The new requirements for written informed consent involve psychotropic medications labeled with a boxed Food and Drug Administration (FDA) warning prescribed to nursing home residents who have degenerative brain disorder.
Informed consent is not the first step in managing psychotropic medications for nursing home residents with dementia. If psychotropic medications are used to treat behaviors of dementia, nursing homes are required to show that the behaviors that are being treated have been harmful, persistent and not caused by some other underlying issue 42CFR483.25(1). Underlying issues can include other illnesses, like infections or pain that may lead to behaviors. Underlying issues may also be environmental issues such as being too hot or the room being too noisy. For help with understanding behaviors of dementia please see the Alzheimer's Association website.
If a nursing home resident is placed on a psychotropic medication and the nursing home does not go through the process of showing that behaviors were persistent, harmful and not from other reasons, the facility is at risk of receiving a citation.
If the nursing home has completed an appropriate evaluation demonstrating that the dementia behavior is persistent, harmful and not from some other medical, environmental or social issue, the facility may determine that use of a psychotropic medication for the behavior is appropriate. The nursing home must then obtain informed consent, monitor the medication, attempt gradual dose reductions and discontinue the medication as soon as possible.
Remember that there are no psychotropic medications that are FDA approved to treat dementia behaviors. There is also very little or no literature to support that psychotropic medications are effective in treating behaviors. Residents must be informed of the risks and the medications need to be closely monitored and discontinued as soon as possible.
Informed Consent Requirements:
- Under Sec 50.09 (1)(n) Wis. Stats. Residents have the right to be fully informed of their treatment and to participate in the planning of the resident's treatment and care.
- Under Wis. Stats. 50.08 residents in a nursing home with degenerative brain disease who are prescribed a psychotropic medication labeled with a boxed warning are specifically required to receive written informed consent.
- Individuals receiving services for mental illness, developmental disabilities, alcoholism or drug dependency have rights specified under Wis. Stats. 51.61 and Wis. Admin. code ch. DHS 94. (See specifically Wis. Admin. Code DHS 94.03 Informed consent.)
Refer to the Informed Consent Requirements in Nursing Homes, P-00336 (PDF) for additional information.