Linked Life Data

17647167

Source:http://linkedlifedata.com/resource/pubmed/id/17647167

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2007-7-24
pubmed:abstractText
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 insurance 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.
pubmed:language
ger
pubmed:journal
pubmed:citationSubset
IM
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
0001-7868
pubmed:author
pubmed:issnType
Print
pubmed:volume
38
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
301-4
pubmed:dateRevised
2008-11-21
pubmed:meshHeading
pubmed:year
2007
pubmed:articleTitle
[Off-label use: update and relevance for urology].
pubmed:affiliation
Urologische Universitätsklinik Essen, Germany. susanne.krege@maria-hilf.de
pubmed:publicationType
Journal Article, Comparative Study, English Abstract, Review