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
- VernacularTitle:我国药品临床综合评价全面质量管理体系的构建
- Author:
Rui ZHAO
1
;
Ruofei HU
2
;
Xiuyuan SHI
3
;
Aizong SHEN
4
;
Yongwu CHEN
4
;
Fan LI
2
;
Kun ZHAO
1
Author Information
1. China National 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 C hina/Anhui Provincial Hospital，Hefei 230002，China
- Publication Type:Journal Article
- Keywords:
clinical comprehensive evaluation of drugs;
total quality management;
quality control
- From:
China Pharmacy
2022;33(12):1409-1414
- CountryChina
- Language:Chinese
-
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.
