Drug Safety Matters: Recent Episodes
Uppsala Monitoring Centre
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.
Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.
Tune in to find out:
- Why we need a Patient Safety Day
- How to prevent common medication errors in children
- How to build child-friendly healthcare environments
Want to know more?
Visit the World Health Organization’s campaign website to learn more about World Patient Safety Day and download campaign materials.
You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.
For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:
- The KIDs List
- What’s trending in pharmacovigilance?
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About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.
This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro-Rojas (president of ISoP), Linda Härmark (director of the Drug Safety Research Unit in the UK), Ghita Benabdallah (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and Daniele Sartori (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance.
The symposium was a collaboration between ISoP and UMC.
Want to know more?
- Visit the official website of the 2025 ISoP Mid-Year Symposium to learn more about its sessions, speakers and chairs.
- Not patient but im-patient – read about Sara Riggare’s research on patient engagement and other topics.
- Listen to Henry Zakumumpa talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.
- Read about the PhD project of Tommy Emil Dzus, Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies, at Oslo Metropolitan University, Norway.
- Sabine Koch is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.
- Details on Mikael Hoffman's research can be found on his profile page on ResearchGate.
- Take a look at what’s in store for participants at the 24th Annual Meeting of ISoP in Cairo, on October 24–27, 2025.
- Visit the websites of the Drug Safety Research Unit (DSRU), ISoP, Centre Anti Poison et Pharmacovigilance du Maroc, and Uppsala Monitoring Centre, to find out more about their work.
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
Spontaneous adverse event reporting from healthcare professionals and patients is a cornerstone in pharmacovigilance systems. Unfortunately, it is a well-known issue that only a fraction of events is reported. To further complicate matters, poor quality reports present a significant challenge for pharmacovigilance assessors. In Uganda, several new routes have been introduced to facilitate reporting for patients and healthcare professionals, including email, WhatsApp and the Med Safety smartphone app. Henry Zakumumpa is a researcher at Makerere University in Kampala, Uganda. He has recently performed a qualitative study to learn more about drivers and obstacles for quality in adverse event reporting from patients and healthcare professionals in Uganda. He joins the Drug Safety Matters studio to help us get a more nuanced picture of challenges and opportunities around the issue.
Tune in to find out:
- Why are HIV patients in Uganda reluctant to report adverse events to their healthcare providers?
- What are the challenges with reporting via WhatsApp?
- How can regulators and PV centres foster better quality in incoming adverse event reports?
Want to know more?
- Listen to Henry talk about the safety of HIV medications in this 2022 episode of Drug Safety Matters.
- Visit this CARTA (Consortium for Advanced Research Training in Africa) profile page to learn more about Henry’s research.
- Improving the spontaneous reporting of suspected adverse drug reactions: An overview of systematic reviews (British Journal of Clinical Pharmacology, 2023)
- Improving adverse drug event reporting by healthcare professionals (Cochrane Database Systematic Review, 2024)
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
There are many reasons why use of medical products during pregnancy requires special attention. First and foremost, we want to be sure that the medicine is as safe as possible for both the pregnant person and the unborn child. Unfortunately, the safety profiles of medicines used in pregnancy are often incomplete, which makes it difficult for patients and healthcare professionals to make informed decisions.
The Research section at Uppsala Monitoring Centre has a team that is currently focussing their efforts on pregnancy-related pharmacovigilance (PV). In this episode, data scientists Sara Vidlin and Levente Papai, and senior pharmacovigilance scientist Lovisa Sandberg from this team, discuss complexities and challenges of pregnancy-related PV, and new solutions for addressing those challenges.
Tune in to find out
- Why is the world still behind when it comes to pregnancy-related PV?
- What are the challenges faced by PV assessors wanting to look at pregnancy cases?
- How can healthcare professionals, patients and carers help assessors overcome these challenges, when reporting pregnancy-related adverse drug events?
- How can the VigiBase pregnancy algorithm, and other algorithms, support the identification of pregnancy cases?
