French Pharmacovigilance Public System and COVID-19 Pandemic

Aurélie Grandvuillemin (), Milou-Daniel Drici, Annie Pierre Jonville-Bera, Joelle Micallef and Jean Louis Montastruc
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Aurélie Grandvuillemin: Centre régional de Pharmacovigilance, Hôpital François Mitterrand
Milou-Daniel Drici: Department of Clinical Pharmacology, Université Côte d’Azur
Annie Pierre Jonville-Bera: Regional Pharmacovigilance Center of Tours, Service de Pharmacosurveillance, CHRU
Joelle Micallef: Assistance Publique Hôpitaux de Marseille, Aix Marseille Université, Institut des Neurosciences des Systèmes, INSERM 1106
Jean Louis Montastruc: IC 1436 INSERM, Faculty of Medicine, University Hospital

Drug Safety, 2021, vol. 44, issue 4, No 3, 405-408

Abstract: Abstract The current COVID-19 pandemic is an exceptional health situation including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different candidates were proposed. In this short article, we present the French public pharmacovigilance activities during this health crisis. Although COVID-19 is a confounding factor per se, owing to its potential for multi-organ damage including the heart and kidney, the quality of the transmitted data in adverse drug reaction reports, the timeliness of feedback from clinicians, and the real-time pharmacological and medical analysis by the French network of the regional pharmacovigilance centers made it possible to swiftly identify relevant safety signals. The French National Agency of Medicine was thus able to validate the data and convey their findings very early. This decentralized organization based on medical and pharmacological evaluation of case reports has proven to be efficient and responsive in this unique and challenging healthcare emergency.

Date: 2021
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DOI: 10.1007/s40264-020-01034-y

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