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 and Benjamin Rolland ()
Additional contact information
Marine Auffret: Centre Régional de Pharmacovigilance, CHU Lille
Julien Labreuche: Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins
Alain Duhamel: Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins
Sylvie Deheul: Service d’Addictovigilance, CHU Lille
Olivier Cottencin: CHU Lille
Régis Bordet: Centre Régional de Pharmacovigilance, CHU Lille
Sophie Gautier: Centre Régional de Pharmacovigilance, CHU Lille
Benjamin Rolland: CHU Lille

Drug Safety, 2017, vol. 40, issue 3, No 7, 257-262

Abstract: 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

Keywords: Alcohol Dependence; Baclofen; Withdrawal Syndrome; Spontaneous Reporting; Spontaneous Reporting System (search for similar items in EconPapers)
Date: 2017
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DOI: 10.1007/s40264-016-0489-7

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