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Nursing Homes: Informed Consent for Psychotropic Medications

Nursing homes must follow certain rules for psychotropic medications labeled with a black boxed warning from the U.S. Food and Drug Administration. These rules apply to nursing home residents who have a degenerative brain disorder.

When to get informed consent

Informed consent is not the first step in managing psychotropic medications for nursing home residents with dementia. First be sure that psychotropic drugs are needed, or your facility may be at risk of receiving a citation. Be prepared to show that the behaviors of dementia being treated have been:

  • Harmful.
  • Persistent.
  • Not caused by some other underlying issue. [42 CFR 483.25]

Underlying issues that could explain the behavior can include:

  • Other illnesses, like infections or untreated chronic conditions.
  • Physical pain.
  • Problems with the environment, such as the room being too hot or too noisy.

For help with understanding behaviors of dementia, visit the Alzheimer's Association website.

If the nursing home has evaluated the resident and shown that the dementia behavior is persistent, harmful, and not from some other issue, then the use of a psychotropic medication may be considered. The nursing home must then:

  • Get informed consent.
  • Monitor medication administration.
  • Try to gradually reduce the dose.
  • Stop the medication as soon as possible.

Remember:

  • No psychotropic medications are approved by the U.S. Food and Drug Administration to treat dementia behaviors.
  • Little or no evidence supports that psychotropic medications effectively treat these behaviors.
  • Residents must be informed of the risks.
  • These drugs must be closely monitored and stopped as soon as possible.

Informed consent laws

  • Under Wis. Stat. § 50.09(1)(n), residents have the right to be fully informed of their treatment. They have the right to take part in planning their own treatment and care.
  • Under Wis. Stat. § 50.08, the nursing home must get written informed consent if a psychotropic drug with a black box warning is prescribed for a resident with degenerative brain disease.
  • Residents with mental illness, developmental disabilities, alcoholism, or drug dependency have rights described in Wis. Stat. § 51.61 and Wis. Admin. code ch. DHS 94. (See specifically Wis. Admin. Code DHS 94.03 on informed consent.)

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Last revised January 12, 2023