Afleveringen
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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?
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.
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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.
Catching black swansWhen drugs damage the liverEmpowering patients as partnersWhy we should listen to patients
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:Join the conversation on social media
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Zijn er afleveringen die ontbreken?
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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 pharmacovigilanceWhat makes an adverse drug reaction a black, white, or grey swan Why flexibility and communication are key to patient safetyWant to know more?
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 sessions
Here are the research articles cited in the episode:If 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 media
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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).
Who is most at risk of developing DILIHow to diagnose the condition and control the damageHow to assess case reports of DILI
Tune in to find out:Want to know more?
This infographic in Nature Reviews nicely summarises the mechanisms, diagnosis, and management of drug-induced liver injury.In this report, the Council for International Organizations of Medical Sciences provides a global perspective on DILI detection, susceptibility factors, outcomes, and more.In this Drug Safety article, industry representatives outline how to identify, mitigate, and communicate the risk of DILI during drug development. The PRO-EURO DILI NETWORK coordinates research efforts on DILI across Europe and provides a forum to exchange knowledge and training on the topic. Similar initiatives include the Spanish DILI Registry and the Latin American DILI Network.The free online tool LiverTox contains up-to-date information on drug-induced liver injury for medicines and herbal products.To learn more about post-marketing surveillance and clinical care of DILI, check out Uppsala Monitoring Centre’s free online course on the topic.
For more on the clustering algorithm vigiGroup, revisit this interview with UMC scientists Jim Barrett and Joe Mitchell.Join the conversation on social media
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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.
Empowering patients as partnersTailoring drug therapy to your genes
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:Join the conversation on social media
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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 media
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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 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. Read a preview of the conversation on Uppsala Reports.
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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?
Why the risks of herbals are rarely discussedHow to encourage safety data collection for herbalsHow to improve herbal nomenclature and regulation
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:Want to know more?
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.
Here are some of the resources cited in the episode:For a comprehensive overview of herbal pharmacovigilance, check out this recent book by Joanne Barnes and colleagues covering advances, challenges, and international perspectives in the field.
The evidence for signalsNavigating the plant names jungle
For more on Daniele’s scoping review of signals or the thorny nomenclature of medicinal plants, listen to these episodes from the Drug Safety Matters archive:Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
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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?
How regulators and healthcare professionals can effectively engage patientsHow patients can get involved in drug safety monitoringWhat the pharmacovigilance community learned from the valproate case
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:Want to know more?
In 2022, the Council for International Organizations of Medical Sciences (CIOMS) published a comprehensive report on patient involvement in the development, regulation and safe use of medicines. They also recorded a webinar to summarise the report’s main conclusions.
Why we should listen to patientsThe challenge of rare diseasesHow to talk about risks
The International Society of Pharmacovigilance (ISoP) runs a patient engagement group to advance patient involvement in the safety monitoring of medicines.
The Valproate toolkit, developed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), supports healthcare professionals in advising women of childbearing age about the risks and benefits of valproate therapy.
PatientsLikeMe is a digital platform where patients can share personal health stories, connect to peers, and learn about different conditions and treatments.
For more on patient engagement and communication, check out these episodes from the Drug Safety Matters archive:Finally, don’t forget to subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.
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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.
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 EU
Tune in to find out:Want to know more?
This review in Trials summarises the methodological challenges of assessing drug safety in clinical trials, while this study in Clinical and Translational Science reviews how sex, racial, and ethnic diversity in clinical trials have changed in recent years.
Post-authorisation safety studies can be imposed or voluntary and can be carried out as clinical trials or as non-interventional studies. Read about the differences on the European Medicines Agency’s website.
Large simple trials can control for biases in observational research while still providing results that are generalisable to real-world use. This review in Drug Safety explains why.
The new Clinical Trials Regulation harmonises how EU trials are assessed and supervised for increased safety and transparency. As part of these efforts, the SAFE CT project aims to facilitate clinical trial coordination and safety assessments in the EU.
For more on 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 media
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Healthcare professionals are key players in medicines safety but they often lack the time or knowledge to report adverse drug reactions. To change that, we need to urgently rethink how we teach pharmacovigilance, argues Michael Reumerman from Amsterdam University Medical Centers.
How real-life education can benefit healthcare studentsWhich educational intervention can be most impactfulHow adverse drug event managers can improve pharmacovigilance
Tune in to find out:
Want to know more?In his PhD thesis, Michael details the current state of pharmacovigilance education and all the real-life interventions he and his colleagues have tested in the Netherlands so far.
As part of an international collaboration, staff at Amsterdam UMC have helped set up the European Open Platform for Prescribing Education (EurOP2E), an online collection of problem-based, open teaching resources to improve clinical pharmacology and therapeutics education.
The World Health Organization’s Guide to Good Prescribing provides a six-step guide for students to the process of rational prescribing – but the time has come to update both its content and form.
In 2018, the Netherlands Pharmacovigilance Centre Lareb developed a core curriculum for pharmacovigilance education in universities.
Whether you’re a healthcare professional or not, check out Uppsala Monitoring Centre’s growing collection of self-paced e-learning courses to learn about different aspects of pharmacovigilance.Join the conversation on social media
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The vast amount of real-world data collected during routine clinical care is a treasure trove of safety information – but there are challenges to overcome before this rich source of evidence can be applied to pharmacovigilance. Patrick Ryan from Johnson & Johnson discusses how to harness real-world data for patient safety.
