title: Off-label medicine use in pediatric inpatients: a prospective observational study at a tertiary care hospital in India.
abstract: 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; P < 0.001) and hospital stay of six to 10 days (OR 1.91, 95% CI; P < 0.001). 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.
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, GH 6, Sector 23, Gandhinagar, Gujarat 382024, India.
authors.forename: Mohd Masnoon
authors.identifier: 0000-0002-6154-7021
authors.initials: MM
authors.lastname: Saiyed
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, K.B. Institute of Pharmaceutical Education and Research, GH 6, Sector 23, Gandhinagar, Gujarat 382024, India.
authors.forename: Tarachand
authors.identifier: 0000-0002-5844-6270
authors.initials: T
authors.lastname: Lalwani
authors.affiliation: Department of Pharmacology, Smt. N.H.L. Municipal Medical College, Sheth V.S. General Hospital, Ellisbridge, Ahmedabad, Gujarat 380006, India.
authors.forename: Devang
authors.initials: D
authors.lastname: Rana