Document Detail

Off-label drug use in children.
MedLine Citation:
PMID:  18810340     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine the extent and nature of off-label drug use in children admitted to a pediatric general ward in a tertiary health care centre METHODS: Consecutive patients aged 1 mo-12 years admitted to the general wards in a tertiary care center in Mumbai over a two-month period were prospectively enrolled in the study. British National Formulary [BNF] version 2005 was used to ascertain if the drug use was "off-label". The off-label use was categorized as: administration of a greater/lesser dose, administration at a higher/lower frequency than indicated, administration for indications not described, administration of a drug not licensed for use in that age group and/ or use of alternative routes of administration. Descriptive statistics was used for calculating the off-label drug use. RESULTS: Two thousand prescriptions received by 600 subjects (M:F= 1.47:1) were analyzed. One thousand and forty-five (50.62%) prescriptions were off-label. The off-label drug use rate was 1.74+/-1.56 per patient. The maximum rate of off-label drugs was in infants (2.33/patient). 'alteration in dosage' was by far the commonest reason for off-label use; followed by 'age' and 'indication'. Furosemide (i. v.), diazepam (i.v), cefotaxime (i.v), ethambutol (tab) and prednisolone (tab) were the five commonest off-label drugs used in the study population. CONCLUSIONS: Off-label drug use was highly prevalent in general pediatric ward of a tertiary care hospital in India.
Surabhi S Jain; S B Bavdekar; Nithya J Gogtay; Pranjali A Sadawarte
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-09-22
Journal Detail:
Title:  Indian journal of pediatrics     Volume:  75     ISSN:  0973-7693     ISO Abbreviation:  Indian J Pediatr     Publication Date:  2008 Nov 
Date Detail:
Created Date:  2009-01-09     Completed Date:  2009-02-09     Revised Date:  2009-07-15    
Medline Journal Info:
Nlm Unique ID:  0417442     Medline TA:  Indian J Pediatr     Country:  India    
Other Details:
Languages:  eng     Pagination:  1133-6     Citation Subset:  IM    
Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India.
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MeSH Terms
Child, Preschool
Drug Labeling*
Drug Prescriptions / standards*,  statistics & numerical data
Drug Utilization / standards*,  statistics & numerical data
Drug Utilization Review / standards*
Formularies, Hospital
Hospital Bed Capacity, under 100
Infant, Newborn
Pharmaceutical Preparations
Physician's Practice Patterns / statistics & numerical data
Prospective Studies
Reg. No./Substance:
0/Pharmaceutical Preparations

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