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Consent for Off-Label Drugs & Devices: Six Considerations

May 09, 2017

Consent for Off-Label Drugs & Devices: Six Considerations
  1. “Off-Label” refers to use of an FDA-approved drug or device for an unapproved use to treat a medical condition. Off-label risks may be unknown until after FDA approval and public release. Patients presume FDA testing has already occurred and has been approved for use in their treatment.
  2. The vast majority of courts (but not all) have held that a provider need not get formal written patient consent to use off-label drugs and devices.
  3. A provider should consider more than the legal requirements when recommending off-label treatments. Consider the ethical elements of beneficence, non-malfeasance, justice and autonomy. Autonomy is the principle that individuals have a right to make their own choices.
  4. Not all off-label uses are created equal. Some cases require additional scrutiny. Consider the differences in the risk/reward balance in prescribing off-label with new drugs or devices, novel off-label uses, treatment with known serious adverse effects, and with high cost off-label drugs. 
  5. Categorize the potential offlabel uses depending on whether the patient will gain a net benefit. Use net benefit when deciding whether to use a formal written consent. Individual circumstances may determine the need for more formal consent.
  6. The prescriber always has a responsibility to act reasonably. Even with patient consent, the physician must act within the standard of care or be subject to medical board disciplinary action.

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