Drug Safety Matters

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 patients.

 Tune in to find out:

• What makes older adults especially at risk of experiencing adverse drug reactions and medication errors
• Why frailty is far more useful than age in predicting adverse drug reaction risk
• How pharmacovigilance in older patients may be improved through pharmaceutical practice and better representation in clinical trials.

Want to know more?

This interview all started with Giovanni's Uppsala Reports article on how age is insufficient a measure of adverse event risk. Read it here.

For a summary of the key points discussed in this interview, read Giovanni’s paper on the status of drug safety in geriatric patients.

If our discussion of frailty piqued your interest, read this paper on the biology of frailty and how this impacts clinical pharmacology, this multi-centre cohort study that shows frailty is significantly correlated with MRH, and this commentary advocating for consideration of MRH as a geriatric syndrome, which needs to be managed as such.

As Giovanni mentioned in the interview, Harlan Krumholz was the first to describe post-hospital syndrome. Learn more about this syndrome by reading his paper.

For more on prescribing cascades, their prevention, detection, and reversal, read this paper by Brath and colleagues.

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

Disproportionality analyses are a mainstay of pharmacovigilance research, but without clear guidelines, they often lead to confusion and misinterpretation. Enter the READUS-PV statement: the first-ever guide for reporting disproportionality analyses that are replicable, reliable, and reproducible.  

Tune in to find out: 

• The history of reporting guidelines in pharmacovigilance and why the READUS-PV guidelines were created 
• Why there has been a spike in the publication of disproportionality analyses in recent years and what this means for their reliability 
• What it means to publish “good” pharmacovigilance science  

Want to know more? 

• Read the READUS-PV guidelines, why they were created, and why they are important. 
• In 2021, Khouri and colleagues showed that current methods and models used for disproportionality analyses are unreliable, and Mouffak and colleagues found that there is a tendency to overstate results in published disproportionality analyses. 
• A book on data mining techniques in Pharmacovigilance by Poluzzi and colleagues delves deeper into this exponential increase in disproportionality analyses.  
• This paper elaborates on the Delphi technique, and how it is used to gather data from reviewers to achieve scientific consensus on a problem. 

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

Duplicate reports are a big problem when it comes to signal detection, but with the help of machine learning and new ways of comparing reports, we may more effectively detect them. 

This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.

After the read, we speak to author Jim Barrett, Senior Data Scientist at UMC, to learn more about the duplicate detection algorithm and UMC’s work to develop AI resources for pharmacovigilance.

Tune in to find out:

• How the new algorithm handles duplicates in VigiBase
• About different approaches for developing algorithms
• Why it can be challenging to evaluate the performance of an algorithm

Want to know more?

• Listen to the Drug Safety Matters interview with Michael Glaser about his Uppsala Reports article “Ensuring trust in AI/ML when used in pharmacovigilance” and check out the episode’s extensive list of links for more on AI in pharmacovigilance. 
• Artificial intelligence in pharmacovigilance – value proposition and the need for critical appraisal, a presentation by Niklas Norén, Head of Research at UMC, given at University of Verona in April 2024.  

Finally, don’t forget to ­subscribe to the monthly Uppsala Reports newsletter for free regular updates from the world of pharmacovigilance.

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

Ensuring trust in AI is vital to fully reap the benefits of the technology in pharmacovigilance. Yet, how do we do so while grappling with its ever-growing complexity?

This episode is part of the Uppsala Reports Long Reads series – the most topical stories from UMC’s pharmacovigilance news site, brought to you in audio format. Find the original article here.

After the read, we speak to one of the authors of the article, Michael Glaser, to learn more about how AI and ML has been used in pharmacovigilance so far, and what needs to happen to ensure its continued use in the field.

Tune in to find out:

●      How AI and ML are being used today in pharmacovigilance processes

●     Why a mindset change is necessary to make full use of AI/ML in pharmacovigilance

●      How we may best move forward to implement AI/ML into healthcare.

 Want to know more?

 To know more about how AI and ML are being used in pharmacovigilance currently, read this scoping review.

To know more about future trends of the use of AI in Biopharma, read this Accenture survey.

• Despite there being major interest in ML and AI to do more than task automation, there are a number of barriers to its implementation in healthcare. Check out this future-focused paper on the use of AI/ML in pharmacovigilance that details how to utilise it to its fullest potential.
• A mindset shift is necessary in terms of how we think about data, in terms of sharing, how to generate data required to effectively train AI/ML models.
• A validation framework must be developed for AI-based pharmacovigilance systems. One suggestion is to do so using a risk-based approach.
• While there is much interest in using recently developed AI technologies such as chatGPT, preliminary studies like this one suggest that the technology has a ways to go to be useful in pharmacovigilance.
• The World Health Organization have published an extensive guideline on the ethics and governance of AI for health.

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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?

Want to know more?

