| アブストラクト | 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. |
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| 投稿者 | Auffret, Marine; Labreuche, Julien; Duhamel, Alain; Deheul, Sylvie; Cottencin, Olivier; Bordet, Regis; Gautier, Sophie; Rolland, Benjamin |
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| 組織名 | Centre Regional de Pharmacovigilance, CHU Lille, 59037, Lille Cedex, France.;Univ. Lille, CHU Lille, EA 2694 - Sante Publique: epidemiologie et qualite des;soins, 59000, Lille, France.;Service d'Addictovigilance, CHU Lille, 59037, Lille Cedex, France.;Service d'Addictologie, CHU Lille, 59037, Lille Cedex, France.;ScaLAB UMR 9193, Univ Lille, 59045, Lille Cedex, France.;Departement de Pharmacologie Medicale, INSERM U1171 Univ Lille, 1 place de;Verdun, 59045, Lille Cedex, France.;benjrolland@gmail.com.;Verdun, 59045, Lille Cedex, France. benjrolland@gmail.com. |
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