ArticleExperimental and therapeutic medicine2024
Off‑label and unapproved pediatric drug utilization: A meta‑analysis.
Article in Experimental and therapeutic medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Characteristics of pediatric drug-related investigator-initiated trials in Chinese children's hospitals: a comparative analysis based on ChiCTR and ClinicalTrials.gov registration data.Frontiers in pharmacology · 2026Pooled it
- Serious Adverse Drug Reactions Associated with Off-Label and Unlicensed Drug Use in Children: A 14-Year Analysis of VigiBase Reports from Serbia.Children (Basel, Switzerland) · 2026Article
- Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.Pharmaceutics · 2025Review
- Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care.Italian journal of pediatrics · 2025Review
- Exploring pediatricians' off-label prescribing behavior in China: A theory of planned behavior-based study.International journal of clinical pharmacy · 2025Article
- Off-label prescribing in Italian pediatric practice: insights from a nationwide survey.European journal of pediatrics · 2025Article
- Paediatric rare diseases: Can large language models assist off-label prescribing?British journal of clinical pharmacology · 2025Article
- Enhancing Drug Development for Paediatric Pulmonary Hypertension-An Integrative Perspective.Pulmonary circulation · 2025Review
- Characteristics of pediatric interventional drug trials registered between 2015 and 2024 on ClinicalTrials.gov.Frontiers in pediatrics · 2025Article
- Analysis of off-label drug use and its influencing factors in pediatric patients undergoing otolaryngology, head, and neck surgery.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.