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作 者:蒋皓 束雅春 蒋永兆 胡晓翔 JIANG Hao;SHU Yachun;JIANG Yongzhao;HU Xiaoxiang(Nanjing Branch of Jiangsu Suncadia Industrial Co.,Ltd.,Nanjing,Jiangsu,China 210000;Jiangsu Hengrui Medicine Co.,Ltd.,Lianyungang,Jiangsu,China 222000;Affiliated Hospital of Nanjing University of Chinese Medicine·Jiangsu Provincial Hospital of Chinese Medicine,Nanjing,Jiangsu,China 210000;Nanjing Administration for Market Regulation,Nanjing,Jiangsu,China 210000;Nanjing Municipal Health Commission,Nanjing,Jiangsu,China 210019)
机构地区:[1]江苏盛迪亚实业有限公司南京分公司,江苏南京210000 [2]江苏恒瑞医药股份有限公司,江苏连云港222000 [3]南京中医药大学附属医院·江苏省中医院,江苏南京210000 [4]江苏省南京市市场监督管理局,江苏南京210000 [5]江苏省南京市卫生健康委员会,江苏南京210019
出 处:《中国药业》2022年第14期30-34,共5页China Pharmaceuticals
摘 要:目的为完善我国药品零售企业(以下用“药店”代称)药品分类管理工作提供参考。方法梳理相关法律法规,以及国家药品监督管理部门和国家卫生健康委员会的规章、规范性文件,分析药店药品分类管理工作的实际情况及问题,并提出有针对性的对策与建议。结果与结论药店药品分类管理在我国已实施逾20年,但目前仍存在可经营的药品品类限制较多、处方来源管理薄弱并面临合规挑战、执业药师数量和质量有待提高、分类管理规章制度有待完善等问题。建议加快落实《药品管理法》提出的药品分类管理要求,促进“三医联动”形成药品分类监管合力,鼓励药店探索“中心药房”模式以及拓宽渠道,提高药学服务质量。Objective To provide a reference for improving the drug classification management in drug retail pharmacies in China.Methods The relevant laws and regulations,the regulations and normative documents issued by the National Medical ProductsAdministration and the National Health Commission were sorted out,the implementation status and problems of the drugclassification management in drug retail pharmacies were analyzed,and the targeted countermeasures and suggestions were putforward.Results and ConclusionThe classified management of drugs in drug retail enterprises has been implemented in Chinafor more than 20 years. However,there are still many problems such as numerous restrictions on the types of drugs that retailpharmacies can handle,weaknesses on the management of the prescription source and challenges facing compliance,low quality andquantity of licensed pharmacists,imperfect regulations of drug classification management. It is suggested that governmentadministration departments should speed up the implementation of requirements for drug classification management proposed in theDrug Administration Law,and accelerate organization associated with the ″3-medicine linkage″ work as one for drug classificationadministration,and encourage drug retail enterprises to explore the "central pharmacy" model and broaden channels to improve thequality of pharmaceutical care.
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