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Clin Orthop Relat Res. 2000 Sep;(378):31-8.

Orthopaedic surgery and Food and Drug Administration off-label uses.

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Hinsdale Orthopaedic Associates, Hinsdale, IL, USA.


The use of a drug or device for a purpose other than that for which it was approved by the Food and Drug Administration has become an important method by which medical knowledge is expanded. Ethical and moral issues are raised whenever a drug or device is used in an unapproved manner. Physicians using devices in an off-label fashion must be aware of these issues and how they affect their patients. Reviewing an ethical checklist before embarking on the use of a device or drug in an off-label fashion can alert the physician to potential ethical and moral conflicts. The ethical physician always will place his or her patient's well-being and best interests above all else. Using this pledge as the cornerstone of all clinical decisions, the virtuous physician is able to offer the most innovative and new procedures without compromising his or her ethical or moral obligations to their patients.

[Indexed for MEDLINE]

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