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我国药品临床综合评价全面质量管理体系的构建
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| 篇名： | 我国药品临床综合评价全面质量管理体系的构建 |
| TITLE： | CHINA PH ARMACY Volume 33，Number 12，June 30，2022 Semimonthly Table of Contents Construction of total q uality managemen t system of clinica l comprehens ive evaluation of drugs in China |
| 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。 |
| ABSTRACT： | OBJECTIVE To provide reference for scientifi c 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. |
| 期刊： | 2022年第33卷第12期 |
| 作者： | 赵锐，胡若飞，石秀园，沈爱宗，陈泳伍，李璠，赵琨 |
| AUTHORS： | ZHAO Rui，HU Ruofei ，SHI Xiuyuan ，SHEN Aizong ，CHEN Yongwu ，LI Fan，ZHAO Kun |
| 关键字： | 药品临床综合评价；全面质量管理；质量控制 |
| KEYWORDS： | clinical comprehensive evaluation of drugs ；total quality management；quality control |
| 阅读数： | 246 次 |
| 本月下载数： | 24 次 |
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