Healthy Skepticism Library item: 11019

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Krege S, Rohde D.
[Off-label use: update and relevance for urology].
Aktuelle Urol 2007 Jul; 38:(4):301-4
http://www.thieme-connect.com/DOI/DOI?10.1055/s-2007-980077

Abstract:

The use of pharmaceuticals beyond the approved indication and conditions (off-label use) is of increasing public interest in times of necessary financial constraints in public health together with the high requirements for drug safety to protect the patient. Remarkably, more than half of the therapies in oncology are performed as off-label use. The discussion on off-label use is controversial and based on different points of interests. Evaluation of therapeutic agents by the pharmaceutical industry is predominantly driven by marketing and business requirements. As a consequence, treatment of rare diseases is often only possible by off-label use, creating more or less an off-label need. Reimbursement by health-care insurances is based on the approval of a pharmaceutical substance for a particular situation, because only the rigorous licensing process assures that the verified efficacy is higher than the, often severe, adverse side effects. It is a well known fact that the sometimes adverse events, which occur on administration of substances in an off-label fashion, are not included in the information on the regular use of a given drug. Finally, physicians request a controlled off-label use, which only allows experienced colleagues and (sub)-specialized oncologists to use pharmaceuticals in an off-label fashion. Up to date no legal documents exist that provide regulations for such an off-label usage.

Keywords:
Publication Types: English Abstract PMID: 17647167 [PubMed - in process]

Notes:

German.