关于中药代煎的运行模式和问题思考_蒋皓.pdfVIP

关于中药代煎的运行模式和问题思考 1＊ 1 2 # 蒋 皓 ，吴振华 ，倪永兵 （1. 中国药科大学药学院，南京 210009；2. 南京市食品药品监督管理局，南京 210007） 中图分类号 R95 文献标志码 A 文章编号 1001-0408（2015）31-4333-03 DOI 10.6039/j.issn. 1001-0408.2015.31.05 摘 要 目的：为加强中药代煎监管提供新思路。方法：调查分析目前南京和杭州地区的中药外包代煎模式，重点剖析其运行模 式，从合法性和规范化两方面分析该模式存在的质量安全问题。结果与结论：中药代煎业务存在中药饮片专业技术人员资格要求 不匹配、药师与处方医师沟通缺失、有毒中药饮片的外包代煎未作出限制性规定、中药汤剂所用包装材料的质量安全关注不够、医 疗机构主体责任难以落实等问题。建议建立中药集中代煎服务机构的备案制度，医疗机构药学技术人员驻点制度，调剂、煎煮等 岗位人员培训考核上岗制度，卫生、药监部门定期联合检查制度，随访医患人员对代煎药剂的质量评价体系，以探索一条“监管部 门职权明晰、医疗机构全程参与、药品批发企业规范管理、患者主动监督”的监管新思路。 关键词 中药代煎；运行模式；质量安全；监管 Operation Mode and Problems of TCM Decoction for Patients 1 1 2 JIANG Hao ，WU Zhen-hua ，NI Yong-bing （1.College of Pharmacy ，China Pharmaceutical University ，Nanjing 210009，China ；2.Nanjing Food and Drug Administration ，Nanjing 210007，China ） ABSTRACT OBJECTIVE ：To provide new ideas for the supervision of TCM decoction for patients. METHODS ：The mode of outsourced TCM decoction for patients in Nanjing and Hangzhou area were investigated and analyzed ，especially their operation mode. The safety problems of quality of the mode were analyzed from the legitimacy and standardization. RESULTS CONCLU- SIONS ：The present problems include the mismatch of professional and technical personnel of TCM decoction pieces and their qua- lification requirements ；the lack of communication of pharmacists and prescribers ；no restrictions for outsourced decoction of toxic TCM decoction pieces for patients ；the insufficient attention for the quality and safety of packaging materials ；being difficult to im- plement the main responsibility of medical institutions ，etc. It is suggested to establish the filing system of centralized TCM decoc- tion institution for patients ；the stationed system of pharmacy technician in medical institutions ；the training an