Prescrição e uso de medicamentos off-label e/ou não licenciados em crianças na atenção primária : uma revisão sistemática

Abstract

The present study aims to evaluate off-label and/or unlicensed prescription of medicines in children in primary health care. This systematic review was based on the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA).The studies were extracted from the databases: LILACS, PubMed / MEDLINE, Scopus between April and November, 2017. The evaluation of the titles, abstracts and two reviewers performed complete articles independently, and the divergences were re-examined through a third reviewer.Six studies met the inclusion criteria. The observed incidence of off-label prescription medicines varied from 29.5% to 51.7% in relation to the total number of drugs prescribed. The prevalence of off-labelmedicines ranged from 31.7% to 93.5% in relation to the total number of drugs prescribed. Regarding the factors that influenced the incidence, indicated a higher proportion of off-label prescription related to age indication. On the other hand, there was a significantly higher proportion of off-label prescriptionsrelated dose as well. For unlicensed medicines, there was a small variation in incidence between 2.4% and 3.9%, relative to the total number of prescriptions, or between 2.4% and 10.0%, relative to the sample size. Thus, it is clear that the prescription of off-label and / or unlicensed medicines occurs in the pediatric population of primary care in the worldwide, making it necessary to have better information on these medicines by the regulatory agencies and the pharmaceutical industries for rational pediatric use.