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 VigiBaseAbout different approaches for developing algorithmsWhy it can be challenging to evaluate the performance of an algorithmWant 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.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.

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 impulsivityWhat the ‘four knights’ of impulsivity areHow patient stories can help detect these conditionsWant 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 swansWhen drugs damage the liverEmpowering patients as partnersWhy we should listen to patientsJoin 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 unexpected.Tune in to find out:What Nassim Nicholas Taleb’s ‘black swan’ theory has to do with pharmacovigilanceWhat makes an adverse drug reaction a black, white, or grey swan Why flexibility and communication are key to patient safetyWant 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 reviewPsychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase studyHepatic disorders with the use of remdesivir for COVID-19Serious bradycardia and remdesivir for COVID-19: a new safety concernOxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experienceAtypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centresTeaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessionsIf you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:Reforming pharmacovigilance educationLessons in pandemic pharmacovigilanceIntuition in pharmacovigilanceJoin 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 DILIHow to diagnose the condition and control the damageHow to assess case reports of DILIWant 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.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.

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 priorityWhat challenges exist in the Latin American regionWhich topics will be in the spotlight next yearWant 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 partnersTailoring drug therapy to your genesJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 settingHow to deal with the financial, cultural, and logistical challenges of campaign planningWhat to keep in mind if you are new to #MedSafetyWeekWant 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 Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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.Tune in to find out:Why under-reporting plagues all pharmacovigilance systemsWhat regulators can do to encourage people to report side effectsWhy we need reports from both patients and healthcare professionalsWant 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. You can read a preview of the conversation on Uppsala Reports.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 discussedHow to encourage safety data collection for herbalsHow to improve herbal nomenclature and regulationWant 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 signalsNavigating the plant names jungleFinally, don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 patientsHow patients can get involved in drug safety monitoringWhat the pharmacovigilance community learned from the valproate caseWant 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 patientsThe challenge of rare diseasesHow to talk about risksFinally, don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 connectedWhy safety assessors can request studies in underrepresented populationsHow new regulations are impacting safety assessments in the EUWant 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 clinical trials, revisit this conversation with Peter Doshi on restoring invisible and abandoned trials.This episode is the last of a three-part series on sources of evidence in pharmacovigilance. Listen to the first two episodes here:The evidence for signalsUnlocking the power of real-world dataJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 studentsWhich educational intervention can be most impactfulHow adverse drug event managers can improve pharmacovigilanceWant 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.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 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 analysedWhich pharmacovigilance processes will benefit most from itHow 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.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.

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 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.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.

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 analysesWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 evidenceWhy clinical expertise matters in the age of big dataWhy 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.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 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 coverHow Uppsala Monitoring Centre will help create and maintain themWhat is expected of other key stakeholdersWant 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.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.

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 drugsWhat the most common side effects of vaccines areHow to address the public’s concerns on vaccine safetyWant 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 risksTalking about vaccine safetyConvincing the vaccine hesitantKeeping vaccines safeJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 surveillanceHow to use pharmacovigilance networks to track resistant pathogens and falsified antimicrobialsWhy collaborating with AMR specialists will benefit the drug safety communityWant 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.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.

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 regimensHow pharmacovigilance data can help shape HIV treatment guidelines Why we should empower patients to share concerns about their healthcareWant 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 AfricaWhy we should listen to patientsJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 monitoringWhy pharmacovigilance centres should strengthen their ties with academiaHow 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.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.

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 differentlyWhy medical communicators should strive to inform rather than persuadeHow to communicate in a trustworthy fashionWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 areHow electronic health records can help prevent harm to patients Why safety monitoring is crucial when there is a shortage of medicinesWant 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to 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 areHow clustering algorithms can improve current signal detection practicesHow vigiGroup has helped monitor the safety of COVID-19 vaccines so farWant 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.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 dataWhy we should be open about uncertainty and always frame risks in the context of benefitsHow to prevent public health advocacy from biasing the science of vaccine safetyWant 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 hesitantKeeping vaccines safeSubstandard and falsified COVID-19 vaccines in the AmericasVaccination errors risk harm and damage trustFinally, 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.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.

