ReviewWorld journal of pediatrics : WJP2018
Two decades of off-label prescribing in children: a literature review.
Review in World journal of pediatrics : WJP, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
49 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Guideline for the management of pediatric off-label use of drugs in China (2021).BMC pediatrics · 2022Guideline
- Suitability of Oral Formulations Available to Children at the Time of Pediatric Labeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Pharmacokinetics of Monoclonal Antibodies in Pediatrics: Model-Based Investigation on Allometric Scaling Exponents.Pharmaceutics · 2026Article
- 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
- ADHD prescribing: national findings of children and adolescents attending mental health services in Ireland.International journal of clinical pharmacy · 2026Article
- Prevalence of pediatric cannabidiol prescribing in the United States.World journal of pediatrics : WJP · 2026Article
- A Quantitative Review of Un-licensed and Off-label Medicines Use in Children Aged 0-2 Years in the Private Sector in South Africa: Extent, Challenges, and Implications.Current pediatric reviews · 2026Article
- Beyond the label: ethical and clinical implications of off-label drug use in pediatric emergency care.Italian journal of pediatrics · 2025Review
- A review on the role of extrapolation as basis for paediatric marketing authorization applications of medicines in the EU.British journal of clinical pharmacology · 2025Review
- Off-label drug use in palliative medicine: Delphi study for the consensus of evidence-based treatment recommendations.Palliative medicine · 2025Article
- Hoping Against Hope: Ethical Considerations when Trying Unproven Treatments for Seriously Ill Children.Asian bioethics review · 2025Article
- Off-Label Treatment in Inflammatory Skin Diseases-European Point of View.Journal of clinical medicine · 2025Review
- LEVERAGING UNSTRUCTURED DATA IN ELECTRONIC HEALTH RECORDS TO DETECT ADVERSE EVENTS FROM PEDIATRIC DRUG USE - A SCOPING REVIEW.medRxiv : the preprint server for health sciences · 2025Article
- Exploring Manipulated Prescribed Medicines for Novel Leads in 3D Printed Personalized Dosage Forms.Pharmaceutics · 2025Article
- Antipsychotic prescribing: national findings of children and adolescents attending mental health services in Ireland.European child & adolescent psychiatry · 2024Article
- Off-Label Pediatric Medication Prescribing and Dispensing: Awareness and Attitudes among Community Pharmacists: A Questionnaire-Based Study.Pharmacy (Basel, Switzerland) · 2024Article
- The implementation of the guideline for the management of pediatric off-label use of drugs in China: a cross-sectional study.Translational pediatrics · 2024Article
- Age-related off-label drug prescribing in pediatric patients in South Korea and consistency of labeling compared to the United States, Europe, and Japan.Clinical and translational science · 2024Article
- Machine Learning: A Potential Therapeutic Tool to Facilitate Neonatal Therapeutic Decision Making.Paediatric drugs · 2024Review
- Paediatric off-label use of drugs in Gansu, China: a multicentre cross-sectional study.BMJ open · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the past two decades, many legislative and regulatory initiatives were taken globally to improve drug use in children. However, children are still found to be prescribed with off-label drugs. This study was conducted to provide an overview of the worldwide trend in off-label prescribing in children from the year 1996 to 2016. DATA SOURCES: The articles published in PubMed, MEDLINE and Google Scholar were searched using text words: off-label, unlicensed, paediatric and children. Additional articles were identified by reviewing the bibliography of the retrieved articles. Full-text articles published in English which reported on the prevalence of off-label prescribing in children between January 1996 and December 2016 were included.
resultsA total of 101 studies met the inclusion criteria. Off-label prescribing definition included four main categories: age, indication, dose and route of administration. The three most common reference sources used in the studies were summary of product characteristics, national formularies and package inserts. Overall, the off-label prescribing rates in children ranged from 1.2 to 99.7%. The most common category of off-label prescribing in children was dose and age.
conclusionsThis review highlighted that off-label prescribing in children was found to be highly prevalent throughout the past two decades, persistently in the neonatal intensive care units. This suggests that besides legislative and regulatory initiatives, behavioural, knowledge aspects and efforts to integrate evidence into practice related to off-label prescribing also need to be evaluated and consolidated as part of the concerted efforts to narrow the gaps in prescribing for children.
Indexed as
Identifiers
30218415What 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.