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

Abstract

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.

Keywords: Drug utilization; Off-label; Outdoor patients; Paediatric; Unlicensed