Nutzen und Risiken der zulassungsüberschreitenden Arzneimittelanwendung in der ambulant-ärztlichen Versorgung

Abstract

Off-label use (OLU) is defined as the prescription of pharmaceutical drugs for an indication or other application that has not been approved by the governing authorization body. Off-label uses are not only common practice but are often the standard and relate to the need for a patient-oriented and patient-specific therapy. The current thesis discusses off-label use from the perspective of health services research. The question is of particular interest because civil and criminal requirements on the one hand and the health insurance law on the other have a direct impact on the doctor as a health care provider and the patient as a beneficiary. The first part of this thesis (Chapters 1-6) briefly outlines the legal aspects, the second part (chapters 7-9) analyses the possible conditions that enable an off-label use in drug therapy of chronic diseases. The focus is primarily on possible structural and administrative gaps as the cause of an OLU. The present work integrates different areas of supply research. This thesis considers the strengths and limitations of different databases and indicates more trans-parency with regard to off-label use discussing the gap between the admission authorised usage and patient-specific care. Finally it outlines the implications for better health care provision.