- and middle-income countries like the PROFORMA target nations face unique challenges in establishing robust pharmacovigilance systems, as described in this comprehensive review.
• PROFORMA’s baseline assessment of national pharmacovigilance systems in Ethiopia, Kenya, Rwanda, and Tanzania identified gaps and laid the groundwork for targeted interventions.
• Their subsequent assessment of pharmacovigilance capacity within the neglected tropical diseases programmes highlighted the urgent need for collaboration between those programmes and the national pharmacovigilance centres.
• You can read about PROFORMA’s accomplishments in more detail on Uppsala Reports and on the PROFORMA website, which also lists the consortium’s publications and upcoming events.

For more on the influence of genetic factors on drug response, revisit this interview with UMC’s pharmacogenetics specialist Qun-Ying Yue or this Uppsala Reports Long Read on pharmacogenomics research in Africa.

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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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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 find out:

• Why people perceive risks so differently
• Why medical communicators should strive to inform rather than persuade
• How to communicate in a trustworthy fashion

Want to know more?

• There is no right way to communicate evidence to patients, but there are a few things you can do to avoid getting it wrong.
• Conventional communication techniques are good for persuading people – but when the aim is to inform, the principles of evidence communication should be applied instead.
• Graphics can help people translate abstract numbers into contextualised risks they can relate to, like these visuals that illustrate the risk of blood clots with the AstraZeneca COVID-19 vaccine.
• These evidence-based guidelines can help professional communicators illustrate the personalised risk of dying from COVID-19.
• The Winton Centre offers plenty of resources on risk and evidence communication, including free e-learning courses for healthcare professionals, the Risky Talk podcast with statistician David Spiegelhalter, and the RealRisk tool to help healthcare professionals and communicators extract the right statistics from academic papers.

For more on communicating benefits and harms in pharmacovigilance, revisit this Drug Safety Matters episode on vaccine safety communication.

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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!

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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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.

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 Mohamed Elhawary and Hadir Rostom, who co-authored the article, to learn more about their work and the overall challenge of ensuring medicines safety in vulnerable communities.

Tune in to find out:

• What the most frequent causes of medication errors in refugee communities are
• How electronic health records can help prevent harm to patients 
• Why safety monitoring is crucial when there is a shortage of medicines

Want to know more?

The International Society of Pharmacovigilance runs a Special Interest Group on medication errors to promote the implementation of best safety practices around the world. They also organise a range of networking and training activities for pharmacovigilance professionals on different aspects of medicines safety.

The United Nations High Commissioner for Refugees (UNHCR) has practical advice for healthcare workers to promote treatment adherence in refugee settings.

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

Got a story to share?
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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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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 disproportionality analysis are
• How clustering algorithms can improve current signal detection practices
• How vigiGroup has helped monitor the safety of COVID-19 vaccines so far

Want to know more?

• By applying vigiGroup to COVID-19 vaccine reports in VigiBase, our Research team was able to identify a number of potential safety signals. Find out more in this poster or in this presentation. 
• Details on how the vigiGroup method was developed and tested can be found in the original publication in Artificial Intelligence in Medicine.
• Appendicitis was one of the possible safety signals for the COVID-19 vaccines identified with vigiGroup.

For more on signal detection at Uppsala Monitoring Centre, visit the Signal Work section on our website or listen to this interview with Helena Sköld and Annette Rudolph on vaccine pharmacovigilance.

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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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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.

Tune in to find out:

• Why we can’t allow bad actors to damage the drive for openness in research and data
• Why we should be open about uncertainty and always frame risks in the context of benefits
• How to prevent public health advocacy from biasing the science of vaccine safety

Want to know more?

The COVID-19 Vaccine Communication Handbook is a practical guide for anyone who wishes to improve their vaccine communication and challenge misinformation.

The CIOMS Guide to Vaccine Safety Communication helps medicine regulators communicate the uncertainties, risks and safety of vaccines.

The World Health Organization provides resources on vaccine communication and a series of illustrated articles on vaccine development and distribution.

