Off-label drug use in pediatric wards: a prospective study in a tertiary care hospital in Pune

Abstract

Aim and objectives The aim of this study was to identify the most common off-label drug used in pediatric wards and to classify the age group in which off-label medications were prescribed. Materials and methods A 2-month prospective study was carried out in a tertiary care hospital in Pune. Seventy patient medication charts were reviewed. Two drug databases, the Micromedex drug database and Medscape drug reference, were the secondary sources of reference used and the National Formulary of India (NFI) was also used as the tertiary source of reference to assess and identify off-label drug use. Results Out of 70 patients enrolled in the study, 57 (81%) patients were prescribed off-label medications. The most common off-label prescription were for ipratropium bromide (12%), pantoprazole (12%), salbutamol (11%), and fosphenytoin (10%); it was found that safety and efficacy in the pediatric population were not established on most of the drugs that were prescribed off label, whereas some drugs were prescribed in an indication for which the drug was not approved by the Food and Drug Administration (FDA). The highest proportion of off-label drugs was prescribed in infants. Conclusion Off-label prescribing in the pediatric population was very high; the highest proportion of off-label drugs was prescribed in infants. Use of a drug database and the NFI can be useful in identifying off-label prescribing in pediatrics.