Use of off-label and unlicensed drugs in pediatric patients: A longitudinal prevalence survey from Lahore, Pakistan.

Purpose: To assess the extent of use of unlicensed/off-label drug in the children hospitalized in The Children’s Hospital and Institute of Child Health, Lahore, Pakistan. Methods: A prospective prevalence study was carried out in the selected hospital. A total of 1946 pediatric patients were hospitalized during study period. The patients’ demographic data and unlicensed/off-label drug use were noted by the researcher using a structured questionnaire and then analyzed. Results: During the survey period, 102 (5.24 %) pediatric patients received at least one off-label drug/unlicensed drug. The unlicensed drug was administered to 65 patients (63.7 %) while off-label drug was administered to 37 patients (36.3%). Milrinone (23.5%) was the most frequently prescribed unlicensed drug. Conclusion: The administration of unlicensed/off-label drug to treat different diseases in pediatric population is widespread in the health facility studied. These findings will provide guidance to new researchers in clinical trials, especially on cardiovascular drugs, opioid analgesic, antiemetic and anticancer drugs. [ABSTRACT FROM AUTHOR]