ArticleThe journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG
Patterns of Off-Label Prescribing in the Pediatric Intensive Care Unit and Prioritizing Future Research.
Article in The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed, 43 citations in OpenAlex.
- Promises, Pitfalls, and Paths Forward for the Pediatric Research Equity Act.JAMA health forum · 2026Article
- Pediatric studies and labeling additions required by the U.S. FDA for novel drugs approved from 2011 to 2023: A retrospective cohort study.PLoS medicine · 2025Article
- Identifying Pediatric Drug Safety Knowledge Gaps: An Integrated Approach Leveraging Real-World Data, a Biomedical Knowledge Base, and Postmarketing Surveillance Data.Pharmacotherapy · 2025Article
- Pediatric-Specific Drug Loss Issue in Japan: Comparison of Pediatric Development Status Between Japan and the United States.Therapeutic innovation & regulatory science · 2025Article
- Off-Label Prescribing in Pediatric Population-Literature Review for 2012-2022.Pharmaceutics · 2023Review
- Prothrombin Complex Concentrate Utilization in Children's Hospitals.Journal of pediatric intensive care · 2023Article
- Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative.Healthcare policy = Politiques de sante · 2023Article
- The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics.Pharmacotherapy · 2023Review
- Update on Therapeutic Drug Monitoring of Beta-Lactam Antibiotics in Critically Ill Patients-A Narrative Review.Antibiotics (Basel, Switzerland) · 2023Review
- Prescribed medicine use and extent of off-label use according to age in a nationwide sample of Australian children.Paediatric and perinatal epidemiology · 2022Article
- Regulating pediatric off-label uses of medicines in the EU and USA: challenges and potential solutions : Comparative regulation framework of off label prescriptions in pediatrics: a review.International journal of clinical pharmacy · 2022Review
- Methylnaltrexone in the Management of Opioid-Associated Urinary Retention in Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Evidence of support used for drug treatments in pediatric cardiology.Health science reports · 2021Article
- Optimizing the Use of Antibiotic Agents in the Pediatric Intensive Care Unit: A Narrative Review.Paediatric drugs · 2021Review
- Medications for Children Receiving Intensive Care: A National Sample.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2020Article
- Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents.Journal of clinical pharmacology · 2019Article
- Paediatric extrapolation: A necessary paradigm shift.British journal of clinical pharmacology · 2019Review
- Serious Adverse Events Associated with Off-Label Use of Azithromycin or Fentanyl in Children in Intensive Care Units: A Retrospective Chart Review.Paediatric drugs · 2019Article
- Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.JAMA pediatrics · 2019Article
- Two decades of off-label prescribing in children: a literature review.World journal of pediatrics : WJP · 2018Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo characterize off-label prescribing among US pediatric intensive care units (PICUs), determine characteristics associated with off-label use, and identify medications in highest need for additional study.
methodsMedications prescribed for ≥1% PICU patients (age < 18 years) in 2010 were identified from 39 children's hospitals. Use in a patient younger than the Food and Drug Administration (FDA)-approved age for any indication was considered off-label. Hierarchical multivariable modeling was used to identify characteristics associated with off-label use, accounting for center effects. Highest-impact drugs were defined by: 1) high off-label use (off-label use in at least 5% of the PICU cohort), 2) high risk medication, and 3) high priority status by the FDA or Best Pharmaceuticals for Children Act (BPCA).
resultsA total of 66,896 patients received ≥1 medication of interest (n = 162) during their PICU stay. A median of 3 (interquartile range, 2-6) unique drugs per patient were used off-label. Those who received ≥1 drug off-label (85% of the cohort) had longer median PICU (2 days vs 1 day) and hospital (6 days vs 3 days) lengths of stay and higher mortality (3.6% vs 0.7%), p < 0.001. Factors independently associated with off-label drug use included: age 1 to 5 years, chronic conditions, acute organ failures, mechanical ventilation, arterial or venous catheters, dialysis, and blood products. Half of prescribed medications (n = 84) had been used off-label: 26 with significant off-label use, 30 high-risk medications, and 47 with high FDA/BPCA priority. The highest impact medications identified were: dexmedetomidine, dopamine, hydromorphone, ketamine, lorazepam, methadone, milrinone, and oxycodone.
conclusionsMost PICU patients are exposed to off-label medication use, with uncertain evidence. Future medication research in this population should focus on medications with high impact potential.
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