ArticlePloS one2018
Use of off-label and unlicensed medicines in neonatal intensive care.
Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 2 of them syntheses that pooled it.
What it found
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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
51 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Assessment of Piperacillin-Tazobactam Population Pharmacokinetic Models in Neonates: An External Validation.European journal of drug metabolism and pharmacokinetics · 2025Pooled it
- Guideline for the management of pediatric off-label use of drugs in China (2021).BMC pediatrics · 2022Guideline
- Value-based neonatology (VBN): a new ethical paradigm for newborn care.European journal of pediatrics · 2026Review
- Off-Label Medication Use in a Serbian Neonatal Intensive Care Unit: A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- [Evidence-based drug information for children and adolescents in Germany-Are we moving in the right direction?]Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz · 2026Article
- Physiologically-Based Pharmacokinetic Modeling to Support Pediatric Clinical Development: An IQ Working Group Perspective on the Current Status and Challenges.CPT: pharmacometrics & systems pharmacology · 2026Review
- Catecholamines and serum potassium alterations in critically ill neonates: a prospective cohort study.Critical care science · 2026Article
- Machine learning prediction of pediatric adverse drug reactions using consensus-derived scarce data.Communications chemistry · 2025Article
- Updates on neonatal cell and novel therapeutics: Proceedings of the Second Neonatal Cell Therapies Symposium (2024).Pediatric research · 2025Article
- Personalized Neonatal Therapy: Application of Magistral Formulas in Therapeutic Orphan Populations.Pharmaceutics · 2025Review
- Rare Disease Drug Repurposing.JAMA network open · 2025Article
- Visceral Pain in Preterm Infants with Necrotizing Enterocolitis: Underlying Mechanisms and Implications for Treatment.Paediatric drugs · 2025Review
- Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches.Trials · 2025Article
- Off‑label and unapproved pediatric drug utilization: A meta‑analysis.Experimental and therapeutic medicine · 2024Article
- Reply to Garnemark et al. The Swedish National Formulary for Children ePed. Comment on "Shaniv et al. A Callout for International Collaboration. Reply to Giger, E.V.; Tilen, R. Comment on "Shaniv et al. Neonatal Drug Formularies-A Global Scope.Children (Basel, Switzerland) · 2024Article
- The Swedish National Formulary for Children ePed. Comment on Shaniv et al. A Callout for International Collaboration. Reply to Giger, E.V.; Tilen, R. Comment on "Shaniv et al. Neonatal Drug Formularies-A Global Scope.Children (Basel, Switzerland) · 2024Article
- Therapeutic potential of extracellular vesicles derived from human amniotic epithelial cells for perinatal cerebral and pulmonary injury.Stem cells translational medicine · 2024Review
- Article
- 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
- Grading the level of evidence of neonatal pharmacotherapy: midazolam and phenobarbital as examples.Pediatric research · 2024Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the use of off-label and unlicensed medicines in a neonatal intensive care unit (NICU) of a teaching maternity hospital specialized in high risk pregnancy.
methodsA prospective cohort study was conducted between August 2015 and July 2016. All newborns admitted to the NICU who had at least one medication prescribed and a hospital stay longer than 24 hours were included. The classification of off-label and unlicensed drugs for the neonatal population was done according to the information of Food and Drug Administration.
resultsA total of 17421 medication items were analyzed in 3935 prescriptions of 220 newborns. The proportion of newborns exposed to off-label drugs was 96.4%, and to unlicensed medicines was 66.8%. About one-half (49.3%) of the medication items were off-label and 24.6% were unlicensed. The main reason for off-label and unlicensed classification was, respectively, frequency of administration and the administration of adaptations of pharmaceutical forms.
conclusionsAlthough there are actions to encourage the development of pharmacological studies with neonates, this study observed a high rate of prescription and exposure of newborns to off-label and unlicensed drugs in NICUs and pointed out areas of neonatal therapy that require scientific investment.
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Registered trials
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