Drug Safety

, Volume 40, Issue 3, pp 257–262

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

  • Marine Auffret
  • Julien Labreuche
  • Alain Duhamel
  • Sylvie Deheul
  • Olivier Cottencin
  • Régis Bordet
  • Sophie Gautier
  • Benjamin Rolland
Original Research Article

DOI: 10.1007/s40264-016-0489-7

Cite this article as:
Auffret, M., Labreuche, J., Duhamel, A. et al. Drug Saf (2017) 40: 257. doi:10.1007/s40264-016-0489-7

Abstract

Introduction

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.

Objective

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.

Method

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.

Results

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.

Conclusion

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.

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Marine Auffret
    • 1
  • Julien Labreuche
    • 2
  • Alain Duhamel
    • 2
  • Sylvie Deheul
    • 3
  • Olivier Cottencin
    • 4
    • 5
  • Régis Bordet
    • 1
    • 3
    • 6
  • Sophie Gautier
    • 1
    • 6
  • Benjamin Rolland
    • 4
    • 6
  1. 1.Centre Régional de Pharmacovigilance, CHU LilleLille CedexFrance
  2. 2.Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soinsLilleFrance
  3. 3.Service d’Addictovigilance, CHU LilleLille CedexFrance
  4. 4.Service d’AddictologieCHU LilleLille CedexFrance
  5. 5.ScaLAB UMR 9193Univ LilleLille CedexFrance
  6. 6.Département de Pharmacologie MédicaleINSERM U1171 Univ LilleLille CedexFrance