title: Off-label paediatric drug use in an Indonesian community setting.
abstract: OBJECTIVE
  Off-label medication is often used in the treatment of paediatric patients. However, it should be restricted due to the lack of evidence related to its efficacy and safety. Little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice in Indonesia. The aim of this study was to investigate the off-label prescribing practice for paediatric patients in Bandung city, Indonesia.
  
  
  METHODS
  We conducted a retrospective and population-based study including 4936 prescriptions written by paediatricians for 0- to 5-year-old patients from 14 selected community pharmacies in 2012 and analysed the off-label uses.
  
  
  CONCLUSIONS
  Of the total prescriptions, 18.6% contained at least one off-label drug. Furthermore, 7% of the 16 516 prescribed drugs were categorized as off-label. Of all of the prescribed drugs, doxycycline and domperidone were the most prescribed drugs with off-label indications.
  
  
  CONCLUSIONS
  This is the first study that shows a significant number of off-label drugs prescribed for children in Indonesia; therefore, efforts should be made to scrutinize under-evaluated off-label prescribing practices that may compromise patient safety.
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: R
authors.identifier: http://orcid.org/0000-0002-8779-6421
authors.initials: R
authors.lastname: Abdulah
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: M A
authors.initials: MA
authors.lastname: Khairinisa
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: A A
authors.initials: AA
authors.lastname: Pratiwi
authors.affiliation: Department of Biological Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: M I
authors.initials: MI
authors.lastname: Barliana
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: I S
authors.initials: IS
authors.lastname: Pradipta
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: E
authors.initials: E
authors.lastname: Halimah
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: A
authors.initials: A
authors.lastname: Diantini
authors.affiliation: Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jatinangor, Indonesia.
authors.forename: K
authors.initials: K
authors.lastname: Lestari
mesh_terms: D002675:Child, Preschool; D006801:Humans; D007214:Indonesia; D007223:Infant; D007231:Infant, Newborn; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D055553:Prescription Drugs / Q000008:administration & dosage* / Q000009:adverse effects; D012189:Retrospective Studies
chemical_list: D055553:Prescription Drugs
keywords: drug safety; off-label prescribing; paediatrics