Guédat Marie-Gabrielle, Gouraud Aurore, Ramiah Takeswarsing, Demazière Jacques, Delanoy Bertrand, Vial Thierry, Leboucher Gilles, Charpiat Bruno
Service Pharmaceutique, Hôpital de la Croix Rousse, Lyon, France.
Therapie. 2012 May-Jun;67(3):243-50. doi: 10.2515/therapie/2012032. Epub 2012 Aug 9.
Underreporting is the main limit in any pharmacovigilance system relying on spontaneous notification. Available data emphasize that pharmacists report few adverse drug reactions (ADRs) in France.
To report how the integration of pharmacists in health care units contributes to reporting of ADRs and to study the validity of the reports.
Over a period of nine years we have prospectively collected and analyzed all ADRs collected by pharmacists in a university hospital setting and notified to the regional center of pharmacovigilance.
Over the study period 2017 notifications were sent. Over the past four years the annual number of reports varied between 250 and 350. This amount is approximately ten times the number referred by physicians during the year preceding the beginning of this work. Only 8.6% of the submitted notifications were rejected by the pharmacovigilance center for various reasons: no causal link between the adverse event and taking medication, problem of timing, lack of data...
The integration of the adverse reaction reporting in the daily activities of the pharmacist is a mean to increase very significantly the number of reports (factor of increase of 9.6 to 13.4).
漏报是任何依赖自发报告的药物警戒系统的主要局限。现有数据表明，在法国药剂师报告的药物不良反应（ADR）较少。
报告医疗保健单位药剂师的参与对ADR报告的贡献，并研究报告的有效性。
在九年时间里，我们前瞻性地收集并分析了一所大学医院环境中药剂师收集并通报给地区药物警戒中心的所有ADR。
在研究期间共发送了2017份通报。在过去四年中，每年的报告数量在250至350份之间。这一数量约为本工作开始前一年医生报告数量的十倍。提交的通报中只有8.6%因各种原因被药物警戒中心拒绝：不良事件与用药之间无因果关系、时间问题、数据不足……
将不良反应报告纳入药剂师的日常工作是大幅增加报告数量的一种方式（增加系数为9.6至13.4）。
