ArticleBritish journal of clinical pharmacology2014
Adverse drug reactions and off-label and unlicensed medicines in children: a prospective cohort study of unplanned admissions to a paediatric hospital.
Article in British journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses 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
50 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The epidemiology of drug-related hospital admissions in paediatrics - a systematic review.Archives of public health = Archives belges de sante publique · 2024Pooled it
- [Pediatric perioperative systemic pain therapy: Austrian interdisciplinary recommendations on pediatric perioperative pain management].Schmerz (Berlin, Germany) · 2014Guideline
- A Complex Intervention to Prevent Medication-Related Hospital Admissions.Deutsches Arzteblatt international · 2023Trial
- Polypharmacy and adverse drug reactions among hospitalised children: determinants and clinical and economic impact in a multicentre prospective cohort and nested matched case-control study in Northwest Ethiopia.BMJ paediatrics open · 2026Article
- [Evidence-based drug information for children and adolescents in Germany-Are we moving in the right direction?]Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026Article
- Risk of drug-related aggression in pediatric populations: a pharmacovigilance analysis using the FAERS database.Frontiers in pediatrics · 2026Article
- Off-label prescribing in ophthalmology: a retrospective analysis.Frontiers in pharmacology · 2026Article
- Evaluation of healthcare professionals' experiences of taking telephone calls from parents of children with congenital heart disease. A risky business.Journal of child health care : for professionals working with children in the hospital and community · 2025Article
- Article
- Analysis of off-label drug use and its influencing factors in pediatric patients undergoing otolaryngology, head, and neck surgery.Frontiers in pharmacology · 2025Article
- [Off-label use of intravenous immunoglobulin g in a highly complex pediatric hospital in Argentina. A prospective observational study]Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina) · 2024Observational
- Paediatric Rheumatology Fails to Meet Current Benchmarks, a Call for Health Equity for Children Living with Juvenile Idiopathic Arthritis, Using Digital Health Technologies.Current rheumatology reports · 2024Review
- Authorized or Off-Label Use? A Structured Analysis of Summaries of Product Characteristics with Regard to Authorization in Pediatrics.Pharmaceutical medicine · 2024Article
- A narrative review on adverse drug reactions of COVID-19 treatments on the kidney.Open medicine (Warsaw, Poland) · 2024Review
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Medical treatment in infants and young children with epilepsy: Off-label use of antiseizure medications. Survey Report of ILAE Task Force Medical Therapies in Children.Epilepsia open · 2023Article
- c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.British journal of clinical pharmacology · 2022Review
- Off-Label, but on-Evidence? A Review of the Level of Evidence for Pediatric Pharmacotherapy.Clinical pharmacology and therapeutics · 2022Review
- [Practical limitations of medical clarification and informed consent in the context of drug therapy].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2022Article
- Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children.Paediatric and perinatal epidemiology · 2022Article
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
aimsTo examine the impact of off-label and unlicensed (OLUL) prescribing on adverse drug reactions (ADRs) causing unplanned admissions to a paediatric hospital.
methodsPrescription 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.
resultsOff-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.
conclusionsIn 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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