Suksham Jain1, Shiv Sajan Saini, Deepak Chawla, Praveen Kumar, Shashikant Dhir. 1. Departments of Pediatrics, Government Medical College Hospital, Chandigarh; and *Post Graduate institute of Medical Education and Research, Chandigarh; India. Correspondence to: Dr Suksham Jain, Associate Professor Paediatrics, GMCH, Chandigarh, India. dr.sukshamj@gmail.com.
Abstract
OBJECTIVE: To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications. METHODS: Chart audit in neonatal intensive care units of two institutions in Chandigarh, India. RESULTS: Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates. CONCLUSION: Use of off-label drugs is common in sick neonates.
OBJECTIVE: To estimate proportion of off-label medication use in neonates and to evaluate evidence of efficacy and safety of these medications. METHODS: Chart audit in neonatal intensive care units of two institutions in Chandigarh, India. RESULTS: Among 568 prescriptions in 156 neonates, 286 (50%) were off-label. Of these, 56% drugs were not approved for use in neonatal age group and 26% prescriptions were off-label for frequency, dose, indication, route or rate. Most common off-label drugs were anti-infective and antiepileptic. Despite lack of regulatory approval, one-third off-label drugs had level I-II evidence of safety and efficacy for use in neonates. CONCLUSION: Use of off-label drugs is common in sick neonates.
Authors: H Christine Allen; M Connor Garbe; Julie Lees; Naila Aziz; Hala Chaaban; Jamie L Miller; Peter Johnson; Stephanie DeLeon Journal: J Okla State Med Assoc Date: 2018-10