Reducing Antipsychotic Drug Use in Nursing Homes:
Save Residents' Lives, Save Medicare Billions of Dollars
Center for Medicare Advocacy
March 21, 2011
Many nursing home residents who do not have a diagnosis that supports their taking antipsychotic medications are nevertheless given antipsychotic drugs. These drugs are both dangerous to residents and extremely expensive for the Medicare program. Reducing the use of antipsychotic drugs in nursing facilities would both dramatically improve the quality of care and quality of life of nursing home residents and save the Medicare program billions of dollars.
This Alert describes the issue of inappropriate use of antipsychotic medications with nursing homes residents and then sets out three ways to reduce the use of such medications in nursing facilities. 
The Use of Antipsychotic Drugs for Nursing Home Residents is Widespread
In the third quarter of calendar year 2010 (July-September 2010), CMS reports that, nationwide, 39.4% of nursing home residents who had cognitive impairments and behavior problems but no diagnosis of psychosis or related conditions received antipsychotic drugs.  A smaller, but still significant, percentage of residents not at high risk (15.6%) - those without cognitive impairments or behavior problems - also received antipsychotic drugs. 
The New York Times has reported that approximately one-quarter of nursing home residents take antipsychotic drugs  - nearly 350,000 people. 
Antipsychotic Drugs Are Dangerous for Older People When Used Inappropriately
In the 1990s, new atypical antipsychotic drugs came on the market. Although these drugs were originally believed to be safer than conventional antipsychotic drugs, later studies questioned the safety and effectiveness of both types of antipsychotic drugs for individuals who do not have severe psychotic disorders. 
Antipsychotic drugs are now viewed as extremely dangerous for older people who do not need them. In April 2005, the Food and Drug Administration (FDA) issued "black box" warnings against prescribing atypical antipsychotic drugs for patients with dementia, cautioning that the drugs increased dementia patients' mortality.  In June 2008, the FDA extended the warning to all categories of antipsychotic drugs, conventional as well as atypical, and advised health care professionals, "Antipsychotics are not indicated for the treatment of dementia-related psychosis." 
The inappropriate use of antipsychotic drugs is believed to lead to many residents' deaths. David Graham, M.D., MPH, Associate Director, Science and Medicine, FDA Office of Surveillance and Epidemiology, testified in the House of Representatives in February 2007 that, by his estimate, "15,000 elderly people in nursing homes [are] dying each year from the off-label use of antipsychotic medications for an indication that FDA knows the drug doesn't work." 
Antipsychotic Drugs Are Expensive to Consumers and Medicare
Antipsychotic drugs are expensive, particularly the new atypical antipsychotic medications, which have largely replaced conventional antipsychotic drugs. Annual revenues for all antipsychotic drugs are $14.6 billion.  Atypical antipsychotic drugs cost more than $13 billion in 2007, "nearly 5 percent of all U.S. drug expenditures."  They are a major expenditure for Medicare Part D. 
Various Approaches Could Reduce the Inappropriate Use of Antipsychotic Drugs
There are many approaches to reducing the use of antipsychotic drugs with nursing home residents. 
1. Implementing a Computerized Order Entry Warning System
A computerized order entry warning system to inform prescribing physicians that antipsychotic drugs carry a black box warning for older people who have dementia, but no diagnosis of psychosis, could result in the reduction of prescriptions of antipsychotic drugs for residents if physicians were so advised at the time they prescribed the antipsychotic medication.
Such a warning system, implemented in a large urban academic medical center in a study in Boston, resulted in the reduced prescribing of potentially inappropriate medications for patients over age 65.  The medications flagged by the computerized warning system in the study were three primary classes of medications (not-recommended medications, dose-reduction medications, and unflagged medications) identified by the Beers criteria as inappropriate for older people. In the study, the ordering physician could bypass the warning and order the medication, but was required to choose a reason. Three choices were offered: (1) "'Patient stabilized on regimen; will monitor appropriate drug levels or laboratory values,'" (2) "'Interaction noted, regimen clinically indicated, will closely monitor,'" or (3) "'Other.'" A fourth choice was added during the study, "'Warning noted, will use smaller dose and monitor for side effects.'"
The Patient Protection and Affordable Care Act (ACA) (the health care reform law enacted in 2010) requires the Secretary to conduct a three-year demonstration project "for the use of information technology to improve resident care.  A demonstration could test a computerized order entry warning system for antipsychotic drugs in nursing facilities.
2. Enforcing the Nursing Home Reform Law's Explicit Limitations on Antipsychotic Drugs
Regulations implementing the federal Nursing Home Reform Law explicitly limit the use of antipsychotic drugs. 42 C.F.R. §483.25(l)(2) provides:
(2) Antipsychotic Drugs. Based on a comprehensive assessment of a resident, the facility must ensure that-
(i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record; and
(ii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.
Guidance issued by CM  encourages facilities to use non-pharmacological alternatives, identifies situations where antipsychotic medications are not indicated,  and provides an investigative protocol for unnecessary drugs, including antipsychotic drugs.
CMS could issue a Survey and Certification letter to state survey agencies, and provide additional focused training for surveyors, stressing the importance of reviewing antipsychotic drug use in nursing facilities in every survey and of citing deficiencies and imposing remedies for inappropriate drug use. ACA's requirement for surveyor training provides an opportunity for a new focus on inappropriate antipsychotic drug use.  The health care reform law's requirement that nurse aide training include "dementia management training" is another opportunity to address antipsychotic drug use. 
