DOI
10.1007/s00431-022-04515-7
Off-label use of drugs in pediatrics: a scoping review
作者地址
Chevidence Lab Child & Adolescent Health Department, Children’s Hospital of Chongqing Medical University, 136 Zhongshan Second Street, Chongqing, 400014, ChinaNational Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, International Science and Technology Cooperation Base of Child Development and Critical Disorders, Children’s Hospital of Chongqing Medical University, Chongqing, 400014, ChinaChongqing Key Laboratory of Pediatrics, Chongqing, 400014, ChinaDepartment of Pharmacy, Gansu Provincial Hospital, Lanzhou, 730000, China
来源期刊
EUROPEAN JOURNAL OF PEDIATRICS
摘要
To explore the current state of research on off-label drug use in children and identify the existing research gaps in this topic. Six literature databases were searched to identify studies focusing exclusively on off-label drug use in children (aged < 18 years) published in Chinese or English between 2016 and 2021. We also searched clinicaltrials.gov for pediatric clinical trials conducted in the same period and compared the numbers of studies on off-label use and clinical trials for the most commonly reported drugs and drug types. Our search revealed 568 studies on off-label drug use. Almost half of the studies (n = 240) were cross-sectional. A total of 212 specific drugs or drug types were addressed in 361 studies, the most frequent being antipsychotic agents (n = 12), dexmedetomidine (n = 10), and rituximab (n = 8). Antipsychotic agents were also the most common type of drug examined in clinical trials in children. We identified a total of 435 different types of off-label use, the top three being unapproved indication (n = 157), population (n = 96), or age (n = 36). Only about one-third of the studies reported collecting informed consent (n = 195) or having ethics committee approval (n = 166).
Conclusions: Off-label use of antipsychotics in children is widely reported in the literature. We suggest pediatric researchers to consider the number of studies on off-label use and existing clinical trials on different drugs when selecting target drugs for new studies and systematic reviews.
What is Known:
center dot There exist a large number of studies on off-label drug use in children.
What is New:
center dot This is the first scoping review of studies on off-label drug use in children.
center dot Off-label use of antipsychotic agents is widely reported.
资助信息
Chongqing “Bayu Scholar” program.
WOS关键词
BONE MORPHOGENETIC PROTEIN
;
CONGENITAL HYPERINSULINISM
;
CHILDREN
;
SAFETY
;
PRESCRIPTION
;
OCTREOTIDE
;
ANTIPSYCHOTICS
;
ADOLESCENTS
;
OUTPATIENTS
;
DISORDERS
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