中英超说明书用药管理政策的对比研究  

A Comparative Study on the Management Policy of Off-label Drug Uses between China and the UK

作　　者：谢菡[1] 宋维 游一中[3] 葛卫红[1] XIE Han;SONG Wei;YOU Yizhong;GE Weihong(Department of Pharmacy,Nanjing Drum Tower Hospital,Nanjing,Jiangsu 210008,China;China Pharmaceutical University,School of Basic Medicine and Clinical Pharmacy,Nanjing,Jiangsu 210009,China;Department of Pharmacy,Changzhou First People's Hospital,Changzhou,Jiangsu 213003,China)

机构地区：[1]南京大学医学院附属鼓楼医院药学部,南京210008 [2]中国药科大学基础医学与临床药学学院,南京210009 [3]常州市第一人民医院药学部,常州213003

出　　处：《药学与临床研究》2020年第6期473-477,共5页Pharmaceutical and Clinical Research

基　　金：南京大学医院管理研究所医院管理课题(NDYG2019012)。

摘　　要：借鉴英国超说明书用药管理经验,建立和完善我国超说明书用药管理制度和规范。分析英国和我国超说明书用药的处方资质、用药风险、用药依据、用药规程等管理政策,并进行对比研究。研究表明,英国超说明书用药的相关准则和规范已经比较成熟,为我国完善和建立超说明书用药管理制度和规范、促进我国超说明书用药的合法、合理性提供了启示和参考。By comparing the management policies of off-label uses between China and the UK,this article explores how to establish and improve the management system and norms in China.The British off-label uses have been analyzed and studied on prescription qualification,risk,basis,procedures and other management policies in comparison with China's counterparts.The relevant standards and norms of off-label uses in the UK are at high levels of maturity,which provide inspiration and reference to improve the management system and norms and promote the legitimacy and rationality of off-label uses in China.

关 键 词：超说明书用药 英国 管理政策 比较研究 

分 类 号：R951[医药卫生—药学]