How real-world data is collected and analysedWhich pharmacovigilance processes will benefit most from itHow to make data accessible without infringing patient privacy
Tune in to find out:
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 real-world evidence and the challenges of working with big data, don’t miss the Voice of EHDEN podcast or this conversation with Elena Rocca from the Drug Safety Matters archive.This episode is the second of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:
The evidence for signalsAssessing safety in clinical trialsJoin the conversation on social media
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Spontaneous reports of adverse drug reactions are a common source of evidence in pharmacovigilance, but as the science evolves, so do the types of data used to find and assess signals. Uppsala Monitoring Centre’s Daniele Sartori reviews how signal detection practices have changed over time.
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
Tune in to find out:
Unlocking the power of real-world dataAssessing safety in clinical trials
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.
This episode is the first of a three-part series on sources of evidence in pharmacovigilance. Listen to the other two episodes here:Join the conversation on social media
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Most pharmacovigilance professionals will have heard of masking – a statistical issue where reports for one drug hide signals for other drugs. But the problem gained fresh attention when record amounts of reports began piling up for the COVID-19 vaccines. How should we be unmasking data in the COVID-19 vaccine era?
How masking evolves with the data Which methods can be used to unmask data What other pitfalls to watch out for when performing quantitative analyses
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:Want to know more?
In the very beginning of the vaccine rollout, the USA FDA observed how early signals for COVID-19 vaccines were delayed because of other drugs masking them, highlighting how masking is not a static phenomenon.
In 2013, Uppsala Monitoring Centre developed a simple strategy to uncover masking by identifying and removing influential outliers.Join the conversation on social media
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The COVID-19 pandemic forced pharmacovigilance experts to revisit their processes to deal with unprecedented volumes of data and catch unexpected safety issues. Elena Rocca from Oslo Metropolitan University reviews the challenges of a global healthcare emergency – and what it can teach us about the science of drug safety.
How to handle uncertain evidenceWhy clinical expertise matters in the age of big dataWhy pharmacovigilance requires interdisciplinary thinking
Tune in to find out: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
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The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort.
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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
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Public trust in vaccines hinges on their safety – but to make sure vaccines are safe, we must have systems in place to detect and manage any side effects. Dr Madhava Ram Balakrishnan, medical officer for vaccine safety at the World Health Organization, discusses how to build an effective vaccine surveillance system and how to respond to safety crises when they occur.
Tune in to find out:
How safety surveillance differs between vaccines and drugsWhat the most common side effects of vaccines areHow to address the public’s concerns on vaccine safetyWant to know more?
How to talk about risksTalking about vaccine safetyConvincing the vaccine hesitantKeeping vaccines safe
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:Join the conversation on social media
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Managing antimicrobial resistance (AMR) will require innovative solutions from many different disciplines. Could pharmacovigilance be one of them? Jean Marie Vianney Habarugira and Albert Figueras, who have been investigating how drug safety tools could help track AMR, think it’s time the two communities joined forces for good.
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 community
Tune in to find out:Want to know more?
In their study, Jean Marie and Albert shortlisted 17 MedDRA codes used to report AMR-related adverse drug reactions in a global and a national pharmacovigilance database.Pharmacovigilance tools could be especially useful in estimating the burden of AMR in low-resource communities that lack diagnostic lab capacity.Jean Marie’s research was inspired by this article in Uppsala Reports, which defined antimicrobial resistance as an overlooked adverse event.Since 2015, the World Health Organization’s GLASS (Global Antimicrobial Resistance and Use Surveillance System) has been used to collect, analyse, and share AMR data around the world.Interested in AMR from a social perspective? Then don’t miss this Drug Safety Matters episode on behaviour change communication.
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With the right care, people infected with HIV can lead long and healthy lives. But as with any life-long medical treatment, it is important to acknowledge and manage any side effects. Henry Zakumumpa from Makerere University School of Public Health tells us about the potential harms of new HIV therapies and the challenges faced by pharmacovigilance specialists in Uganda.
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 healthcare
Tune in to find out:Want to know more?
Hyperglycemia, insomnia and reduced libido were the most common side effects observed by Ugandan clinicians in patients taking dolutegravir.
Nurses are the backbone of HIV disease management in Uganda and could play an important role in pharmacovigilance activities as well.
Henry Zakumumpa’s research was supported by Uppsala Monitoring Centre in collaboration with CARTA, the Consortium for Advanced Research Training in Africa, which is working to build up research capacity in public health.
The World Health Organization’s resources on HIV/AIDS include easily digestible information for patients, epidemiological data on disease spread, and current guidelines for prevention and treatment.For more on African and patient-centred pharmacovigilance, check out these episodes from the Drug Safety Matters archive:
Advancing pharmacovigilance in AfricaWhy we should listen to patientsJoin the conversation on social media
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Access to medical products has increased considerably in Africa in recent years, but safety monitoring systems haven’t exactly kept pace and many African countries still struggle to address safety issues. We sat down with Eleni Aklillu and Abbie Barry of the PROFORMA project to learn about their efforts to strengthen pharmacovigilance capacity in East Africa – especially within public health programmes.
How comorbidities and genetic variation affect drug safety monitoringWhy pharmacovigilance centres should strengthen their ties with academiaHow to apply the PROFORMA model elsewhere
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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.
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