I have a thick tongue when they do that. I ask them not to [give me the antipsychotic drugs]. When I say that, they threaten to remove me from the [nursing] home.
It used to be like a death prison here. We cut our antipsychotics in half in six months. Half our residents were on antipsychotics. Only 10 percent of our residents have a mental illness. In an average week, nursing facilities in the United States administer antipsychotic drugs to over , people who do not have diagnoses for which the drugs are approved. The drugs are often given without free and informed consent, which requires a decision based on a discussion of the purpose, risks, benefits, and alternatives to the medical intervention as well as the absence of pressure or coercion in making the decision.
While these symptoms can be distressing for the people who experience them, their families, and nursing facility staff, evidence from clinical trials of the benefits of treating these symptoms with antipsychotic drugs is weak. Studies find that on average, antipsychotic drugs almost double the risk of death in older people with dementia. When the drugs are administered without informed consent, people are not making the choice to take such a risk.
They can also make it easier for understaffed facilities, with direct care workers inadequately trained in dementia care, to manage the people who live there.
In many facilities, inadequate staff numbers and training make it nearly impossible to take an individualized, comprehensive approach to care. Many nursing facilities have staffing levels well below what experts consider the minimum needed to provide appropriate care.
Federal regulations require individuals to be fully informed about their treatment and provide the right to refuse treatment. Some state laws require informed consent prior to the administration of antipsychotic drugs to nursing home residents.
Yet nursing facilities often fail to obtain consent or even to make any effort to do so. While all medical interventions should follow from informed consent, it is particularly egregious to administer a drug posing such severe risks and little chance of benefit without it. Such nonconsensual use and use without an appropriate medical indication are inconsistent with human rights norms. The US has domestic and international legal obligations to protect people who live in nursing facilities from the inappropriate use of antipsychotic drugs, among other violations of their rights.
These obligations are particularly important as people in nursing facilities are often at heightened risk of neglect and abuse. Many individuals in nursing facilities are physically frail, have cognitive disabilities, and are isolated from their communities. Often, they are unable or not permitted to leave the facility alone.
On paper, nursing home residents have strong legal protections of their rights, but in practice, enforcement is often lacking. The US government should use its full authority to enforce longstanding laws, including by penalizing noncompliance to a degree sufficient to act as an effective deterrent, to end this practice. The report is based on visits by Human Rights Watch researchers to nursing facilities, mostly with above-average rates of antipsychotic medication use, between October and March in California, Florida, Illinois, Kansas, New York, and Texas; interviews with people living in nursing facilities, their families, nursing facility staff, long-term care and disability experts, officials, advocacy organizations, long-term care ombudsmen, and others; analysis of publicly available data; and a review of regulatory standards, government reports, and academic studies.
This report is especially relevant at this time because the US is aging rapidly. Most of the people in the nursing facilities Human Rights Watch visited are over the age of Older people now account for one in seven Americans, almost 50 million people.
The number of older Americans is expected to double by The system of long-term care services and supports will have to meet the needs—and respect the rights—of this growing population in coming years. Instead, antipsychotic drugs are used sometimes almost by default for the convenience of the facility, including to control people who are difficult to manage.
Most or all antipsychotic drugs are associated with sedation and fatigue in people with dementia. A year-old woman in a nursing facility in Texas who said she was given Seroquel, a common antipsychotic drug, without her knowledge or consent said: I sleep all the time. I have to ask people what the day is. The fight is gone. One director of nursing said: The practicalities of obtaining consent from an older person with dementia can be fraught.
However, in many of the cases Human Rights Watch documented, nursing facilities made no effort to obtain meaningful, informed consent from the individual or a health proxy before administering the medications in cases where it clearly would have been possible to do so. Our research suggests that in many other cases, facilities that purport to seek consent fail to provide sufficient information for consent to be informed; pressure individuals to give consent; or fail to have a free and informed consent procedure and documentation system in place.
Under international human rights law, in the absence of free and informed consent, a nonemergency medical intervention that is not necessary to address a life-threatening condition is forced treatment. One former nursing facility administrator explained: The facility usually gets informed consent like this: This is going to help her. They gloss over them.
And, by the way, we already started them on it. But really antipsychotics are a go-to thing. The family is notified. I had no idea Because many people living in nursing facilities have dementia and other progressive conditions that affect their cognitive ability, it is a highly complex question how medical and other decisions concerning their care should be made in a rights-respecting manner. While the initiative—which set targets for the industry to reduce antipsychotic drug rates—may have contributed to the reduction of the use of antipsychotic medications over the last six years, it cannot substitute for the effective regulation of nursing homes, including by ensuring that facilities face meaningful sanctions for noncompliance with mandatory standards.
Our research found that CMS is not using its full authority to address this issue. Recently, CMS is in fact moving in the opposite direction, limiting the severity of financial penalties and the regulatory standards with which facilities must comply.
