Explore every episode of the podcast Drug Safety Matters
Dive into the complete episode list for Drug Safety Matters. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.
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#48 Building a career in pharmacovigilance – Myriam Salem & Francesco Salvo
Pharmacovigilance specialists can have very different roles depending on their organisation and job title. With so many career paths to choose from, how do you find your place? Myriam Salem from Health Canada and Francesco Salvo from the University of Bordeaux share advice on how to break into the field and navigate the job market.
Tune in to find out:
What PV work looks like across regulators, academia and industry
Which skills you need to remain competitive
How to balance training and hands-on experience
Want to know more?
These are some of the leading organisations offering online courses in pharmacovigilance:
Two-part podcast on artificial intelligence in pharmacovigilance
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Global pharmacovigilance requires harmonised methods, but solutions must be tailored to the local context. We sat down with Salvador Alvarado and Matthew Barwick from Uppsala Monitoring Centre to explore how local constraints affect drug safety and how a new film series by UMC can inspire PV professionals across borders.
Tune in to find out:
How the thalidomide tragedy triggered a global pharmacovigilance collaboration
How UMC supports members of the WHO Programme for International Drug Monitoring
Please note that the views and opinions expressed in the episode are not those of Uppsala Monitoring Centre.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems.
Tune in to find out:
Where in the environment pharmaceutical residues are turning up, and why this should be on every pharmacovigilance scientist's radar
How the dramatic collapse of India's vulture populations in the early 2000s speaks to the importance of the One Health approach
Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution.
Want to know more?
For a deep dive into ecopharmacovigilance, the following references provide foundational information on the topic in pharmacovigilance, most of them penned by Professor Giampaolo Velo, who coined the term:
The revised Erice declaration for the inclusion of environmental issues in pharmacovigilance
A book chapter on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editors
A paper summarising the main concepts in ecopharmacovigilance and pharmaceutical pollution
A paper with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use.
A recent paper with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.
Tune in to find out:
Why we should never treat disproportionality signals as verdicts
How poorly performed analyses affect scientists, regulators and patients
In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.
Michele also reviewed the method’s limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.
Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.
In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.
Tune in to find out:
How reporting for medical devices differs from medicines and vaccines
How AI may be used for predictive safety monitoring
Why regulatory and data harmonisation remains the key to improving medical device safety
If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.
Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.
In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.
Tune in to find out:
What defines a medical device and how prevalent they are in our society
Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short
How global initiatives aim to strengthen safety monitoring standards
If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.
Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy.
In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.
Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?
In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.
Tune in to find out:
How to keep up with rapid developments in AI technology
Why model and performance transparency both matter
How to protect sensitive patient data when using AI
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?
In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.
Tune in to find out:
Why pharmacovigilance needs specific AI guidelines
How a risk-based approach to AI regulation works
Where in the PV cycle is human oversight most needed
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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:
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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?
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
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.
The Swedish Medical Products Agency's online reporting form for suspected adverse drug reactions in animals (In Swedish).
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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?
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
This paper elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
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:
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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:
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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 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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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-Rojas, 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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
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.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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:
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:
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
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:
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
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
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.
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Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.
Tune in to find out:
How real-life education can benefit healthcare students
Which educational intervention can be most impactful
How adverse drug event managers can improve pharmacovigilance
Want to know more?
In his PhD thesis, Michael details the current state of pharmacovigilance education and all the real-life interventions he and his colleagues have tested in the Netherlands so far.
Whether you’re a healthcare professional or not, check out Uppsala Monitoring Centre’s growing collection of self-paced e-learning courses to learn about different aspects of pharmacovigilance.
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The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety.
Tune in to find out:
How real-world data is collected and analysed
Which pharmacovigilance processes will benefit most from it
How to make data accessible without infringing patient privacy
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.
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Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.
Tune in to find out:
Which features of case reports are most often used to assess causality
Why pharmacovigilance experts should report clinical assessments clearly
How to shorten the time between signal detection and communication
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Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?
This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.
After the read, we speak to data scientist Sara Vidlin, who authored the article, to learn more about masking and how to deal with it.
Tune in to find out:
How masking evolves with the data
Which methods can be used to unmask data
What other pitfalls to watch out for when performing quantitative analyses
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The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.
Tune in to find out:
How to handle uncertain evidence
Why clinical expertise matters in the age of big data
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.
Elena’s reflections on big data pharmacovigilance and its ethical implications were inspired by Sabina Leonelli’s work on big data biology and mathematician Cathy O’Neil’s Weapons of Math Destruction.
The CauseHealth Pharmacovigilance project, a collaboration between UMC and the NMBU Centre for Applied Philosophy of Science in Norway, ran between 2018 and 2021.
For more philosophical inspiration, revisit this interview with Eugene van Puijenbroek on intuition in pharmacovigilance or this Uppsala Reports Long Read on new approaches to causality.
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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.
You can learn more about Uppsala Monitoring Centre’s role in the IDMP project and how the standards will affect the WHODrug Global drug dictionary on our website.
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Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur.
