The aim of this study was to evaluate the extent of, and compare the rates of, off-label drug use in pediatric therapies throughout the world in order to reveal which therapeutic areas are common to different countries and which areas are therefore important for effective interventions. A literature review was performed and 29 studies were evaluated, 11 of which involved pediatric hospital wards, 7 neonatal hospital wards, and 11 the community setting. In the pediatric hospital wards, off-label/unlicensed prescriptions ranged from 16-62%, in the neonatal wards they ranged from 55-80%, and in the community setting they ranged from 11-37%. The drugs most commonly involved in these prescriptions were acetaminophen, caffeine, salbutamol, and amoxicillin. The criteria used to classify prescriptions according to off-label or unlicensed status differed between studies, making a direct comparison difficult. Off-label prescribing exists everywhere and to a significant extent, but does not necessarily imply irrational prescribing. There is a lack of harmonization between the evidence, the product licenses, and clinical practice, and this is part of the reason off-label prescribing is so common. Many attempts have been made to improve knowledge on pediatric therapies, but more focused interventions are needed, also taking into consideration this lack of harmonization.
|Translated title of the contribution||The off-label use of drugs in children is a common aspect of prescribing throughout the world|
|Number of pages||9|
|Journal||Giornale Italiano di Farmacia Clinica|
|Publication status||Published - Oct 2004|
ASJC Scopus subject areas
- Pharmacology (medical)