title: Off-label use of drugs in neonatal intensive care units.
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.
  
  
  CONCLUSIONS
  Use of off-label drugs is common in sick neonates.
authors.affiliation: 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.
authors.forename: Suksham
authors.initials: S
authors.lastname: Jain
authors.forename: Shiv Sajan
authors.initials: SS
authors.lastname: Saini
authors.forename: Deepak
authors.initials: D
authors.lastname: Chawla
authors.forename: Praveen
authors.initials: P
authors.lastname: Kumar
authors.forename: Shashikant
authors.initials: S
authors.lastname: Dhir
mesh_terms: D006801:Humans; D007194:India / Q000453:epidemiology; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal / Q000706:statistics & numerical data*; D008485:Medical Audit; D056687:Off-Label Use / Q000706:statistics & numerical data*