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 pr...
Dec 17, 2024•47 min•Transcript available on Metacast 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 ...
Nov 29, 2024•39 min•Transcript available on Metacast 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 pat...
Oct 25, 2024•48 min•Transcript available on Metacast 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 ...
Sep 30, 2024•43 min•Transcript available on Metacast 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 alg...
Aug 26, 2024•25 min•Transcript available on Metacast 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 pharmaco...
Jun 27, 2024•30 min•Transcript available on Metacast 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...
May 15, 2024•34 min•Transcript available on Metacast Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders. Tune in to find out: Which medicines may cause impulsivity What the ‘four knights’ of impulsivity are How patient stories can help detect these conditions Want to know more? This review by Daniel Wei...
Apr 23, 2024•31 min•Transcript available on Metacast 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 co...
Feb 29, 2024•27 min•Transcript available on Metacast 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 s...
Feb 01, 2024•29 min•Transcript available on Metacast What did the drug safety community achieve in 2023 and how will the field develop in 2024? As the year comes to a close, we asked Angela Caro, president of the International Society of Pharmacovigilance (ISoP), to walk us through current and future trends in pharmacovigilance. Tune in to find out: Why patient engagement is a growing priority What challenges exist in the Latin American region Which topics will be in the spotlight next year Want to know more? ISoP is a non-profit society open to a...
Dec 20, 2023•28 min•Transcript available on Metacast 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 sho...
Nov 13, 2023•33 min•Transcript available on Metacast 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 ...
Nov 02, 2023•27 min•Transcript available on Metacast 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 fin...
Sep 29, 2023•34 min•Transcript available on Metacast 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...
Sep 05, 2023•43 min•Transcript available on Metacast 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...
Jun 27, 2023•31 min•Transcript available on Metacast 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 P...
May 08, 2023•33 min•Transcript available on Metacast 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 infringi...
Mar 30, 2023•34 min•Transcript available on Metacast 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 dete...
Feb 23, 2023•46 min•Transcript available on Metacast 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 artic...
Jan 26, 2023•21 min•Transcript available on Metacast The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety. Tune in to find out: How to handle uncertain evidence Why clinical expertise matters in the age of big data Why pharmacovigilance requires interdisciplinary thinking Want to kn...
Dec 15, 2022•33 min•Transcript available on Metacast 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...
Sep 29, 2022•23 min•Transcript available on Metacast 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 ...
Aug 24, 2022•28 min•Transcript available on Metacast 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 anti...
Jun 30, 2022•34 min•Transcript available on Metacast 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 shap...
Apr 29, 2022•33 min•Transcript available on Metacast 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 Wh...
Mar 24, 2022•37 min•Transcript available on Metacast 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 ...
Feb 24, 2022•38 min•Transcript available on Metacast 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 t...
Jan 27, 2022•25 min•Transcript available on Metacast 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 mon...
Dec 16, 2021•23 min•Transcript available on Metacast 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...
Nov 03, 2021•29 min•Transcript available on Metacast 