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 populationHow the KIDs List can improve prescribing for children How to collect even better safety information on paediatric drugs in the futureWant 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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-vaccinationWhy directing appropriate communication at the vaccine hesitant is more effective than attacking the vaccine deniersHow cultural sensitivity and emotional intelligence can benefit pro-vaccine communicationWant 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 safeSubstandard and falsified COVID-19 vaccines in the AmericasVaccination errors risk harm and damage trustFinally, don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 recommendationsWhat we need to effectively implement genetic-based prescribing in clinical practiceHow 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 worldWhy a mere list of reported side effects says little about a vaccine’s safety profileHow a global database like VigiBase can help spot unexpected safety issuesWant 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 farWhat threats substandard and falsified vaccines pose to people and countriesHow you can help mitigate the spread of compromised productsWant 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

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 globallyHow the context around us influences the decisions we makeHow patients’ stories can help communicate the urgency of AMRWant 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 or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

As the COVID-19 pandemic spread around the world, so did waves of viral misinformation. For pharmacovigilance manager Marco Tuccori, fighting the “infodemic” is a massive, but necessary, battle.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.After the read, Marco tells us how the pandemic has affected his work at the University Hospital of Pisa, Italy – and what are the most pressing challenges in pharmacovigilance communication today. Tune in to find out:What consequences the infodemic had on the use of medicinesHow the pharmacovigilance community has fought the infodemic so farWhy empathy can be a powerful tool to counteract misinformationWant to know more?Marco Tuccori’s piece in Uppsala Reports was inspired by an article that he and his colleagues wrote for Drug Safety, on the impact of the infodemic on drug-utilisation behaviours.  Don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

By definition, a rare disease is one that only affects a handful of people in the world. But with more than 300 million people collectively affected by these conditions and only few approved treatments available, rare diseases constitute a major unmet medical need. Christina Ström Möller from Swedish biopharmaceutical company Sobi walks us through the scientific, commercial and human challenges of the rare disease landscape.Tune in to find out:What drug development, testing and distribution look like when patients are few and far apart Why patient narratives are especially important when monitoring the safety of rare disease drugsHow patient organisations work to support rare disease patients and raise awareness of their conditionWant to know more?Read the stories of patients living with rare diseases on the Sobi website.Show your support for Rare Disease Day on 28 February by sharing campaign materials online with the hashtag #RareDiseaseDay or joining one of the many events planned around the world.Rare Disease Day is organised by EURORDIS-Rare Diseases Europe, a non-profit alliance of rare disease patient organisations from 73 countries.When assessing the safety of rare disease medicines, also known as orphan drugs, it is important to include all available sources of data.A recent review of orphan drug policies found that several low- and middle-income countries had developed such policies in the last decade ­– although disparities between countries with different income levels still remain.A survey conducted by EURORDIS in 2020 found that the COVID-19 pandemic exacerbated the many challenges that people living with a rare disease face.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

As the cradle of modern humanity, the African continent is home to populations with high levels of genetic diversity. But while this diversity has implications for the safety and efficacy of many drugs, African patients remain underrepresented in drug studies. In fact, while more than 400 medicines have pharmacogenetics information and public guidelines available, only 15 have been studied in African populations. Thankfully efforts to boost pharmacogenomics research in Africa are now underway.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.Tune in to find out:How drug metabolism is affected by genetic variationWhy African patients urgently need genotype-guided drug dosing How different research initiatives are trying to fill the knowledge gapWant to know more?A review of the disease burden in Africa concluded that a pharmacogenomics-based healthcare approach – where drug choices and doses are optimised for each patient ­– would benefit the genetically diverse African population.Clinical pharmacogenetics studies conducted in African populations have so far highlighted several pharmacogenetics associations ­– but also gaps in knowledge.The African Pharmacogenomics Consortium drives pharmacogenomics research in Africa and aims to improve the safety of drugs for use in African populations.The Global Alliance for Genomics and Health aims to enable the safe and effective sharing of genomic and health-related data between different research and healthcare institutions.Finally, don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses.Together with Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb, we explore the role of intuitive reasoning in the science of drug safety.Tune in to find out:How clinical and intuitive reasoning complement each other for optimal decision-makingHow adverse drug reaction reporting forms could be improved to detect intuitive reasoningHow pharmacovigilance professionals can train their intuitionWant to know more?Here are a few reading resources to get you started:A study on real cases of intuition in family medicine concluded that automatic, non-analytical processes in clinical judgment extend beyond first impressions.The dual-process theory highlights the importance of physicians’ intuition and the high level of interaction between analytical and non-analytical processes in clinical reasoning.Gut feelings may help general practitioners efficiently navigate the often complex and uncertain diagnostic situations of general practice.In a discussion paper on intuition and evidence, professor Trisha Greenhalgh suggests that the experienced practitioner should follow clinical hunches as well as applying the deductive principles of evidence-based medicine.If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out this interview with Linda Härmark on patient reporting.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