Strong CMS guidance on the issue of antipsychotic drugs could make a significant difference. Implementation of the Nursing Home Reform Law in 1990 led to a 26.7% reduction in antipsychotic drug use by residents. 
3. Requiring Part D Plans to Use Utilization Control Mechanisms
Antipsychotic drugs are a protected class of drugs under Part D.  Nevertheless, various utilization control mechanisms - such as prior authorization or step therapy  - as well as medication therapy management,  could bring greater attention to the inappropriate use of antipsychotic drugs. Part D plans could also use a computerized order entry warning system, discussed above.
Better care can be less costly than poor care. Antipsychotic drugs are a prime example. Reducing the inappropriate use of antipsychotic drugs with nursing home residents who do not have a psychosis supporting their use would both provide better care to residents and save the government and Medicare beneficiaries billions of dollars.
For more information, contact attorney Toby Edelman (firstname.lastname@example.org) in the Center for Medicare Advocacy's Washington, DC office at (202) 293-5760.
 The Center for Medicare Advocacy has before written about antipsychotic drug use in nursing facilities. See CMA, "Off-Label Drug Use Is Common and Hurts Nursing Home Residents" (March 25, 2010).
 CMS, MDS Quality Measure/Indicator Report, Psychotropic Drug Use, July/September 2010, Measure 10_1_HI.
Id. Measure 10_1_LO.
Duff Wilson, "Side Effects May Include Lawsuits," The New York Times (Oct. 2, 2010).
Charlene Harrington, Helen Carrillo, Brandee Woleslagle Blank, Teena O'Brian, Nursing Facilities, Staffing, Residents and Facility Deficiencies, 2004 Through 2009, page 15, Table 4 (Sep. 2010), (click on the report). The report indicates that in 2009, there were 1,393,127 nursing home residents nationwide.
Stephen Crystal, Mark Olfson, Cecilia Huang, Harold Pincus, and Tobias Gerhard, "Broadened Use Of Atypical Antipsychotics: Safety, Effectiveness, And Policy Challenges," Health Affairs, 2009; 28:w770-w781.
FDA, "Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances" (April 5, 2005).
FDA, "Information for Healthcare Professionals: Conventional Antipsychotics," FDA Alert (June 16, 2008).
 Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce, "The Adequacy of FDA to Assure the Safety of the Nation's Drug Supply," 110th Cong., First Sess. (March 13, 2007), Serial No. 110-5, page 66.
 Duff Wilson, "Side Effects May Include Lawsuits," The New York Times (Oct. 2, 2010).
G.C. Alexander, S.A. Gallagher, A. Mascola, R.M. Moloney, and R.S. Stafford, "Increasing off-label use of antipsychotic medications in the United States, 1995-2008," Pharmacoepidemiology and Drug Safety (on-line, Jan. 7, 2011), (click on the article).
 Stephen Crystal, Mark Olfson, Cecilia Huang, Harold Pincus, and Tobias Gerhard, "Broadened Use Of Atypical Antipsychotics: Safety, Effectiveness, And Policy Challenges," Health Affairs, 2009; 28:w770-w781
 Other approaches are discussed in CMA, "Off-Label Drug Use Is Common and Hurts Nursing Home Residents" (March 25, 2010).
Melissa L.P. Mattison, Kevin a. Afonso, Long N. Ngo, Kenneth J. Mukamal, "Preventing Potentially Inappropriate Medication Use in Hospitalized Older Patients With a Computerized Provider Order Entry Warning System," Arch Intern Med Vol. 170 (No. 15) Aug. 2/23, 2010.
Patient Protection and Affordable Care Act, §6114.
State Operations Manual, Appendix PP, (scroll down to page 344 for the beginning of guidance for §483.25(l)).
 Id. 386 ("1) wandering; 2) poor self-care; 3) restlessness; 4) impaired memory; 5) mild anxiety; 6) insomnia; 7) unsociability; 8) inattention or indifference to surroundings; 9) fidgeting; 10) nervousness; 11) uncooperativeness; or 12) verbal expressions or behavior that are not due to the conditions listed under 'indications' and do not represent a danger to the resident or others").
 ACA §6703, the Elder Justice Act of 2009, creates a National Training Institute for Surveyors. 42 U.S.C. §2041
 ACA §6121.
Ronald I. Shorr, Randy L. Fought, Wayne A. Ray, "Changes in Antipsychotic Drug Use in Nursing Homes During Implementation of the OBRA-78 Regulations," Journal of the American Medical Association, 1994; 271:358-362. See also Stephen Crystal, Mark Olfson, Cecilia Huang, Harold Pincus, and Tobias Gerhard, "Broadened Use Of Atypical Antipsychotics: Safety, Effectiveness, And Policy Challenges," Health Affairs, 2009; 28:w770-w781.
 42 U.S.C. §1395w-104(b)(3)(G)(iv).
 Elizabeth Hargrave, Jack Hoadley, Laura Summer, Juliette Cubanski, and Tricia Neuman, "Coverage of Top Brand-Name and Specialty Drugs," (Kaiser Family Foundation, Medicare Part D 2010 Data Spotlight) (Sep. 2010), http://www.kff.org/medicare/upload/8095.pdf.
 42 C.F.R. §423.153(d).
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