Off-Label Baclofen Prescribing Practices among French Alcohol Specialists: Results of a National Online Survey

Benjamin Rolland1,2*, François Paille1,3, Benoit Fleury1,4, Olivier Cottencin1,2, Amine Benyamina1,5, Henri-Jean Aubin1,5

1 Société Française d’Alcoologie, Issy-les-Moulineaux, France, 2 Service d’Addictologie, CHU Lille, Univ Lille Nord de France, Lille, France, 3 Service d’Addictologie, CHU Nancy, Université , Univ Nancy, Nancy, France, 4 Service d’Hépatogastroentérologie et d’Alcoologie, CHU Bordeaux, Bordeaux, France, 5 CERTA L’Albatros, Hôpital Paul Brousse, AP-HP, INSERM U 669, Villejuif, France

Abstract
Objective: To evaluate, among alcohol specialists belonging to the Société Française d’Alcoologie (SFA), i.e., the French Alcohol Society, the proportion of physicians who prescribed off-label baclofen for alcohol use disorders (AUDs). The secondary objective was to depict the features of individual prescribing and monitoring practices.
Methods: On-line survey among 484 French alcohol specialists. Physicians were asked whether they prescribed baclofen for AUDs. If they did not, the reasons for this choice were investigated. If they did, the features of the physician’s prescribing practice were explored, including the number of patients treated, the mean and maximum doses, the monitoring precautions and the pharmacovigilance reporting. Participants were also asked about their empirical findings on HDB’s efficacy and safety.
Results: In total, 302 physicians (response rate of 62.4%) participated in the survey. Data from 296 participants were analysed, representing 59.4% of all active prescribing physicians belonging to the SFA. HDB use was declared by 74.6% of participants (mean dose 109.5+-43.6 mg/d; maximum dose 188+-93.3 mg/d). However, 79.2% of prescribers had treated less than 30 patients, and 67.8% used HDB as a second-line medication. Although HDB was perceived as more efficacious than approved drugs by 54.3% of prescribers, it was also declared less safe by 62.8%. Nonetheless, 79.7% of prescribers had never filed any pharmacovigilance report. Non-prescribers (25.6%) were primarily deterred by the current lack of scientific data and official regulation.
Conclusion: A majority of French alcohol specialists reported using HDB, although often on a limited number of their patients. HDB was considered efficacious but also potentially hazardous. Despite this, physicians reported minimal safety data to the health security system. While French health authorities are planning to draft a specific regulatory measure for framing off-label HDB prescribing practices, the sustained education of prescribers on spontaneous pharmacovigilance reporting should be enhanced.

Off-Label Baclofen Prescribing Practices among French Alcohol Specialists: Results of a National Online Survey