title: Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications.
abstract: OBJECTIVE
  To study the current patterns of medication use, assess the extent of off-label parenteral medication use, and evaluate evidence for efficacy and safety of parenteral medications used off-label in neonates.
  
  
  METHODS
  We collected information on all medications dispensed for infants admitted to an urban tertiary care neonatal intensive care unit over a 3-year period. Parenteral drugs were reviewed for off-label use, and medications not approved for use in neonates were evaluated for evidence of efficacy and safety in neonates.
  
  
  RESULTS
  The ranges of gestational age, length of stay, and number of medications per infant were 23 to 42 weeks, 1 to 190 days, and 1 to 62, respectively, for 2304 admissions during the study period. Infants with lower birth weight and shorter gestational age received more medications compared with more mature infants. Of 61 parenteral medications evaluated, 27 (45%) were used off-label in neonates. Food and Drug Administration (FDA) approval for use in neonatal period was highest for antibiotics (14/16); the parenteral medications most frequently used off-label were analgesics, vasopressors, and hematologic agents.
  
  
  CONCLUSIONS
  Critically ill neonates are exposed to numerous medications, a significant proportion of which are not yet FDA-approved for use in this vulnerable group of patients.
authors.affiliation: Department of Pediatrics, Northwestern Memorial Hospital and Children's Memorial Hospital, Chicago, IL, USA.
authors.forename: Praveen
authors.initials: P
authors.lastname: Kumar
authors.forename: Jennifer K
authors.initials: JK
authors.lastname: Walker
authors.forename: Kristin M
authors.initials: KM
authors.lastname: Hurt
authors.forename: Kimberly M
authors.initials: KM
authors.lastname: Bennett
authors.forename: Neal
authors.initials: N
authors.lastname: Grosshans
authors.forename: Michael A
authors.initials: MA
authors.lastname: Fotis
mesh_terms: D015331:Cohort Studies; D017277:Drug Approval; D004348:Drug Labeling; D004363:Drug Utilization; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D007363:Intensive Care Units, Neonatal; D008297:Male; D017063:Outcome Assessment, Health Care; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010818:Practice Patterns, Physicians'; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations