USAGE OF OFF-LABEL DRUGS AMONG PRETERM BABIES ADMITTED IN A LEVEL III NEONATAL INTENSIVE CARE UNIT ATTACHED TO A MEDICAL COLLEGE IN SOUTHERN KARNATAKA
Journal Title: Journal of Evolution of Medical and Dental Sciences - Year 2017, Vol 6, Issue 93
Abstract
BACKGROUND Drug therapy in the neonatal age group is not always supported by systematic clinical testing. Organ immaturity and consequently difficulties adapting to extra-maternal life are reasons for preterm neonates being often multi-morbid and in need of intensive care. Consequently, they are exposed to high number of drugs, putting them at a higher risk of adverse drug reactions. This study gives an insight to the extent of usage and nature of off-label drug use among preterm infants admitted in Neonatal Intensive Care Unit (NICU) attached to a tertiary care hospital. MATERIALS AND METHODS This cross-sectional study was conducted over a six-month period (Aug. 2015 - Jan. 2016) in a Level III NICU attached to a Medical College in Southern India. All inborn and outborn Preterm infants admitted in NICU, during the study period were included in the study. Drugs prescribed were categorised based on World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) Classification System.9 Data collected was evaluated for off-label category of drugs using the National Formulary of India (NFI, 4th edition, 2011) RESULTS The study included a total of 154 Preterm infants, with majority of the study population in the late Preterm (>34 weeks gestational age) group accounting for 66.2% (n=102). A total of 1426 medications were administered to Preterm infants during the hospitalisation of which 1083 (75.9%) medicines were prescribed in off-label manner. The most common cause of off-label prescribing was for age (55%). The extent of off-label prescribing was highest (78%) in very Preterm 28- 34 weeks gestational age group, followed by 76.2% in late Preterm >34 weeks gestational age group. Of the 154 Preterm infants included in the study, 150 (97.4%) received at least one off-label medication and 100% of the Extreme Preterm group infants received one or more off-label medicines. Among the total off-label medicines (n= 1083) prescribed, 58% was accounted by Anti-infectives for Systemic use group of drug. CONCLUSION Off-label prescribing is a reality and will not end soon. Implementing evidence-based approach can significantly improve rationality of neonatal pharmacotherapy.
Authors and Affiliations
Keerthi Budnoor Jayaram, Usha D, Divya V. J
Keywords
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- EP ID EP279342
- DOI 10.14260/jemds/2017/1444
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