Drug Safety Matters

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While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait ­– and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably around the world.

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 talk to Danini about the COVAX programme, organised crime, and trust in vaccinations.

Tune in to find out:

• Why COVID-19 vaccine delivery to low- and middle-income countries has been inadequate so far
• What threats substandard and falsified vaccines pose to people and countries
• How you can help mitigate the spread of compromised products

Want to know more?

Tune into our first episode to learn about the deadly trade of fake medicines from former Interpol officer Aline Plançon.

The US Food and Drug Administration has more information on the COVID-19 vaccines authorised for emergency use in the country, plus other useful resources on vaccines.

In March 2021, the Infectious Disease Data Observatory reported 54 incidents of COVID-19 vaccines being substandard, falsified, or diverted from the legal supply chain.

In the same month, Interpol and the US’s Homeland Security Investigations warned the public against purchasing alleged COVID-19 vaccines online, while the World Health Organization issued a medical product alert on a falsified COVID-19 vaccine detected in Mexico.

WHO also curates a database on COVID-19 vaccine candidates in development around the world.

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

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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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Antimicrobial resistance (AMR) is not only a biological issue, but a complex social problem. As a consequence, changing the way patients, healthcare professionals and policymakers think about antibiotics will require input from both the natural and social sciences. In March 2021, the Uppsala Health Summit on “Managing antimicrobial resistance through behaviour change” tackled this very problem. We spoke to three key participants – Otto Cars, Eldar Shafir and Vanessa Carter – to learn more.

Tune in to find out:

• How the COVID-19 pandemic might affect AMR globally
• How the context around us influences the decisions we make
• How patients’ stories can help communicate the urgency of AMR

Want to know more?

The Uppsala Health Summit is a recurring international policy arena for dialogue on healthcare challenges and how we can overcome them.

Otto Cars is founder and now senior advisor to ReACT (Action on Antibiotic Resistance). He set the scene at Uppsala Health Summit 2021 with a lecture on the current status of AMR globally. In a recent interview, he described how to make the most of the COVID-19 momentum to spur much-needed action in the AMR sphere.

Eldar Shafir is professor of behavioural science and public policy at Princeton University, with a special interest in the effect of poverty on decision-making. In his keynote lecture at the summit, he commented on the AMR problem from a behavioural perspective. He points us to a 2016 research paper on the effect of behavioural interventions on inappropriate antibiotic prescribing.

Vanessa Carter is a South Africa-based patient advocate for AMR and e-patient scholar at Stanford University Medicine X. She suggests reading Tom Ferguson’s white paper on e-patients and their contribution to healthcare.

This episode was produced in collaboration with The AMR Studio podcast at Uppsala Antibiotic Center. Tune into their show for more stories on antimicrobial resistance.

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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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As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.

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, Marco tells us how the pandemic has affected his work at the University Hospital of Pisa, Italy – and what are the most pressing challenges in pharmacovigilance communication today.

Tune in to find out:

• What consequences the infodemic had on the use of medicines
• How the pharmacovigilance community has fought the infodemic so far
• Why empathy can be a powerful tool to counteract misinformation

Want to know more?

Marco Tuccori’s piece in Uppsala Reports was inspired by an article that he and his colleagues wrote for Drug Safety, on the impact of the infodemic on drug-utilisation behaviours. 

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

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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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By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commercial and human challenges of the rare disease landscape.

Tune in to find out:

• What drug development, testing and distribution look like when patients are few and far apart 
• Why patient narratives are especially important when monitoring the safety of rare disease drugs
• How patient organisations work to support rare disease patients and raise awareness of their condition

Want to know more?

Read the stories of patients living with rare diseases on the Sobi website.

Show your support for Rare Disease Day on 28 February by sharing campaign materials online with the hashtag #RareDiseaseDay or joining one of the many events planned around the world.

Rare Disease Day is organised by EURORDIS-Rare Diseases Europe, a non-profit alliance of rare disease patient organisations from 73 countries.

When assessing the safety of rare disease medicines, also known as orphan drugs, it is important to include all available sources of data.

A recent review of orphan drug policies found that several low- and middle-income countries had developed such policies in the last decade ­– although disparities between countries with different income levels still remain.

A survey conducted by EURORDIS in 2020 found that the COVID-19 pandemic exacerbated the many challenges that people living with a rare disease face.

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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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As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 15 have been studied in African populations. Thankfully efforts to boost pharmacogenomics research in Africa are now underway.

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.

Tune in to find out:

• How drug metabolism is affected by genetic variation
• Why African patients urgently need genotype-guided drug dosing 
• How different research initiatives are trying to fill the knowledge gap

Want to know more?

