EXTENT AND PATTERN OF OFF-LABEL AND UNLICENSED DRUG UTILIZATION IN NEONATAL INTENSIVE CARE UNIT IN THE TERTIARY CARE TEACHING HOSPITAL

Abstract

Background & Objectives: Many drugs that are used to treat children have not undergone evaluation to assure acceptable standards for optimal dose, safety and efcacy. As a result, drugs that are used to treat children are either not licensed for use in pediatric patients (unlicensed) or prescribed outside the terms of the product license (off-label).The extent of off-label and unlicensed drug use in neonates is unknown. Hence the purpose of the study is to determine the extent and pattern of off-label and unlicensed use of drugs amongst neonates in neonatal intensive care unit of a tertiary care hospital. A prospective study was carried Materials and Methods: out on 69 patients admitted in a tertiary care hospital for the period of ve months. Demographic data and complete prescriptions were noted in predesigned case record form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classied in regards to their indications by using Anatomical Therapeutic Chemical Classication. The frequency was measured in terms of percentage and multiple binary logistic regressions were used for selecting confounding factors. A Results: total of 329 drugs were prescribed out of which 183(55.6%) were off-label and 65(19.8%) were unlicensed remaining 81(24.6%) labelled drugs. Most off-label drugs were prescribed for indication of alimentary tract (93.6%) and anti-infective (38.6%). Signicant confounding factors for prescription of unlicensed drugs were single diagnosis (OR 0.20, P<0.05) and hospital stay (OR 1.30, P<0.05) Common reasons for off-label prescribing were dosage 52.4% and age 23.2%. There was a high extent of utilization of off-label and unlicensed drugs. Hence Conclusion: , national drug regulatory authorities need to review and revise existing guidelines for safe administration of such drugs.