In November 2020, longstanding UMC director Marie Lindquist began her well-earned retirement, leaving the reins of the organisation to her successor Hervé Le Louët. As she prepared to open a new chapter in her life, she sat down with Uppsala Reports to take a fond look back at an extraordinary career: a 40-year-long path that began with a knock on the door and turned her into one of the world’s leading advocates for patient safety.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.Tune in to find out:Why monitoring the safety of medicines and vaccines matters more than ever during the COVID-19 pandemicHow UMC’s methods and tools have advanced the science of pharmacovigilance Why it’s important to see the patient behind the dataWant to know more?Uppsala Monitoring Centre has been leading a global effort to improve the science of pharmacovigilance for more than 40 years.You can read a comprehensive history of the organisation in the book Making Medicines Safer.If you’d like free regular updates from the world of pharmacovigilance, subscribe to the monthly Uppsala Reports newsletter.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Medication errors with vaccines can harm individual patients, but when they also undermine trust in public health programmes, serious problems can ripple across entire communities – as the Samoan healthcare crisis of 2018 dramatically showed. The Institute for Safe Medication Practices offers straightforward advice that could prevent those errors from happening again.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.Tune in to find out:Which errors can occur in the vaccination processWhy two-component vaccines are especially susceptible to administration errorsHow vaccine packaging and labelling can be improved to prevent errorsWant to know more?The Institute for Safe Medication Practices has repeatedly warned about the risks with two-component vaccines. In 2015, they issued a position statement calling for safer design of vaccine packaging and labelling.Tragic errors can occur when dangerous substances are accidentally used instead of the vaccine diluent, like the incident that occurred in Syria in 2014.The measles outbreak that took root in Samoa as a consequence of vaccine hesitancy – which in turn stemmed from an earlier, tragic vaccination error – holds important lessons for the rest of the world.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Clinical trials are the “gold standard” of evidence-based medicine – the best way we have to test whether a drug is safe and effective before it enters the market. But if trial data is poorly reported or – even worse – left unpublished, how are we supposed to determine the true value of a medical treatment? Peter Doshi from the RIAT Support Center has made it his mission to fix the problem and improve data transparency for good.Tune in to find out:How publication and reporting biases affect our understanding of trial resultsHow an investigation into anti-influenza drugs helped galvanise a general movement towards greater data transparency How the RIAT Support Center is facilitating the correction of the scientific recordWant to know more?The Restoring Invisible & Abandoned Trials (RIAT) Support Center offers free support to researchers anywhere in the world that would like to publish an unpublished trial or correct a misreported trial.The AllTrials campaign calls for all past and present clinical trials to be registered and their results reported.The Tamiflu campaign highlighted important discrepancies between journal publications and the underlying clinical study reports, and increased awareness of the importance of independent access to underlying trial data.A 2016 systematic review found that much of the information on adverse events remains unpublished and that the number and range of adverse events is higher in unpublished than in published versions of the same study. Authors from the European Medicines Agency debate whether clinical trial publications are a sufficient basis for healthcare decisions.Peter Doshi and David Healy argue that doctors should not recommend COVID-19 treatments and vaccines when full data are not publicly available.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Communication and public outreach are an important part of a scientist’s job. But researchers often find it daunting to translate their expert knowledge for a lay audience. In this episode, UMC’s video producer Matthew Barwick shares a report from the Global Science Film Festival 2019, including interviews with festival organiser Samer Angelone and other participants. Tag along to learn their best tips for effective science communication and how to harness the power of film to tell stories in science.Tune in to find out:What scientists can gain from communicating their workWhy passion and emotions are an important element of science communication Why a two-way dialogue between scientist and audience is better than traditional one-way forms of communicationWant to know more?Here are a few resources to get you started:Why Science Communication, and Does It Work? reviews the main aims of science communication efforts and their success.Good science communication should stir AEIOU in an audience: Awareness, Enjoyment, Interest, Opinions, and Understanding.In “Talking Science”, a free YouTube course in science communication, BBC presenter Greg Foot shares tips and techniques to help scientists talk to the public.The Global Science Film Festival offers scientists the opportunity to learn basic communication and filmmaking skills, and showcase their work. The two films mentioned in the episode are “The woman who loves giraffes” (best film, Global Science Film Festival 2019) and “Aquarela”.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

