OBJECTIVES: Off label medication use is very common in paediatric department and it is one of the main problems in the current clinical practice. Due to lack of suitable drugs and dosage form in paediatrics patients most of physician prescribe some medicines without any approved labelling indication. So in this context we aimed to evaluate the off label medication use in paediatric department of hospital.

METHODS: 6 Months prospective observational study was conducted on paediatric inpatient department of hospital during October 2019 to March 2020. Demographic data, clinical history, diagnosis, and complete prescription were noted in predesigned data collection form, and prescriptions were analyzed for drug utilization pattern and off-label drug use as per NFI and MICROMEDEX. Descriptive statistics were used to analyse data.

RESULTS: Out of 120 patients 95(79.01%) of patient have received off-label drug according to Micromedex and as per NFI 52(43.03%). We also found that highest no. of off-label medication were prescribed in the age group 1-3 years. The main reason for hospitalization was respiratory disorders (36.66%) followed by an allergic and bacterial infection (11.66%). The most commonly prescribed medication was Inj. Ceftriaxone (41.75%) and fixed drug combination (FDC) was amoxicillin + clavulanic acid (48.30%). During the study duration of 6 months total (n = 183) prescriptions are given in children patients and category-wise off – labelled uses were reviewed. It was found that Non – FDA approval/indications (81.41 %) and Efficacy and safety (77.60 %) was most common variables of off – label use during our study.

CONCLUSIONS: Most of the paediatric patients are receiving off label medication in the hospital. Off label practice is most common in among paediatric patients and to ensure rational and safe use of off label medication require improving knowledge and quality data of off label drug use.