What is known and 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.
Results and discussion: 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.
What is new and conclusion: 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.
Keywords: drug safety; off-label prescribing; paediatrics.
© 2015 John Wiley & Sons Ltd.