32 episodes

Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.

Drug Safety Matters Uppsala Monitoring Centre

    • Health & Fitness
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Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.

    Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era

    Uppsala Reports Long Reads – Unmasking data in the COVID-19 vaccine era

    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 media
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    Got a story to share?
    We’re always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!

    About UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 21 min
    #19 Lessons in pandemic pharmacovigilance – Elena Rocca

    #19 Lessons in pandemic pharmacovigilance – Elena Rocca

    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 media
    Follow 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 UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 33 min
    #18 The IDMP standards explained – Malin Fladvad & Olle Lagerlund

    #18 The IDMP standards explained – Malin Fladvad & Olle Lagerlund

    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 media
    Follow 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 UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 23 min
    #17 Why we need vaccine surveillance systems – Madhava Balakrishnan

    #17 Why we need vaccine surveillance systems – Madhava Balakrishnan

    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 media
    Follow 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 UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 27 min
    #16 How drug safety can help fight resistant bugs – Jean Marie Vianney Habarugira & Albert Figueras

    #16 How drug safety can help fight resistant bugs – Jean Marie Vianney Habarugira & Albert Figueras

    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 media
    Follow 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 UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 33 min
    #15 Safety of HIV medications – Henry Zakumumpa

    #15 Safety of HIV medications – Henry Zakumumpa

    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 media
    Follow 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 UMC
    Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

    • 33 min

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