医药导报2024，Vol.43Issue(7)：1065-1069,5.DOI:10.3870/j.issn.1004-0781.2024.07.007
《超说明书用药标准》制订与解析
Formulation and Analysis on the Standard of Off-label Drug Use
摘要
Abstract
Off-label use means that the intended use of the drug is not included in the instructions approved by the National Medical Products Administration,including unapproved indication,dosage,the course of treatment,route of administration,or population.The formulation of Pharmaceutical Supply Services-Key Medications Management-Off-label Uses is based on relevant laws,regulations,normative documents,guidelines,literatures,and expert opinions,and follows the principles of scientificity,versatility,instructiveness,and operability.This standard regulates and standardizes the institutional and organizational construction,process management,and the whole process of quality management and evaluation improvement of off-label uses,which is the basis for medical institutions to carry out off-label uses management.This article introduced the formulation process of the off-label uses standard and analyzed the key contents of the standard,which would help medical institutions to better comply with and meet the requirements of this standard in the practice of off-label use management.关键词
超说明书用药/标准制订/循证医学Key words
Off-label drug use/Standard formulation/Evidence-based medicine分类
医药卫生引用本文复制引用
刘容吉,张波,左玮,甄健存,张威,姜玲,卢晓阳,吕迁洲,张志清,陈英..《超说明书用药标准》制订与解析[J].医药导报,2024,43(7):1065-1069,5.基金项目
中央高水平医院临床科研业务费资助(2022-PUMCH-B-059). （2022-PUMCH-B-059）
