ReviewInternational journal of clinical pharmacy2022
Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions : Comparative regulation framework of off label prescriptions in pediatrics: a review.
Review in International journal of clinical pharmacy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Off-label use of canakinumab in pediatric rheumatology and rare diseases.Frontiers in medicine · 2022Pooled it
- A Complex Intervention to Prevent Medication-Related Hospital Admissions.Deutsches Arzteblatt international · 2023Trial
- Awareness, attitudes, and practices concerning the use of indirect evidence in pediatrics: a cross-sectional survey of healthcare professionals in China.European journal of pediatrics · 2026Article
- Off-label prescribing in pediatrics: between regulatory gaps and clinical evidence.Italian journal of pediatrics · 2026Article
- Stable Overall Volume, Shifting Structure: Nine Years of Paediatric Outpatient Prescribing and Dispensing in Finland, 2017-2025.Clinical epidemiology · 2026Article
- 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
- Prevalence of drug-drug interactions in children with cardiac disorders receiving off-label drugs in a single centre in Pakistan: a cross-sectional study.BMJ paediatrics open · 2025Article
- Utilization of Child-Appropriate Medicines: Use of Pediatric Use Marketing Authorisation (PUMA) Products in Croatia.Journal of clinical medicine · 2025Article
- Potential drug-drug interactions analysis in Polish pediatric hemato-oncologic unit, including acute lymphoblastic leukemia patients.Pharmacological reports : PR · 2025Article
- Polypharmacy in Pediatric Palliative Care: Exploring Discrepancies Between Physicians and Pharmacists.Children (Basel, Switzerland) · 2025Article
- Next-generation pediatric care: nanotechnology-based and AI-driven solutions for cardiovascular, respiratory, and gastrointestinal disorders.World journal of pediatrics : WJP · 2025Review
- The Current and Potential Role of Pediatric Clinical Pharmacologists in Italy: A Review with Evidence Synthesis and Literature Analysis.Current medicinal chemistry · 2025Review
- Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications.Therapeutic advances in drug safety · 2025Article
- Pharmacovigilance and bioethics: the importance of a neglected relationship.Frontiers in drug safety and regulation · 2025Review
- Barriers and facilitators to guideline for the management of pediatric off-label use of drugs in China: a qualitative descriptive study.BMC health services research · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Evaluation of off-label medication use and drug safety in a pediatric intensive care unit.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative.Healthcare policy = Politiques de sante · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Off-label uses of medicines are common in pediatrics. The literature reports that at least one-third of children in hospital and up to 90% of newborns in neonatal intensive care units receive off-label prescriptions. Moreover, the lack of data on safety and efficacy in the pediatric population may sometimes increase the risk of adverse drug reactions. Objective This paper aims to (a) map the main gaps in the existing EU and US regulatory frameworks for pediatric drug development and off-label use and (b) propose potential solutions for further discussion. Conclusion The selected jurisdictions aim to limit off-label prescribing, but implementation levels generally seem low, including in pediatric settings. Subject to further research, we propose potential concerted actions and initiatives of international cooperation to fill this gap. In particular, regulators and pediatric societies could strengthen manufacturers' incentives to develop pediatric medicines, pediatricians' information about off-label uses, and patients' and parents' awareness.
Indexed as
Identifiers
34495453What OpenQuestion holds
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.