Verabreichung von Medikamenten außerhalb der zugelassenen Indikationsgebiete („off-label-use”)

Abstract

In the medical treatment of psychiatric patients drugs not registered for this specific indication are often prescribed. This so-called "off-label-use" is an increasing matter of discussion in the last years. In the article several aspects concerning "off-label-use" of psychotropic drugs debated in Germany are reviewed. According to a sentence of the German Supreme Court for Social Law an "off-label-use" is only allowed under strong conditions. Furthermore, controlled randomized studies are judged to be the basis of an evaluation of the permission to prescribe an "off-label" medication. Since in clinical practice a comprehensive research of suitable controlled studies is time consuming, in this article controlled randomized studies concerning the main problematic fields of psychopharmacotherapy: treatment of single psychopathological symptoms, therapy resistance, contraindications or severe side-effects, absence of well-established medical treatment strategies and "add-on"-therapy are reviewed. The problems and legal aspects of an "off-label-use" in psychiatry are discussed.