Research Literature And The Popular Press Identify The Extensive Off
A retrospective analysis of the use of anti-psychotic drugs by Medicare beneficiaries in nursing homes in 2000-2001 found the highest rate of antipsychotic drug use in more than a decade. The analysis reported that 27.6% of residents received at least one prescription for antipsychotic drugs and that, of those, more than half “took doses exceeding maximum levels, received duplicative therapy, or had inappropriate indications according to guideline requirements.” The atypical antipsychotic drugs were inappropriately used for residents with depression, dementia, and nonaggressive behavior problems, such as restlessness, unsociability, uncooperativeness, and indifference to surroundings. Resident outcomes did not improve with use of the atypical antipsychotics. The most common atypical antipsychotic prescribed in 2000-2001 was risperidone .
Using data from the 2004 National Nursing Home Survey, a later study found that 23.5% of residents received at least one atypical antipsychotic drug, that 86.3% of the drug use was off-label, and that 43% of the use “was without strong scientific support.”
Does Psychotropic Drug Prescription Change In Nursing Home Patients The First 6 Months After Admission
- Enrico CallegariCorrespondenceAddress correspondence to Enrico Callegari, MD, Østfold Hospital Trust, Sykehuset Østfold HF, postboks 300 1714, Grålum, Norway.Østfold Hospital Trust, Grålum, NorwayFaculty of Medicine, University of Oslo, Oslo, Norway
- Institute of Clinical Medicine, Campus Ahus, University of Oslo, Oslo, NorwayResearch Centre for age related functional decline and diseases, Innlandet Hospital Trust, Ottestad, NorwayHealth Services Research Unit, Akershus University Hospital, Lørenskog, Norway
- Faculty of Medicine, University of Oslo, Oslo, NorwayNorwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, NorwayFaculty of Medicine, Department of Geriatric Medicine, Oslo University Hospital, Oslo, Norway
- Østfold Hospital Trust, Grålum, NorwayFaculty of Social Sciences, Department of Psychology, University of Oslo, Oslo, Norway
- Research Centre for age related functional decline and diseases, Innlandet Hospital Trust, Ottestad, NorwayNorwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway
Failure To Set Effective Standard To Address Gross Understaffing
The right to health requires governments to ensure that health services are of adequate quality. Gross understaffing and under-training of staff may contribute to the inappropriate use of anti-psychotics. According to one state long-term care ombudsman: Insufficient CNAs is the crux of the antipsychotics problem. The federal government has not taken effective steps to tackle this problem.
Instead of requiring facilities to ensure every resident has a minimum number of nursing staff hours per day or staff per number of residents, CMS imposes a more general requirement that staffing be sufficient and competent, based on the facilitys own annual assessment of residents acuity, diagnoses, and care plans. This self-regulation is inadequate, given the continuing prevalence of staff shortages at many facilities.
I dont think theres enough staff. Many of the residents are two-person transfers. I tell you, its been very frustrating to me to sit here waiting. On weekends it has been horrendous. If they know State is coming, theyll get six or seven more than usual to come in. Otherwise its just kitchen, waiter, two or three CNAs on the floor, and a nurse.
One former ombudsman in Kansas said: What distinguishes facilities most of all is their staffing. Especially with dementia, you need consistent staffing. An ombudsman in Florida said:
Similarly, AHCA wrote to Human Rights Watch regarding its opposition to stronger staffing requirements:
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Freedom From Chemical Restraints A Form Of Abuse And Unnecessary Drugs
Federal and state laws protect individuals in nursing facilities from chemical restraints and other forms of abuse. US regulations also prohibit the use of any unnecessary drugs, including antipsychotic drugs, in nursing facilities even if they do not amount to chemical restraints.
Regulations particular to psychotropic drugs mandate that any prescription for someone not already taking such medication must be necessary to treat a specific condition as diagnosed and documented in the clinical record and anyone given psychotropic medications must receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs. For antipsychotic drugs, gradual dose reduction must be attempted twice in the first year of administration and annually thereafter.
Americans With Disabilities Act
Based on the admission criteria for skilled nursing facilities and nursing facilities, almost all nursing facility residents are protected by the Americans with Disabilities Act of 1990. The ADA defines disability as: a physical or mental impairment that substantially limits one or more major life activities or a record of such an impairment. A disability under this law could also be merely being regarded as having such an impairment whether or not the impairment limits or is perceived to limit a major life activity, so long as the impairment is not transitory or minor.
The US Attorney General has jurisdiction to enforce the ADA: to prosecute the violation of the rights of people with disabilities articulated under it. However, it does not have exclusive jurisdiction private individuals may sue as well. Anyone who has been subjected to discrimination on the basis of disability may institute a civil action for preventive relief, including an application for a permanent or temporary injunction, restraining order, or other order. The ADA has not been employed frequently to protect the rights of older people in nursing facilities. However, it is a relevant legal protection for people with dementia.