Tune in to find out:
How safety surveillance differs between vaccines and drugs
What the most common side effects of vaccines are
How to address the public’s concerns on vaccine safety
Want to know more?
The World Health Organization offers free manuals on surveillance and causality assessment of adverse events following immunisation (AEFI).
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Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.
Tune in to find out:
How to code adverse drug reactions for optimal AMR surveillance
How to use pharmacovigilance networks to track resistant pathogens and falsified antimicrobials
Why collaborating with AMR specialists will benefit the drug safety community
Jean Marie’s research was inspired by this article in Uppsala Reports, which defined antimicrobial resistance as an overlooked adverse event.
Since 2015, the World Health Organization’s GLASS (Global Antimicrobial Resistance and Use Surveillance System) has been used to collect, analyse, and share AMR data around the world.
Interested in AMR from a social perspective? Then don’t miss this Drug Safety Matters episode on behaviour change communication.
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With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.
Tune in to find out:
How dolutegravir-based HIV therapies compare to earlier regimens
How pharmacovigilance data can help shape HIV treatment guidelines
Why we should empower patients to share concerns about their healthcare
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:
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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.
You can read about PROFORMA’s accomplishments in more detail on Uppsala Reports and on the PROFORMA website, which also lists the consortium’s publications and upcoming events.
For more on the influence of genetic factors on drug response, revisit this interview with UMC’s pharmacogenetics specialist Qun-Ying Yue or this Uppsala Reports Long Read on pharmacogenomics research in Africa.
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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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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
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
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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.
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With vaccine hesitancy on the rise and misinformation spreading like wildfire on social media, drug safety specialists may have a hard time knowing how to talk about side effects without affecting people’s trust in vaccinations. Anthony Cox from the University of Birmingham and Daniel Salmon from the Institute for Vaccine Safety share their best advice for balanced and responsible vaccine safety communication.
Tune in to find out:
Why we can’t allow bad actors to damage the drive for openness in research and data
Why we should be open about uncertainty and always frame risks in the context of benefits
How to prevent public health advocacy from biasing the science of vaccine safety
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:
Finally, we featured these interviews with Anthony Cox and Daniel Salmon as an article in Uppsala Reports, too.
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It’s not always easy to choose the best medicine for a child. Some drugs are inappropriate for young patients, while others require special consideration or monitoring. For years, clinicians had only historical dogmas, word of mouth and their own experience to guide their choices. But a valuable new resource promises to change paediatric prescribing for the better.
This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.
After the read, we speak to Rachel Meyers and David Hoff, who co-authored the KIDs List, to learn more about their work and the overall challenges of medicines safety in children.
Tune in to find out:
Why adverse drug reactions tend to occur more often in the paediatric population
How the KIDs List can improve prescribing for children
How to collect even better safety information on paediatric drugs in the future
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.
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Fuelled by disinformation and an array of other cultural and economic factors, vaccine hesitancy is one of the greatest global health communication challenges of our times. But to craft the empathetic and tailored communication strategies required to boost confidence in vaccines, we first need to understand the difference between anti-vaccination belief and vaccine hesitancy.
This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.
After the read, we speak to Uppsala Reports editor Gerard Ross about the dangers of polarising the conversation on vaccines, the role of social media, and how it all boils down to trust.
Tune in to find out:
Why having questions or worries about vaccines is not the same thing as being anti-vaccination
Why directing appropriate communication at the vaccine hesitant is more effective than attacking the vaccine deniers
How cultural sensitivity and emotional intelligence can benefit pro-vaccine communication
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
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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.
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With COVID-19 vaccinations rolling at full speed in many countries, there’s a lot of talk about vaccine safety monitoring. But what exactly does that mean and how should we be interpreting data on side effects? Uppsala Monitoring Centre’s Helena Sköld and Annette Rudolph walk us through the basics of vaccine pharmacovigilance.
Tune in to find out:
How suspected side effects are reported and studied around the world
Why a mere list of reported side effects says little about a vaccine’s safety profile
How a global database like VigiBase can help spot unexpected safety issues
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While COVID-19 vaccinations are picking up speed in many wealthy countries, citizens of lower-income countries still face a long wait – and where demand exceeds supply, black markets tend to form. So to curb the spread of substandard and falsified products, says drug regulatory specialist Danini Marin, we must ensure that COVID-19 vaccines are distributed equitably around the world.
This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.
After the read, we talk to Danini about the COVAX programme, organised crime, and trust in vaccinations.
Tune in to find out:
Why COVID-19 vaccine delivery to low- and middle-income countries has been inadequate so far
What threats substandard and falsified vaccines pose to people and countries
How you can help mitigate the spread of compromised products
Want to know more?
Tune into our first episode to learn about the deadly trade of fake medicines from former Interpol officer Aline Plançon.
The US Food and Drug Administration has more information on the COVID-19 vaccines authorised for emergency use in the country, plus other useful resources on vaccines.
In March 2021, the Infectious Disease Data Observatory reported 54 incidents of COVID-19 vaccines being substandard, falsified, or diverted from the legal supply chain.
Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
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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.
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