PHARMACOVIGILANCE IS THE AFFAIR OF ALL

Pharmacovigilance ensures continuous monitoring of adverse effects but also the monitoring of other situations at risk for patient safety such as misuse, use outside Marketing Authorization (off-label), abuse, overdose use during pregnancy or lactation, medication errors and drug interactions, occupational exposures, suspicions of therapeutic inefficiency, suspected transmission of infectious agents. Preventing the risks associated with the use of medicines is also part of the missions of pharmacovigilance, in particular by monitoring risk management plans (RMPs), provided by the laboratories under the control of the Health Authorities. In France, the health authorities responsible for pharmacovigilance are the ANSM (National Agency for the Safety of Medicines and Health Products), which was created in 2011 to replace the French Agency for Sanitary Safety of Health Products. AFSSAPS) and the 31 CRPVs (Regional Pharmacovigilance Centers) spread over French territory. The ANSM whose missions are carried out in accordance with national and European regulations cooperates with the EMA (European Medicines Agency) to ensure the monitoring of medicines in the European Union.

Pharmaceutical companies also have a pharmacovigilance department which is in continuous contact with the ANSM and the EMA. Laboratories must, in particular, train all their employees, and in particular their medical representatives, to submit information on the tolerance of their medicines.

Health Professionals also have pharmacovigilance obligations: they must immediately report any adverse reaction suspected of being due to a drug that they know about at their CRPV or via the reporting portal. They can also make a pharmacovigilance declaration to the laboratory that markets the medicine in question.

Since June 2011, Patients and Registered Patient Associations have been contributing to pharmacovigilance since they can report to their CRPV or via the reporting portal any adverse reactions suspected to be due to a drug

In practice to report a case of pharmacovigilance, materiovigilance (adverse effects with medical devices) or nutrivigilance (adverse effects with food supplements) on a product marketed by Athelis.