O uso Off Label de medicamentos: as fronteiras entre os benefícios e riscos dessa prática clínica.

Abstract

To use a drug, it goes through an approval process that looks for evidence of drug efficacy and safety through clinical trials. The marketing authorization for a medicinal product translates a risk-benefit ratio so that when the medicinal product is used in the approved circumstances, the benefits of its use outweigh the associated risks. The off-label use of drugs consists of using drugs for a population indication or subgroup, or at a dose / route of administration not approved by the relevant regulatory body, since this entity, while regulating the drug market, has no jurisdiction to Regulate the uses / prescriptions. This practice is an unavoidable reality in modern health systems. Based on this, this review work was carried out in order to contain a greater number of classic and modern information about the use of off label drugs. The research was done in the databases: Scielo, Bireme, PubMed and Portal CAPES, articles and monographs published in the last 10 years (2007-2017) were used. We found 95 articles, of which 69 were used. He sought to analyze the benefits and risks of this practice. It was also found that, in most studies, there was no scientific evidence to support off label prescriptions, thus constituting a worrying reality that needs to be regulated by the competent authorities. Analyzing the articles, we see the importance of the contribution of the pharmacist to the treatment of the patient, and the pharmacist can consider risks and benefits when opting for off label prescription.