Off-label drug use in children

  • Surabhi S. Jain
  • S. B. Bavdekar
  • Nithya J. Gogtay
  • Pranjali A. Sadawarte
Original Article



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

Key words

Licensing Drug use Pediatrics Hospital-based Survey 


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Copyright information

© Dr. K C Chaudhuri Foundation 2008

Authors and Affiliations

  • Surabhi S. Jain
    • 1
  • S. B. Bavdekar
    • 1
    • 3
  • Nithya J. Gogtay
    • 2
  • Pranjali A. Sadawarte
    • 1
  1. 1.Department of PediatricsSeth GS Medical College and KEM HospitalParel, MumbaiIndia
  2. 2.Department of Clinical PharmacologySeth GS Medical College and KEM HospitalParel, MumbaiIndia
  3. 3.Worli, MumbaiIndia

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