Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India
Joint Authors
Saiyed, Mohd Masnoon
Lalwani, Tarachand
Rana, Devang
Source
International Journal of Pediatrics
Issue
Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-6, 6 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2014-11-25
Country of Publication
Egypt
No. of Pages
6
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Saiyed, Mohd Masnoon& Lalwani, Tarachand& Rana, Devang. 2014. Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India. International Journal of Pediatrics،Vol. 2014, no. 2014, pp.1-6.
https://search.emarefa.net/detail/BIM-1037485
Modern Language Association (MLA)
Saiyed, Mohd Masnoon…[et al.]. Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India. International Journal of Pediatrics No. 2014 (2014), pp.1-6.
https://search.emarefa.net/detail/BIM-1037485
American Medical Association (AMA)
Saiyed, Mohd Masnoon& Lalwani, Tarachand& Rana, Devang. Off-Label Medicine Use in Pediatric Inpatients: A Prospective Observational Study at a Tertiary Care Hospital in India. International Journal of Pediatrics. 2014. Vol. 2014, no. 2014, pp.1-6.
https://search.emarefa.net/detail/BIM-1037485
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1037485