How to use the VigiBase pregnancy algorithm
- Users of VigiLyze and VigiBase Custom Searches can use the VigiBase pregnancy algorithm as a filter when performing searches.
- In the qualitative view in VigiLyze, click on “Filter” -> “Patient” -> “Pregnancy” to apply the filter.
Want to know more?
- Read about the VigiBase pregnancy algorithm in this Uppsala Reports article and in this scientific paper, published in Drug Safety in 2025.
- EURAP – an international prospective observational study of pregnancies with antiepileptic drugs. EURAP - International Registry of Antiepileptic Drugs and Pregnancy
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - E2B(R3) Individual Case Safety Report (ICSR) Specification and Related Files
- The IMI-concePTION project
- Medical Dictionary for Regulatory Activities (MedDRA) support documentation
- Zaccaria C, Piccolo L, Gordillo-Marañón M, et al. Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. Drug Safety. 2024
- Sakai T, Mori C, Koshiba H, et al. Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Dispro
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous animal species that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV.
Tune in to find out
- How the types of ADRs reported for animals and humans differ
- How the many species and breeds included in veterinary PV affect the ADR coding
- What the Veterinary Big Data Strategy is
... and much more!
Want to know more?
- The public portal of the European Union Veterinary Pharmacovigilance Database.
- One Health – an integrated approach to the well-being of people, animals and the environment.
- A survey of veterinary professionals in Sweden, about practices and attitudes in relation to ADR reporting.
- A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicines.
- The EMA Big Data strategy for veterinary medicines and Data quality framework for medicines regulation
- Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool
- VetCompass - Royal Veterinary College, RVC
- Veterinary good pharmacovigilance practices (VGVP) | European Medicines Agency (EMA)
- Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) | European Medicines Agency (EMA)
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
Human and veterinary pharmacovigilance (PV) share many goals, challenges and approaches. But there are also significant differences, such as the numerous species and breeds that veterinary PV needs to take into account. In this two-part episode of Drug Safety Matters, James Mount, Veterinary Pharmacovigilance assessor at the Swedish Medical Products Agency, and EU elected chair of the Pharmacovigilance Working Party for veterinary medicinal products, joins the show to talk about veterinary PV practice and its differences and similarities to human PV.
Tune in to find out:
- What are the similarities and differences between veterinary and human pharmacovigilance?
- How is animal health connected to public health?
- What types of adverse events are reported on the veterinary side compared with the human side?
- What can be found in the EU veterinary pharmacovigilance database?
Want to know more?
- The new veterinary medicines regulation (Regulation (EU) 2019/6) can be found here.
- The public portal of the European Union Veterinary Pharmacovigilance Database.
- WHO's information page on One Health, an integrated approach to the well-being of people, animals and the environment.
- A survey of veterinary professionals in Sweden, about current practices and attitudes in relation to adverse events reporting and the accessibility of product safety information.
- A review of adverse events in animals and children after secondary exposure to transdermal hormone-containing medicinal products.
- A study looking at suspected adverse drug reaction reporting in veterinary free‐text clinical narratives.
- The EMA Big Data strategy for veterinary medicines in the EU.
- Data quality framework for medicines regulation | European Medicines Agency (EMA)
- Small Animal Veterinary Surveillance Network (SAVSNET) - University of Liverpool
- VetCompass - Royal Veterinary College, RVC
- Reflection paper on the use of artificial intelligence in the lifecycle of medicines | European Medicines Agency (EMA)
- The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish).
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.
Tune in to find out:
- What challenges are PV assessors faced with, when working with narratives?
- How could automation of certain tasks help streamline narrative analyses in the future?
- How can reporters craft narratives that effectively document adverse events?
Want to know more?
- Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada.
- Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices.
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
Medication-related-harm (MRH) is especially prevalent in older adults due to changing physiology as the body ages, increased frailty, and the incidence of polypharmacy in this patient group. Giovanni Furlan, Worldwide Safety Site Lead for Thessaloniki of Pfizer discusses what makes this patient group so vulnerable to adverse drug reactions, how poor representation and using age alone to define older adults exacerbates this problem, and suggests ways forward in monitoring drug safety in older patients.
