我国临床超说明书用药现状和风险防范建议  

Situation and Risk Prevention Suggestion of Off-label Drug Use in China

作　　者：杨丽杰[1] 李希娜[1] 张郝程 李星达[1] 赵文婷[1] 胡月[1] 何晶波 马满玲[1] 

机构地区：[1]哈尔滨医科大学附属第一医院药学部,哈尔滨150001 [2]哈尔滨医科大学附属第一医院医务部,哈尔滨150001

出　　处：《中国药房》2014年第42期4006-4009,共4页China Pharmacy

基　　金：哈尔滨医科大学医疗风险管理研究所2012年度医疗卫生风险管理服务体系科研项目(No.LHYLFXYB201203)暨北京联合保险经纪集团资助项目

摘　　要：目的:为规范临床超说明书用药提供参考。方法:通过对临床超说明书用药问题进行分析,探讨存在问题的原因并提出风险防范建议。结果与结论:临床超说明书用药问题既是临床常见问题又是亟待规范解决的问题。要加强临床规范化和制度化管理,建立临床超说明书用药的规范和患者知情同意管理流程,促进临床合理用药。OBJECTIVE： To provide reference for normalizing off-label drug use in the clinic. METHODS： Through analyzing off-label drug use in the clinic, their reasons were investigated and the suggestions for risk prevention were put forward. RESULTS＆CONCLUSIONS： The clinical off-label drug use is a clinical common problem and need to be urgently normalized and solved. It is suggested to strengthen clinical standardized and institutionalized management, establish clinical off-label drug use standard and the process of patients＇ informed consent management, and promote clinical rational drug use.

关 键 词：超说明书用药 影响因素 管理策略 

分 类 号：R952[医药卫生—药学] R969.3