Pharmacovigilance- Adverse drug reaction monitoring

The occurrence of adverse drug reactions, also known as iatrogenic drug reactions, is a major public health problem, mainly because of its repercussions in terms of morbidity and mortality. French studies have estimated that around 3.5% of hospital admissions are due to adverse drug reactions.

The role of pharmacovigilance is to monitor medicines after they have been placed on the market, and to prevent the risk of adverse effects resulting from their use. In France, it is based on the collection of adverse effects through spontaneous reporting by healthcare professionals, patients and approved patient associations, and manufacturers, with the support of the network of 31 regional pharmacovigilance centers. This system, coordinated by France's Agence Nationale de Sécurité du Médicament et des Produits de Santé, is part of a European organization for pharmacovigilance and drug evaluation, in compliance with European regulations.

Drug safety data is assessed by means of case grouping surveys and/or pharmaco-epidemiological studies, enabling the detection of signals that specify the drug's safety profile. The implementation of risk management plans by pharmacovigilance, as soon as the drug is marketed, enables the drug to be monitored proactively in real life.

Pharmacovigilance involves taking corrective action (precautions or restrictions on use, contraindications, even withdrawal of the drug from the market) and communicating these measures to healthcare professionals and the public. Pharmacovigilance thus contributes to the ongoing reassessment of the risk/benefit ratio of drugs, and to public health policy in the fight against drug iatrogenicity. The aim of this article is to describe, using examples, the organization, methods and operation of pharmacovigilance in France, in the European and international context.

A glossary and table of acronyms are provided at the end of the article.