Off-label drug use in children.
Indian J Pediatr
;
2008 Nov; 75(11): 1133-6
Article
in English
| IMSEAR
| ID: sea-80362
ABSTRACT
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 centreMETHODS:
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 (MF= 1.471) 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.
Full text:
Available
Index:
IMSEAR (South-East Asia)
Main subject:
Pediatrics
/
Drug Prescriptions
/
Practice Patterns, Physicians'
/
Female
/
Humans
/
Male
/
Infant, Newborn
/
Pharmaceutical Preparations
/
Child
/
Child, Preschool
Type of study:
Observational study
/
Prognostic study
Country/Region as subject:
Asia
Language:
English
Journal:
Indian J Pediatr
Year:
2008
Type:
Article
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