Off-label drug use in children
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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
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.
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.
Off-label drug use was highly prevalent in general pediatric ward of a tertiary care hospital in India
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- Off-label drug use in children
The Indian Journal of Pediatrics
Volume 75, Issue 11 , pp 1133-1136
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- Drug use
- Hospital-based Survey
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- Author Affiliations
- 1. Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India
- 3. 9, A2 Worli Seaside CHS, Pujari Nagar, KAG Khan Road, Worli, Mumbai, 400018, India
- 2. Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India