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Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital
Open accessAbstract
AIMS: To examine the impact of off-label and unlicensed (OLUL) prescribing on adverse drug reactions (ADRs) causing unplanned admissions to a paediatric hospital. METHODS: Prescription data from a 12 month prospective cohort study of ADRs detected in children admitted to a paediatric hospital were scrutinized. The relative risk for off-label and unlicensed medicines being implicated in an ADR was calculated. Logistic regression analyses were carried out with exposure to off-label and unlicensed medicines and number of off-label and unlicensed medicines administered as predictor variables. RESULTS: Off-label and unlicensed medicines were more likely to be implicated in an ADR than authorized medicines (relative risk 1.67, 95% CI 1.38, 2.02, P < 0.001). There was a 25% increase in ADR risk (95% CI 1.16, 1.35, P < 0.001) with each additional authorized medicine and 23% (95% CI 1.10, 1.36, P < 0.001) with each additional off-label or unlicensed medicine. Logistic regression analysis focusing on non-oncology patients demonstrated that the number of authorized medicines (odds ratio 1.33, 95% CI 1.23, 1.44, P < 0.001), but not the number of off-label and unlicensed medicine courses, was a predictor of ADR risk. CONCLUSIONS: In a heterogeneous population of children admitted to a secondary/tertiary hospital, off-label and unlicensed medicines are more likely to be implicated in an ADR than authorized medicines. This was largely driven by ADRs related to drugs used in oncological practice, where the usage of off-label or unlicensed medicines was associated with a higher ADR risk than in non-oncological areas.
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“transplanting adult evidence into children can yield sub-therapeutic dosing, diminished efficacy, or an elevated risk of adverse reactions [2-4].”
From PED-X-Bench: A Benchmark of Adult-to-Pediatric Extrapolation Decisions in FDA Drug Labels (2025) · cites this paper as [4]
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“Because growth and maturation reshape both pharmacokinetics and disease biology”
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Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes
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Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study
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Self-citationAdverse drug reactions to unlicensed and off‐label drugs on paediatric wards: a prospective study
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Self-citationAdverse drug reactions and off-label drug use in paediatric outpatients
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Self-citationThe Impact of Unlicensed and Off-Label Drug Use on Adverse Drug Reactions in Paediatric Patients
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Self-citationRisk factors for the development of adverse drug events in hospitalized patients.
van den Bemt, P. M. L. A., Egberts, T. C. G., Lenderink, A. W., Verzijl, J. M., Simons, K. A., van der Pol, W. S. C. J. M., & Leufkens, H. G. M. (2000) · Pharmacy World & Science · doi:10.1023/a:1008721321016 · Cited by 102
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- Paediatric Formulary Committee, 2008/2009, BNF for Children
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Chen, J., & Zhao, L. (2026) · Frontiers in Pediatrics · doi:10.3389/fped.2026.1803086
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Kassaw, A. T., Wondm, S. A., Mussie, D. A., Tarekegn, G. Y., Zerihun, T. E., Moges, T. A., Zewdu, W. S., Beriso, E. A., Tamene, F. B., Melese, T. B., et al. (2026) · BMJ Paediatrics Open · doi:10.1136/bmjpo-2026-004745
Off-label drug use in children: prevalence, risks, and regulation
Neubert, A. C., & Eberl, S. (2026) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2026.2742318
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Metadata
- Authors
- Bellis, J. R., Kirkham, J. J., Nunn, A. J., & Pirmohamed, M.
- Affiliations
- Alder Hey Children's NHS Foundation Trust (GB)
- University of Liverpool (GB)
- Corresponding author
- Bellis, Jennifer R.
- Venue
- British Journal of Clinical Pharmacology
- Publisher
- Wiley
- Published
- 2014-02-21
- Volume
- 77
- Issue
- 3
- Pages
- 545-553
- ISSN
- 0306-5251 (ISSN-L)
- PMC
- PMC4371534
- OpenAlex
- W1484081358
- Cited by
- 120
- References
- 17
- Citations by year
- 2026: 6 · 2025: 3 · 2024: 18 · 2023: 8 · 2022: 13 · 2021: 12 · 2020: 9 · 2019: 7 · 2018: 10 · 2017: 8 · 2016: 8 · 2015: 6 · 2014: 11
- FWCI
- 7.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- British Journal of Clinical Pharmacology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- Funders
- National Institute for Health and Care Research (NF-SI-0512-10064)
- Medical Research Council (MR/L006758/1)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
- Keywords
- adverse drug reactions, off-label drug use, unlicensed medicines, pediatric hospital admissions, emergency admissions, children, oncology drugs, drug safety, polypharmacy
- MeSH terms
- Adolescent, Child, Child, Preschool, England, Female, Hospitals, Pediatric, Humans, Infant, Infant, Newborn, Male, Patient Admission, Prospective Studies, Risk Factors, Time Factors, Chi-Square Distribution, Logistic Models, Odds Ratio, Polypharmacy, Off-Label Use, Tertiary Care Centers, Drug-Related Side Effects and Adverse Reactions
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