The Consumer Voice is actively fighting to end the misuse of antipsychotic drugs as chemical restraints. Our campaign seeks to address this problem through:
Click on the links above to learn more about each aspect of our campaign. Click on the links below to find more information on the topic of the misuse of antipsychotic medications.
Residents of long-term care facilities are increasingly being placed on antipsychotic medications despite having no proper diagnosis to warrant their use.Twenty-six percent (26%) of all nursing home residents are given antipsychotic medications. Use is even higher (nearly 40%) among residents with dementia - the very individuals that the Food and Drug Administration (FDA) warns are at serious risk of medical complications and death from taking antipsychotics. In addition, far too often the dangers of these medications are not even discussed with residents and their families and are administered without consent.
The misuse of antipsychotic medications in nursing homes can harm long-term care consumers in many ways. When used inappropriately among nursing home residents, antipsychotic medications can:
Place Nursing Home Residents at Increased Risk of Injury, Harm and Death: Antipsychotic drugs, when prescribed for elderly persons with dementia, can have serious medical complications, including loss of independence, over-sedation, confusion, increased respiratory infections, falls, and strokes. In fact, one study found residents taking antipsychotics had more than triple the likelihood of having a stroke compared to residents not taking these medications. Even worse, antipsychotics can be deadly; in 2005, the Food and Drug Administration (FDA) issued “Black Box” warnings for antipsychotics stating that individuals diagnosed with dementia are at an increased risk of death from their use and that physicians prescribing antipsychotic medications to elderly patients with dementia should discuss the risk of increased mortality with their patients, patients’ families and caregivers. The FDA has also stated that these medications are not approved for the treatment of dementia-related psychosis, nor is there any medication approved for such a condition.
Be Employed as a Chemical Restraint for Nursing Home Residents: A chemical restraint is a drug not needed to treat medical symptoms and used because it is more convenient for facility staff or to punish residents. Although the Medicare and Medicaid programs prohibit chemical restraints, antipsychotic medications continue to be used for residents with dementia as a means of behavior control and/or as a substitute for good, individualized care. For this reason, it is important to ensure these medications are being used only when appropriate among residents with proper diagnoses for psychotic disorders.
Destroy the Quality of Life and Dignity of Nursing Home Residents: Antipsychotics can be so powerful that they sedate residents to the point where they become listless and unresponsive. Residents may be slumped in wheelchairs or unable to get up from bed; they may no longer be able to participate in activities they enjoy or even talk with their loved ones.
Cost All Long-Term Care Consumers Billions of Dollars: These medications often come with a hefty price tag, so the misuse and overprescribing of antipsychotics in long-term care facilities is extremely costly for the Medicare and Medicaid programs as well as for taxpayers. Ending the misuse of these medications among nursing home residents would help save precious health care dollars that could be used to serve beneficiaries. According to the Office of the Inspector General for the Department of Health and Human Services, more than half of atypical antipsychotic medications (a class of antipsychotic medications that work significantly differently from older, previously introduced antipsychotics) paid for in the first half of 2007 by Medicare were incorrectly prescribed and cost the program $116 million during that six-month time period. Ending the misuse of these medications among nursing home residents would help save precious health care dollars that could be used to serve beneficiaries.
As mentioned previously, the Consumer Voice is engaged in a multi-faceted campaign to end the misuse of antipsychotic medications in nursing homes, including the following:
The Consumer Voice strongly supports Congressional efforts to address inappropriate antipsychotic use among residents. We are currently advocating for the reintroduction and passage of the Improving Dementia Care Treatment for Older Adults Act, previously introduced in the 112th Congress by Senators Kohl (D-WI), Grassley (R-IA) and Blumenthal (D-CT).
This bipartisan, no cost bill would require nursing homes to obtain informed consent before an antipsychotic medication is prescribed for a resident with dementia. It also includes other important provisions, such as education for prescribers; monthly reports on instances where antipsychotics are administered to nursing home residents with dementia for uses not approved by the FDA; and a study on the appropriate prescribing of antipsychotics for hospital patients.
To read the Consumer Voice's group support letter for S. 3604 (the legislation introduced in the last Congress), click here. To read more about S. 3604, click here.
Regulation and Guidance
The Consumer Voice, along with several groups, has provided input and feedback to the Centers for Medicare and Medicaid Services (CMS) on the agency’s National Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Medication Use in Nursing Homes. Advocacy efforts have included submitting written comments to CMS on its draft guidance to surveyors about regulations regarding antipsychotics and dementia care and its new surveyor, as well as meetings and conference calls with CMS top officials. In May of 2013, CMS released its new survey guidelines for antipsychotic medications, which can be read here.
