中药制剂备案制度的风险归因、辨识与防控管理研究  

Research on Risk Attribution,Identification,Prevention and Control Management of Traditional Chinese Medicine Preparation Record System

作　　者：王乾 田侃[2] WANG Qian;TIAN Kan(College of Health Economics and Management,Nanjing University of Chinese Medicine,Jiangsu Nanjing 210023,China;College of Elderly Care Service and Management,Nanjing University of Chinese Medicine,Jiangsu Nanjing 210023,Chian)

机构地区：[1]南京中医药大学卫生经济管理学院,江苏南京210023 [2]南京中医药大学养老服务与管理学院,江苏南京210023

出　　处：《中国药物评价》2023年第2期182-187,共6页Chinese Journal of Drug Evaluation

基　　金：江苏省社科基金后期资助项目,中医药立法问题研究(项目编号:20HQ019)。

摘　　要：目的:全面风险管理理论分析传统工艺配制中药制剂备案制度实施过程的风险因素,以期为改善我国中药制剂应用的安全性和有效性提供思路。方法:从全面风险管理视角分析风险归因及类型,并从不同维度提出风险防控应对策略。结果:不同主体对备案制下中药制剂的风险防控认识有待提高,需进一步提高对备案制的过程管理。结论:基于全面风险管理视角,监管机构层面主要有监督管理、电子备案、应急预警、管理激励、风险评估;医疗机构的管理机制主要有内部监督、人员规范、生产质量、动态监测;法律法规层面主要有技术导向、风险界定、权责统一。Objective:To analyze the risk factors in the implementation of the record system of traditional Chinese medicine preparations by comprehensive risk management theory,so as to improve the safety and effectiveness of the application of traditional Chinese medicine preparations.Methods:Risk attribution and types were analyzed from the perspective of comprehensive risk management,and risk prevention and control strategies were proposed from different dimensions.Results:Different subjects need to improve their understanding of the risk prevention and control of TCM preparations under the filing system,and further improve the process management of the filing system.Conclusion:From the perspective of comprehensive risk management,the management mechanisms of regulatory agencies mainly include supervision and management,electronic filing,emergency warning,management incentive,and risk assessment.The management mechanism of medical institutions mainly includes internal supervision,personnel specification,production quality and dynamic monitoring.The management mechanism of laws and regulations mainly includes technology orientation,risk definition and unity of power and responsibility.

关 键 词：传统工艺配制中药制剂备案制度 医疗机构制剂 风险管理 

分 类 号：R95[医药卫生—药学]