Senators push for informed consent before nursing homes use antipychotic drugs

Three US senators are ratcheting up a campaign to slash the misuse of powerful sedatives, known as antipsychotics, in the nation’s nursing homes.

The three — Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn. — have filed a proposal that would require federal regulators to issue standardized rules for nursing homes to follow in seeking permission from patients, or their designated health care agents, such as a family member, before administering antipsychotics for so-called off-label use.

The Food and Drug Administration (FDA) has approved antipsychotic drugs to treat an array of psychiatric conditions such as schizophrenia, but physicians are allowed to prescribe antipsychotics “off-label’’ for other illnesses.


Numerous studies have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. Twice in the past decade, the FDA issued “black box’’ warnings — the agency’s most serious safety alert — citing increased risk of death when these drugs are used to treat elderly patients with dementia.

“We need a new policy that helps to ensure that these drugs are being appropriately used to treat people with mental illnesses, not used to curb behavioral symptoms of Alzheimer’s or other dementias,’’ Kohl said in a statement.

Federal data show that roughly 185,000 nursing home residents in the United States received antipsychotics in 2010 contrary to federal nursing home regulators’ recommendations — often elderly people who have Alzheimer’s or other dementias, according to an investigative series last month in the Boston Globe.

The data show that in more than one in five nursing homes in the United States, antipsychotics are administered to a significant percentage of residents despite the fact that they do not have a psychosis or related condition that nursing home regulators say warrants their use. The proportion of homes using antipsychotic drugs , such as Seroquel and Risperdal, in this fashion is even higher in Massachusetts.


The proposal by the senators would require nursing homes to provide information about the possible risks and side effects associated with antipsychotic medications, as well as alternative treatment options, before administering the drugs for off-label use.

The proposal, made as an amendment to pending legislation, also calls for a new prescriber education program to promote high-quality, evidence-based treatments, including ones that do not involve antipsychotics. The prescriber education programs would be funded through settlements, penalties and damages recovered in cases related to off-label marketing of prescription drugs.

Several pharmaceutical companies have paid millions of dollars in fines for illegally marketing antipsychotic drugs for off-label uses, often to doctors who prescribe them in nursing homes.

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