Off-label and Unlicensed Drug Use in Paediatric Outpatient Department – A Prospective Study at a Tertiary Care Teaching Hospital

Objective: To assess prevalence and pattern of off-label and unlicensed use of drugs in paediatric outpatient department. Methods: In this prospective study, children attending paediatric outpatient department of a tertiary care teaching hospital were enrolled. Demographic data, clinical history and completeprescription given to the patient were noted. Prescriptions were analysed for off-label and unlicensed drug use with the help ofrecent British National Formulary for Children (BNFC) and National Formulary of India (NFI). Results: Total of 170 patient’s data was collected over 2 months with mean age 4.19 ± 3.66 years. Out of total of 405 drugs prescribed, 41 (10.1%)-BNFC and 32 (7.9%)-NFI were used in off-label manner. Number of children who received at least one off-label drug as per BNFC and NFI was 22.4% and 17.1%, respectively. Most common off-label drug was amoxicillin being 48.8%-BNFC and 34.4%-NFI of all drugs prescribed in this manner. Most common category for off-label prescription was inappropriate dose. Only one case was noted for unlicensed drug use. Offlabel drug prescribing significantly correlated with age of the patient and number of drugs per prescription. Conclusion: Off-label drug use is prevalent in paediatric outpatient department, amoxicillin being the commonest drug.