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

1, 1★, 1★ Corresponding author

  1. 1Department of Pharmacology, Smt. NHL Municipal Medical College, Ellisbridge, Ahmedabad-380006, INDIA.

CORRESPONDENCE

Devang Ashwinkumar Rana

Department of Pharmacology, Smt. NHL Municipal Medical College, Ellisbridge, Ahmedabad-380006, INDIA.

devangandu@gmail.com

Volume 7, Issue 3 · pp. 164-170 · 2015 · DOI: 10.5530/jyp.2015.3.5

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.

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    Bhadiyadara, S. N., Rana, D. A., & Malhotra, S. D. (2015). Off-label and Unlicensed Drug Use in Paediatric Outpatient Department – A Prospective Study at a Tertiary Care Teaching Hospital. Journal of Young Pharmacists, 7(3), 164-170. https://doi.org/10.5530/jyp.2015.3.5

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    © 2015 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms. CC BY-NC-SA 4.0