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Failure To Obtain Free And Informed Consent
I dont take Seroquel. I take Clonidine for cholesterol, something for my heart and blood. But I dont take Seroquel. It is nowhere in my record.Ruth D., a 62-year-old woman in a nursing facility in Texas, December 2016
I dont think antipsychotic drugs are presented well to the family in informed consent conversations. Because if it were, theyd all reject it. And when they dont inform them beforehand, then the family is not having a real choice.A long-term care pharmacist in Kansas, January 2017
International human rights standards require that any medical intervention be provided only with free and informed consent. At its foundation, this right arises from an individuals right to decide what is done with his or her own body. Free and informed consentcontrary to mere consent: written or oral permission, however it is obtained and whatever its basisrequires a full understanding of the purpose, risks, benefits, and alternatives to the medical intervention, and the absence of pressure or coercion in making the decision.
US federal regulations, including revised regulations that intended to go into effect on November 28, 2017, state that nursing home residents have the right to be fully informed in advance of their treatment and have the right to refuse treatment. Combining the right to be informed with the right to refuse treatment, individuals should have protection that is substantially similar and potentially equal to informed consent if enforced effectively.
A Doubled Risk Of Death
For decades, nursing homes have been using drugs to control dementia patients. For nearly as long, there have been .
In 1987, President Ronald Reagan signed a law banning the use of drugs that serve the interest of the nursing home or its staff, not the patient.
But the practice persisted. In the early 2000s, studies found that antipsychotic drugs like Seroquel, Zyprexa and Abilify made older people drowsy and more likely to fall. The drugs were also linked to heart problems in people with dementia. More than a dozen clinical trials concluded that the drugs nearly doubled the risk of death for older dementia patients.
In 2005, the Food and Drug Administration required manufacturers to put a label on the drugs warning that they increased the risk of death for patients with dementia.
Seven years later, with antipsychotics still widely used, nursing homes were required to report to Medicare how many residents were getting the drugs. That data is posted online and becomes part of a facilitys quality of resident care score, one of three major categories that contribute to a homes star rating.
The only catch: Antipsychotic prescriptions for residents with any of three uncommon conditions schizophrenia, Tourettes syndrome and Huntingtons disease would not be included in a facilitys public tally. The theory was that since the drugs were approved to treat patients with those conditions, nursing homes shouldnt be penalized.
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Factors Associated With Use Of Psychotropic Drugs At Two Consecutive Time Points
The adjusted risk for persistent use of antipsychotics at two consecutive time points was elevated when residents had higher psychosis sub-syndrome score or were younger, were male or had a longer NH stay at baseline . The adjusted risk for persistent use of antidepressants was elevated when residents had higher P-ADL functioning or higher affective sub-syndrome score. The adjusted risk for persistent use of anxiolytics was elevated when residents had higher P-ADL functioning or higher affective sub-syndrome score or stayed in a larger NH . The adjusted risk for persistent use of sedatives was elevated when residents had better cognitive functioning or higher affective sub-syndrome score or lower apathy symptom score.
Litigation Against Drug Companies
The extensive use of atypical antipsychotic drugs for nursing home residents may in part reflect drug companies’ marketing of such off-label uses for residents, as reflected in recent litigation by the United States against a drug company and the nation’s largest nursing home pharmacy.
In January 2009, Eli Lilly & Company pleaded guilty to the misdemeanor of introducing misbranded drugs into interstate commerce. Between September 1999 and November 2003, its long-term care sales force, as trained by the company, promoted Zyprexa for the treatment of dementia, depression, anxiety, and sleep problems in nursing home residents, read more at the MyEtizolam website. Admitting its off-label marketing, the company agreed to pay the United States a criminal fine of $615 million. At the same time, the company entered a separate civil settlement under the federal False Claims Act, admitting that it “caused invalid claims for payment for Zyprexa to be submitted to various government programs.” Eli Lilly agreed to pay a civil fine of $835 million to the United States and states. Between 2000 and 2008, Eli Lilly received $36 billion in revenues for Zyprexa, “more than 25 times as much as the total penalties Lilly paid in January.”
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Ethics Approval And Consent To Participate
The medical ethics committee of the University Medical Center Groningen concluded that the Reducing Inappropriate psychotropic Drug use study does not fall within the scope of Medical Research Involving Human Subjects Act because residents will not be directly involved. Given the absence of risks, no data monitoring committee will be involved. The study will be conducted in accordance with the declaration of Helsinki and the law for the protection of personal information . Participation will require that written informed consent is obtained. The informed consent form we will use has been approved by the medical ethics committee of the University Medical Center Groningen. Any modifications to the protocol that may affect the conduct of the study will be notified to the medical ethics committee of the University Medical Center Groningen, and we will ensure that their approval is granted before implementation.
Lack Of Informed Consent Prior To Antipsychotic Medication Administration
The use of antipsychotic drugs to control people without their knowledge or against their will in nonemergency situations violates international human rights. 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: they call you up. They say, X, Y, and Z is happening with your mom. This is going to help her. Black box warning ? Its best just not to read that. The risks? They gloss over them. They say, That only happens once in a while, and well look for problems. We sell it. And, by the way, we already started them on it.
