《超说明书用药循证评价规范》团体标准解读

Interpretation on the Specification of Evidence-based Pharmaceutical Evaluation Method for Off-label Drug Use

2021年5月,广东省药学会发布了由中山大学孙逸仙纪念医院起草的《超说明书用药循证评价规范》团体标准(T/GDPA 1-2021),为超说明书用药提供了循证评估指引。本文对该标准进行了介绍,以期帮助临床医师与药学人员掌握超说明书用药循证评价的方法与流程,从而进一步促进超说明书用药的合理使用与规范管理,并探索建立具有中国特色的超说明书用药循证评价体系。

In May 2021, Guangdong Pharmaceutical Association released the group standard(T/GDPA1-2021) of evidence-based evaluation specification for off-label drug use drafted by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, thus providing evidence-based assessment guidance for off-label drug use. In this paper, the standard was introduced in order to help clinicians and pharmacy personnel to master the methods and procedures of evidence-based evaluation for off-label drug use, thus further promoting the rational use and standardized management for off-label drug use, and explore the establishment of its evidence-based evaluation system with Chinese characteristics.