ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
Unlicensed and Off-Label Drug Use in Children Before and After Pediatric Governmental Initiatives.
Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Prevalence of Dose Errors Among Paediatric Patients in Hospital Wards with and without Health Information Technology: A Systematic Review and Meta-Analysis.Drug safety · 2019Pooled it
- Off-Label Manipulation of Paediatric Medication Remains a Challenge in Clinical Practice: An Observational Study.Acta paediatrica (Oslo, Norway : 1992) · 2026Observational
- 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
- Off-label use of medicines in South Africa: a review.Orphanet journal of rare diseases · 2024Review
- 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
- Prevalence of inappropriate antibiotic doses among pediatric patients of inpatient, outpatient, and emergency care units in Bangladesh: A cross-sectional study.PLOS global public health · 2024Article
- Off-Label and Unlicenced Medicine Use among Hospitalised Children in South Africa: Practice and Policy Implications.Pharmacy (Basel, Switzerland) · 2023Article
- 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.International journal of clinical pharmacy · 2022Review
- Adjusting the dose in paediatric care: dispersing four different aspirin tablets and taking a proportion.European journal of hospital pharmacy : science and practice · 2021Article
- Association of Selective Serotonin Reuptake Inhibitors With the Risk of Type 2 Diabetes in Children and Adolescents.JAMA psychiatry · 2021Article
- Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems.Therapeutics and clinical risk management · 2021Article
- Biological and Clinical Changes in a Pediatric Series Treated with Off-Label JAK Inhibitors.International journal of molecular sciences · 2020Article
- International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States.Clinical pharmacology and therapeutics · 2020Article
- High prevalence of off-label and unlicensed paediatric prescribing in a hospital in Indonesia during the period Aug.-Oct. 2014.PloS one · 2020Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Review
- Unlicensed and off-label use of drugs in pediatric surgical units at tertiary care hospitals of Pakistan.International journal of clinical pharmacy · 2017Observational
- In the Real-World, Kids Use Medications and Devices.Drugs - real world outcomes · 2017Article
- Off-label and unlicensed medicines to hospitalised children in Norway.The Journal of pharmacy and pharmacology · 2017Article
- Oral drug absorption in pediatrics: the intestinal wall, its developmental changes and current tools for predictions.Biopharmaceutics & drug disposition · 2017Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesGovernmental agencies (US Food and Drug Administration and European Medicines Agency) implemented initiatives to improve pediatric clinical research, starting in 1997 and 2007, respectively. The aim of this review was to quantify the unlicensed and off-label drug uses in children before and after these implementations.
methodsLiterature review of unlicensed and off-label drug uses was performed on PubMed and Google-Scholar from 1985 to 2014. Relevant titles/abstracts were reviewed, and articles were included if evaluating unlicensed/off-label drug uses, with a clear description of health care setting and studied population. Included articles were divided into 3 groups: studies conducted in United States (before/after 2007), in Europe (before/after 2007), and in other countries.
resultsOf the 48 articles reviewed, 27 were included. Before implementation of pediatric initiatives, global unlicensed drug use rate in Europe was found to be 0.2% to 36% for inpatients and 0.3% to 16.6% for outpatients. After implementation, it marginally decreased to 11.4% and 1.26% to 6.7%, respectively. Concerning off-label drug use rates, it was found to be 18% to 66% for inpatients and 10.5% to 37.5% for outpatients before the implementation. After implementation, it decreased marginally to 33.2% to 46.5% and to 3.3% to 13.5%, respectively. In other countries, unlicensed and off-label drug use rates were found to be, respectively, 8% to 27.3% and 11% to 47%.
conclusionsGovernmental initiatives to improve clinical research conducted in children seem to have had a marginal effect to decrease the unlicensed and off-label drug uses prevalence in Europe.
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What 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.