基层药品流通领域监管存在的问题及对策  

Problems and Suggestions in the Supervision of Grassroots Drug Circulation

作　　者：郭永刚 刘华 Guo Yonggang;Liu Hua(Hebei Province Drug Professional Inspectors General Team(South Area),Shijiazhuang,Hebei 050000;Hebei Province Drug Professional Inspectors General Team(North Area),Qinhuangdao,Hebei 066100)

机构地区：[1]河北省药品职业化检查员总队(南片区),河北石家庄050000 [2]河北省药品职业化检查员总队(北片区),河北秦皇岛066100

出　　处：《科技与健康》2024年第1期121-124,共4页Technology and Health

摘　　要：药品流通是保障人民群众安全用药的终端环节之一,在药品全生命周期中发挥着极其重要的作用。近年来,随着《药品经营质量管理规范》严格执行、新修订的《中华人民共和国药品管理法》及其他法律法规的实施,我国基层药品流通监管能力水平明显提升,但仍存在着一些问题,例如基层监管人员数量有限,专业知识相对欠缺,监管企业众多,尤其是政府机构改革以来,药监、工商、质检等多部门合并,一部分内部科(股)室调整后的过渡阶段人员还不能精确把握基层药品监管的风险点;基层药品流通领域监管技术手段落后,监管手段单一,尽管部分地区已建立了药品流通监管系统,但由于基层零售药店工作人员对该系统的重视程度不够,导致一部分购、销、存数据缺失,为非现场监管带来了一定的难度。针对上述问题,提出建立药品流通追溯体系,加大对药品质量和安全问题的监测和处罚力度,保障民众用药的权益,不断完善和加强监管机制等建议,以促进基层药品流通领域的规范化、有序发展。The circulation of drugs is one of the terminal links to ensure the safe use of drugs by the people,and plays an extremely important role throughout the entire lifecycle of drugs.In recent years,with the strict implementation of the Good Manufacturing Practice for Drug Operations,the newly revised Drug Administration Law of the People’s Republic of China,and the implementation of other laws and regulations,the level of grassroots drug distribution supervision in China has significantly improved.However,there are still some problems,such as a limited number of grassroots regulatory personnel,a relative lack of professional knowledge,and a large number of regulatory enterprises,especially since the reform of government institutions,drug supervision,industry and commerce The merger of multiple departments such as quality inspection has resulted in some personnel in the transitional stage of internal departments(stocks)being unable to accurately grasp the risk points of grassroots drug supervision;The regulatory technology in the field of grassroots drug circulation is outdated and the regulatory methods are single.Although some regions have established drug circulation regulatory systems,the lack of attention from grassroots retail pharmacy staff to the system has led to a lack of data on purchase,sales,and storage,which has brought certain difficulties to off-site supervision.In response to the above issues,it is necessary to establish a drug circulation traceability system,increase monitoring and punishment of drug quality and safety issues,protect the rights and interests of the public to use drugs,continuously improve and strengthen regulatory mechanisms,and promote the standardized and orderly development of grassroots drug circulation.

关 键 词：基层药品 流通领域监管 问题及建议 

分 类 号：R95[医药卫生—药学] D630[政治法律—政治学]