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Pharmacotherapy for Sarcoidosis: An Example of an Off-Label Procedure.
MedLine Citation:
PMID:  22826074     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Sarcoidosis is a granulomatous multiorgan diseases with an unknown etiology, with the predominant lung involvement. Immunosuppressive agents such as corticosteroids, methotrexate, azathioprinum, ciclosporinum A, chlorambucil, cyclophosphamide, hydroxychlorochinum, indomethacin, pentoxyfillinum, thalidomide, leflunomidum, and adalimumab, or infliximab have been used in its treatment. It should be emphasized that the Summary of Products Characteristics (SPC) of these drugs does not specifically recommend their use in the therapy for sarcoidosis. That makes the application of the drugs in sarcoidosis an off-label use, which is not formally accepted by the authorities but is supported by medical bibliography or recommendations given by scientific bodies. Thus the off-label drugs raise legal, but also ethical and medical problems. The dosing regimen and the required duration of therapy for sarcoidosis are missing. In effect the therapy usually follows the recommendations from the American and European Respiratory Societies (ATS/ERS), based on the long-term medical research. The American Food and Drug Administration recognizes the existence of the off-label use. European legislations do not precisely specify the rules for the admissibility of the off-label use. The doctrine of law assumes that the off-label use constitutes a medical experiment. Therefore, the commencement of therapy with such drugs requires patients' informed consent, which must be kept along with other medical records. Insufficient knowledge of the legal regulations may result in civil and professional liability of a physician supervising the therapy of a sarcoidosis patient, especially in case of adverse effects.
Authors:
A Zimmermann; A Dubaniewicz; J M Slominski
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Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Advances in experimental medicine and biology     Volume:  755     ISSN:  0065-2598     ISO Abbreviation:  -     Publication Date:  2013  
Date Detail:
Created Date:  2012-7-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0121103     Medline TA:  Adv Exp Med Biol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  251-256     Citation Subset:  -    
Affiliation:
Department of Nursing Management, Medical University of Gdansk, Do Studzienki St. 38, 80-227, Gdansk, Poland, agnieszkazimmermann@gumed.edu.pl.
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