Signal Identification in Addictovigilance: the Functioning of the French System

Abstract

-The French addictovigilance network (addictovigilance: surveillance of addiction), composed of 13 Addictovigilance Centres, was set up in 1990 in order to achieve reliable surveillance and evaluation of abuse and dependence cases due to psychoactive substances (alcohol and tobacco excepted). The detection of safety signals is one of the roles of the addictovigilance centres. Signals from spontaneous reports need to be analyzed before further communication. In addictovigilance, signals may be linked to adverse effects (deaths, pathological signs), to products (new psychoactive substances with potentially dangerous effects) or to practices (new administration routes, new contexts of use). These signals are provided by numerous partners among whom the addictovigilance network has to raise awareness about information that may possibly be an alert signal. The watchful attitude of all partners will make it possible that signals will be, after analyze, considered as true alerts. The addictovigilance network collects data, assess the potential for addiction of psychoactive drugs to provide information on the risk of addiction and give opinions for public health decisions (harm reduction or prevention programs, psychoactive substances control, health alerts).Abbreviations: see end of article.

Disproportionality Analysis for the Assessment of Abuse and Dependence Potential of Pregabalin in the French Pharmacovigilance Database

“…According to the experience of the French addictovigilance system, addictovigilance signals can be identified only by crossing several datasources [19]. In other words, the lack of a statistically significant disproportionality in a pharmacovigilance database is insufficient to ascertain the lack of an addiction issue linked to pregabalin.…”

“…In France, a specific Addictovigilance system exists, with a network of 13 Evaluation and Information on Pharmacodependence Centres [17][18][19].…”

Which psychoactive substances are used by patients seen in the healthcare system in French overseas territories? Results of the OPPIDUM survey

“…In France, substance abuse is monitored through several surveillance programmes that have been developed by the French addictovigilance network (FAN), under the coordination of the French medicines agency (ANSM) . Most data concern Metropolitan France or include aggregated overseas data ; for overseas territories, there is little information and published reports are often focused on a specific area and on a particular substance ( e.g .…”

Ephenidine, diphenidine, and methoxphenidine complications reported to the French Addictovigilance Network

“…The FAN, under the supervision of the French National Agency for Medicines and Health Products Safety (ANSM for Agence Nationale de Sécurité du Médicament et des Produits de Santé), monitors addiction to psychoactive substances (with the exclusion of tobacco and alcohol) . This surveillance system was established in 1990 with the aim of monitoring the abuse potential of psychoactive substances (sentinel community pharmacies, drug addiction care centers …), and is based on spontaneous reporting (mandatory for health professionals) and on specific surveillance programs using several data sources . The analysis of cases collected by the FAN allows identifying the main misused substances, their consumption patterns, and the associated risks.…”