Analysis on off-label use of drugs in pediatric guidelines and consensus published by Chinese authors
Meng Min, Wang Ping, Lan Hui, Lei Wenjuan, Shen Quan, Zhou Qi, Su Renfeng, Lyu Meng, Yang Bo, Luo Xufei, Lei Ruobing, Hou Tianchun, Li Qiu, Chen Yaolong
Abstract
ObjectiveTo 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.
MethodsThis 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.
ResultsAmong 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%).
ConclusionsOff-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.
Key words:
Child; Off-label use of drugs; Clinical practice guidelines; Recommendations
Contributor Information
Meng Min
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Wang Ping
Lanzhou University GRADE Center, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000,China
Lan Hui
School of Public Health, Lanzhou University, Lanzhou 730000,China
Lei Wenjuan
Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730000, China
Shen Quan
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Zhou Qi
Lanzhou University GRADE Center, Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000,China
Su Renfeng
School of Public Health, Lanzhou University, Lanzhou 730000,China
Lyu Meng
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Yang Bo
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Luo Xufei
School of Public Health, Lanzhou University, Lanzhou 730000,China
Lei Ruobing
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Hou Tianchun
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Li Qiu
Department of Pediatric Research Institute, Children′s Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Chongqing 400014,China
Chen Yaolong
Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
