中国药房2024，Vol.35Issue(13)：1545-1551,7.DOI:10.6039/j.issn.1001-0408.2024.13.01
集采常态化背景下仿制药质量安全应急管理能力评估指标体系构建
Construction of an index system for assessing generic drug quality and safety emergency management capacity in the context of the normalization of centralized procurement
摘要
Abstract
OBJECTIVE To provide reference for assessing and improving the emergency management capacity of generic drug quality and safety under the background of normalization of centralized procurement by constructing emergency response capacity assessment index system of China's generic drug quality and safety.METHODS Based on theoretical research and literature analysis,the emergency response capacity assessment index system of generic drug quality and safety was formulated preliminarily;the Delphi method and hierarchical analysis method were used to determine the evaluation index system and calculate the weights.RESULTS The degree of experts'enthusiasm,authority coefficient and the degree of experts'coordination were relatively good in the two rounds of consultation.The assessment indicator system was finally constructed for emergency management capacity of generic drug quality and safety,including 4 first-level indicators(quality risk early warning capabilities,emergency preparedness capabilities,response and disposal capabilities,and emergency recovery capabilities),11 second-level indicators(ability to monitor and early warn of quality risks in the development and production process of generic drugs,emergency organization mechanism guarantee,disposal and recovery,etc.)and 75 third-level indicators(risk monitoring of raw material quality of generic drugs,consistency evaluation of quality and efficacy of generic drugs,and monitoring of profit margin risks and hidden dangers of generic drugs,etc.).Among them,the weight of generic drug quality risk monitoring and early warning capacity was the highest among the first-level indicators(0.392 4),the combined weight of generic drug R&D and production quality risk monitoring and early warning capacity was the highest among the second-level indicators(0.146 0),and the combined weight of generic drug raw material quality risk monitoring was the highest among the third-level indicators(0.023 0).CONCLUSIONS The emergency management capacity assessment index system of generic drug quality and safety constructed in this study is hierarchical,reasonably weighted,and has a certain degree of credibility,and it can be used as an effective tool for the management and decision-making of generic drug quality and safety emergency management capacity assessment in the context of the normalization of centralized procurement.关键词
仿制药质量安全/应急能力评价/应急管理/评估指标体系/国家药品集中带量采购政策Key words
generic drug quality and safety/emergency response capacity evaluation/emergency management/assessment indicator system/national centralized drug volume-based procurement policy分类
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董慧秋,汤少梁..集采常态化背景下仿制药质量安全应急管理能力评估指标体系构建[J].中国药房,2024,35(13):1545-1551,7.基金项目
国家自然科学基金项目(No.72074125) （No.72074125）
