The Never-Ending Misuse of Antipsychotics In Nursing Homes

May 31, 2018

In response to a generic question about post-market drug surveillance posed during a February 2007 House Energy and Commerce Committee hearing, Dr. David Graham, then associate director of science and medicine in the Food and Drug Administration’s (FDA’s) Office of Surveillance and Epidemiology, stated: “I would pay careful attention to antipsychotic medications. … The problem with these drugs are that we know that they are being used extensively off label in nursing homes to sedate elderly patients with dementia … . It is known that the drugs don’t work in those settings. … But the fact is, is that it increases mortality perhaps by 100 percent. It doubles mortality. So I did a back-of-the-envelope calculation on this and you probably got 15,000 elderly people in nursing homes dying each year from the off-label use of antipsychotic medications for an indication that FDA knows the drug doesn’t work. This problem has been known to FDA for years and years and years.”

Despite this candid and somewhat remarkable admission, nothing happened in response. Sadly, that indifference is not surprising; the problem of antipsychotic drug misuse in nursing homes has been raised to policy makers going back six decades.

For example, in 1975, the Senate Special Committee on Aging published a series of papers collectively titled “Nursing Home Care in the United States: Failure in Public Policy.” Included in the committee’s description of ongoing “scandal and abuse” in nursing home care dating back to the 1950s was a finding that “perhaps most disturbing is the ample evidence that nursing home patients are tranquilized to keep them quiet and to make them easier to take care of.”

Eleven years later in 1986, the Institute of Medicine (IOM) revisited nursing home care quality, producing a report titled, “Improving the Quality of Care in Nursing Homes.” Citing the misuse of antipsychotic drugs among many factors, the authors concluded that “over the past 15 years many studies of nursing home care have identified both grossly inadequate care and abuse of residents.”

One year after the IOM report was published, the Nursing Home Reform Act of 1987 was signed into law. The law established survey, certification, and enforcement processes intended to ensure, in part, residents’ care quality and quality of life. The law also created a nursing home residents’ “bill of rights” that included the right to be free from abuse and mistreatment, the right to self-determination, and the right to be fully informed.

Reform legislation, however, did not dampen the use of antipsychotics, for example, Haldol, Seroquel, and Risperdal, among others. Misuse continued unabated. For example, a 2011 report by the Department of Health and Human Services’ Office of Inspector General found that in 2007 14 percent of Medicare nursing home residents had claims for an antipsychotic drug and 83 percent of these claims were for off-label use, or use for which there was no clinical indication. By 2010, the Centers for Medicare and Medicaid Services (CMS), the agency largely responsible for enforcing the Nursing Home Reform Act, reported nearly 40 percent of nursing home residents who had no diagnosis of psychosis received antipsychotic medications.

They Want Docile

With decades of documented abuse and more than one million Americans older than age 65 currently residing in 15,000 nursing homes, two-thirds of whom are women, and with a rapidly aging population that is projected to triple the number of adults with dementia, it is not surprising that the Human Rights Watch (HRW) has now weighed in on the problem. In 2016 and 2017, the HRW, whose mission is to uphold human dignity and advance the cause of human rights, visited 109 nursing homes in six states with the highest number of nursing home residents and the highest proportion of residents on antipsychotic medications, that is, California, Florida, Illinois, Kansas, New York, and Texas. The organization also interviewed more than 320 nursing home residents, facility staff and administrators, and various experts in the field and made a detailed analysis of CMS’s regulatory enforcement efforts. Its overarching conclusion is made evident in its February report’s title, “ ‘They Want Docile:’ How Nursing Homes in the United States Overmedicate People with Dementia.”

“Nursing facilities in the US,” the HRW report found, “use antipsychotic medications on a massive scale.” The HRW estimated on an average week nursing homes administer antipsychotic drugs to more than 179,000 residents who do not have a diagnosis for which antipsychotic medications are approved. The report cites CMS’s own data that estimates 16 percent of long-stay nursing home residents, or those residing in a nursing home for more than 100 days, received an antipsychotic medication without one of three exclusionary diagnoses: schizophrenia, Huntington’s disease, or Tourette’s syndrome.

The impetus or motivation for misuse is obvious: convenience. These drugs can control behavioral and psychological symptoms associated with dementia, for example, aggression, agitation, irritability, and wandering. As one 62-year-old woman who was administered Seroquel without her consent, the medication was mixed in with her food, told the HRW, “[It] knocks you out. It’s a powerful, powerful drug. I sleep all the time. I have to ask people what the day is.” With residents effectively narcotized, nursing homes, of which 70 percent are for-profit, are able to significantly reduce staffing levels. The report states that, “the conditions in about 20 of the 109 facilities visited, across all six states, were disturbingly grim … many facilities visited on weekends appeared to be severely understaffed … [we] encountered residents who desperately needed an aide to help them use the bathroom.”

Particularly disturbing is the fact that these drugs carry severe potential side effects including blood clots, diabetes, dyskinesia, fall risk, irreversible cognitive decompensation, pneumonia, severe nervous system problems, stroke, visual disturbances, and, again, death. This explains why these drugs have come with an FDA black-box warning label since 2008 cautioning their use for patients with dementia-related psychosis. While the report notes FDA studies that found the use of antipsychotics almost doubles the risk of death in older people with dementia, a 2015 study published in JAMA Psychiatryfound mortality risk may actually be higher and increases with the dosage.

