执业药师在药品分类管理中的作用探讨  

Roles of licensed pharmacists in drug classification management

作　　者：周玥 刘硕 宋海波 ZHOU Yue;LIU Shuo;SONG Haibo(Certification Center for Licensed Pharmacis of NMPA,Beijing 100061,China;Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]国家药品监督管理局执业药师资格认证中心,北京100061 [2]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076

出　　处：《中国药物警戒》2024年第4期428-434,共7页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82230118)。

摘　　要：目的为推进药品分类管理,加强执业药师队伍建设提出建议。方法梳理国内外药品分类管理法规现状及其对执业药师的要求,分析执业药师队伍在药品分类管理中的作用。结果国内外药品分类管理制度注重执业药师职责,国外对执业药师提出具体、细化的职责要求。我国执业药师在落实药品分类管理工作中具备必要性、可行性、代表性、广泛性特点,应充分发挥其作用,推进药品分类管理。结论建议加快修订《处方药与非处方药分类管理办法(试行)》;执业药师职责与药品品种分类要求相衔接;多措并举加快执业药师队伍发展;加强能力提升培训和宣传教育,促进药品安全合理使用,推进药品分类管理。Objective To offer recommendations about how to improve the quality of licensed pharmacists and promote drug classification.Methods The current requirements for(licensed)pharmacists in domestic and foreign regulations on drug classification were analyzed,and the role of licensed pharmacists in promoting drug classification was studied.Results Drug classification systems at home and abroad attached importance to the responsibilities of licensed pharmacists.There were specific and detailed requirements for(licensed)pharmacists in other countries.In terms of drug classification,licensed pharmacists in China were characterized by irreplaceability,feasibility,representativeness and extensiveness,whose roles should be brought into full play.Conclusion It is recommended that guidelines for drug classification be formulated as soon as possible,the duties of licensed pharmacists align with the requirements of drug classification,multiple measures be taken to produce more licensed pharmacists,related training be improved,and that drug classification be promoted.

关 键 词：执业药师 药品分类 管理 队伍建设 处方药 非处方药 

分 类 号：R954[医药卫生—药学]