Prevalência do uso off label de medicamentos em pediatria: uma revisão integrativa

Abstract

The off-label use of medicines refers to their use under conditions different from those indicated in the package leaflet of the medicine and, therefore, different from those for which they were registered and approved, their indication differs from what appears on the package leaflet, in relation to age, dose , the indication or the route of administration, being used, in some cases, for a therapeutic purpose other than that authorized by the regulatory agency of the country, occurs when there is no approval of a medicine for a certain population or certain disease that for some reason were not included in clinical trials. Considering the risks of this practice, and that the use of OL in pediatrics is not fully identified, this study aims to assess the prevalence of off-label drug use in the pediatric population. This is an integrative literature review. Using the DeCS: Pediatrics, child, off label, drugs, a search was carried out in the databases: PubMed, Scopus and BVS August 2021, sixteen studies met the requirements and were included in the study. The prevalence of off-label prescription drugs between 18.7% and 84.6%. As for the reasons that influenced off-label prescription, a higher proportion of off-label prescription was observed related to age, followed by reasons for indication and dose different from those recommended by regulatory agencies. The therapeutic classes with the most off-label prescriptions were the classes of anti-infectives for systemic use, for the nervous system and for the alimentary tract and metabolism. Ranitidine, ondasetron and gentamicin were the drugs with the highest prescription prevalence. Therefore, it is clear that the prescription of off-label drugs is recurrent in the pediatric population in several countries, making better information about these drugs necessary by regulatory bodies and pharmaceutical industries, in order to guarantee rational use in children.