Informed consent and shared decision-making: A requirement to disclose to patients off-label prescriptions
2008
Informed Consent for Off-Label Prescriptions
publication
Evidence: moderate
Author Information
Author(s): Michael Wilkes, Margaret Johns
Primary Institution: University of California, Davis
Hypothesis
Should doctors be required to disclose off-label prescriptions to patients?
Conclusion
Patients need to be informed about off-label drug uses to make better health care decisions.
Supporting Evidence
- Off-label prescriptions account for roughly half of all prescriptions written today.
- Patients often assume prescribed drugs are FDA-approved and safe.
- Disclosure of off-label uses can enhance patient autonomy and decision-making.
Takeaway
Doctors should tell patients when they are giving them medications that are not officially approved for their condition, so patients can make informed choices.
Potential Biases
Pharmaceutical companies may promote off-label uses through biased research and marketing.
Limitations
No court has required disclosure of off-label prescriptions, and there is a lack of rigorous evidence for many off-label uses.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website