Pharmacoepidemiological assessment of off-label drug use in pediatric ambulatory departments at four tertiary care hospitals in Pakistan

Abstract

Purpose: To assess the frequency and possible predictors of off-label drug use in ambulatory pediatric units of four tertiary healthcare institutions in a Pakistani city. Methods: A prospective study was conducted at the pediatric ambulatory department of four tertiary care hospitals of Peshawar, Pakistan. A total 1589 patients were included in the study which to evaluate their prescriptions for off-label drug use with the aid of Thomson Healthcare Micromedex DRUGDEX database. Results: A total of 79 different drugs were prescribed 5668 times to pediatric patients. A high rate of offlabel drug use (71.8 %) was observed in this study. Compared to corresponding reference categories, infants (OR 4.134, 95 % CI 2.076-8.235) and children (OR 1.857, 95 % CI 0.967-3.568) were more likely to receive off-label prescriptions. However, pediatric patients receiving less than four drugs (OR 0.414, 95 % CI 0.312-0.548) were less likely to receive off-label prescriptions. Conclusion: A high incidence of off-label drug use has been observed in the ambulatory pediatric population studied, especially in infants. More research is needed to identify and evaluate the contributory factors to off-label use of drugs in ambulatory pediatric population in developing countries to achieve optimal drug therapy for pediatrics.