Document Detail

Unlicensed and off-label drug use in an Australian neonatal intensive care unit.
MedLine Citation:
PMID:  12415058     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To determine the extent of unlicensed and off-label drugs prescribed in the level 3 neonatal intensive care unit (NICU) at the Royal Women's Hospital, Melbourne, Australia. METHODS: A prospective cohort study was conducted of all infants who were admitted to the NICU during a 10-week period. Each drug prescribed was evaluated in relation to the licensed approved uses to determine whether the drug was administered in a licensed manner or was unlicensed or used in an off-label manner. RESULTS: There were a total of 101 admissions involving 97 infants. A total of 1442 prescriptions were administered; 42% were licensed, 11% were unlicensed, and 47% were off-label. Twenty-one percent were off-label for 2 or more reasons. Eighty percent of infants received either an unlicensed or an off-label prescription or both; this proportion rose to 93% of extremely low birth weight infants. CONCLUSIONS: This is the largest study performed of unlicensed and off-label drug use in the NICU. This practice remains widespread despite clear recommendations to improve this undesirable situation. The attendant risks to infants and prescribers remain. It is time for legislation to be introduced to govern this area.
Colm P F O'Donnell; Robyn J Stone; Colin J Morley
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Pediatrics     Volume:  110     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2002 Nov 
Date Detail:
Created Date:  2002-11-04     Completed Date:  2003-01-16     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e52     Citation Subset:  AIM; IM    
Neonatal Unit, Royal Women's Hospital, Victoria, Australia.
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MeSH Terms
Age Factors
Cohort Studies
Drug Approval / legislation & jurisprudence*,  statistics & numerical data
Drug Utilization Review*
Drug and Narcotic Control / legislation & jurisprudence
Drugs, Generic / therapeutic use
Infant, Newborn
Intensive Care Units, Neonatal / standards*,  statistics & numerical data
Physician's Practice Patterns
Prospective Studies
Respiratory Distress Syndrome, Newborn / drug therapy
Reg. No./Substance:
0/Drugs, Generic

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

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