title: Proactive Regional Pharmacovigilance System Versus National Spontaneous Reporting for Collecting Safety Data on Concerning Off-Label Prescribing Practices: An Example with Baclofen and Alcohol Dependence in France.
abstract: Off-label prescribing (OLP) may raise serious safety concerns that traditional spontaneous reporting of adverse drug reactions (ADRs) may not identify in a timely manner. In France, the 'Multidisciplinary Consultation Service for Off-Label Prescribing in Addiction Medicine' (CAMTEA) is a proactive regional system established to identify ADRs associated with the OLP of baclofen for alcohol dependence.
  
  
  
  The aim was to demonstrate, using the French pharmacovigilance database (FPVD), that CAMTEA allowed for the reporting of a substantial amount of ADRs, comparable in nature to those provided via spontaneous reporting.
  
  
  
  The 2012-2013 FPVD notifications associated with baclofen OLP were extracted. The ten most frequent types of ADRs among 'serious' and 'non-serious' reports were listed. The frequency of each type of ADR was compared between CAMTEA and spontaneous reporting, and the magnitudes of the differences were assessed using standardized differences.
  
  
  
  A total of 428 baclofen reports (1043 ADRs) were identified, among which 221 (51.64%) originated from CAMTEA. The ten most frequent ADRs in 'serious' reports were (1) confusion (17.3%), (2) seizures (11.5%), (3) drowsiness/sedation (11.5%), (4) agitation (10.9%), (5) coma (9.6%), (6) hallucinations (7.7%), (7) falls (7.1%), (8) behavioral disorders (5.8%), (9) withdrawal syndrome (5.1%), and (10) space-time disorientation (5.1%). A standardized difference of <0.2 was identified for six out of the ten most frequent 'serious' ADRs, and eight of the ten 'non-serious' ADRs.
  
  
  
  A proactive regional pharmacovigilance system could collect a substantial amount of safety data on a specific OLP practice. The profile of the ADRs collected was similar to that seen in the nationwide spontaneous reporting system.
authors.affiliation: Centre Régional de Pharmacovigilance, CHU Lille, 59037, Lille Cedex, France.
authors.forename: Marine
authors.initials: M
authors.lastname: Auffret
authors.affiliation: Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins, 59000, Lille, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Labreuche
authors.affiliation: Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins, 59000, Lille, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Duhamel
authors.affiliation: Service d'Addictovigilance, CHU Lille, 59037, Lille Cedex, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Deheul
authors.affiliation: Service d'Addictologie, CHU Lille, 59037, Lille Cedex, France.|ScaLAB UMR 9193, Univ Lille, 59045, Lille Cedex, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Cottencin
authors.affiliation: Centre Régional de Pharmacovigilance, CHU Lille, 59037, Lille Cedex, France.|Service d'Addictovigilance, CHU Lille, 59037, Lille Cedex, France.|Département de Pharmacologie Médicale, INSERM U1171 Univ Lille, 1 place de Verdun, 59045, Lille Cedex, France.
authors.forename: Régis
authors.initials: R
authors.lastname: Bordet
authors.affiliation: Centre Régional de Pharmacovigilance, CHU Lille, 59037, Lille Cedex, France.|Département de Pharmacologie Médicale, INSERM U1171 Univ Lille, 1 place de Verdun, 59045, Lille Cedex, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Gautier
authors.affiliation: Service d'Addictologie, CHU Lille, 59037, Lille Cedex, France. benjrolland@gmail.com.|Département de Pharmacologie Médicale, INSERM U1171 Univ Lille, 1 place de Verdun, 59045, Lille Cedex, France. benjrolland@gmail.com.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Rolland
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D000437:Alcoholism / Q000188:drug therapy*; D001418:Baclofen / Q000008:administration & dosage / Q000009:adverse effects*; D016208:Databases, Factual; D005260:Female; D005602:France; D058786:GABA-B Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D060735:Pharmacovigilance; D055815:Young Adult
chemical_list: D058786:GABA-B Receptor Agonists; D001418:Baclofen