When reporting adverse reactions to drugs, people can choose from a plethora of different terms to describe their experience. But that makes it difficult and time-consuming for analysts to tell how similar two case safety reports are. A new method developed by UMC data scientist Lucie Gattepaille comes to the rescue.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.After the read, Uppsala Reports editor Gerard Ross interviews Lucie on her work behind the scenes and the broader implications of her research for the pharmacovigilance field. Tune in to find out:How natural language processing can help connect related drug and adverse reaction termsWhat advantages the new method offers over MedDRA classificationsWhich pharmacovigilance tasks could benefit from this new researchWant to know more?Lucie presented her work on vector representations for pharmacovigilance at the IEEE International Conference on Healthcare Informatics in 2019. And here’s some background reading on distributed representations of words and phrases.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

How do we minimise the harm caused to patients by medicines and medical devices? In October 2019, a diverse, multi-stakeholder group met in Erice, Italy and drew up a 10-point plan for improving patient safety worldwide.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the original article here.After the read, we reach UMC director Marie Lindquist in her home in Gothenburg, Sweden to discuss the relevance of the Erice statement, as the world copes with the COVID-19 pandemic.Tune in to find out:What actions we should be taking to protect patients from medicine-related harmWhy collaboration between evidence-based medicine and pharmacovigilance is crucialWhy transparency is of the essence when communicating uncertaintyWant to know more?The full statement produced by the Erice group is entitled “Improving the detection, analysis, and reporting of harms in medicines and devices”.The original Erice Declaration of 1997 laid the groundwork for good communication practices in the pharmacovigilance field and was updated in 2006 and in 2017.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Herbal substances can be found in a number of pharmaceutical drugs, cosmetics and food supplements – so it's not surprising that using plant names inconsistently can have serious health consequences. But with so much confusion around medicinal plant names, it’s easy to get it wrong. Bob Allkin from Royal Botanic Gardens, Kew explains what we can do about it.Tune in to find out:How common, scientific and pharmaceutical plant names differHow Kew’s Medicinal Plant Names Services worksHow healthcare and pharmacovigilance professionals working with herbal medicines can avoid mistakesWant to know more?Here are a few resources to get you started:Bob Allkin discusses the regulation of medicinal plant names in UMC’s magazine Uppsala ReportsKew’s “State of the World’s Plants 2017” report includes a chapter on use and regulation of medicinal plants around the worldThese are the most common mistakes when using plant names – and how to avoid themIDMP standards improve the description of medicinal products worldwideKew’s Medicinal Plant Names Services is freely accessible online – start browsing!Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

