Off‑label and unapproved pediatric drug utilization: A meta‑analysis

Despite legislative enforcement on authorized drugs, off‑label and unapproved pediatric drug use is prevalent. The present study aimed to assess the global prevalence of off‑label and unlicensed prescriptions among hospitalized children via meta‑analysis. A comprehensive examination of articles published between 1990 and 2023 from the PubMed, Scopus, Excerpta Medica Database, Web of Science and Google Scholar databases was conducted. Key word‑based advanced searches were executed using the aforementioned databases. A total of 45 studies that reported the prescriptions of off‑label and unlicensed drugs to pediatric patients were included. The global prevalence of off‑label and unlicensed drug prescriptions to children in pediatrics or neonatal departments was 56%. Patient sample sizes varied from 40‑13,426, with a range of 240‑8,891 total prescriptions issued. Of the 45 studies examined, 22 studies originated from Europe, 13 from Asia, 3 from South America, 3 from Africa, and 2 each from North America and Australia. Africa had the highest prevalence rate at 66%, followed by Asia, South America, North America, Australia and Europe. The present meta‑analysis demonstrated that the prevalence of off‑label and unlicensed drug prescriptions given to pediatric patients was notably high and geographically diverse. Therefore, drug authorities should standardize pediatric prescription practices in future.