规避超说明书用药风险的管理决策  

Management strategies on avoiding the risk of off-label use of drugs

作　　者：张宏丽[1] 许建辉[1] 侯惠荣[2] 孙蒙蒙[1] 刘国婷[1] 李永生[1] 陈凯[1] 

机构地区：[1]天津市北辰医院,天津市北辰区北医道7号300040 [2]中国医学科学院肿瘤医院

出　　处：《中国医院》2017年第7期26-27,共2页Chinese Hospitals

基　　金：中国科协调研课题"医药领域新技术风险评估机制研究"(2014ZCYJ03)

摘　　要：目的:国内当前超说明书用药现象广泛存在但管理不统一,为超说明书用药规范化管理提出相关建议。方法:通过分析超说明书用药存在的安全隐患及原因,对规避超说明书用药风险提出管理对策。结果:超说明书用药有其合理性,但其应用的风险无可避免。结论:完善超说明书用药立法体系,完善保险体系,确立风险预警机制,减少不合理超说明书用药并规避超说明书用药风险。Objectives：To provide references on off-label drug use management under the status quo of widespread off-label drug use in clinical treatment currently.Methods：By analyzing the hidden risks and causes of off-label drug use,countermeasures on off-label drug use were presented.Results：Off-label drug use was rational in healthcare sometimes but the risk wad hard to avoid.Conclusions：It is considered to reduce the incidence of irrational off-label drug use and the risk of the off-label use by strengthening off-label drug use legal system and security system,and set up risk early warning mechanism.

关 键 词：超说明书用药 药物风险 药物管理 

分 类 号：R184[医药卫生—流行病学]