[Off-label use in dermatological practice. The conflict between professional duty and legal requirements].
When making therapeutic decisions, doctors often find themselves faced with a dilemma regarding ethical, professional, legal liability, social and service aspects of their duties. These conflicts may be enhanced when medications have to be prescribed for non-approved usages, known as off-label prescribing, because existing therapy options have been exhausted. This option become considerably more difficult since the German Federal Social Court decision of March 2002 which limited off-label use to a number of very strictly defined circumstances. In order to clarify the basis for taking decisions in a given situation, an oncology expert commission has been formed under the coordination of the Department of Health and Social Security. However, this is no solution for the great variety of uncommon dermatological diseases which often require off-label medication usage.
Brunne
V
V
Klinik für Dermatologie und Allergologie, Ruhr-Universität Bochum.
Mertins
G
G
Reimann
G
G
Brockmeyer
N H
NH
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D003879:Dermatologic Agents / Q000627:therapeutic use* / Q000633:toxicity; D003880:Dermatology / Q000941:ethics / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D015507:Drugs, Investigational / Q000627:therapeutic use* / Q000633:toxicity; D004992:Ethics, Medical; D005104:Expert Testimony / Q000331:legislation & jurisprudence; D005858:Germany; D006801:Humans; D028681:Moral Obligations; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D012871:Skin Diseases / Q000188:drug therapy*
D003879:Dermatologic Agents; D015507:Drugs, Investigational