“They are leaving out the primary component, and that is regulation,” said Janet Wells, a public policy consultant for California Advocates for Nursing Home Reform. Setting goals and educating nursing home staff about overuse is a good place to start, but she and others say it's not enough. “Goal-setting is not going to get us to protecting all residents who are being given these drugs,” she said.
In a letter sent in July to the CMS (PDF), representatives from California Advocates for Nursing Home Reform, the Center for Medicare Advocacy, National Consumer Voice for Quality Long-Term Care and the Long Term Care Community Coalition said they could not endorse a proposal that “promotes paltry, numerical goals that many nursing homes ignore with impunity.” They also said the goals would still allow nursing homes to use antipsychotics for thousands of nursing home residents.
The overuse of antipsychotics in nursing home patients, and the negative outcomes associated with their use are well-documented. In April 2005, the Food and Drug Administration issued an alert about the increased risk of mortality in elderly patients receiving atypical antipsychotic drugs to treat dementia-related psychosis following a review of 17 placebo-controlled trials. The studies found increased risk of heart failure, sudden death and pneumonia, among other issues. A black-box warning was later added to the prescribing label.
Among patients 65 and older, antipsychotic drug use was associated with a higher risk of hospitalization from acute kidney injury, as well as increased incidence of low blood pressure, the inability to urinate and all-cause mortality, a Canadian study published in August in the Annals of Internal Medicine found.
Almost 150,000 Americans are being inappropriately prescribed antipsychotic drugs and their use contributes to an estimated 1,800 deaths a year, according to the Alzheimer's Association. Of 2.1 million elderly nursing home residents, about 14% had at least one Medicare claim for an atypical antipsychotic drug from Jan. 1 to June 30, 2007, according to a 2011 analysis by HHS' Office of the Inspector General. Claims for elderly nursing home residents accounted for 20% of the total 8.5 million claims for atypical antipsychotic drugs for all Medicare beneficiaries, at a cost of $309 million, the OIG found.
“Where's the outrage?,” asked Richard Mollot, executive director of the Long-Term Care Community Coalition. Though he lauds CMS for efforts to elevate the issue, he is disappointed the agency has not taken stronger regulatory steps. “It concerns me greatly that they are characterizing this as something forceful. It is not even adequate”
The CMS plans to incorporate a measure of the use of antipsychotic drugs into its nursing home star-rating system for consumers, which it launched in 2008.
At last week's CMS news conference, Mark Parkinson, CEO of the American Health Care Association, which represents about 10,000 U.S. nursing homes, said the CMS-led effort to reduce antipsychotic drug use “is really a fantastic success story of provider groups coming together with CMS.” His group, he said, began educating members, pushing out best practices, and holding seminars. “The results speak for themselves. Behind each of those percentages are literally thousands of lives that are being improved.”
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