Use of off-label medicines in pediatric population

Abstract

Modern use of drugs in the treatment of diseases of children and newborns is increasingly based on off-label use of drugs. The lack of adequate formulations for the pediatric population, the lack of appropriate therapeutic parallels for the treatment of children's diseases and the small number of clinical trials involving the pediatric population have contributed to the mass use of these drugs. The use of these drugs implies extrapolation of doses and indications registered for adults to children, although it is known that the pharmacodynamics and pharmacokinetics of children and adults differ significantly. In the past two decades, many legislative and regulatory initiatives have been taken around the world to improve the use of drugs in children. However, children are still prescribed off-label and unlicensed drugs. The aim of this study was to present a review of the literature in which off-label and unlicensed use in the pediatric population was investigated. Literature was searched through the Google Scholar and Pub Med search engines and using the keywords off label drug, pediatric medicine, use in pediatrics, in the period from May to August 2019. Selected and presented in this article are studies published in the period from 1996 to 2015, which as a subject of research had the use of off-label and unlicensed drugs in the pediatric population. Medicines prescribed for children should be registered for use in the pediatric population and used in accordance with approved indications for children, whenever possible. It is necessary to take measures for more rational use of medicines in pediatrics, which include the collaboration of health workers in order to provide medicines for children that are proven to be effective, high quality and safe to use.