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

T. Wetterling

doi:10.1055/s-2004-818383

Fortschritte der Neurologie · Psychiatrie, Table of Contents

Fortschr Neurol Psychiatr 2004; 72(5): 245-254
DOI: 10.1055/s-2004-818383

Originalarbeit

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

Für welche Medikamente und psychiatrischen Indikationen liegen hinreichend wissenschaftlich fundierte Studien vor?Prescription of Drugs without Registered Indication For which Drugs and for which Psychiatric Indications are Controlled Studies Available? T. Wetterling¹

¹Klinik für Psychiatrie und Psychotherapie - Gerontopsychiatrie, Vivantes Klinikum Hellersdorf, Berlin

Abstract

Zusammenfassung

Anliegen: In der Behandlung von psychiatrischen Patienten werden neben offiziell zugelassenen Medikamenten auch andere noch nicht zugelassene eingesetzt. Dieser so genannte „off-label-use” wird in den letzten Jahren unter verschiedenen Aspekten zunehmend diskutiert. Ein Urteil des Bundessozialgerichts hat den Rahmen, in dem ein „off-label-use” zulässig ist, stark eingegrenzt und eine Reihe von Bedingungen gestellt, die erfüllt sein müssen. Bei der Prüfung der Zulässigkeit des „off-label-use” sind nach diesem Urteil bevorzugt kontrollierte Studien heranzuziehen. Da im Einzelfall eine Suche von geeigneten Studien aufwändig ist, wurden in dieser Übersicht kontrollierte Studien aus den wesentlichen Problembereichen der Psychopharmakotherapie zusammengestellt: symptomatische Behandlung, Therapieresistenz, Vorliegen von Kontraindikationen bzw. schweren Nebenwirkungen, bisher keine hinreichend abgesicherte medikamentöse Behandlungsmöglichkeit und Zusatzmedikation. Die Probleme und rechtlichen Fragen, die sich bei der Behandlung mit (noch) nicht zugelassenen Medikamenten im Bereich der Psychiatrie ergeben können, werden erörtert.

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 resistence, 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.

Full Text

References

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Prof. Dr.
Tilman Wetterling

Klinik für Psychiatrie und Psychotherapie - Gerontopsychiatrie · Vivantes Klinikum Hellersdorf

Myslowitzer Str. 45

10621 Berlin

Email: tilman.wetterling@vivantes.de