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

Xingxing Yuan1,2, Jiawei Gao2, Liuxin Yang2

  • 1Department of Gastroenterology, Heilongjiang Academy of Traditional Chinese Medicine, Harbin, Heilongjiang 150006, P.R. China.

Experimental and Therapeutic Medicine
|September 13, 2024
PubMed

Insights

Off-label and unapproved drug use in hospitalized children is common globally, affecting 56% of pediatric patients. This highlights a need for standardized pediatric prescription practices worldwide.

Area of Science:

  • Pediatric Pharmacology
  • Global Health
  • Drug Safety

Background:

  • Off-label and unapproved drug use in pediatric populations remains a significant concern despite regulatory efforts.
  • Ensuring safe and effective medication use in children is critical for their health outcomes.

Purpose of the Study:

  • To determine the global prevalence of off-label and unlicensed drug prescriptions among hospitalized children.
  • To analyze geographical variations in pediatric off-label and unapproved drug use.

Main Methods:

  • A comprehensive meta-analysis was conducted on studies published between 1990 and 2023.
  • Searches were performed across major scientific databases including PubMed, Scopus, EMBASE, Web of Science, and Google Scholar.
  • Data from 45 eligible studies reporting pediatric off-label and unlicensed drug prescriptions were synthesized.

Main Results:

  • The global prevalence of off-label and unlicensed drug prescriptions in hospitalized children was found to be 56%.
  • Prevalence rates varied geographically, with Africa reporting the highest rate (66%), followed by Asia, South America, North America, Australia, and Europe.
  • Included studies encompassed a wide range of patient sample sizes and total prescriptions issued.

Conclusions:

  • Off-label and unlicensed drug prescriptions in pediatric patients are highly prevalent and geographically widespread.
  • There is a critical need for drug authorities to establish standardized pediatric prescription guidelines to improve patient safety.

Keywords:
licensed drugoff-label prescriptionspediatricsunlicensed prescribing

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