Drug utilization pattern in neonatal intensive care unit of a tertiary care hospital with particular emphasis on off-label drug use

Abstract

Context: Drugs should be used rationally in the newborn admitted to a neonatal intensive care unit (NICU), especially in view of their higher susceptibility to the adverse effects owing to relative immaturity of body functions. However, not infrequently, drugs are used not keeping with the guidelines, such use being called “off-label drug use.” Aims: The aim of this study was to evaluate the drug utilization pattern in an NICU of a tertiary care hospital and to know the frequency of off-label drug use of various types. Settings and Design: A prospective, observational study was carried out in an NICU for a period of 3 months. Materials and Methods: Demographic details, diagnosis, and treatment given were recorded. The World Health Organization drug utilization core indicators and proportion of off-label usage of drugs were evaluated. Results: Among 560 prescription items used in 81 neonates over a 3-month period, the most commonly used drugs were antimicrobials, followed by vitamins and minerals and then sedatives and anticonvulsants. Hypoxic–ischemic encephalopathy and neonatal sepsis were the most common diagnoses. Overall, off-label usage of drug use was 43%. Antimicrobials were the most common group of drugs (136/240) used off label, followed by sedatives and anticonvulsants (42/240). While antimicrobials were commonly used off label in dose followed by frequency and age, anticonvulsants and sedatives were mostly used off label in the age category. Conclusions: The present study highlights a trend toward multiple drug usage with high off-label drug use in sick neonates and the need for further studies for safety and efficacy of drugs used in NICUs.