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In 9 Residents Diagnosed With Schizophrenia
Schizophrenia diagnoses are soaring in nursing homes, but related behaviors like delusions and hallucinations are not.
15% of nursing home residents
Schizophrenia
15% of nursing home residents
Schizophrenia
2021
Some portion of the rise in schizophrenia diagnoses reflects the fact that nursing homes, like prisons, have become a refuge oflast resort for people with the disorder, after large psychiatric hospitals closed decades ago.
But unfounded diagnoses are also driving the increase. In May, a report by a federal oversight agency said nearly one-third of long-term nursing home residents with schizophrenia diagnoses in 2018 had no Medicare record of being treated for the condition.
For nursing homes, money is on the line. High rates of antipsychotic drug use can hurt a homes public image and the star rating it gets from the government. Medicare designed the ratings system to help patients and their families evaluate facilities using objective data a low rating can have major financial consequences. Many facilities have found ways to hideserious problems like inadequate staffing and haphazard care from government audits and inspectors.
One result of the inaccurate diagnoses is that the government is understating how many of the countrys 1.1 million nursing home residents are on antipsychotic medications.
The figures showed that at least 21 percent of nursing home residents about 225,000 people are on antipsychotics.
To The Centers For Medicare & Medicaid Services
- Strengthen enforcement of existing regulatory requirements in conjunction with contracted state agencies to end all inappropriate use of antipsychotic medication in nursing facilities, including when the medication would be an unnecessary drug when it would amount to a chemical restraint when it would be inconsistent with other regulatory requirements and when it is not based on free and informed consent .
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The Us Nursing Facility Industry
Seventy percent of nursing facilities in the USabout 11,000are owned by for-profit companies, and almost 25 percent are nonprofit. About 6 percent are publicly owned, most of which are owned by counties, followed by hospital districts , states , city-county , city , and the federal government . In 2014, almost three in five nursing facilities were part of a chain, meaning they were owned by an entity that owns multiple facilities. Private equity firms own about 12 percent of all nursing facilities . Ten chains own the facilities in which 14 percent of the nations residents live, the largest concentration.
In 2015, the nursing facility industry, assisted living, and other types of long-term care recorded annual revenues of $156.8 billion, 41 percent of which came from Medicaid and 21 percent from Medicare. Medicare and Medicaid have provided the financial foundation of the nursing facility industry since their creation.
The federal government regulates the nursing facility industry through the Nursing Home Reform Act of 1987, requiring facilities to meet certain standards to be certified and paid by Medicare and Medicaid. CMS contracts with state agencies to certify facilities and to ensure substantial compliance with minimum health and safety requirements.
Examples of nonpharmacologic interventions include:
Similarly, CMS has warned against inappropriate use of antipsychotic drugs, given the risks that are unwarranted when the drugs do not serve a medical purpose:
To State Attorneys General Offices State Departments On Aging Disability Elder Affairs And Public Health And Other State Agencies
For Free and Informed Consent:
- Provide resources to assist nursing facilities to connect residents with supported decision-making resources, and require nursing facilities to post this information inside facilities, as it does with long-term care ombudsman services posters.
- Take measures to maximize the use of advanced directives, living wills, and, as appropriate, proxies or surrogates.
- Conduct public service message campaigns to ensure that individuals know that they have the right to informed consent, including with regard to the administration of antipsychotic drugs and other nonemergency medical interventions.
For Enforcement Specific to Antipsychotic Medications
- Keep track of facilities and chains using antipsychotic drugs at higher than average rates or struggling to reduce their rate of use to provide additional oversight, or take other appropriate action to protect the rights of residents at heightened risk of nonconsensual and inappropriate uses of antipsychotic drugs.
For General Enforcement to Protect Residents Rights and Wellbeing:
- Require Medicaid fraud control units to investigate and prosecute abuse, including the use of chemical restraints, and neglect in nursing facilities.
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Social Harm And Health Risks Caused By Antipsychotic Drugs Used Unnecessarily Or As Chemical Restraints
The American Psychiatric Association Practice Guideline on the Use of Antipsychotics to Treat Agitation or Psychosis in Patients with Dementia states that, after eliminating or addressing underlying medical, physical, social, or environmental factors giving rise to manifestations of distress associated with dementia, antipsychotic drugs can be appropriate as a means to minimize the risk of violence, reduce patient distress, improve the patients quality of life, and reduce caregiver burden. However, given the at best small potential benefits and the consistent evidence that antipsychotics are associated with clinically significant adverse effects, including mortality, it is essential that the drug treatment is only attempted when appropriate.
Nursing facility staff, individuals living in facilities, their families, long-term care advocates, and others told Human Rights Watch that the drugs are not used only as a last resort, after all factors potentially giving rise to a persons distress have been ruled out, and after nonpharmacologic interventions have been attempted unsuccessfully. Instead, antipsychotic drugs are used sometimes almost by default for the convenience of the facility, including to control people who are difficult to manage.