静脉注射剂说明书给药途径描述的分析  

Routes of Administration Described in Specifications of 236 Types of Intravenous Injections

作　　者：罗一冲 蔡丽萍 普燕芳[3] 赵锦华 LUO Yichong;CAI Liping;PU Yanfang;ZHAO Jinhua(Department of Pharmacy,the First Hospital of Mile City,Mile Yunnan 652399,China;Medical Products Administration of Yunnan Province,Kunming Yunnan 650106,China;Department of Pharmacy,the First People's Hospital of Yunnan Province,Kunming Yunnan 650032,China)

机构地区：[1]云南省弥勒第一医院药剂科,云南红河652399 [2]云南省药品监督管理局,云南昆明650106 [3]云南省第一人民医院药学部,云南昆明650032

出　　处：《中国药物警戒》2021年第9期872-875,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的分析静脉注射剂说明书中给药途径的描述,为临床合理开具给药方法提供参考。方法统计分析236种静脉注射剂说明书中的给药方法,探讨静脉注射剂给药方法描述的差异。结果236种静脉注射剂说明书中对给药途径描述不规范的有11种(4.7%),静脉注射和静脉滴注概念不清。结论静脉注射剂说明书中对给药途径描述不规范性问题,亟待生产企业和药品监管部门进一步规范。Objective To investigate how routes of administration are described in the specifications of intravenous injections in order to provide reference for clinical rational drug use and prevent off-label use of medicines.Methods The routes of administration of 236 types of intravenous injections described in the specifications were statistically analyzed,and the difference in the descriptions of how these intravenous injections were administered was studied.Results The descriptions about routes of administration of eleven of these intravenous injections were non-standard in the specifications(4.7%),and intravenous injection and intravenous infusion were not clearly defined.Conclusion Non-standard descriptions of routes of administration in the specifications of intravenous injections are an urgent issue to be addressed by enterprises and related departments of the National Medical Products Administration.

关 键 词：静脉注射剂 说明书 给药方法 调查分析 

分 类 号：R969.3[医药卫生—药理学]