ArticleInternational journal of clinical pharmacy2015
Off-label and unlicensed utilisation of medicines in a French paediatric hospital.
Article in International journal of clinical pharmacy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 30 citations in OpenAlex.
- 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
- Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications.Therapeutic advances in drug safety · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data.Healthcare (Basel, Switzerland) · 2024Article
- How to handle off-label prescriptions of rupatadine, a second-generation antihistamine and PAF antagonist: a review.Drugs in context · 2024Review
- Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval.BMC pediatrics · 2022Observational
- Off-Label Drug Use in Pediatric Out-Patient Care: A Multi-Center Observational Study.Hospital pharmacy · 2021Article
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- Supporting patients with unlicensed medicine use: Analysing the script schemas for prescribing, pharmaceutical assessment and supply.Exploratory research in clinical and social pharmacy · 2021Article
- Off-label antibiotic use among paediatric in-patients: a mixed-method prospective study at a tertiary hospital in southwestern Uganda.International journal of clinical pharmacy · 2021Article
- Cross-sectional survey of off-label and unlicensed prescribing for inpatients at a paediatric teaching hospital in Western Australia.PloS one · 2019Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.The Journal of the Oklahoma State Medical Association · 2018Article
- Safety and Efficacy of Off-label and Unlicensed Medicines in Children.Journal of Korean medical science · 2018Article
- Off-label and unlicensed medicines to hospitalised children in Norway.The Journal of pharmacy and pharmacology · 2017Article
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOff-label or unlicensed medicine use is very common in paediatric practice, ranging from 11 to 80 %, and is one of the predisposing factors for adverse events (23-60 %). Medicine indications are the third leading reason for doctors to perform off-label prescriptions.
objectiveThe aim of our study was to determine the prevalence and nature of off-label and unlicensed medicine prescriptions in children and propose methods for risk reduction and management.
setting475 bed maternity-paediatric university hospital.
methodRetrospective cross-sectional study lasting 1 day on new prescriptions issued over the previous 24 h by departments using electronic prescribing. Age and indication were compared to those in the French independent formulary Thériaque(®) database.
main outcome measureNumber of off-label/unlicensed prescriptions, number of patients, proportion of off-label/unlicensed prescriptions by age group, treatment class and International Non proprietary Name (INN), using the established classification.
resultsA total of 315 prescription medicines were analysed for 120 patients, of average age 5.1 years old. For the classification of medicine utilisation, the majority of the medicines were prescribed as licensed (190/60.3 %), followed by off-label (115/36.5 %) and unlicensed (10/3.2 %) medicines. Alimentary tract, metabolic and nervous system medicines constituted the most widely prescribed ATC classes. At least 54 % of patients received an off-label/unlicensed medicine. The indications for these were mainly for off-label prescriptions (80/25.4 %) followed by medicines not evaluated for safety and regarding safety and efficacy in children (14/4.5 %). Pantoprazole was the most widely prescribed off-label INN for stress ulcer prevention (62 %). For risk reduction, we found esomeprazole being prescribed instead of pantoprazole; esomeprazole is indicated for children under a year old.
conclusionThis study reflects one given day: 36.5 % of off-label prescriptions and 3.2 % of unlicensed prescriptions in a paediatric setting. Few risk reductions for off-label number prescriptions have been found. This work confirmed the necessity of carrying out further studies in children.
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