Informed Consent for Psychotropic Medications for Nursing Home Residents
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: http://www.alz.org/living_with_alzheimers_behaviors.asp
(exit DHS)
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 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. http://www.legis.state.wi.us/statutes/Stat0050.pdf
Informed Consent Forms
Informed Consent Form Instructions
Informed Consent Q&A
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Last Updated: October 20, 2011
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