Tune in to find out:
- What makes older adults especially at risk of experiencing adverse drug reactions and medication errors
- Why frailty is far more useful than age in predicting adverse drug reaction risk
- How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.
Want to know more?
This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here.
For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of drug safety in geriatric patients.
If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such.
As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper.
For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues.
Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky 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 promote safer use of medicines and vaccines for everyone everywhere.
Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible.
Tune in to find out:
- The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created
- Why there has been a spike in the publication of disproportionality analyses in recent years and what this means for their reliability
- What it means to publish “good” pharmacovigilance science
Want to know more?
- Read the READUS-PV guidelines, why they were created, and why they are important.
- In 2021, Khouri and colleagues showed that current methods and models used for disproportionality analyses are unreliable, and Mouffak and colleagues found that there is a tendency to overstate results in published disproportionality analyses.
- A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this exponential increase in disproportionality analyses.
- This paper elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem.
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
Duplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them.
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 Jim Barrett, Senior Data Scientist at UMC, to learn more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance.
Tune in to find out:
- How the new algorithm handles duplicates in VigiBase
- About different approaches for developing algorithms
- Why it can be challenging to evaluate the performance of an algorithm
Want to know more?
- Listen to the Drug Safety Matters interview with Michael Glaser about his Uppsala Reports article “Ensuring trust in AI/ML when used in pharmacovigilance” and check out the episode’s extensive list of links for more on AI in pharmacovigilance.
- Artificial intelligence in pharmacovigilance – value proposition and the need for critical appraisal, a presentation by Niklas Norén, Head of Research at UMC, given at University of Verona in April 2024.
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 X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?
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 one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field.
Tune in to find out:
● How AI and ML are being used today in pharmacovigilance processes
● Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance
● How we may best move forward to implement AI/ML into healthcare.
Want to know more?
To know more about how AI and ML are being used in pharmacovigilance currently, read this scoping review.
To know more about future trends of the use of AI in Biopharma, read this Accenture survey.
- Despite there being major interest in ML and AI to do more than task automation, there are a number of barriers to its implementation in healthcare. Check out this future-focused paper on the use of AI/ML in pharmacovigilance that details how to utilise it to its fullest potential.
- A mindset shift is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.
- A validation framework must be developed for AI-based pharmacovigilance systems. One suggestion is to do so using a risk-based approach.
- While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies like this one suggest that the technology has a ways to go to be useful in pharmacovigilance.
- The World Health Organization have published an extensive guideline on the ethics and governance of AI for health.
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
Look-alike medicines, unclear communication and distractions during administration – medication errors may occur for many different reasons. They all have in common that they are unintended mistakes in the drug treatment process that may or may not lead to patient harm. In this episode Ghita Benabdallah and Loubna Alj from the national pharmacovigilance centre of Morocco, and Alem Zekarias from Uppsala Monitoring Centre discuss how we can prevent medication errors from occurring – and, when they do occur, make sure that they are reported as such.
Tune in to find out:
- What are the most common causes for medication errors?
- How should strategies for preventing medication errors be devised?
- How does the assessment of suspected medication error reports differ from “regular” ADR signal assessment?
- What can be done to encourage healthcare professionals to report medication errors?
Want to know more?
- In March 2024, WHO published this systematic review of the global burden of preventable medication-related harm in healthcare.
- According to this 2021 article in BMJ, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths.
- This 2012 meta-analysis confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.
- The European Medicines Agency (EMA) has a dedicated webpage with recommendations, guidelines, legal requirements and a good practice guide on medication errors.
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders.
Tune in to find out:
- Which medicines may cause impulsivity
- What the ‘four knights’ of impulsivity are
- How patient stories can help detect these conditions
Want to know more?
