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The Identification of Medicinal Products (IDMP) standards promise to harmonise how pharmaceutical products and substances are described around the world. But how will that benefit patients and who will make sure the standards are properly implemented? Uppsala Monitoring Centre’s Malin Fladvad and Olle Lagerlund discuss the advantages and challenges of this global standardisation effort.Tune in to find out:What the IDMP standards 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 safety Want 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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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 make medicines safer for patients.
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!
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