Prescrição off-label: Análise científica tendo como exemplo a utilização de bevacizumab em oftalmologia

Abstract

Off-label prescribing poses specific technical/scientific, professional and ethical problems. In this study we carry out a technical and scientific analysis of the off-label prescribing using a current, clinical and economically relevant example: the paradigmatic case of the use of bevacizumab in ophthalmologic pathologies for which it has no formal indication. We conducted a systematic review of the literature on the efficacy and safety of this drug, as well as ranibizumab - which has approved ophthalmologic indications, in order to qualitatively analyze the available evidence on the two interventions. This is a typical case for technical and scientific analysis of the off-label prescribing problems. According to the results of the systematic review, the use of bevacizumab in this context has in fact scientific evidence of appreciable size, including clinical trials head-to-head with ranibizumab. However, the identified safety issues raise the question of the use of this drug in ophthalmologic pathologies. The different players involved in the treatment decisions (physicians, patients and institutional decision makers) should be adequately informed about the existing evidence that supports off-label prescribing which, by definition, must always be on an exceptional basis and properly justified.