山东省超药品说明书用药专家共识(2022版)系列——心血管药物超药品说明书用药专家共识  

Expert Consensus on Off-Label Drug Use in Shandong Province(2022 Edition):Cardiovascular Drugs

作　　者：侯飞[1] 李冬梅[1] 唐琳 侯宁 HOU Fei;LI Dong-mei;TANG Lin;HOU Ning(Department of Pharmacy,the Affiliated Hospital of Qingdao University,Qingdao 266000,China;Department of Pharmacy,Shandong Provincial Hospital Affiliated to Shandong First Medical University,Jinan 250021,China)

机构地区：[1]青岛大学附属医院药学部,青岛266000 [2]山东第一医科大学附属省立医院药学部,济南250021

出　　处：《中国合理用药探索》2022年第12期23-29,共7页Chinese Journal of Rational Drug Use

摘　　要：药品说明书是判定处方是否合理的法律文件,但其存在内容滞后、更新不及时的情况,致使超药品说明书用药(OLDU)在全球普遍存在。但是,OLDU的安全性尚无充分的循证依据支持,若引起不良事件,还会导致法律纠纷。我国新修订的《中华人民共和国医师法》为OLDU提供了法律依据,但临床实践中如何规范、安全的OLDU是一项亟待解决的难题。《山东省超药品说明书用药专家共识》中收录的心血管药物OLDU均来自临床实践并经循证评价,详实列出了循证证据,经药学与临床专家进一步论证形成推荐意见,旨在提高临床对OLDU的认识,规范OLDU的管理,促进合理用药。Drug package insert is a legal document used to determine whether a prescription is reasonable,but its content always lags behind and is not updated in a timely manner,thus off-label drug use(OLDU)is common in the world.However,the safety of OLDU cannot be supported by sufficient evidence-based evidence.Especially when it causes adverse events,it will lead to legal disputes.The newly enacted Law on Doctors of the People’s Republic of China provides a legal basis for OLDU,however,the safety and standardization of OLDU is the first important problem need to be solved.All the OLDU of cardiovascular drugs listed in the Expert Consensus on Off-label Drug Use in Shandong Province were supported by evidence-based evidence and accepted by clinical experts,aiming to improve clinical understanding of OLDU,standardize the management of OLDU,and promote rational drug use.

关 键 词：超药品说明书用药 心血管药物 循证药学 专家共识 用药目录 

分 类 号：R95[医药卫生—药学]