A review of the disease burden in Africa concluded that a pharmacogenomics-based healthcare approach – where drug choices and doses are optimised for each patient ­– would benefit the genetically diverse African population.

Clinical pharmacogenetics studies conducted in African populations have so far highlighted several pharmacogenetics associations ­– but also gaps in knowledge.

The African Pharmacogenomics Consortium drives pharmacogenomics research in Africa and aims to improve the safety of drugs for use in African populations.

The Global Alliance for Genomics and Health aims to enable the safe and effective sharing of genomic and health-related data between different research and healthcare institutions.

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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In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses.

Together with Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb, we explore the role of intuitive reasoning in the science of drug safety.

Tune in to find out:

• How clinical and intuitive reasoning complement each other for optimal decision-making
• How adverse drug reaction reporting forms could be improved to detect intuitive reasoning
• How pharmacovigilance professionals can train their intuition

Want to know more?

Here are a few reading resources to get you started:

• A study on real cases of intuition in family medicine concluded that automatic, non-analytical processes in clinical judgment extend beyond first impressions.
• The dual-process theory highlights the importance of physicians’ intuition and the high level of interaction between analytical and non-analytical processes in clinical reasoning.
• Gut feelings may help general practitioners efficiently navigate the often complex and uncertain diagnostic situations of general practice.
• In a discussion paper on intuition and evidence, professor Trisha Greenhalgh suggests that the experienced practitioner should follow clinical hunches as well as applying the deductive principles of evidence-based medicine.

If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out this interview with Linda Härmark on patient reporting.

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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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In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her into one of the world’s leading advocates for patient safety.

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.

Tune in to find out:

• Why monitoring the safety of medicines and vaccines matters more than ever during the COVID-19 pandemic
• How UMC’s methods and tools have advanced the science of pharmacovigilance 
• Why it’s important to see the patient behind the data

Want to know more?
Uppsala Monitoring Centre has been leading a global effort to improve the science of pharmacovigilance for more than 40 years.

You can read a comprehensive history of the organisation in the book Making Medicines Safer.

If you’d like free regular updates from the world of pharmacovigilance, subscribe to the monthly Uppsala Reports newsletter.

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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Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.

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.

Tune in to find out:

• Which errors can occur in the vaccination process
• Why two-component vaccines are especially susceptible to administration errors
• How vaccine packaging and labelling can be improved to prevent errors

Want to know more?

The Institute for Safe Medication Practices has repeatedly warned about the risks with two-component vaccines. In 2015, they issued a position statement calling for safer design of vaccine packaging and labelling.

Tragic errors can occur when dangerous substances are accidentally used instead of the vaccine diluent, like the incident that occurred in Syria in 2014.

The measles outbreak that took root in Samoa as a consequence of vaccine hesitancy – which in turn stemmed from an earlier, tragic vaccination error – holds important lessons for the rest of the world.

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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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Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission to fix the problem and improve data transparency for good.

Tune in to find out:

• How publication and reporting biases affect our understanding of trial results
• How an investigation into anti-influenza drugs helped galvanise a general movement towards greater data transparency 
• How the RIAT Support Center is facilitating the correction of the scientific record

Want to know more?

The Restoring Invisible & Abandoned Trials (RIAT) Support Center offers free support to researchers anywhere in the world that would like to publish an unpublished trial or correct a misreported trial.

The AllTrials campaign calls for all past and present clinical trials to be registered and their results reported.

The Tamiflu campaign highlighted important discrepancies between journal publications and the underlying clinical study reports, and increased awareness of the importance of independent access to underlying trial data.

A 2016 systematic review found that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study.

Authors from the European Medicines Agency debate whether clinical trial publications are a sufficient basis for healthcare decisions.

Peter Doshi and David Healy argue that doctors should not recommend COVID-19 treatments and vaccines when full data are not publicly available.

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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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Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Tag along to learn their best tips for effective science communication and how to harness the power of film to tell stories in science.

Tune in to find out:

• What scientists can gain from communicating their work
• Why passion and emotions are an important element of science communication 
• Why a two-way dialogue between scientist and audience is better than traditional one-way forms of communication

Want to know more?

Here are a few resources to get you started:

• Why Science Communication, and Does It Work? reviews the main aims of science communication efforts and their success.
• Good science communication should stir AEIOU in an audience: Awareness, Enjoyment, Interest, Opinions, and Understanding.
• In “Talking Science”, a free YouTube course in science communication, BBC presenter Greg Foot shares tips and techniques to help scientists talk to the public.
• The Global Science Film Festival offers scientists the opportunity to learn basic communication and filmmaking skills, and showcase their work. The two films mentioned in the episode are “The woman who loves giraffes” (best film, Global Science Film Festival 2019) and “Aquarela”.

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.