In October 2011, the Centers for Medicare and Medicaid Services (CMS) announced that the agency was considering regulations that would require nursing homes to hire independent pharmacists to assess residents’ prescriptions. The regulations would have required consultant pharmacists in nursing homes to be free of conflicts of interests so they could make drug recommendations based on what is best for the resident – not what’s best for the pharmacy companies or drug companies. However, in April 2012, CMS decided NOT to publish these rules (click here to read CMS's comments on this decision). CMS instead launched the “Partnership to Improve Dementia Care Initiative” in May 2012, which sought to reduce the misuse of antipsychotics among nursing home residents by 15% by the end of 2012 (click here to read more about this CMS initiative.) The Partnership failed to meet its reduction goal by the end of 2012, only recently doing so in early 2014. Although the Consumer Voice commends CMS for launching this effort to reduce the misuse of antipsychotics, our organization strongly supports the implementation of federal regulations regarding the independence of consultant pharmacists and will continue to call on CMS to publish formal rules on this matter.
In addition, the Consumer Voice submitted recommended changes to federal regulations for long-term care facilities that would strengthen protections for residents and require informed consent before residents are prescribed antipsychotic medications. These recommendations can be read here.
The National Long-Term Care Ombudsman Resource Center – funded by the Administration on Aging (AoA) and operated by the Consumer Voice – has developed a toolkit in part through a grant from AoA on the misuse of antipsychotic medications among nursing home residents. This toolkit contains take-away resources for consumers, family members and advocates describing how to recognize symptoms of the improper use of antipsychotics; the rights of residents under federal nursing home laws and regulations; and what consumers, family members and advocates can do to combat this problem. The contents of the toolkit include the following:
Misuse of Antipsychotics Status Update
Misuse of Antipsychotics Issue Sheet
Misuse of Antipsychotics Issue Sheet (Spanish)
Misuse of Antipsychotics Issue Sheet (Chinese)
Promising Practices to Reduce the Use of Antipsychotic Medications
The Interpretive Guidelines: A Tool for Advocates
The Interpretive Guidelines: A Tool for Advocates (Spanish)
The Interpretive Guidelines: A Tool for Advocates (Chinese)
Information About Inappropriate Drug Use for Long-Term Care Consumers (Postcard)
Information About Inappropriate Drug Use for Long-Term Care Consumers (Postcard in Spanish)
Information About Inappropriate Drug Use for Long-Term Care Consumers (Postcard in Chinese)
Sample Letter to the Editor
You can purchase a hard copy of the Toolkit, containing all of the above components plus five printed postcards and a disk with electronic copies of all of the resources, from the Consumer Voice store. You can also purchase the postcards separately in packs of ten from the Consumer Voice store and pass them out to consumers, family members and advocates!
In September 2012, the National Ombudsman Resource Center hosted a webinar entitled "Ending Misuse of Anti-Psychotics in Long-Term Care." This webinar included a discussion of the dangers and signs of inappropriate psychotropic drug use, successful alternative person-centered treatments and therapies, resources for more information and current national and state-level efforts to reduce inappropriate medications. Expert speakers included Mary Evans, a Geriatrician/Medical Director; Morris Kaplan, a Nursing Home Administrator; and Claire Curry, a Consumer Advocate. The speaker presentations (in PowerPoint and PDF form) can be accessed below:
Mary Evans, MD CMD - President, Virginia Medical Directors Association
Morris Kaplan, Esq., NHA - President, Kaplan Health Management, LLC and Operating Partner, Gwynedd Square Nursing Center (please note that the videos have been deleted from this version)
Claire Curry - Legal Director, Civil Advocacy Program of the Legal Aid Justice Center
Also, a recording of the webinar can be downloaded here.
According to the Office of Inspector General for the Department of Health and Human Services, the three most commonly prescribed antipsychotic medications in 2007 among nursing home residents were: Seroquel, Risperdal, and Zyprexa. Other commonly prescribed antipsychotics according to the report included Abilify, Clozaril, Geodon, and Symbyax. Click here to read the report.
The Centers for Medicare and Medicaid Services (CMS) Nursing Home Compare Website - This resource allows users to research data on individual nursing homes, including the percentage of residents receiving antipsychotic medications under the section entitled 'Quality Measures'. It also lists the state average and the national average of antipsychotic use in comparison to each individual nursing home's data.
ProPublica's Nursing Home Inspect Website - This resource allows you to search nursing home inspection reports listing deficiencies cited in nursing homes nationwide. You can search by state, severity of the deficiency and by keyword (i.e. "antipsychotic") to find deficiencies related to the inappropriate use of antipsychotic medications in individual nursing homes.
Resources on Legislation and Regulations
Kohl-Grassley-Blumenthal amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act, to require informed consent to administer antipsychotic drugs to elderly persons with dementia
CMS Surveyor Training - This online training on the Use of Antipsychotic Medication by CMS for surveyors, includes two modules, Overview of Antipsychotic Medication Use in Nursing Homes, and Surveying for Antipsychotic Medication Use in Nursing Homes. A third module, Severity & Scope Guidance: Antipsychotic Medication Use in Nursing Homes is in development.
News and Media Resources
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