Guideline Formulation of the Off-label Use of Drugs Based on Evidences
10.6039/j.issn.1001-0408.2017.16.02
- VernacularTitle:以证据为基础的超药品说明书用药指导规范的制订
- Author:
Jing ZHAO
;
Guoyu GU
;
Yaolong CHEN
;
Rong SHAO
;
Xiaomei ZHAI
;
Xingguo ZHANG
;
Qingwei ZHAO
;
Hongyu YANG
;
Rongrong WANG
;
Lin LIU
;
Yan LOU
;
Dongsheng HONG
;
Yuefeng RAO
;
Jiaying WU
;
Jun LI
;
Saiping JIANG
;
Huiqun YU
;
Xin ZHAO
;
Yun YE
- Keywords:
Evidence-based;
Off-label drug use;
Guide-lines;
Formulation
- From:
China Pharmacy
2017;28(16):2167-2170
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To explore an effective method to formulate management-related strategies for off-lable use of drugs by the evidence-based medicine. METHODS:The process of guideline formulation included seven procedures,i.g. establishment ofguideliesformulation workgroup;investigation and selection of the status quo on off-label drug use;identification of the clinical problems;retrieval and evaluation and comprehensing of evidence;applification of GRADE in evidence quality grading;formation of the recommendations consensus;peer review and result publication. And eventually guidelines were formed based on the steps. This study took off-label use of rheumatoid immunoprotective subjects as a case to explore. RESULTS & CONCLUSIONS:Based on the evidence evaluation system and above 7 steps,the methods and process of guideline formulation on off-label use of rheuma-toid immunoprotective subjects that integrated administration,law,clinical medicine,pharmacy subjects were made .The process of guideline formulation fully reflects multidisciplinary characteristics of the workgroup,the advanced nature of the process,the comprehensiveness of evidence ,the rigor of evidence quality grading,and the normalization of consensus. It provides reference in methodology for establishing a comprehensive evidence-based evaluation and management system of off-label use of drugs for all clinical specialist disease. Therefore,this scientific research results may promote the standardization and legalization of the off-label use of drugs management in China.