The HRW also found that these medications are frequently administered without residents’ or their families’ or surrogates’ free and informed consent or, again, even without their awareness. (The Nursing Home Reform Act does not provide for express, written informed consent.) The HRW report identified several variations on this theme. In addition to secretively administering antipsychotics, the report found nursing homes do not identify the drug as an antipsychotic; claim the resident would get hurt without such medication; guilt the family into agreeing to consent; fail to note potential side effects or risks; threaten discharge; schedule a meeting after administering the antipsychotic claiming they tried to contact the family member or surrogate; or argue they do not know what the consent process is. All these techniques are perversely reinforced by CMS’s decision last year to reverse the agency’s policy on binding arbitration. In 2016, the agency argued that arbitration agreements have a deleterious impact on the quality of nursing home care by effectively reducing accountability. However, last year CMS reversed its decision and allowed nursing homes to deny admission to those refusing to sign an arbitration agreement.

In 2012, CMS did create a voluntary program titled the National Partnership to Improve Dementia Care in Nursing Homes. Last fall, the agency reportedpartnership efforts had reduced the national prevalence of antipsychotic use in long-stay nursing home residents without psychosis from 24 percent in 2011 to 16 percent in 2016. While these results are encouraging, there has been no formal evaluation of the program, so it is unclear whether this reduction is due to the partnership or the result of increased industry attention.

The HRW also found “several significant shortcomings in nursing home enforcement of federal regulations” relative to the misuse of antipsychotics. For the 30-month-period ending June 30, 2017, of the 7,000 deficiency reports related to antipsychotic drugs, the HRW found that less than 2 percent were categorized by state health officials as higher-level or level 3 or level 4 deficiencies, or as “actual harm” or “immediate jeopardy” respectively. “This apparently systematic underestimation of the severity or harm,” the HRW wrote, “appears to point to woefully inadequate enforcement and protection of nursing home residents’ rights.” Similarly, the HRW also found that 80 percent of fines assessed in all states for this same time period were less than $10,000. Because financial penalties were trivial to modest, those nursing homes fined for antipsychotic use-related deficiencies had in the following year no statistically significant difference in the rate of change in antipsychotic drug use than those nursing homes not fined. The HRW concluded bluntly, “CMS is not using its full authority to force them [nursing homes] to improve their performance.”

Recommendations

In light of 60 pages of findings, the report makes numerous federal and state-level recommendations. Thematically, the HRW emphasized ensuring adequate staffing, free and informed consent, regulatory enforcement, and transparency measures. For example, the HRW recommends that Congress reintroduce 2015 legislation (HR 952) that would have required at least one registered nurse to be on duty at all times. The HRW also recommends the full implementation by CMS of Section 6106 of the Affordable Care Act, which requires nursing home staffing data be publicly reported. For unexplained reasons, CMS has to date failed to accomplish this task. States should pursue similar policy goals.

Concerning informed consent, the HRW encourages regulators to develop and disseminate, including publicly posting, shared decision-making tools. Regulators should also maximize the use of advanced directives, conduct targeted public service campaigns, and make informed consent a nursing home ombudsman program priority. Again, states should take the lead. In 2009, the California legislature to its credit passed related legislation; however, it was vetoed by then-Governor Arnold Schwarzenegger.

Based on the HRW’s profiling, Kansas, the state that ranks worst in the nation in misuse of antipsychotics in nursing homes, has recently introduced legislation, HR 2704, that would require nursing homes obtain written consent from nursing home residents or their guardians prior to administering medications. Successful passage is unlikely since the bill is opposed by both the Kansas Medical Society, which represents state physicians, and the Kansas Hospital Association. It appears that none of the remaining five states the HRW profiled are attempting to legislate similar informed-consent reforms.

The HRW identifies numerous enforcement opportunities. As suggested above, CMS should begin to use its full enforcement authority. For example, inappropriate use of antipsychotics should automatically be reported as level 3 or 4 violations and create an explicit or discrete reporting tag (so called f-tags), identifying the misuse of antipsychotics. Make publicly available enforcement data at the nursing homeownership-level, and use the full weight of law: not only the Nursing Home Reform Act but also all protections and authority under the Americans with Disabilities Act, the Civil Rights of Institutionalized Persons Act, the False Claims Act, the Food, Drug and Cosmetic Act, the Older Americans Act, and others. Although the US has signed but not ratified the international Convention on the Rights of Persons with Disabilities, which protects the disabled from cruel, inhuman, or degrading treatment or punishment, the US should honor it.

It appears unlikely that any of these recommendations will be effectively acted upon at least in the near term. It is encouraging that this past fall CMS’s national dementia partnership announced a goal to reduce the misuse of antipsychotics among long-stay nursing home residents by an additional 15 percent by 2019. Yet, in the partnership’s most recent report dated June 3, 2016, there is no mention of greater or more accurate regulatory deficiency enforcement nor any mention of, for example, sanctions.

Moreover, last year the administration placed an 18-month moratorium on imposing civil monetary penalties on nursing homes. Included on the moratorium list of things for which nursing homes cannot currently be penalized: the misuse of psychotic medications. CMS explained the moratorium by stating, “providers are spending time complying with regulations that get in the way of caring for their patients.” The moratorium comes on the heels of several other actions taken by CMS to reduce nursing home regulatory oversight. In addition to its reversal last June on arbitration as noted above, the agency issued a memo in July recommending to state agencies that in surveying nursing homes they issue one-time fines instead of daily fines for noncompliance that began prior to an inspection. Then in October, an agency memo recommended that CMS regional offices not levy fines against nursing homes for one-time mistakes.

“Care for older persons in need of long-term attention,” the Senate Special Committee on Aging concluded in 1975, “should be one of the most tender and effective services a society can offer to its people.” It’s not. The HRW report provides the latest evidence that despite more recent industry improvements nursing homes remain our most troubled and troublesome health care provider. Sadly, tragically, Dr. Graham’s estimate of annual deaths via the misuse of antipsychotics continues apace.