超药品说明书用药的相关法律问题  

Legal Issues Related to Off-label Uses

作　　者：江依帆 赵敏[1] 

机构地区：[1]湖北中医药大学人文学院

出　　处：《医学与法学》2015年第5期60-66,共7页Medicine and Jurisprudence

摘　　要：药品说明书是一定时期内医疗水平的总结或诊疗指导规范,滞后于临床实践的发展与更新,需要不断地更新。超药品说明书用药的现象一直存在,这种行为存在法律风险。通过制订全国统一的超药品说明书用药的相关指南、建立超药品说明书用药的医院内部审查制度、加强超说明书用药时患者知情同意权的保护、强化药品生产企业完善药品说明书的法律义务、规范医师临床用药行为及建立和推广超药品说明书用药的医疗意外保险等措施,以从根本上规范医生的相关行为,更合理地保护医患双方的合法权益。The drug instruction embodies the medical level during a certain period of time and the diagnosis and treatment guidelines, and it needs constant updating. It lags behind the development and updating of clinical practice. Off-label uses long existed, which has some legal risks. We should regulate doctors＇ related behaviors fundamentally, and protect the legitimate rights and interests of both doctors and patients reasonably by taking the following measures： formulating unified national drug guidelines for off-label uses, building internal review system of off-label uses, strengthening patients informed consent right protection in off-label uses, strengthening pharmaceutical production enterprises＇ legal obligation of perfecting drug instruction, regulating doctors＇ clinical drug use, establishing and promoting medical accident insurance for off-label uses, etc..

关 键 词：超药品说明书用药 法律问题 法律解决 

分 类 号：R95[医药卫生—药学] D922.16[政治法律—宪法学与行政法学]