Journal of Pharmacovigilance

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

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Mangesh Bankar

Andaman & Nicobar Islands Institute of Medical Sciences, India

Scientific Tracks Abstracts: J Pharmacovigil

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 of all 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.

Biography :

Mangesh Bankar has completed his MD in Pharmacology from Government Medical College, Nagpur in 2006. Currently he is working as an Associate Professor in Department of Pharmacology of Andaman & Nicobar Islands Institute of Medical Sciences. He has published 10 papers in various national and international journals. He has presented research papers in three international conferences. He is also working as a member of Institutional Ethics Committee of Shravan Hospital, Nagpur. He is reviewer and member of scientific advisory board of International Journal of Basic and Clinical Pharmacology. Besides, he is a good badminton player and regularly participates in various state level competitions.

Email: drmangesh_bankar@yahoo.co.in