On ‐the‐ground application of the ‘temporary recommendation for use’ regulatory measure on off‐label use of baclofen for alcohol dependence in France: a regional survey of community pharmacies

Abstract The ‘temporary recommendation for use’ (TRU) is a French novel regulatory measure for off‐label drug. The first TRU to be issued by the French drug agency (in March 2014) pertained to the off‐label use of baclofen for alcohol dependence (AD). We performed a questionnaire‐based survey of the on‐the‐ground application of the baclofen TRU among community pharmacies in northern France. A pharmacist from 70 of the 219 pharmacies contacted (response rate: 32.0%) completed the questionnaire. The mean ± standard deviation number of off‐label baclofen prescriptions for AD was 2.3 ± 2.2 per pharmacy per month. 65.2% of these prescriptions were issued by primary care physicians. 65.7% of the pharmacists had never seen ‘TRU’ written on the prescription, and 80.3% delivered a prescription without checking whether the patient had been included by the prescriber in the TRU. The main criterion used to identify off‐label prescribing was the patient's medical history (according to 74.6% of pharmacists) and the prescription of an above‐threshold dose (73.1%). 87.1% of the pharmacists were aware of the baclofen TRU, and 42.9% had actually read the document. 17.9% of the pharmacists estimated that the TRU had changed their attitude to off‐label baclofen prescription, and 29.9% (20 out of 67) of them wanted to be more involved in the TRU process. Community pharmacists were well informed about the off‐label use of baclofen for AD and the TRU. However, a majori...
Source: Fundamental and Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Original Article Source Type: research