Page 7 - 《中国药房》2024年13期

·药事管理·

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
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董慧秋 ，汤少梁（南京中医药大学卫生经济管理学院，南京 210023）
＊
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2024）13-1545-07
DOI 10.6039/j.issn.1001-0408.2024.13.01

摘 要 目的 构建我国仿制药质量安全应急管理能力评估指标体系，为评估并提高集采常态化背景下仿制药质量安全应急管理
能力提供参考。方法 基于理论研究和文献分析初步拟定仿制药质量安全应急管理能力评估指标体系，采用德尔菲法和层次分析
法确定评价指标体系并计算权重。结果 两轮咨询专家积极程度、权威系数与意见协调程度较好，最终构建了仿制药质量安全应
急管理能力评估指标体系，包括一级指标4个（质量风险监测预警能力、应急准备能力、响应处置能力与应急恢复能力）、二级指标
11个（如仿制药研发与生产过程质量风险监测预警能力、应急组织机制保障能力、应急响应处置能力等）、三级指标75个（如仿制
药原料质量风险监测、仿制药质量和疗效一致性评价、仿制药利润空间风险隐患监测等）。其中，一级指标中质量风险监测预警能
力的权重最大（0.392 4），二级指标中仿制药研发与生产过程质量风险监测预警能力的组合权重最大（0.146 0），三级指标中仿制药
原料质量风险监测的组合权重最大（0.023 0）。结论 本研究构建的仿制药质量安全应急管理能力评估指标体系层次分明、权重合
理，具有一定的可信度，可作为集采常态化背景下仿制药质量安全应急能力评估管理与决策的有效工具。
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

Construction of an index system for assessing generic drug quality and safety emergency management
capacity in the context of the normalization of centralized procurement
DONG Huiqiu，TANG Shaoliang（School of Health Economics and Management， Nanjing University of Chinese
Medicine， Nanjing 210023， China）

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.
KEYWORDS generic drug quality and safety； emergency
Δ 基金项目 国家自然科学基金项目（No.72074125） response capacity evaluation； emergency management；
＊ 第一作者 硕 士 研 究 生 。 研 究 方 向 ：药 事 管 理 。 E-mail：
assessment indicator system； national centralized drug volume-
20210965@njucm.edu.cn
based procurement policy
# 通信作者 教授，博士生导师，博士。研究方向：卫生事业管理、
药事管理。E-mail：280098@njucm.edu.cn

中国药房 2024年第35卷第13期 China Pharmacy 2024 Vol. 35 No. 13 · 1545 ·