As the end users of medicines, patients can provide first-hand information on side effects. The issues they report add a richness to our understanding of medicine safety that we could never achieve by relying on healthcare professionals’ reports alone – so it’s crucial that we listen to them. Linda Härmark from the Netherlands pharmacovigilance centre Lareb tells us more.Tune in to find out:What patient reports reveal about people’s use of medicinesHow to make best use of the information relayed by patientsWhat to consider when setting up a patient reporting systemWant to know more?Here are a few reading resources to get you started:After fifteen years in the business, Lareb has lessons to share on implementing and running patient reporting systems.Pharmacovigilance pioneer Sten Olsson argues that patient reporting is the future of pharmacovigilance.Collaborating with patient organizations can help pharmacovigilance centres deliver medicine safety updates to the right audiences and understand how patients use medicines.Patient reports can help identify previously unrecognized side effects, like in the case of panic attacks with the contraceptive desogestrel.A collaborative signal detection workshop on patient reports taught Lareb and Uppsala Monitoring Centre staff some valuable lessons.Every year, the #MedSafetyWeek campaign raises awareness of medicine side effects and pharmacovigilance reporting systems – join in!If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out this interview with Eugene van Puijenbroek on intuitive and clinical reasoning.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Most of us want healthcare to be both patient-centric and evidence-based. But are those two goals compatible? Can we tailor healthcare to our unique circumstances­, while relying on the average statistical measurements that scientific evidence is based on? Emerging ideas in the philosophy of science are challenging a rigid reliance on evidence-based medicine and offering a more nuanced understanding of patient safety.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the text version here. Tune in to find out:What causal dispositions areWhy pharmacovigilance would benefit from a new approach to causalityHow to promote trans-disciplinary approaches to medical inquiryWant to know more?Here are a few reading resources to get you started:The CauseHealth Risk and Safety project is bridging pharmacovigilance and philosophy of scienceCausal evidence and dispositions can improve our understanding of causality in medicine and public healthMedical scientists and philosophers worldwide appeal to expand the notion of “evidence”Patient experiences can enhance the quality and safety of healthcare, say the authors of the Erice Call for ChangeJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Most women are prescribed some form of medication during their pregnancy. Yet we know very little about the safety of those medicines when they’re used during pregnancy or breastfeeding. New collaborative efforts are now underway to plug that knowledge gap.This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance magazine, brought to you in audio format. Find the text version here.Tune in to find out:Why clinical trials often fail to include pregnant and breastfeeding womenWhat the lack of safety information means for women who need medicines during pregnancy and breastfeedingHow new multi-disciplinary initiatives are planning to boost pharmacovigilance activities related to pregnancy and lactationWant to know more?Read how EUROmediCAT plans to evaluate the safety of medicines in pregnancy in relation to the risk of congenital anomalies. Find out how ConcePTION wants to help women make informed decisions about the medications they need before, during and after pregnancy.Read about:Lareb’s survey of pregnancy-related pharmacovigilance activitiesthe history of women’s involvement in clinical trialsthe ethical debate surrounding the inclusion of pregnant women in researchJoin the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Fake medicines claim at least 200,000 lives every year, with the World Health Organization estimating that 1 in 10 medicines worldwide is now substandard or falsified. But with the market in illicit drugs worth up to $200 billion a year, and traffickers more likely to face a fine than jail time when they are caught, the financial incentives far outweigh the deterrents. So how do we put a stop to this deadly trade? Drug Safety Matters investigates with former Interpol officer and PMEDS program founder Aline Plançon.Tune in to find out:How widespread and dangerous fake medicines areWhat makes pharmaceutical crime so successfulWhat action is being taken to curb the problemHow modern tracking technology can helpWhat we can do to raise awarenessWant to know more?Read Aline Plançon’s book on fake medicines, Faux Médicaments: Un Crime Silencieux (in French).Find out how the World Health Organization is fighting falsified and substandard medicines in UMC’s magazine Uppsala Reports.Teach your children about falsified medicines with UMC’s comic book Annie & Mac’s Adventures: Lord Fake Strikes Again. It’s available in English and Spanish.Help raise awareness of the problem by joining the Fight the Fakes campaign.Join the conversation on social mediaFollow us on Twitter, Facebook or LinkedIn and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we work to advance medicines safety.