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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 pharmacovigilance
• What makes an adverse drug reaction a black, white, or grey swan
•  Why flexibility and communication are key to patient safety

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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

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