美国专业药房质量管理体系及对我国双通道药店管理的启示  

Enlightenment from the Quality Management System of Specialty Pharmacies in US on Dual-Channel Pharmacies in China

作　　者：蒋蓉[1,2] 王怡诺 祝晶京 严明聪 陈童 邵蓉 Jiang Rong(Research Center of National Drug Policy&Ecosystem,China Pharmaceutical University,Nanjing,P.R.China)

机构地区：[1]中国药科大学国家药物政策与医药产业经济研究中心,江苏南京211198 [2]国家药品监督管理局药品监管创新与评价重点实验室 [3]杭州师范大学

出　　处：《中国卫生事业管理》2022年第3期185-189,220,共6页Chinese Health Service Management

基　　金：国家社会科学基金重大项目“我国创新药物政策环境研究”(15ZDB167);江苏省教育厅高校哲学社会科学研究项目“霍恩-米特模型视角下江苏省医疗机构三医联动政策执行效果与影响因素研究”(2019SJA0059)。

摘　　要：目的分析美国专业药房质量管理体系,并结合我国双通道药店现有质量管理要求,为完善我国双通道药店管理体系提供政策建议。方法通过文献研究法和比较分析法,对美国专业药房质量管理体系和我国双通道药店质量管理体系进行梳理、归纳和比较。结果美国专业药房通过第三方机构认证、注重药房专业人员队伍建设和强化冷链管理建立了成熟的质量管理体系,对完善我国双通道药店质量管理体系具有借鉴意义。结论建议我国应当建立双通道药店第三方认证机构、强化执业药师和其他人员队伍的建设,并加强冷链药品的储运管理以完善我国双通道药店质量管理体系。Objective To analyze the quality management system of specialty pharmacies in US, and provide policy recommendations for improving China’s dual-channel pharmacies management system. Methods Through literature research and comparative analysis methods, the quality management system of specialty pharmacies in US and dual-channel pharmacies in China were sorted, summarized and compared. Results A mature quality management system has been established in specialty pharmacies of US through third-party certification, focusing on the construction of pharmacy professionals and strengthening cold chain management, which are of reference significance for improving the quality management system of China’s dual-channel pharmacies. Conclusion It is recommended that China should establish a third-party certification agency for dual-channel pharmacies, intensify the construction of licensed pharmacists and other personnel, and strengthen the storage and transportation management of cold chain drugs to improve the quality management system of dual-channel pharmacies.

关 键 词：双通道药店 专业药房 质量管理 

分 类 号：R95[医药卫生—药学]