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International Journal of Pediatrics
Volume 2014 (2014), Article ID 415815, 6 pages
Research Article

Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India

1Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, GH 6, Sector 23, Gandhinagar, Gujarat 382024, India
2Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Sheth V.S. General Hospital, Ellisbridge, Ahmedabad, Gujarat 380006, India

Received 23 July 2014; Revised 17 November 2014; Accepted 17 November 2014; Published 25 November 2014

Academic Editor: Julie Blatt

Copyright © 2014 Mohd Masnoon Saiyed et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background. In the absence of standard pediatric prescribing information, clinicians often use medicines in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian drug formulary. Methods. The prospective observational study included pediatric patients in ages between 0 and 12 years admitted in a tertiary care hospital. Off-label use was assessed using the National Formulary of India (NFI). Predictors of off-label use were determined by logistic regression. Results. Of the 1645 medications prescribed, 1152 (70%) were off-label based on 14 possible off-label categories. Off-label medicines were mainly due to dose difference and use in restricted age limits as indicated in NFI. Respiratory medicines (82%), anti-infectives (73%), and nervous system medicines (53%) had higher off-label use. Important predictors of off-label prescribing were pediatric patients in age of 0 to 2 years (OR 1.68, 95% CI; ) and hospital stay of six to 10 days (OR 1.91, 95% CI; ). Conclusion. Off-label prescribing is common among pediatric patients. There is need to generate more quality data on the safety and efficacy of off-label medicines to rationalize pediatric pharmacotherapy.