In his Is it Safe? newsletter, Anthony Cox discusses the science, practice, and practicalities of medicine safety – including the latest developments with COVID-19 vaccines.

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

• Convincing the vaccine hesitant
• Keeping vaccines safe
• Substandard and falsified COVID-19 vaccines in the Americas
• Vaccination errors risk harm and damage trust

Finally, we featured these interviews with Anthony Cox and Daniel Salmon as an article in Uppsala Reports, too.

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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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 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 Rachel Meyers and David Hoff, who co-authored the KIDs List, to learn more about their work and the overall challenges of medicines safety in children.

Tune in to find out:

• Why adverse drug reactions tend to occur more often in the paediatric population
• How the KIDs List can improve prescribing for children 
• How to collect even better safety information on paediatric drugs in the future

Want to know more?

The KIDs List was first published in The Journal of Pediatric Pharmacology and Therapeutics, where you can find more information on how the list was compiled and how it is meant to be used.

In an earlier commentary for the Journal of Pharmaceutical Sciences, Rachel Meyers reflects on the changes she’d like to see in how paediatric drugs are developed.

In Europe, the conect4children (c4c) project aims to speed up and facilitate high-quality clinical trials in children while ensuring that the voices of young patients and their families are heard.

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

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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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 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 Uppsala Reports editor Gerard Ross about the dangers of polarising the conversation on vaccines, the role of social media, and how it all boils down to trust.

Tune in to find out:

• Why having questions or worries about vaccines is not the same thing as being anti-vaccination
• Why directing appropriate communication at the vaccine hesitant is more effective than attacking the vaccine deniers
• How cultural sensitivity and emotional intelligence can benefit pro-vaccine communication

Want to know more?

The World Health Organization provides resources on vaccine communication in general and COVID-19 vaccines in particular.

The University of Queensland’s online course on Antivaccination and Vaccine Hesitancy is available to people anywhere in the world.

For more on vaccine safety and confidence, check out these episodes from the Drug Safety Matters archive:

• Keeping vaccines safe
• Substandard and falsified COVID-19 vaccines in the Americas
• Vaccination errors risk harm and damage trust

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

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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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 guide medicine use and dosing recommendations
• What we need to effectively implement genetic-based prescribing in clinical practice
• How increasing diversity in clinical trials can aid pharmacogenomics research 

Want to know more?

Here are a few resources to get you started:

• SWEDEGENE is a Swedish nation-wide DNA sample collection established to facilitate pharmacogenomic studies of serious adverse drug reactions.
• The African continent, with its genetically diverse populations, is a treasure trove of pharmacogenomics data – as long as African patients are included in drug studies, as we discussed in this Uppsala Reports Long Read episode.
• As a past member of the European Medicines Agency’s Pharmacogenomics Working Party, Ying contributed to the “Guideline on key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products”.
• Ying also chairs ISoP’s Pharmacogenomics Special Interest Group, whose work and objectives have been described in Uppsala Reports and Drug Safety.

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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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 effects are reported and studied around the world
• Why a mere list of reported side effects says little about a vaccine’s safety profile
• How a global database like VigiBase can help spot unexpected safety issues

Want to know more?

Media coverage can greatly affect the rate at which side effects of medicines and vaccines are reported, as shown by this study by the New Zealand Centre for Adverse Reactions Monitoring.

When talking about side effects of any medicine or vaccine, it’s important not to confuse reporting rates with incidence.

In its COVID-19 vaccine safety surveillance manual, the World Health Organization (WHO) outlines how countries should prepare for the introduction of COVID-19 vaccines.

Uppsala Monitoring Centre (UMC) has developed guidelines for carrying out pharmacovigilance work during the COVID-19 pandemic and a list of frequently asked questions on suspected side effects of COVID-19 vaccines.

Among other things, UMC has been supporting members of the WHO Programme for International Drug Monitoring in their vaccine safety surveillance efforts by improving the VigiLyze and VigiFlow tools.

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.