药品上市许可持有人药物警戒工作评价指标体系的构建

Construction of Pharmacovigilance Evaluation Index System for Drug Marketing Authorization Holders

目的:建立一套评价药品上市许可持有人(MAH)药物警戒工作水平的指标体系,为企业的药物警戒工作提供指导性工具。方法:基于文献分析和对政策法规的解读,以MAH药物警戒年度报告的撰写指南模板为基础,构建初级的指标体系;采用德尔菲法确立指标体系,并利用三角模糊数计算指标权重,构建评价模型。结果:最后两轮专家咨询问卷回收率分别为100%,专家的权威系数为0.92,专家重要性和可行性评分的协调系数检测为0.358和0.177。最终建立的指标体系包括一级指标3个,二级指标9个,三级指标38个。结论:构建的指标体系具有较高的权威性和科学性,对提升MAH药物警戒工作水平具有较好的指导意义。

Objective: To establish a set of indicators to evaluate MAH pharmacovigilance, to provide a guiding tool for enterprise pharmacovigilance. Methods: An evaluation model was built based on literature analysis and interpretation of policies and regulations, with an index system preliminarily constructed based on the guideline template for writing MAH annual pharmacovigilance report, and then established by the Delphi method with the weight of each index calculated by triangular fuzzy number. Results: In the last two rounds of expert consultation questionnaire, the recovery rate was 100%, the authority coefficient of experts was 0.92, and the coordination coefficient of expert importance and feasibility score was 0.358 and0.177, respectively. Finally, the index system included 3 first-level indexes, 9 second-level indexes and 38third-level indexes. Conclusion: The established index system is authoritative and scientific and it has a good guiding significance for improving the level of MAH pharmacovigilance.