WASHINGTON - Senators Herb Kohl, D-Wis., Chuck Grassley, R-Iowa, and Richard Blumenthal, D-Conn., have introduced bipartisan legislation to address the growing costs and concerns about the overuse of antipsychotics in nursing homes and other long-term care facilities.
The Improving Dementia Care Treatment in Older Adults Act, S. 3604, would require the Secretary of Health and Human Services to develop a standardized protocol for obtaining informed consent prior to administering antipsychotics. The bill also would create prescriber education programs to promote evidence-based treatments using objective informational materials. The legislation would also use the drug regimen review process already in place at nursing homes to produce a monthly aggregate report of antipsychotic utilization for each facility.
"Despite the black box warnings and numerous multi-billion dollar settlements levied against pharmaceutical manufacturers for illegal off-label marketing, we continue to see an alarming number of dementia patients in nursing home and assisted living facilities being prescribed antipsychotics off-label to deal with agitation or other behavioral issues," Kohl, chairman of the Senate Special Committee on Aging, said. "Our legislation provides some straightforward and commonsense steps that will help decrease the improper, dangerous and costly use of antipsychotics and accelerate the shift toward the broader use of safer alternatives."
"The safety and dignity of older nursing home residents, in particular, is at risk because of a growing use of antipsychotic drugs for symptoms related to conditions other than those the drugs are effective in treating. Alzheimer's victims and older people with other dementia are particularly at risk for receiving these drugs inappropriately," Grassley said. "The overprescribing has negative consequences for taxpayers, too, with most nursing home residents dependent on Medicaid. The potential for abusive prescribing would be rightly curbed by the reforms in our legislation."
"Excessive prescription of antipsychotic drugs in nursing homes is elder abuse - plain and simple. It is chemical restraint, as pernicious and predatory as unnecessary physical restraint. While these drugs have warnings against using them for patients with dementia, an alarming majority of claims are for patients with dementia," said Blumenthal. "We must to do more to protect consumers from this blatant misuse and encourage responsible use of antipsychotic drugs."
The legislation is based on findings in a report last year from the Inspector General for the Department of Health and Human Services, a study published in the Journal of the American Medical Association, a heightened warning about such drug use from the Food and Drug Administration, and lawsuits associated with the overutilization of antipsychotics.
The Food and Drug Administration has approved antipsychotic drugs to treat numerous psychiatric conditions, but studies conducted during the last decade 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.
Despite warnings from the Food and Drug Administration and the medical research community, antipsychotic prescription rates in long-term care facilities for patients with dementia and no diagnosis of psychosis remain high. The Inspector General report issued in 2011 found that 305,000, or 14 percent, of the nation's 2.1 million elderly nursing home residents had at least one claim for these drugs. The report said 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with the condition specified in the warning issued by the Food and Drug Administration.
The senators said they hope to have their legislation considered by the end of this year, along with a number of Medicare payment issues that Congress must address before the end of the session.