Pharmacovigilance is the science related to the collection, detection, assessment, monitoring, and prevention of adverse reactions with pharmaceutical products, whether potential or proven.
It is governed by rules of good practice, laws, directives and decrees. It is based on :
- spontaneous notification of adverse effects by doctors, health personnel or the patient.
- recording and evaluation of this data.
- setting-up of studies and investigations of adverse effects.
- establishment and monitoring of a rigorously developed RMP (risk management plan).
- assessment of the safety profile of the use of the drug based on the collected information.
- taking corrective measures, ranging from simple corrections to a withdrawal of the batch if necessary.
- communication and dissemination of information relating to job security.
- participation in the public health policy for the prevention of iatrogenic drugs.