Antipsychotics for nursing home residents with dementia: Chemical restraints or essential therapeutic intervention?

Abstract

In this issue of the Journal of the American Geriatrics Society, Dr. Theresa Shireman and her colleagues from Brown University and the University of Michigan make the case that federal policies on antipsychotics were not responsible for the increased rates of exclusionary diagnoses in U.S. nursing homes (diagnoses for which antipsychotic use is appropriate, including schizophrenia, Tourette's syndrome, and Huntington's disease) during the period of 2009–2018.¹ Five years after this data collection period ended, in January of 2023, the Centers for Medicare and Medicaid Services (CMS) announced plans to conduct audits of schizophrenia coding and related antipsychotic prescription in nursing homes, and for facilities that fail the audit, adjust the overall quality measure component of their Five-Star rating for six months downward to a rating of one Star. This would have the net effect of dropping a nursing home's overall Five-Star rating by one star.² Five-Star ratings are calculated based on quality measures, as well as health inspection (survey) results, nursing staffing levels, and nurse and administrator turnover. These ratings are meant to be used by consumers to select nursing homes, and a drop of one star could negatively affect a nursing home's census and revenue by influencing potential patient and family perceptions, and in some cases, make the facility ineligible for Medicare Advantage program waivers of the 3-day hospital stay requirement and the ability to directly admit people from home or the Emergency Department. These waivers generally require a minimum three-star rating.

The use of antipsychotics as “chemical restraints” in nursing home residents with dementia and related behavioral symptoms, such as verbal agitation and physical aggression, has been discussed in the medical literature and lay press for decades. Many studies document that these drugs are associated with an increase in all-cause mortality and the risk of stroke and myocardial infarction among older people, nursing home residents in general, and nursing home residents with dementia in particular.^{3, 4} Antipsychotics may impair glucose tolerance and are associated with weight gain and obesity, can be sedating and cause hypotension, and can have significant extrapyramidal side effects, including tardive dyskinesia, gait disturbances, and bradykinesia. These side effects can in turn not only lead to metabolic and cardiovascular consequences but can increase the risk of conditions that cause mortality. For example, hypotension and effects on mentation and mobility can increase the risk of falls and related injuries, as well as death. Sedation and altered mental status can also interfere with quality of life by reducing the ability to participate in various activities, and exercise, as well as predispose to aspiration and complications including death. Not all studies demonstrate these adverse effects in nursing home residents with dementia, and despite propensity matching in many of the studies, there is a risk of residual confounding and confounding by indication (sicker individuals with dementia may be prescribed antipsychotics more often). But, there is enough evidence for the U.S. Food and Drug Administration (FDA) to have issued a “black box warning” to alert healthcare professionals and patients of the risks associated antipsychotics (Figure 1).

The main driver that prompted the CMS nursing home schizophrenia audits is the appearance of new diagnoses of schizophrenia and schizoaffective disorder in residents aged 65 and older without adequate documentation of: (1) a history of these conditions; (2) how residents meet the DSM-5 criteria for these diagnoses⁵; (3) what evaluations have been done to exclude an underlying illness from causing or contributing to the symptoms; (4) what non-pharmacologic interventions have been used; (5) the results of any attempts at gradual dose reduction of the antipsychotic(s) for residents who are taking these drugs; or (6) an appropriate indication for antipsychotic medication (Table 1). The prevalence of schizophrenia in people aged 65 and older is estimated to be between 0.1% and 0.5%. This is relatively rare, as the typical age of onset for schizophrenia is in the 20s. However, about 15%–20% of all cases of schizophrenia are late-onset, meaning symptoms first appear after age 44.⁶ Thus, the new onset of schizophrenia or schizoaffective disorder in nursing home residents aged 65 and older is extremely rare.

Despite the data presented by Shireman et al. that reflect practice through 2018, results of the first year of CMS antipsychotic audits have documented that several nursing homes have multiple (in some cases ten or more) residents aged 65 and older with the new diagnosis of schizophrenia or schizoaffective disorder, without meeting any of the criteria in Table 1. Nursing homes who failed an audit and had their quality rating downgraded are noted on the CMS Care Compare website.⁷ Although some of these nursing homes may “specialize” in the care of residents with serious mental illness, and they are the only facility in a wide geographic area that will accept such residents, this does not preclude them from documenting appropriate evaluation and diagnosis for antipsychotic prescriptions in their resident population.

CMS and the Veterans Administration have undertaken initiatives to reduce the prescription of antipsychotics with modest success,^{8, 9} and one randomized controlled trial in 16 nursing homes in the United Kingdom concluded that it is possible to reduce antipsychotic prescription, but that it may not be of benefit to people with dementia unless nonpharmacological interventions such as social interaction or exercise are provided.¹⁰ Non-pharmacologic interventions using the DICE approach (Describe, Investigate, Create, Evaluate)¹¹ and other behavioral interventions have been shown to be effective in some studies, but they can be challenging to implement, due to limited staff and frequent staff turnover in most U.S. nursing homes. Another strategy that has apparently gained widespread use is the substitution of gabapentin and other antiepileptic drugs for antipsychotics without evidence of their efficacy or an FDA approved indication.^{12, 13} Although nursing homes can suffer regulatory and financial consequences for inappropriate use of these medications, prescribers should also hold some accountability for these prescriptions. One randomized trial involving over 5000 primary care physicians identified by CMS as high prescribers of quetiapine demonstrated that physician antipsychotic overprescribing warning letters safely reduced prescribing to their patients with dementia.¹⁴ There is also evidence from a cluster randomized trial in 18 nursing homes in Norway that a stepwise approach to treating pain can reduce behavioral symptoms in residents with moderate to severe dementia.¹⁵ The fact that behavioral symptoms in this population can be reduced by addressing unrecognized pain is a clinical pearl that clinicians who care for nursing home residents should always keep in mind.

