文章摘要
李丹,沈俊,殷志勇,李曹龙,茹原芳.药品上市许可持有人药物警戒工作评价指标体系的构建[J].药学与临床研究,2022,30(6):492~496
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
投稿时间:2022-06-06  修订日期:2022-12-18
DOI:
中文关键词: 药物警戒  德尔菲法  三角模糊数  指标体系  MAH
英文关键词: Pharmacovigilance  Delphi method  Triangular fuzzy number  Index system
基金项目:江苏省药品监督管理局课题(202029)
作者单位邮编
李丹 中国药科大学 211198
沈俊 中国药科大学 
殷志勇 江苏省药物监督管理局 
李曹龙 中国药科大学 
茹原芳 中国药科大学 211198
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中文摘要:
      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。
英文摘要:
      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 and 0.177, respectively. Finally, the index system included 3 first-level indexes, 9 second-level indexes and 38 third-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.
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