Health Letter, October 2021
By Michael Carome, M.D.
If you’re not outraged,
you’re not paying attention!
Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.
Shocking findings presented in a New York Times investigation published on Sept. 11, 2021, revealed that many nursing homes across the U.S. are hiding the true extent to which their residents are being irresponsibly prescribed sedating and potentially deadly antipsychotic drugs to control behavioral problems. According to the New York Times, nursing homes obscure the true prevalence of antipsychotic use by giving some of their elderly dementia patients a phony diagnosis of schizophrenia.
For years, the product labeling for all antipsychotic drugs has included the following stark black-box warning — the strongest warning that the Food and Drug Administration (FDA) can require for an approved medication — highlighting the dangers of using these drugs in elderly dementia patients:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS …
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. [DRUG NAME] is not approved for the treatment of patients with dementia-related psychosis.
The FDA initially required the inclusion of this warning on the labels of all newer “atypical” antipsychotic drugs (for example, Abilify [aripiprazole], Risperdal [risperidone] and Zyprexa [olanzapine]) in 2005. In 2008, the agency expanded this requirement to the labels of all older “conventional” antipsychotic drugs (for example, Haldol [haloperidol] and Thorazine [chlorpromazine]).
The warnings about the increased risk of death were based on analyses of data from 17 placebo-controlled clinical trials involving elderly patients with dementia-related psychosis. Most of these trials tested atypical antipsychotic medications. Over the course of a typical 10-week controlled trial, the rate of death was 4.5% in subjects receiving an antipsychotic drug and 2.6% in those receiving a placebo, which represents a 1.6- to 1.7-fold increased risk. Most of the deaths were due to cardiovascular causes (such as heart failure or sudden death) or infections (such as pneumonia).
Despite these long-standing prominent warnings, physicians for many years have prescribed antipsychotic drugs to too many elderly patients with dementia. According to a 2015 report issued by the U.S. Government Accountability Office, in 2012 about a third of Medicare beneficiaries with dementia who received long-term care in a nursing home were prescribed an antipsychotic medication.
To rein in the overprescribing of antipsychotic drugs to dementia patients in nursing homes, the Centers for Medicare and Medicaid Services (CMS) in 2012 launched the National Partnership to Improve Dementia Care in Nursing Homes. As part of this initiative, CMS required nursing homes to report to Medicare how many residents were prescribed antipsychotic drugs. CMS posts the reported data online and factors antipsychotic prescribing into its public one-to-five–star ratings of nursing homes. The agency in 2012 also began tracking and publishing quarterly data on the prevalence of antipsychotic drug use in long-term nursing home residents.
However, as the New York Times reports, antipsychotic prescriptions for residents with any of three uncommon diseases — schizophrenia, Tourette’s syndrome and Huntington’s disease — are not included in nursing homes’ publicly reported data on use of these drugs, nor are these cases included in CMS’s quarterly data on the prevalence of antipsychotic use in long-term nursing home residents. The reason behind these exclusions was that because these drugs were approved by the FDA to treat patients with those three conditions, nursing homes should not be penalized when antipsychotics were prescribed to such patients.
According to the New York Times investigation, since this loophole in reporting antipsychotic use in nursing home residents was implemented by CMS in 2012, the proportion of residents diagnosed as having schizophrenia has increased implausibly from less than 7% to 11%. Notably, during this same period, the proportion of residents experiencing delusions, a common feature of schizophrenia, decreased from 6% to 4%.
The New York Times described the case of a 64-year-old nursing home resident with severe dementia and no evidence of prior schizophrenia who was prescribed Haldol. The nursing home’s doctor wrote “Add Dx [diagnosis] of schizophrenia for use of Haldol” in the medication order. The patient died eight months later with severe weight loss and pneumonia. The New York Times reported finding a similar pattern of questionable diagnoses in nursing home residents nationwide.
A spokesperson for CMS told the New York Times that the agency is “concerned about this practice as a way to circumvent the protections these regulations afford…It is unacceptable for a facility to inappropriately classify a resident’s diagnosis to improve their performance measures. We will continue to identify facilities which do so and hold them accountable.”
But disturbingly, CMS appears to be complicit in the widespread efforts to cover up dangerous overuse of antipsychotics in nursing homes because lower reported rates of antipsychotic drug use make the agency’s National Partnership to Improve Dementia Care in Nursing Homes look more successful than it really is. CMS reported that the quarterly prevalence has decreased from 24% in the fourth quarter of 2011 to 15% in the fourth quarter of 2020. But according to the New York Times, if nursing home residents diagnosed with schizophrenia are included, “at least 21% of nursing home residents — about 225,000 people — are on antipsychotics.”
CMS must be held accountable too. The agency should immediately begin publicly reporting for each nursing home the prevalence of antipsychotic prescriptions for all residents, including those with schizophrenia, Tourette’s syndrome and Huntington’s disease, and use these total prevalence figures when calculating the public ratings for each nursing home. Likewise, when the agency reports quarterly prevalence of antipsychotic drug use in nursing home residents across the U.S., it must include residents with these three diagnoses.
Until CMS closes the reporting loophole for use of antipsychotics, unscrupulous nursing homes will continue to mislead patients, their families and the public about the true extent of misprescribing of antipsychotic drugs to elderly dementia patients.