title: Off-label baclofen prescribing practices among French alcohol specialists: results of a national online survey.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; Service d'Addictologie, CHU Lille, Univ Lille Nord de France, Lille, France.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rolland
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; Service d'Addictologie, CHU Nancy, Université, Univ Nancy, Nancy, France.
authors.forename: François
authors.initials: F
authors.lastname: Paille
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; Service d'Hépatogastroentérologie et d'Alcoologie, CHU Bordeaux, Bordeaux, France.
authors.forename: Benoit
authors.initials: B
authors.lastname: Fleury
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; Service d'Addictologie, CHU Lille, Univ Lille Nord de France, Lille, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Cottencin
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; CERTA L'Albatros, Hôpital Paul Brousse, AP-HP, INSERM U 669, Villejuif, France.
authors.forename: Amine
authors.initials: A
authors.lastname: Benyamina
authors.affiliation: Société Française d'Alcoologie, Issy-les-Moulineaux, France; CERTA L'Albatros, Hôpital Paul Brousse, AP-HP, INSERM U 669, Villejuif, France.
authors.forename: Henri-Jean
authors.initials: HJ
authors.lastname: Aubin
mesh_terms: D000437:Alcoholism / Q000188:drug therapy* / Q000453:epidemiology; D001418:Baclofen / Q000008:administration & dosage / Q000627:therapeutic use*; D003625:Data Collection; D004305:Dose-Response Relationship, Drug; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D005602:France / Q000453:epidemiology; D006801:Humans; D020407:Internet; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires
chemical_list: D001418:Baclofen