AAN Policy on Consent for IV Thrombolytics
AAN Policy on Consent for IV Thrombolytics
The American Academy of Neurology’s policy on consent for IV thrombolytics is important for every stroke team member to read and understand. The AAN supports proceeding with administration of IV thrombolytics for qualified individuals without a written consent as delaying emergency care can be a risk to patient safety.
AMERICAN ACADEMY OF NEUROLOGY POLICY ON CONSENT ISSUES FOR THE ADMINISTRATION OF IV TPA
Acute ischemic stroke is a neurological emergency with a time-dependent treatment. IV tPA is recognized as the standard of care—and is approved by the FDA—for qualified individuals who present within 3 hours of ischemic stroke onset. If the patient has decision-making capacity or aproxy decision maker is present, a documented discussion regarding risks, benefits, and alternatives to IV tPA should take place prior to the administration of the medication. Unless required by local practices, a signed informed consent document is not a prerequisite to the administration of IV tPA in these circumstances.
If the patient lacks capacity and no proxy decision maker can be found after a reasonable effort, then the physician may administer the medication based on the principle of implied consent foremergency treatment. The physician and other members of the health care team should document the patient’s absence of decision-making capacity, that attempts to contact a proxy decisionmaker were unsuccessful, and that there is an urgent medical need to proceed with treatment in the absence of consent.
The scientific basis for guidelines regarding the safety and efficacy of IV tPA in relation to the duration of acute stroke symptoms will continue to evolve. Therefore, the standard of care for the administration of IV tPA using the principle of implied consent for emergency treatment will also evolve. When the duration of stroke symptoms exceeds the duration indicated by standard of care for IV tPA administration, the principle of implied consent for emergency treatment is not applicable, and physicians should obtain informed consent. Local practices will determine whether a signed informed consent document is necessary in these cases. Regardless of whether written or verbal consent is required, physicians should document the informed consent discussion in the medical record.
Policy History
Approved by the Ethics, Law and Humanities Committee, a joint committee of the AAN, ANA and CNS, April 11, 2011. Approved by the AAN Board of Directors August 4, 2011.
(AAN Policy 2011-21)