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Ethical and Legal Considerations of Off-Label Drug Use

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Using medications to treat conditions for other than which they are approved can raise concerns over ineffective treatment, adverse reactions and possible litigation.

EDUCATIONAL OBJECTIVES
After reading this course, the participant should be able to:

  1. Explain the process of federal drug approvals, and the ethical and legal implications of off-label therapy.
  2. Describe the need for careful clinical decisions regarding off-label indications, and the levels of evidence supporting such use.
  3. Discuss the importance of informed consent when providing off-label drug treatment.

This course was issued in the March 2018 issue and expires 3/31/21. The authors have no commercial conflicts of interest to disclose. This 2 credit hour self-study activity is electronically mediated.

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