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See Latest ArticlesInformed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions
PLoS Medicine, 11/14/08
Wilkes M et al. - Patients need information about off-label uses to make well-informed health care decisions. The legal doctrine of informed consent should be expanded to require disclosure of off-label prescribing where the drug has not been proven safe and effective for the condition, especially where scientific evidence is inadequate and risks are substantial or unknown. The ethical requirement of SDM should be expanded to require discussions of off-label uses under the same circumstances. Requiring disclosure will protect patient autonomy and educate patients about alternatives and risks, leading to improved health care decisions.
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