Abstract
Objective: To determine the proportion of unlicensed &/or off-label prescriptions in paediatric
patients.
Patients & Methods; This prospective study of drugs administered to children in two
paediatric hospital (ib-A!theer, A!-Kanasaa hospital for pediatrics in mosul city, over 6 months
from 1st Nov. 2007 to 1st May 2008. One hundred-forty children were included in this study
aged from at birth to 6 years admitted to paediatric medical wards. Drug-licensing status of all
prescriptions given to these patients was determined.
Results: Of the 1208 prescription given to these children, more than half of all prescriptions
626 (51 ,8%) were unlicensed or off-label. Where as 582 (48.2%) licensed. The most common
category of off-label use 365 (30.2%) was related to age 217 (17.9%), the other off-label uses
were related to dose and frequency of administration 77 (6.4%), indication 55 (4.6%) and
route of administration 16 (1.3%) and the most common reason of unlicensed preparation
was the administration of preparation not licensed for use at all.
Conclusion: The use of unlicensed or off- label medicines to treat children was found to be
common in paediatric patients, this problem is Widespread in peadiatric wards &the clinical
