ArticleArchives of disease in childhood2000
Off label and unlicensed drug use among French office based paediatricians.
Article in Archives of disease in childhood, 2000. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 2 of them syntheses that pooled it.
What it found
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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
56 citing papers in PubMed, 2 syntheses or guidelines pooled it, 167 citations in OpenAlex.
- Parental awareness, attitudes and decision-making of off-label use in children: a systematic review and meta-analysis.BMJ paediatrics open · 2026Pooled it
- Acetylcysteine and carbocysteine for acute upper and lower respiratory tract infections in paediatric patients without chronic broncho-pulmonary disease.The Cochrane database of systematic reviews · 2013Pooled it
- Younger Children with Respiratory Tract Infections Are More Exposed to Off-Label Treatments: An Exploratory Retrospective Study in a Pediatric Emergency Setting.Children (Basel, Switzerland) · 2024Article
- Potentially Harmful Excipients: State of the Art for Oral Liquid Forms Used in Neonatology and Pediatrics Units.Pharmaceutics · 2024Article
- Unlicensed/Off-Label Drug Prescriptions at Hospital Discharge in Children: An Observational Study Using Routinely Collected Health Data.Healthcare (Basel, Switzerland) · 2024Article
- Off-label medications in the treatment of hospitalized children with atopic dermatitis.Postepy dermatologii i alergologii · 2023Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
- Hospital pharmacists' perceived beliefs and responsibilities in indication-based off-label prescribing.International journal of clinical pharmacy · 2018Article
- Do Paediatric Investigation Plans (PIPs) Advance Paediatric Healthcare?Paediatric drugs · 2017Article
- Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.PloS one · 2017Article
- Off-label and unlicensed utilisation of medicines in a French paediatric hospital.International journal of clinical pharmacy · 2015Article
- Respiratory drugs prescribed off-label among children in the outpatient clinics of a hospital in Malaysia.International journal of clinical pharmacy · 2015Article
- Ethical and legal framework and regulation for off-label use: European perspective.Therapeutics and clinical risk management · 2014Review
- Off-label medicine use in children and adolescents: results of a population-based study in Germany.BMC public health · 2013Article
- Article
- Search strategies to identify reports on "off-label" drug use in EMBASE.BMC medical research methodology · 2012Article
- Population pharmacokinetic analysis during the first 2 years of life: an overview.Clinical pharmacokinetics · 2012Review
- Off-label and unlicensed drug use in neonatal intensive care units in Turkey: the old-inn study.International journal of clinical pharmacy · 2012Article
- Licensing and labelling of drugs in a paediatric oncology ward.British journal of clinical pharmacology · 2011Article
- Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine.International journal of clinical pharmacy · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo determine the extent of off label and unlicensed drug use in French office based paediatric practice.
methodsA prospective one day survey of all written prescriptions, for patients under 15 years, among 95 office based paediatricians in the Paris, France metropolitan area. Main outcome measures were: comparison of the use of each drug with its product licence for age, indication, dose, and route of administration.
resultsA total of 2522 prescriptions were administered to 989 patients; 844 (33%) were used either in an unlicensed (4%) or an off label (29%) manner. A total of 550 (56%) paediatric patients received one or more off label prescriptions.
conclusionsOff label prescriptions (that is, outside the terms of the Summary of Product Characteristics) are widespread in office based paediatric practice, while unlicensed drug use is rare in our study. New regulations in the licensing process in Europe are needed to allow children to receive drugs that have been fully evaluated in their specific age group.
Indexed as
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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.