A Prospective Study of on-Label and off-Label Drug use in Paediatrics at Tertiary Care Hospital

Abstract

The study to be undertaken with an aim of investigation of incidence and pattern of off-label drug use, to identify drugs most commonly used as off-label, and to identify factors associated with off-label drug use in Indian paediatrics population at tertiary care hospital.This study was conducted in Inpatient Paediatrics Department of S.N.Medical College and H.S.K Hospital and Research Centre, Bagalkot. According to age group, use of licensed and unlicensed medication out of 1205 medications, 851 are licensed medications of which 415 (34.43%) were used for neonates, 308(25.56%) infants, 100 (8.29%) young child, 28 (2.32%) child. 16 are unlicensed medications of which 4 (0.33%) were used for neonates, 5 (0.41%) infants, 6 (0.49%) young child & 1 (0.08%) child.  338 are off-labelled medications out of this 124 (10.29%) were neonates, 173 (14.35%) were infants, 30 (2.48%) were young child, and 11 (0.91%) are child.The beneficial effects of studying off-label drugs that are being prescribed to children include important dose changes, frequency, as well as improved safety information on how to more appropriately prescribe these drugs for the paediatric population.