Off-label drug use in children.
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.
Jain
Surabhi S
SS
Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India.
Bavdekar
S B
SB
Gogtay
Nithya J
NJ
Sadawarte
Pranjali A
PA
D000328:Adult; D002648:Child; D002675:Child, Preschool; D004348:Drug Labeling; D011307:Drug Prescriptions / Q000592:standards* / Q000706:statistics & numerical data; D004363:Drug Utilization / Q000592:standards* / Q000706:statistics & numerical data; D017723:Drug Utilization Review / Q000592:standards*; D005260:Female; D005572:Formularies, Hospital as Topic; D006743:Hospital Bed Capacity, under 100; D006801:Humans; D007194:India; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010372:Pediatrics; D004364:Pharmaceutical Preparations; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D011446:Prospective Studies
D004364:Pharmaceutical Preparations