CMS and the state agencies with which it contracts to enforce federal regulations are not meeting their obligation to protect people from the nonconsensual, inappropriate use of antipsychotic drugs.
Human Rights Watch identified several key areas of concern: Failure to adequately enforce the right to be fully informed and to refuse treatment or to require free and informed consent requirement. If it were enforced fully, these protections would not differ substantially from the right to free and informed consent. However, without adequate enforcement, current practice falls far short of this protection.
Lack of minimum staffing regulations. Adequate numbers of sufficiently competent staff are at the crux of nursing facility care. While experts put minimum adequate nursing staffing time at 4. Weak enforcement of federal regulations specifically banning chemical restraints and unnecessary drugs. Federal regulations prohibit chemical restraints—drugs used for the convenience of staff or to discipline residents without a medical purpose—and unnecessary drugs: The regulations also provide for the right to refuse treatment.
However, federal and state enforcement of these regulations is so weak that the drugs are routinely misused without significant penalty. With such vast numbers of nursing facility residents still getting antipsychotic drugs that many do not need, do not want, and that put their lives and quality of life at risk, federal and state governments need to do more to ensure that the rights of residents are adequately protected. An industry entrusted to provide care—and paid billions of public and private dollars to do so—cannot justify compounding the vulnerabilities, challenges, and loss that people often experience with dementia and institutionalization.
Key Recommendations Federal and state government agencies should take steps to end the inappropriate and nonconsensual use of antipsychotic medications in nursing facilities. Federal regulations providing for the right to be fully informed and to refuse treatment—as well as state laws that provide for informed consent—should be enforced more effectively.
Congress and CMS should require that consent be documented and revisited as appropriate. Ensure nurse staffing numbers and training levels are adequate. CMS should establish minimum nurse staffing levels for facilities or undertake other effective measures to address understaffing, inadequate training, and high turnover rates in many nursing facilities.
Implementation of the payroll-based staffing data collection system, as required by the Affordable Care Act, should be completed, particularly with regard to nursing staff who provide direct resident care. This includes public reporting of staff-to-resident hours of care per day and turnover and retention rates in each nursing home certified by Medicare and Medicaid. Strengthen enforcement on particular subjects linked to the inappropriate use of antipsychotic drugs, including care planning requirements and transfer and discharge rights.
CMS should improve inspection and penalty guidance and enforcement practices related to antipsychotic drugs. Surveyors should follow CMS guidance indicating that many inappropriate uses of antipsychotic drugs amount to Level 3 or 4—actual harm and immediate jeopardy—severity of violations.
Methodology This report focuses on the inappropriate use of antipsychotic drugs among older people, primarily with dementia, in nursing facilities across the US. Many older people who live in nursing facilities or reside there temporarily are at risk of suffering from this abuse. Human Rights Watch found that enforcement is inadequate to deter the misuse of antipsychotic drugs.
This topic was chosen because of the paradox that misuse of the drugs has been well-documented for decades, prohibited by law, and yet persists as a pervasive, serious problem. The amount of publicly available data on nursing homes and antipsychotic drugs specifically made it feasible to conduct the research. The project was also chosen to attempt to amplify the voice and highlight the circumstances of some of the most isolated individuals: Additional interviews were conducted over the phone from September to April In addition, Human Rights Watch consulted secondary sources, conducted significant background research, and analyzed copious amounts of data.
These six states were selected for multiple reasons. California and Texas have the highest number of nursing facilities, with 1, and 1, respectively in California, Florida, Illinois, New York, and Texas have among the highest numbers of nursing facility residents of any state.
Kansas, Texas, and Illinois have some of the highest proportions of residents on antipsychotic drugs. More detailed data on these states and their rankings nationally can be found in Appendix 3. Most of these states were also chosen based on their strong citizen advocacy organizations working on nursing facility reform and resident rights protection and their long-term care ombudsman programs.
In the six states, Human Rights Watch interviewed 74 people between the ages of 37 and 93 who live in nursing facilities, including 15 under the age of Almost all of the individuals were in facilities with high rates of antipsychotic drug use; in many cases, they or someone who knows them told Human Rights Watch that they currently or previously took antipsychotic drugs.
However, not all interviewees claimed to take antipsychotic drugs, and it was not possible to view the medical records of the majority of interviewees. We interviewed 36 family members of residents, 20 long-term care ombudsmen, 18 advocates including attorneys, 10 state and federal government officials, 90 facility administrators, nursing, and social services staff, and six medical professionals such as pharmacists, psychologists, psychiatrists, and doctors.
Human Rights Watch also interviewed 69 experts, including lawyers, academic researchers, professors, journalists, doctors in addition to those interviewed associated with nursing facilities or nursing facility residents mentioned above , government officials, and advocates.
We did not receive a response from CMS at time of writing.