Document Detail


Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications.
MedLine Citation:
PMID:  18280851     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: 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. STUDY DESIGN: 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:
Praveen Kumar; Jennifer K Walker; Kristin M Hurt; Kimberly M Bennett; Neal Grosshans; Michael A Fotis
Publication Detail:
Type:  Journal Article     Date:  2007-10-22
Journal Detail:
Title:  The Journal of pediatrics     Volume:  152     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2008 Mar 
Date Detail:
Created Date:  2008-02-18     Completed Date:  2008-03-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  412-5     Citation Subset:  AIM; IM    
Affiliation:
Department of Pediatrics, Northwestern Memorial Hospital and Children's Memorial Hospital, Chicago, IL, USA.
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MeSH Terms
Descriptor/Qualifier:
Cohort Studies
Drug Approval*
Drug Labeling*
Drug Utilization
Female
Humans
Infant, Newborn
Infusions, Intravenous
Intensive Care Units, Neonatal*
Male
Outcome Assessment (Health Care)
Pharmaceutical Preparations / administration & dosage*
Physician's Practice Patterns
Registries
Retrospective Studies
Risk Assessment
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations
Comments/Corrections
Comment In:
J Pediatr. 2008 Mar;152(3):A2   [PMID:  18280822 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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