Auffret Marine, Labreuche Julien, Duhamel Alain, Deheul Sylvie, Cottencin Olivier, Bordet Régis, Gautier Sophie, Rolland Benjamin
Centre Régional de Pharmacovigilance, CHU Lille, 59037, Lille Cedex, France.
Univ. Lille, CHU Lille, EA 2694 - Santé Publique: épidémiologie et qualité des soins, 59000, Lille, France.
Drug Saf. 2017 Mar;40(3):257-262. doi: 10.1007/s40264-016-0489-7.
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.
超说明书用药（OLP）可能引发严重的安全问题，而传统的药品不良反应（ADR）自发报告可能无法及时识别这些问题。在法国，“成瘾医学超说明书用药多学科咨询服务”（CAMTEA）是一个主动设立的区域系统，旨在识别与巴氯芬用于酒精依赖的超说明书用药相关的药品不良反应。
旨在利用法国药物警戒数据库（FPVD）证明，CAMTEA能够报告大量的药品不良反应，其性质与通过自发报告提供的不良反应相当。
提取2012 - 2013年与巴氯芬超说明书用药相关的FPVD通知。列出“严重”和“非严重”报告中最常见的十种药品不良反应类型。比较CAMTEA和自发报告中每种药品不良反应的发生频率，并使用标准化差异评估差异的大小。
共识别出428份巴氯芬报告（1043例药品不良反应），其中221份（51.64%）来自CAMTEA。“严重”报告中最常见的十种药品不良反应为：（1）意识模糊（17.3%），（2）癫痫发作（11.5%），（3）嗜睡/镇静（11.5%），（4）激越（10.9%），（5）昏迷（9.6%），（6）幻觉（7.7%），（7）跌倒（7.1%），（8）行为障碍（5.8%），（9）戒断综合征（5.1%），（10）时空定向障碍（5.1%）。十种最常见的“严重”药品不良反应中有六种，十种“非严重”药品不良反应中有八种的标准化差异<0.2。
一个主动的区域药物警戒系统可以收集大量关于特定超说明书用药实践的安全数据。所收集的药品不良反应特征与全国自发报告系统中所见的相似。
