Background & Objectives: Many drugs that are used to treat children have not undergone evaluation to assure
acceptable standards for optimal dose, safety and efcacy. 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 classied in
regards to their indications by using Anatomical Therapeutic Chemical Classication. 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%). Signicant 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.
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