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Construction of an index system for assessing generic drug quality and safety emergency management capacity in the context of the normalization of centralized procurement
- ZHONGGUO YAOFANG Vol. 35, Issue 13, Pages: 1545-1551(2024)
- 作者机构：
南京中医药大学卫生经济管理学院，南京 210023
- 作者简介：
- 基金信息：
DOI：10.6039/j.issn.1001-0408.2024.13.01
CLC： R95Published：15 July 2024，
Received：18 January 2024，
Revised：02 May 2024，
- 稿件说明：
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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 Δ[J].中国药房,2024,35(13):1545-1551.
DONG Huiqiu,TANG Shaoliang.Construction of an index system for assessing generic drug quality and safety emergency management capacity in the context of the normalization of centralized procurement[J].ZHONGGUO YAOFANG,2024,35(13):1545-1551.
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 Δ[J].中国药房,2024,35(13):1545-1551. DOI： 10.6039/j.issn.1001-0408.2024.13.01.
DONG Huiqiu,TANG Shaoliang.Construction of an index system for assessing generic drug quality and safety emergency management capacity in the context of the normalization of centralized procurement[J].ZHONGGUO YAOFANG,2024,35(13):1545-1551. DOI： 10.6039/j.issn.1001-0408.2024.13.01.
摘要
目的
2
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
2
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
2
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
2
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。
Abstract
OBJECTIVE
2
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
2
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
2
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
2
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
Keywords
emergency response capacity evaluationemergency managementassessment indicator systemnational centralized drug volume-based procurement policy
references
中国政府网.第九批国家组织药品集中带量采购开标[EB/OL].[2023-11-06].https：//www.gov.cn/lianbo/bumen/202311/content_6913890.htmhttps://www.gov.cn/lianbo/bumen/202311/content_6913890.htm.
Chinese Government Website. Bid opening for the ninth batch of state-organized centralized band purchasing of medicines[EB/OL].[2023-11-06].https：//www.gov.cn/lianbo/bumen/202311/content_6913890.htmhttps://www.gov.cn/lianbo/bumen/202311/content_6913890.htm.
鲁金月，王莹，徐慧，等. 我国药物分析前沿技术十年发展回顾[J]. 中国药学杂志，2023，58（8）：649-657.
LU J Y，WANG Y，XU H，et al. Review on the research of progress of China pharmaceutical analysis in the past decade[J]. Chin Pharm J，2023，58（8）：649-657.
国家医疗保障局. 第二、三批国家组织药品集中采购中选仿制药临床疗效和安全性真实世界研究结果[EB/OL].[2023-10-17]. https：//news.cnr.cn/native/gd/20231018/t20231018_526454611.shtmlhttps://news.cnr.cn/native/gd/20231018/t20231018_526454611.shtml.
National Healthcare Security Administration. Results of the real-world study on the clinical efficacy and safety of generic drugs selected in the second and third batches of centralized procurement of medicines by state organizations[EB/OL].[2023-10-17].https：//news.cnr.cn/native/gd/20231018/t20231018_526454611.shtmlhttps://news.cnr.cn/native/gd/20231018/t20231018_526454611.shtml.
陈昊，张莉. 关于药品质量、价格与供应三者关系的思考[J]. 中国政府采购，2020（7）：71-76.
CHEN H，ZHANG L. Reflections on the relationship among drug quality，price and supply[J]. China Gov Procure，2020（7）：71-76.
邵靖，路云，常峰. 药品集中带量采购的应急管理机制研究[J]. 中国药房，2023，34（8）：902-906.
SHAO J，LU Y，CHANG F. Study on emergency management mechanism of drug volume-based procurement[J]. China Pharm，2023，34（8）：902-906.
田菁，邢花. 我国药品应急管理体系现状、问题及对策探讨[J]. 中国药学杂志，2018，53（6）：477-482.
TIAN J，XING H. The current situation，problems and countermeasures of China’s drug emergency management system[J]. Chin Pharm J，2018，53（6）：477-482.
刘梦灵. 中医院公共卫生事件应急能力评价指标构建及实证研究[D]. 广州：南方医科大学，2021.
LIU M L. The construction and empirical research on evaluation indexes for public health emergencies response capability of traditional Chinese medicine hospital[D].Guangzhou：Southern Medical University，2021.
