| Dissemination of information on the off-label (unapproved) use of medication: a comparative analysis. | |
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MedLine Citation:
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PMID: 21528801 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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"Off-label" in relation to the use of medication means that a medicine is used in another way or for indications other than those specified in its conditions of registration and reflected in its labelling. The off-label use of medication accounts for an estimated 21 per cent of drug use overall and is an important part of mainstream, legitimate medical practice worldwide. In South Africa, legislation prohibits the dissemination of information regarding the off-label use of medication. There are diverging views on whether pharmaceutical companies should be allowed to distribute scientific publications on off-label uses of approved drugs. Current policy in the United States of America (USA) eases restrictions on the dissemination of information of this nature. The prohibitions existing in South Africa, however, are more comparable with those in European countries. After analysing the different legal positions on the issue, it is submitted that pharmaceutical companies should not be allowed to disseminate information on off-label uses, but that the regulatory authority play an active and leading role in providing the latest, objective medical and scientific information, as well as guidelines on the off-label use of medication. Other related recommendations are also made. |
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Authors:
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Rita-Marié Jansen |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Medicine and law Volume: 30 ISSN: 0723-1393 ISO Abbreviation: Med Law Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-05-02 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8218185 Medline TA: Med Law Country: Israel |
Other Details:
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Languages: eng Pagination: 115-32 Citation Subset: IM |
Affiliation:
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Faculty of Law, University of the Free State, Bloemfontein, South Africa. jansenr@ufs.ac.za |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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