Journal of Pharmacovigilance

Analysis of off-label use of drugs among pediatric inpatients of a tertiary care teaching hospital

4^th International Conference and Exhibition on Pharmacovigilance & Clinical Trials

August 10-12, 2015 London, UK

Mangesh Bankar

Posters-Accepted Abstracts: J Pharmacovigilance

Abstract:

Introduction: Off-label use of drugs refers to use of approved drugs in a situation that is not mentioned in the product information. As considerable risks are involved to the children and the extent of ?off-label? drug use among children in India is largely unknown due to limited studies, this study was planned to determine the extent of off-label drug use in children admitted in a pediatric wards of a tertiary care teaching hospital. Material & Methods: This was a prospective, observational exploratory study in which data were collected from prescription records ofall patients admitted between June and August 2014, in pediatric wards of Government Medical College, Nagpur. Results: Data were collected from 200 patients admitted in pediatric wards; all of them received at least two or more drugs. Of 1188 prescriptions, 524 (44.10%) were found off-label. The anatomical therapeutic chemical classes most involved in off-label prescriptions were anti-infectives for systemic use (45.03%), alimentary tract and metabolism (17.55%), Nervous system (13.74%) and Blood and blood forming organs (9.92%). The highest rate of off-label drug prescriptions was observed in the age range of 1-30 days (36%) followed by age range of 1-12 months (22.51%). Conclusions: The study found a high percentage of off-label use of drugs in the Pediatric inpatients. We identified inappropriate prescriptions for specific drug classes. The findings emphasize a need for further clinical studies as well as compilation of existing clinical experience and scattered evidence, particularly for drug treatment in pediatric population.