熊尚志，张圣捷，宫恩莹，等. 应用德尔菲法构建中国城市地区慢病相关社区效能评估体系[J]. 中国慢性病预防与控制，2021，29（9）：674-678.
XIONG S Z，ZHANG S J，GONG E Y，et al. Establishing the evaluation system of community efficacy for non-communicable diseases in Chinese urban area by Delphi method[J]. Chin J Prev Contr Chronic Dis，2021，29（9）：674-678.
杨诗晗，田芳琼，王露露，等. 基于德尔菲法的医生执业环境指标体系构建研究[J]. 中国卫生统计，2020，37（5）：642-644，648.
YANG S H，TIAN F Q，WANG L L，et al. Research on the construction of doctor’s practice environment index system based on Delphi method[J]. Chin J Health Stat，2020，37（5）：642-644，648.
王高玲，蒋欣静，张怡青. 慢性病患者健康素养评价指标体系Delphi法构建[J]. 中国公共卫生，2018，34（1）：71-74.
WANG G L，JIANG X J，ZHANG Y Q. Establishment of an evaluation index system for health literacy among chronic disease patients with Delphi method[J]. Chin J Public Health，2018，34（1）：71-74.
黄炜，孟慧莹. 面向公共卫生事件的大数据治理能力评价与应急管理策略研究[J]. 现代情报，2021，41（10）：119-129.
HUANG W，MENG H Y. Research on evaluation index system of big data governance capability and emergency management strategy for public health emergency[J]. J Mod Inf，2021，41（10）：119-129.
周文婧，王璐，郭杨，等. 灾难性医疗需求激增情境下卫生系统韧性评价指标体系构建[J]. 中国公共卫生，2022，8（2）：134-138.
ZHOU W J，WANG L，GUO Y，et al. Establishment of an evaluation index system for health system resilience in the context of catastrophic medical surge[J]. Chin J Public Health，2022，8（2）：134-138.
周亚霖，张艺馨，田新宇，等. 基于德尔菲法中国县（区）突发公共卫生事件应急能力评估指标体系构建[J]. 中国公共卫生，2023，39（9）：1180-1184.
ZHOU Y L，ZHANG Y X，TIAN X Y，et al. Establishment of an indicator system for assessing public health emergency response capacity at county/district level：a Delphi study[J]. Chin J Public Health，2023，39（9）：1180-1184.
张海波. 应急管理的全过程均衡：一个新议题[J]. 中国行政管理，2020（3）：123-130.
ZHANG H B. The full process balance of emergency management：a new topic[J]. Chin Public Adm，2020（3）：123-130.
单珊. 党的十八大以来我国突发公共卫生事件应急管理体系建设的重大成就和重要经验[J]. 管理世界，2022，38（10）：70-78.
SHAN S. The major achievements and important expe- rience in the construction of China’s emergency management system for public health emergencies since the 18th National Congress of the CPC[J]. J Manag World，2022，38（10）：70-78.
张海波，童星. 中国应急管理结构变化及其理论概化[J]. 中国社会科学，2015（3）：58-84，206.
ZHANG H B，TONG X. Changes in the structure of emergency management in China and a theoretical generalization[J]. Soc Sci China，2015（3）：58-84，206.
王家峰. 完善常态与应急结合的国家治理体系的理论思考[J].国家治理，2022（1）：46-51.
WANG J F. Theoretical reflections on improving the national governance system that combines normality and emergency response[J]. Governance，2022（1）：46-51.
国家药品监督管理局.国家药监局关于印发《药品监管网络安全与信息化建设“十四五”规划》的通知[EB/OL].[2023-11-06].https：//www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20220511110329171.htmlhttps://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20220511110329171.html.
National Medical Products Administration.State Drug Administration on the issuance of The Drug Regulatory Network Security and Information Construction “14th Five-Year Plan” notice[EB/OL].[2023-11-06].https：//www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20220511110329171. htmlhttps://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20220511110329171.html.
张海波，戴新宇，钱德沛，等. 新一代信息技术赋能应急管理现代化的战略分析[J]. 中国科学院院刊，2022，37（12）：1727-1737.
ZHANG H B，DAI X Y，QIAN D P，et al. Strategic perspective of leveraging new generation information technology to enable modernization of emergency management[J]. Bull Chin Acad Sci，2022，37（12）：1727-1737.
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