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Drug Safety Matters

Author: Uppsala Monitoring Centre

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Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.
15 Episodes
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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 medicineshow the pharmacovigilance community has fought the infodemic so farwhy empathy can be a powerful tool to counteract misinformationWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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 drugsHow patient organisations work to support rare disease patients and raise awareness of their conditionWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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 variationwhy African patients urgently need genotype-guided drug dosing how different research initiatives are trying to fill the knowledge gapWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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-makingHow adverse drug reaction reporting forms could be improved to detect intuitive reasoningHow pharmacovigilance professionals can train their intuitionWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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 pandemichow UMC’s methods and tools have advanced the science of pharmacovigilance why it’s important to see the patient behind the dataWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!
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 processwhy two-component vaccines are especially susceptible to administration errorshow vaccine packaging and labelling can be improved to prevent errorsWant 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.  Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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 resultsHow 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 recordWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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 workWhy 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 communicationWant 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”.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.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, Uppsala Reports editor Gerard Ross interviews Lucie on her work behind the scenes and the broader implications of her research for the pharmacovigilance field. Tune in to find out:how natural language processing can help connect related drug and adverse reaction termswhat advantages the new method offers over MedDRA classificationswhich pharmacovigilance tasks could benefit from this new researchWant to know more?Lucie presented her work on vector representations for pharmacovigilance at the IEEE International Conference on Healthcare Informatics in 2019. And here’s some background reading on distributed representations of words and phrases.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.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 reach UMC director Marie Lindquist in her home in Gothenburg, Sweden to discuss the relevance of the Erice statement, as the world copes with the COVID-19 pandemic.Tune in to find out:what actions we should be taking to protect patients from medicine-related harmwhy collaboration between evidence-based medicine and pharmacovigilance is crucialwhy transparency is of the essence when communicating uncertaintyWant to know more?The full statement produced by the Erice group is entitled “Improving the detection, analysis, and reporting of harms in medicines and devices”.The original Erice Declaration of 1997 laid the groundwork for good communication practices in the pharmacovigilance field and was updated in 2006 and in 2017.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it's not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it.Tune in to find out:How common, scientific and pharmaceutical plant names differHow Kew’s Medicinal Plant Names Services worksHow healthcare and pharmacovigilance professionals working with herbal medicines can avoid mistakesWant to know more?Here are a few resources to get you started:Bob Allkin discusses the regulation of medicinal plant names in UMC’s magazine Uppsala ReportsKew’s “State of the World’s Plants 2017” report includes a chapter on use and regulation of medicinal plants around the worldThese are the most common mistakes when using plant names – and how to avoid themIDMP standards improve the description of medicinal products worldwideKew’s Medicinal Plant Names Services is freely accessible online – start browsing!Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more.Tune in to find out:What patient reports reveal about people’s use of medicinesHow to make best use of the information relayed by patientsWhat to consider when setting up a patient reporting systemWant to know more?Here are a few reading resources to get you started:After fifteen years in the business, Lareb has lessons to share on implementing and running patient reporting systems.Pharmacovigilance pioneer Sten Olsson argues that patient reporting is the future of pharmacovigilance.Collaborating with patient organizations can help pharmacovigilance centres deliver medicine safety updates to the right audiences and understand how patients use medicines.Patient reports can help identify previously unrecognized side effects, like in the case of panic attacks with the contraceptive desogestrel.A collaborative signal detection workshop on patient reports taught Lareb and Uppsala Monitoring Centre staff some valuable lessons.Every year, the #MedSafetyWeek campaign raises awareness of medicine side effects and pharmacovigilance reporting systems – join in!If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out this interview with Eugene van Puijenbroek on intuitive and clinical reasoning.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances­, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering a more nuanced understanding of 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 text version here. Tune in to find out:What causal dispositions areWhy pharmacovigilance would benefit from a new approach to causalityHow to promote trans-disciplinary approaches to medical inquiryWant to know more?Here are a few reading resources to get you started:The CauseHealth Risk and Safety project is bridging pharmacovigilance and philosophy of scienceCausal evidence and dispositions can improve our understanding of causality in medicine and public healthMedical scientists and philosophers worldwide appeal to expand the notion of “evidence”Patient experiences can enhance the quality and safety of healthcare, say the authors of the Erice Call for ChangeJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap.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 text version here.Tune in to find out:Why clinical trials often fail to include pregnant and breastfeeding womenWhat the lack of safety information means for women who need medicines during pregnancy and breastfeedingHow new multi-disciplinary initiatives are planning to boost pharmacovigilance activities related to pregnancy and lactationWant to know more?Read how EUROmediCAT plans to evaluate the safety of medicines in pregnancy in relation to the risk of congenital anomalies. Find out how ConcePTION wants to help women make informed decisions about the medications they need before, during and after pregnancy.Read about:Lareb’s survey of pregnancy-related pharmacovigilance activitiesthe history of women’s involvement in clinical trialsthe ethical debate surrounding the inclusion of pregnant women in researchJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. So how do we put a stop to this deadly trade? Drug Safety Matters investigates with former Interpol officer and PMEDS program founder Aline Plançon.Tune in to find out:How widespread and dangerous fake medicines areWhat makes pharmaceutical crime so successfulWhat action is being taken to curb the problemHow modern tracking technology can helpWhat we can do to raise awarenessWant to know more?Read Aline Plançon’s book on fake medicines, Faux Médicaments: Un Crime Silencieux (in French).Find out how the World Health Organization is fighting falsified and substandard medicines in UMC’s magazine Uppsala Reports.Teach your children about falsified medicines with UMC’s comic book Annie & Mac’s Adventures: Lord Fake Strikes Again. It’s available in English and Spanish.Help raise awareness of the problem by joining the Fight the Fakes campaign.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and our mission to build a global patient safety culture.
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