(New York) – The United States government has proposed new rules for facilities administering antipsychotic drugs that would increase the risks to older people, Human Rights Watch said today. Human Rights Watch submitted formal comments to the Centers for Medicare and Medicaid Services (CMS), the government regulator for nursing facilities in the United States.

Under US regulations, a physician or prescriber must evaluate every 14 days a person who is being given antipsychotic drugs on an as-needed basis. The proposed rule would lengthen the review period for most residents to every 70 days, decreasing prescriber supervision for drugs that increase the risk of death when used for older people with dementia. 

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“Older people face a documented threat of overmedication with potentially dangerous drugs in US nursing homes,” said Bethany Brown, researcher on older people’s rights at Human Rights Watch. “The proposed rules appear to heighten the risk to older people and should be withdrawn.”

Human Rights Watch urged CMS to withdraw the proposed changes and instead improve enforcement of existing protections against overuse of antipsychotic medications. These drugs can be inappropriately used to control people’s behavior or for staff convenience – a practice known as chemical restraint – rather than to treat medical symptoms. They also pose special health risks to older people with dementia.

CMS should ensure that nursing home residents and their families are informed of treatment alternatives and have the right to refuse medication. The government should also ensure that  nursing  homes employ sufficient staff to provide supportive care to residents rather than using chemical restraint.

In a 2018 report, “‘They Want Docile’: How Nursing Homes in the United States Overmedicate People with Dementia,” Human Rights Watch documented US nursing facilities’ inappropriate use of antipsychotic drugs in older people as well as the administration of the drugs without informed consent. This practice occurred mostly as a result of inadequate enforcement of existing laws and regulations.

Nursing home residents who had been subjected to overmedication told Human Rights Watch about the trauma of losing their ability to communicate, think, and remain awake. Their family members described the pain of witnessing these losses in loved ones.

The US Food and Drug Administration (FDA) has never approved antipsychotic drugs for use in older people with dementia and warns against their use for symptoms of dementia. Clinical research has found that on average, antipsychotic drugs almost double the risk of death in older people with dementia.

CMS is facing scrutiny from the US House of Representatives Ways and Means Committee for  failing to enforce existing regulations regarding inappropriate antipsychotic drug use in nursing homes.

“The Centers for Medicare and Medicaid Services should improve protection for nursing home residents by enforcing existing rules, not look for ways to lower the bar,” Brown said. “Residents should have the support they need to live in dignity.”