[Prescription of drugs without registered indication].
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.
Wetterling
T
T
Klinik für Psychiatrie und Psychotherapie -- Gerontopsychiatrie, Vivantes Klinikum Hellersdorf, Berlin. tilman.wetterling@vivantes.de
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004359:Drug Therapy, Combination; D019317:Evidence-Based Medicine / Q000331:legislation & jurisprudence*; D005858:Germany; D006801:Humans; D008318:Malpractice / Q000331:legislation & jurisprudence; D001523:Mental Disorders / Q000188:drug therapy*; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D009422:Nervous System Diseases / Q000188:drug therapy*; D017410:Practice Guidelines as Topic; D011619:Psychotropic Drugs / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*
D011619:Psychotropic Drugs