超说明书用药认识问题及管理对策研究  

Perception and Management Strategies on Off-label Use of Drugs

作　　者：刘利军[1] 肖龙华[1] 李睿[1] 张凤奎[1] 

机构地区：[1]中国医学科学院北京协和医学院血液学研究所血液病医院,天津300020

出　　处：《中国医院用药评价与分析》2014年第4期361-364,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：科技部"重大新药创制"科技重大专项子课题(No.2011ZX09302-007-04)

摘　　要：目的:厘清超说明书用药的现状和认识误区,为制订超说明书用药的管理措施提供参考依据。方法:采用文献综述及与68位医师、药师调查访谈的方法,分析超说明书用药认识误区的形成原因及其存在的合理性与必要性,并对超说明书用药的管理提出对策和建议。结果:超说明书用药在临床治疗中广泛存在,其中符合疾病治疗规范的超说明书用药应属于合理用药,需要加强用药管理。结论:应采取制订超说明书用药的指导原则或指南、建立有效的医患沟通机制、加强临床药师的监督作用等措施,减少不合理用药,降低超说明书用药风险。OBJECTIVE：To clarify the status and misunderstanding of off-label use of drugs so as to provide references for establishing management measures on off-label use of drugs.METHODS：By means of literature review and in-depth interview of 68 physicians and pharmacists,we analyzed the causes for misunderstanding on the off-label use and the rationality and necessity of its existence and put forward strategies and suggestions for the management of the off-label use of drugs.RESULTS：Off-label use of drugs was widespread in clinical treatment.The off-label use of drugs meeting treatment guideline should be regarded as rational administration of drugs in medical practice.It is important to intensify management on drug use.CONCLUSIONS：It is important to establish such management measures as establishing guidelines for off-label use of drugs,setting up effective doctor-patient communication mechanism and strengthening clinical pharmacists＇ supervisory role so as to reduce the incidence of irrational use of drugs and the risk of the off-label use.

关 键 词：超说明书用药 合理用药 管理 

分 类 号：R954[医药卫生—药学] R969.3