Formulation and Analysis on the Standard of Off-label Drug Use
10.3870/j.issn.1004-0781.2024.07.007
- VernacularTitle:《超说明书用药标准》制订与解析
- Author:
Rongji LIU
1
,
2
;
Wei ZUO
;
Jiancun ZHEN
;
Wei ZHANG
;
Ling JIANG
;
Xiaoyang LU
;
Qianzhou LYU
;
Zhiqing ZHANG
;
Ying CHEN
;
Bo ZHANG
Author Information
1. 中国医学科学院北京协和医学院北京协和医院药剂科,北京 100730
2. 疑难重症及罕见病国家重点实验室,北京 100730
- Keywords:
Off-label drug use;
Standard formulation;
Evidence-based medicine
- From:
Herald of Medicine
2024;43(7):1065-1069
- CountryChina
- Language:Chinese
-
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.
