Abstract

OFF-LABEL USE OF DRUGS AMONG CHILDREN AND ITS IMPLICATIONS IN A TERTIARY CARE HOSPITAL IN NORTH INDIA

Dr. Puja*, Dr. D.C. Dhasmana, Dr. Saurabh Kohli and Dr. Vipin Chander

Abstract

Background: Children are routinely prescribed medicine and most of them are lacking safety and efficacy data. This study was envisaged to find the prescribing pattern in pediatric general ward and extent of offlabel use of medicines and its implications. Methods and materials: This was an observational cross-sectional study. Prescription of 120 patients were analysed and off-label use was determined on the basis of Summary Of Product Characteristics/Product Label and National Formulary Of India, 2015 for each drug. Result: In a cohort of 120 patients atleast one off-label drug was prescribed to 72(60%). 48(40%) received 2 or more than 2 drugs off-label. Out of the total number of drugs 128(16%) were prescribed off-label based on the US FDA criteria which classifies offlabel use on the basis of age if the drug is used in the age group for which it is not approved or not recommended for use, dose if used at a higher or lower dose than approved, on the basis of route if any other route of administration is employed than approved or if used at a higher or lower frequency than approved. Dose (46%) was the most common reason for offlabel use of drugs and followed by age(40.6%). Conclusion: off-label use of drugs is common in children and carries a risk of increased adverse drug reactions but this study could not establish a association between off-label use and increased risk of adverse drug reactions necessiating need for such more studies.

Keywords: Off-label, hospitalised children, adverse drug reactions.