美国重新包装药品监管对我国药品拆零的启示  

Enlightenment of United States repackaged drugs supervision on China′s drug dismantling

作　　者：王慧玲[1] 卓胜男 袁冬冬[3] 刘伟[2] WANG Huiling;ZHUO Shengnan;YUAN Dongdong;LIU Wei(School of Pharmacy,Zhengzhou Railway Vocational&Technical College,He′nan Province,Zhengzhou450002,China;School of Pharmaceutical Sciences,Zhengzhou University,He′nan Province,Zhengzhou450001,China;Department of Pharmacy,Zhengzhou Seventh People′s Hospital,He′nan Province,Zhengzhou410100,China)

机构地区：[1]郑州铁路职业技术学院药学院,河南郑州450002 [2]郑州大学药学院,河南郑州450001 [3]郑州市第七人民医院药学部,河南郑州410100

出　　处：《中国当代医药》2022年第15期139-142,共4页China Modern Medicine

基　　金：河南省医学教育研究项目(Wjlx2019263)。

摘　　要：药品拆零可减轻患者负担,减少浪费和污染环境。我国对拆零药品管理缺乏具体的标准和要求,拆零药品存在的问题较多,主要包括环境卫生不标准、操作不当、包装材料不规范、有效期的确定方法不明确等问题。美国对重新包装药品的监管政策较完善,对包装和储存环境、设备和人员卫生、重新包装操作、包装材料、有效期的确定原则、标签信息以及重新包装记录等方面都做出明确规定。建议我国相关监管部门借鉴美国重新包装监管的相关政策,建立健全拆零管理制度,促进医疗机构提供优质的药学服务,保障患者用药安全。Dismounted drugs can reduce the burden of patients,waste and pollution of the environment.China lacks specific standards and requirements for the management of dismounted drugs,and there are more problems with dismounted drugs,mainly including substandard environmental hygiene,improper operation,non-standard packaging materials,and unclear methods of determining expiration dates.The United States regulatory policy for repackaged drugs is more complete,with clear provisions for packaging and storage environment,equipment and personnel hygiene,repackaging operations,packaging materials,principles of determining expiration dates,labeling information and repackaging records.It is recommended that the relevant regulatory authorities in China learn from the relevant policies of the United States repackaging regulation,establish a sound management system for dismounted drugs,promote medical institutions to provide quality pharmacy services,and protect the safety of patients′medication.

关 键 词：拆零药品 监管 重新包装药品 政策 美国 

分 类 号：R951[医药卫生—药学]