This review by Daniel Weintraub summarises twenty years of research on impulse control disorders in Parkinson’s disease.
In 2003, Driver-Dunckley and colleagues in the US published the first case series linking pathological gambling to dopamine agonists.
In 2016, the US Food and Drug Administration warned about impulse-control problems associated with the antipsychotic drug aripiprazole.
Michele and colleagues in Italy have investigated the mechanisms and burden of drug-induced impulsivity.
In their 2024 guidelines for managing impulsivity in Parkinson's disease, an expert consensus group highlighted the pivotal role of caregivers and of psychosocial interventions.
Finally, these are the Drug Safety Matters episodes cited in the interview:
- Catching black swans
- When drugs damage the liver
- Empowering patients as partners
- Why we should listen to patients
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
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:
- Reforming pharmacovigilance education
- Lessons in pandemic pharmacovigilance
- Intuition in pharmacovigilance
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
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.
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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 advance medicines safety.
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:
- Empowering patients as partners
- Tailoring drug therapy to your genes
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
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.
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
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.
Join the conversation on social mediaFollow us on X, LinkedIn, or Facebook 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 advance medicines safety.
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:
- The evidence for signals
- Navigating the plant names jungle
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 X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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:
- Why we should listen to patients
- The challenge of rare diseases
- How to talk about risks
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.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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 evidence in pharmacovigilance and clinical trials, check out these episodes from the Drug Safety Matters archive:
- Unlocking the power of real-world data
- The evidence for signals
- Restoring invisible and abandoned trials
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
The vast amounts of real-world data collected during routine clinical care are 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 best use 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 evidence in pharmacovigilance, don’t miss this interview with Daniele Sartori on spontaneous reporting or this conversation with Elena Rocca on uncertain evidence and big data.
You can hear more about working with real-world data from the EHDEN network partners on the Voice of EHDEN podcast.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
In partnership with the EHDEN consortium, UMC researchers are exploring whether observational health data can assist signal prioritisation and validation – more on that in the next episode!
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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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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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook, orLinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.
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 UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn, and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook, orLinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.
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About UMCRead more about Uppsala Monitoring Centre and how we work to make medicines safer for patients.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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.
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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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-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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 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.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn 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 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”.
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 terms
- What advantages the new method offers over MedDRA classifications
- Which pharmacovigilance tasks could benefit from this new research
Want 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 orLinkedIn, 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 harm
- Why collaboration between evidence-based medicine and pharmacovigilance is crucial
- Why transparency is of the essence when communicating uncertainty
Want 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 orLinkedIn, 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 differ
- How Kew’s Medicinal Plant Names Services works
- How healthcare and pharmacovigilance professionals working with herbal medicines can avoid mistakes
Want 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 Reports
- Kew’s “State of the World’s Plants 2017” report includes a chapter on use and regulation of medicinal plants around the world
- These are the most common mistakes when using plant names – and how to avoid them
- IDMP standards improve the description of medicinal products worldwide
- Kew’s Medicinal Plant Names Services is freely accessible online – start browsing!
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 medicines
- How to make best use of the information relayed by patients
- What to consider when setting up a patient reporting system
Want 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 orLinkedIn, 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 are
- Why pharmacovigilance would benefit from a new approach to causality
- How to promote trans-disciplinary approaches to medical inquiry
Want 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 science
- Causal evidence and dispositions can improve our understanding of causality in medicine and public health
- Medical 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 Change
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 women
- What the lack of safety information means for women who need medicines during pregnancy and breastfeeding
- How new multi-disciplinary initiatives are planning to boost pharmacovigilance activities related to pregnancy and lactation
Want 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 activities
- the history of women’s involvement in clinical trials
- the ethical debate surrounding the inclusion of pregnant women in research
Join the conversation on social mediaFollow us on Twitter, Facebook orLinkedIn, 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 are
- What makes pharmaceutical crime so successful
- What action is being taken to curb the problem
- How modern tracking technology can help
- What we can do to raise awareness
Want 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 orLinkedIn, 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.