Page 7 - 《中国药房》2022年12期

·药事管理·

我国药品临床综合评价全面质量管理体系的构建 Δ

赵 锐 ，胡若飞 ，石秀园 ，沈爱宗 ，陈泳伍 ，李 璠 ，赵 琨（1.国家卫生健康委卫生发展研究中心/国家药
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物与卫生技术综合评估中心，北京 100044；2.昆明医科大学药学院，昆明 650500；3.深圳市卫生健康发展研究
和数据管理中心，广东深圳 518000；4.中国科学技术大学附属第一医院/安徽省立医院药剂科，合肥 230002）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）12-1409-07
DOI 10.6039/j.issn.1001-0408.2022.12.01
摘 要 目的 为保障我国药品临床综合评价工作的科学、规范开展提供参考。方法 以全面质量管理理论为指导，借鉴英、德两国
开展卫生技术评估的成功经验，结合戴明环等质量管理方法和工具，按照我国有关政策要求和地方实际，构建药品临床综合评价
全面质量管理体系。结果与结论 从组织体系、管理流程、考核制度、评价监管平台、支撑保障机制5个方面构建我国药品临床综合
评价全面质量管理体系。其中，组织体系包括国家、省级、医疗机构3级，管理流程应围绕主题遴选、评价实施、结果转化应用3个
阶段的重点环节进行要求，并配合建立考核制度、评价监管平台、支撑保障机制，以进一步提高药品临床综合评价全面质量管理的
科学性、合理性、实用性和规范性。开展全面质量管理是推进药品临床综合评价工作持续改进的有效抓手，政府有关部门和实施
评价的医疗机构要进一步树立质量管理意识，建立报告质量反馈机制和结果共建共用共享机制，强化专业人才队伍培养和创新协
同监管模式，从而确保评价结果真实可靠。
关键词 药品临床综合评价；全面质量管理；质量控制

Construction of total quality management system of clinical comprehensive evaluation of drugs in China
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ZHAO Rui ，HU Ruofei ，SHI Xiuyuan ，SHEN Aizong ，CHEN Yongwu ，LI Fan ，ZHAO Kun（1. China National
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Health Development Research Center， National Health Commission of the People’s Republic of China/
Comprehensive Evaluation Center for Drug and Health Technology，Beijing 100044，China；2. College of
Pharmacy，Kunming Medical University，Kunming 650500，China；3. Shenzhen Health Development Research
and Data Management Center，Guangdong Shenzhen 518000，China；4. Dept. of pharmacy，the First Affiliated
Hospital of University of Science and Technology of China/Anhui Provincial Hospital，Hefei 230002，China）
ABSTRACT OBJECTIVE To provide reference for scientific and standardized development of clinical comprehensive evaluation
of drugs in China. METHODS Guided by the theory of total quality management（TQM），drawing lessons from the successful
experience of the British and German conducting evaluation，combining with plan-do-check-act cycle and other quality management
methods and tools，drug clinical comprehensive evaluation of total quality management system was constructed in accordance with
the requirements for our country related policy and local practice. RESULTS & CONCLUSIONS To construct total quality
management system of clinical comprehensive evaluation of drugs in China from 5 aspects of organization system，management
process，assessment system，evaluation and supervision platform，support and guarantee mechanism. The organization system
included national，provincial and medical institutions；management process should focus on the key links in the 3 stages of theme
selection，evaluation and implementation，and result transformation and application；assessment system，evaluation and supervision
platform，support and guarantee mechanism should be established together so as to further improve the scientificity，rationality，
practicality and standardization of total quality management of clinical comprehensive evaluation of drugs. The development of total
quality management is an effective starting point to promote the continual improvement of the drug clinical comprehensive
evaluation；relevant government departments and the implementation of evaluation of medical institutions should further set up
quality management consciousness，establish report quality feedback mechanism and the results co-constructing and sharing
mechanism and strengthen professional personnel training and innovation synergy regulation mode to ensure that the authenticity
and reliability of evaluation results.
KEYWORDS clinical comprehensive evaluation of drugs；total quality management；quality control

药品临床综合评价是以人民健康为中心、促进药品
Δ 基金项目：国家卫生健康委药政司委托项目（No.CNHDRC-KJ-L-
回归临床价值的基础性工作，是促进医疗机构合理用药
2020-143）
＊副研究员，博士。研究方向：医药卫生政策评价、卫生技术评 的重要抓手，也是健全药品供应保障制度的具体要求。
估。E-mail：zhaoruibsb@126.com 随着我国药品临床综合评价工作顶层设计的逐步完善，

中国药房 2022年第33卷第12期 China Pharmacy 2022 Vol. 33 No. 12 ·1409 ·