Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors.
10.3760/cma.j.cn112140-20210923-00813
- VernacularTitle:中国儿童指南共识类文章中超说明书用药分析
- Author:
Min MENG
1
;
Ping WANG
2
;
Hui LAN
3
;
Wen Juan LEI
4
;
Quan SHEN
1
;
Qi ZHOU
2
;
Ren Feng SU
3
;
Meng LYU
1
;
Bo YANG
1
;
Xu Fei LUO
3
;
Ruo Bing LEI
1
;
Tian Chun HOU
1
;
Qiu LI
1
;
Yao Long CHEN
5
Author Information
1. Department of Pediatric Research Institute, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China.
2. Lanzhou University GRADE Center, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000,China.
3. School of Public Health, Lanzhou University, Lanzhou 730000,China.
4. Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730000, China.
5. Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China.
- Publication Type:Journal Article
- MeSH:
Child;
China;
Consensus;
Cross-Sectional Studies;
Humans;
Off-Label Use;
Pharmaceutical Preparations
- From:
Chinese Journal of Pediatrics
2022;60(3):215-220
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To understand the current situation regarding pediatric off-label use of drugs recommendations in Chinese clinical practice guidelines and to make recommendations for standardized reporting format regarding off-label use of drugs for children. Methods: This cross-sectional study was carried out by systematically searching the databases for Chinese guideline consensus articles published in journals between 2018 and 2020 and extracting recommendations regarding off-label use of drugs from those articles. The essential characteristics of the included guidelines, the ranking of off-label drug types, the order of drug information, the type of off-label drug use, and the percentage of citation studies on which the recommendations were based were analyzed. Results: Among 108 studies that included Chinese off-label guidelines and consensus, 364 recommendations on pediatric off-label use of drugs were included. The Chinese Medical Association published the most, 48 out of the 108 studies (44.4%), and of those 14 studies (13.0%) were on infectious and parasitic diseases. Of the 364 recommendations on off-label use of drugs, the most commonly addressed drugs were 16 recommendations (4.4%) for cyclosporine A, 11 recommendations (3.0%) for methotrexate , and 11 recommendations (3.0%) for fentanyl. The most commonly addressed drug categories were as follows: 68 recommendations (18.6%) were immune system drugs, 66 recommendations (18.1%) were anti-infectives, and 56 recommendations (15.4%) were oncology drugs. The most commonly addressed drug information accounts were as follows: 364 recommendations (100.0%) were indications, 204 recommendations (56.0%) were dosages, and 198 recommendations (54.4%) were the route of administration. Based on the instructions approved by the Chinese Food and Drug Administration, the main forms of the off-label drug were as follows: 175 recommendations (48.1%) were unapproved indications, 127 recommendations (34.9%) were unapproved populations, and 72 recommendations (19.8%) were unapproved ages. Only 129 recommendations (35.4%) were cited, mainly including clinical guidelines (48 studies, 23.4%), reviews (22 studies, 10.7%), and pediatric randomized controlled trials (22 studies, 10.7%). Conclusions: Off-label use of drugs is commonly recommended in pediatric guidelines and consensus documents written by Chinese authors. However, the reporting of the recommendations varies widely, and the quality of the supporting evidence is poor.
