ArticleEuropean journal of clinical pharmacology2012
Unlicensed and off-label drug use in hospitalized children in Croatia: a cross-sectional survey.
Article in European journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 2 of them syntheses that pooled it.
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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
20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- Association between histamine-2 receptor antagonists and adverse outcomes in neonates: A systematic review and meta-analysis.PloS one · 2019Pooled it
- Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review.European journal of clinical pharmacology · 2015Pooled it
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Effect of proton pump inhibitors in infants with esophageal atresia on the gut microbiome: a pilot cohort.Gut pathogens · 2022Article
- Extent, reasons and consequences of off-labeled and unlicensed drug prescription in hospitalized children: a narrative review.World journal of pediatrics : WJP · 2021Review
- Drug Utilisation and Off-Label Use on a German Neonatal Intensive Care Unit: A Retrospective Cohort Study and 10-Year Comparison.Pharmacy (Basel, Switzerland) · 2020Article
- Off-label and unlicensed drug use in Ayder comprehensive specialized hospital neonatal intensive care unit.Italian journal of pediatrics · 2020Article
- 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
- Evaluation of antibiotic prescriptions and use in under-five children in Ibadan, SouthWestern Nigeria.African health sciences · 2018Article
- 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
- Use of ranitidine is associated with infections in newborns hospitalized in a neonatal intensive care unit: a cohort study.BMC infectious diseases · 2017Article
- Off-label use of antimicrobials in neonates in a tertiary children's hospital.European journal of clinical pharmacology · 2017Article
- Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study.European journal of clinical pharmacology · 2016Article
- Off-label and unlicensed utilisation of medicines in a French paediatric hospital.International journal of clinical pharmacy · 2015Article
- Clinical setting influences off-label and unlicensed prescribing in a paediatric teaching hospital.PloS one · 2015Article
- Off-label prescribing for allergic diseases in children.The World Allergy Organization journal · 2014Article
- 10-year trend in quantity and quality of pediatric randomized controlled trials published in mainland China: 2002-2011.BMC pediatrics · 2013Article
- Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aim of this study was to determine the prevalence and pattern of unlicensed and off-label drugs prescribed to hospitalized children at the Department of Paediatrics, University Hospital Rijeka, Croatia.
methodsA prospective cross-sectional study was performed on 1 day each month during a 12 month period and included all hospitalized children and adolescents.
resultsA total of 1,643 prescriptions for 198 different drugs were prescribed to 531 out of 691 (77%) hospitalized patients. Forty-six percent of the different drugs were prescribed in an unlicensed or off-label manner. Of all drug prescriptions, 25% were either unlicensed or off-label. Forty-eight percent of the patients received either an unlicensed or off-label drug. The most frequently prescribed off-label drugs were proton pump inhibitors.
conclusionUnlicensed and off-label drug use is common. It is not illegal and may be clinically appropriate but is associated with a number of clinical, safety, and ethical issues. Regulatory authorities should use existing clinical evidence on the use of off-label and unlicensed drugs in decision making. Marketing authorization holders and national regulatory authorities should monitor for any safety concerns associated with unlicensed and off-label drug use and take appropriate measures as well as identify research priorities and mandate clinical studies to resolve important questions.
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Registered trials
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