• In March 2024, WHO published this systematic review of the global burden of preventable medication-related harm in healthcare.
• According to this 2021 article in BMJ, an estimated 237 million medication errors occur in England every year. Avoidable adverse drug events were calculated to cost the National Health Service an annual sum of GBP 98 462 582 per year, consuming 181 626 bed-days, and causing/contributing to 1708 deaths. 
• This 2012 meta-analysis confirmed what had been suggested in several observational studies: that preventable adverse drug reactions are a significant healthcare burden.
• The European Medicines Agency (EMA) has a dedicated webpage with recommendations, guidelines, legal requirements and a good practice guide on medication errors. 

Join the conversation on social media
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Got a story to share?
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About UMC
Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

Medicines can affect our personality in positive ways, but they may also lead to destructive behaviours that can damage our relationships, finances, and overall quality of life. Michele Fusaroli from the University of Bologna explains how to diagnose and treat drug-induced impulse control disorders.

Tune in to find out:

• Which medicines may cause impulsivity
• What the ‘four knights’ of impulsivity are
• How patient stories can help detect these conditions

Want to know more?

This review by Daniel Weintraub summarises twenty years of research on impulse control disorders in Parkinson’s disease.

In 2003, Driver-Dunckley and colleagues in the US published the first case series linking pathological gambling to dopamine agonists.

In 2016, the US Food and Drug Administration warned about impulse-control problems associated with the antipsychotic drug aripiprazole.

Michele and colleagues in Italy have investigated the mechanisms and burden of drug-induced impulsivity.

In their 2024 guidelines for managing impulsivity in Parkinson's disease, an expert consensus group highlighted the pivotal role of caregivers and of psychosocial interventions.

Finally, these are the Drug Safety Matters episodes cited in the interview:

• Catching black swans
• When drugs damage the liver
• Empowering patients as partners
• Why we should listen to patients

Join the conversation on social media
Follow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.

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

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

Serious and unexpected adverse drug reactions – the ‘black swans’ of pharmacovigilance – can place enormous strain on safety monitoring systems. Drawing examples from the COVID-19 pandemic, François Montastruc from Toulouse University Hospital explains how we can get better at dealing with the 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 communication are key to patient safety

Want to know more?

Here are the research articles cited in the episode:

• Quality of reporting of adverse events in clinical trials of COVID-19 drugs: systematic review
• Psychiatric disorders and hydroxychloroquine for COVID-19: a VigiBase study
• Hepatic disorders with the use of remdesivir for COVID-19
• Serious bradycardia and remdesivir for COVID-19: a new safety concern
• Oxford-AstraZeneca COVID-19 vaccine-induced cerebral venous thrombosis and thrombocytopaenia: a missed opportunity for a rapid return of experience
• Atypical thrombosis associated with VaxZevria® (AstraZeneca) vaccine: data from the French network of regional pharmacovigilance centres
• Teaching pharmacovigilance to French medical students during the COVID-19 pandemic: interest of distance learning clinical reasoning sessions

If you enjoyed this podcast, check out these related episodes from the Drug Safety Matters archive:

• Reforming pharmacovigilance education
• Lessons in pandemic pharmacovigilance
• Intuition in pharmacovigilance

Join the conversation on social media
Follow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.

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

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

The liver is the primary site for drug metabolism in the body, but it can be severely damaged by medicines or their toxic compounds. Rita Baião from the North Lisbon University Hospital Center reviews what pharmacovigilance professionals should know about drug-induced liver injury (DILI).

Tune in to find out:

• Who is most at risk of developing 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 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.

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About UMC
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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 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 anyone with an interest in pharmacovigilance.

Through 14 chapters and 13 special interest groups, the society works to enhance the safe and proper use of medicines across countries.

Their latest annual meeting took place in Bali, Indonesia in November 2023, while the next one will take place in Montreal, Canada in October 2024.
 
To learn more about ISoP’s activities in patient engagement and pharmacogenomics, listen to these episodes from the Drug Safety Matters archive:

• Empowering patients as partners
• Tailoring drug therapy to your genes

Join the conversation on social media
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Got a story to share?
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About UMC
Read more about Uppsala Monitoring Centre and how we work to advance medicines safety.

To mark #MedSafetyWeek, which took place from 6–12 November, we’re releasing a special two-part episode on pharmacovigilance communication campaigns. In this second part, we hear from three #MedSafetyWeek veterans – Anne-Cécile Vuillemin from the Ministry of Health in Luxembourg, Ban Al-Shimran from the Iraqi Ministry of Health, and Frieda Shigwedha from the Therapeutic Information and Pharmacovigilance Centre in Namibia – about what makes a successful campaign.

Tune in to find out:

• Why you should always tailor your communication strategy to your setting
• How to deal with the financial, cultural, and logistical challenges of campaign planning
• What to keep in mind if you are new to #MedSafetyWeek

Want 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
Follow us on X, LinkedIn, or Facebook and share your thoughts about the show with the hashtag #DrugSafetyMatters.

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

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