[Involvement of pharmacists in systems for supervising off-label medications: example of the CAMTEA system for the prescription of baclofen in alcohol use disorder in Northern France]

Abstract

Off-label prescribing matches the using of medications outside the summary of product characteristics. Adverse drug reactions are often poorly studied in off-label situations, which may expose patients to additional safety risks, and impose taking specific precautions. The current off-label prescribing practice of baclofen for alcohol-dependence in France is a typical illustration of such a situation. CAMTEA is a regional system set up in 2010 in Northern France, which gathers addiction and pharmacovigilance specialists, and aims at strengthening the prescription supervising and the monitoring of some off-label medication used for addictive disorders, especially baclofen. Until now, institution or office-based pharmacists have not been implicated, whereas they engaged their liability when delivering off-labeled treatment and they may highly contribute to the patient monitoring and the spotting of adverse events. We propose hereby possible measures for involving pharmacists into the patient supervising system developed within CAMTEA. In the current French context concerning the off-label use of baclofen, which will be the first off-label prescribing practice to be framed by a new legal disposition called "temporary use recommendation", the key role of pharmacists should be highlighted.

Keywords: Alcohol use disorder; Alcoolodépendance; Baclofen; Baclofène; Drug safety; Hors-AMM; Off-label; Pharmacien; Pharmacist; Sécurité médicamenteuse.