There is now one antipsychotic medication that has gained FDA approval specifically for the treatment of agitation in Alzheimer's disease. Brexpiprazole was originally approved in 2014 and close to 10 years later has been shown in a 12-week randomized controlled trial in 345 patients (302 completed the trial with a mean age of 74, about 55% female) to be associated with a significant reduction in agitation as measured by the Cohen-Mansfield Agitation Inventory.¹⁶ This inventory has a possible range of scores of 29–203, with a score higher than 45 indicating clinically significant agitation. Both groups in this trial had a baseline mean score of approximately 80, with the brexpiprazole treated patients having a mean reduction of 22.6 versus 17.3-point reduction in the placebo group, resulting in a mean least-squares difference of 5.3 (p = 0.003). Overall the mean within patient reductions in both groups have been considered as “much improved”,¹⁷ but the mean difference, although statistically significant, is not close to a 17-point difference, which has been reported as the minimal clinically important difference (MCID) on the Inventory.¹⁸ Although approved, this drug can still be associated with the aforementioned side effects. Thus, the impact of this newly approved drug on the outcomes of nursing home residents with dementia and behavioral symptoms should be closely studied and monitored in post-approval surveillance over the next few years.

To be sure, there is substantial amount of inappropriate prescription of antipsychotic drugs in U.S. nursing homes, and they are still some cases in which these drugs are used as “chemical restraints”. But there is a flip side to the story. For some nursing home residents, not just those who have a well-documented exclusionary diagnosis, antipsychotics can be an essential therapeutic intervention. Most clinicians who read JAGS have had experiences with residents like the ones I have cared for over the last 40 years. Residents with moderate and advanced dementia who are “agitated” and “aggressive” are among the most challenging to manage. They often do not have durable responses to re-direction and other non-pharmacologic measures such as physical and social activities, music, and pet therapy. If you have not yet seen Teepa Snow, an internationally recognized occupational therapist who specializes in care of older people with dementia, imitate such a person, you must.¹⁹ You will immediately resonate with her amazing ability to portray the symptoms that are so bothersome to caregivers and the person her or himself.

Here is the rub: some of these individuals are in fact psychotic, and the use of antipsychotics IS appropriate to prevent danger to themselves or others, to make essential care feasible to perform, to treat intense psychological distress, and to prevent major declines in function and quality of life. Just last week during nursing home teaching rounds, I saw a patient admitted from the hospital with moderately advanced dementia and residual delirium who was verbally agitated and resisting care because she wanted to see her mother. When I asked her about her mother, she became visibly agitated and tearful, and said something to the effect of “… the people who work here killed her and now they want to kill me”. This is a clear example of a patient in whom antipsychotic use would be appropriate to manage her distressing and disruptive paranoid delusions; a qualifying diagnosis is not necessary in this clinical scenario. A similar situation occurred with my mother, Mama O, who sold her cookbooks at annual AGS meetings to help support travel for students to present their research at the meeting. Mama O lived with my wife and I for the last three years of her life while suffering from the stepwise deterioration of multi-infarct dementia. She taught me a lot of lessons about Geriatrics that you cannot get by reading research papers and textbooks.^{20, 21} Despite placing a bedside commode next to the head of her bed, she got up one night and on the way to the bathroom fell and fractured her hip. Two days after admission to a local nursing home for postsurgical rehabilitation she became extremely agitated and started scratching and hitting the nursing staff during their attempts to provide routine care. When I arrived at the facility I asked Mama O what happened, she said: “… last night the police came in and took me to the basement and assaulted me. I'm afraid they will do it again.” The staff wanted her treated with an antipsychotic, which certainly was justified given her paranoid delusion. But, after we talked she calmed down and her delusion did not recur avoiding the need for drug treatment.

So, are antipsychotics in nursing home residents with dementia chemical restraints or an essential therapeutic intervention? My answer is the two words I always use whenever a patient, family member, staff, colleague, or trainee ask me a clinical question: “It depends”. In this situation, it depends on whether criteria outlined in Table 1 are met. Moreover, Geriatrics is all about person-centered care.²² If the patient/resident has a well-documented qualifying diagnosis, or has another appropriate indication for prescribing an antipsychotic, and they or their surrogate decision-maker perceives that the benefits of drug treatment outweigh the risks given their preferences, willing to take risks, and their previous experiences, then prescription of an antipsychotic should be considered an essential therapeutic intervention when non-pharmacologic interventions are ineffective, not a chemical restraint.

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The author declares no financial conflicts of interest.

None.