Objectives: To determine the pattern of prescription and utilization of off-label and unlicensed drugs among pediatric patients attending outpatients department of tertiary care teaching hospital of Gujarat state. Methods: A prospective study was conducted for 6 months among 140 pediatric patients attending outpatient department of Gujarat Medical Education and Research Society Medical College, Dharpur, Patan. The demographic details and complete prescription were noted in predesigned form. The off-label drugs were categorized by using National Formulary of India. Off-label drugs were classified by using Anatomical Therapeutic Chemical classification. Results: Out of 481 drugs prescribed, the pattern of distribution of off-label and unlicensed drugs were 215(44.7%) and 3(0.6%) respectively.Majority (n=151,70.2%) of off-label drugs prescribed among 1-12 years age group.Most of off-label drugs were prescribed for indication of respiratory system (68%). Conclusion: The findings of this study showed a high incidence of off-label prescribing mainly antibiotics for respiratory disease.

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.