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On May 24, 2013, the Centers for Medicare & Medicaid Services (CMS), as part of the National Partnership to Improve Dementia Care in Nursing Homes, issued new guidelines discouraging the use of antipsychotic drugs to treat dementia in nursing home patients.[1] The recommendations belatedly follow a May 2011 report by the Inspector General of the Department of Health and Human Services, which found that 14 percent of nursing home residents had filed Medicare claims for atypical antipsychotic...
On May 24, 2013, the Centers for Medicare & Medicaid Services (CMS), as part of the National Partnership to Improve Dementia Care in Nursing Homes, issued new guidelines discouraging the use of antipsychotic drugs to treat dementia in nursing home patients.[1] The recommendations belatedly follow a May 2011 report by the Inspector General of the Department of Health and Human Services, which found that 14 percent of nursing home residents had filed Medicare claims for atypical antipsychotic medications, which have never been approved by the Food and Drug Association (FDA) for managing dementia.[2]
Since the first edition of the Worst Pills, Best Pills book, published in 1988, we have consistently warned consumers about the dangers associated with the inappropriate use of antipsychotic medications.
Overview of antipsychotics
Antipsychotic drugs, also called neuroleptic drugs or major tranquilizers, are correctly used to treat serious psychotic mental disorders — usually schizophrenia. Examples include aripiprazole (ABILIFY), clozapine (CLOZARIL, FAZACLO, FAZACLO ODT), olanzapine (ZYPREXA, ZYPREXA ZYDIS), quetiapine (SEROQUEL), risperidone (RISPERDAL) and ziprasidone (GEODON, ZELDOX).
Though active schizophrenia is much less common in adults 65 and older than in the rest of the population, the use of antipsychotic drugs in nursing homes is notoriously high. Nursing homes often misuse these drugs to sedate patients, to treat anxiety or to generally control the overall level of disturbance by nonpsychotic dementia patients.
In nursing homes in the U.S., antipsychotic drugs were found to be the leading cause of all adverse drug reactions — responsible for 23 percent of them — and also the leading cause of preventable adverse drug reactions.[3]
Drug safety warning and side effects
In 2005, the FDA issued a black box warning, its strongest advisory, alerting physicians to the increased risk of death when antipsychotic medications are used to treat elderly patients with dementia.[4] Specifically included in the warning were aripiprazole, clozapine, olanzapine, olanzapine with fluoxetine (SYMBYAX), quetiapine, risperidone and ziprasidone. In 15 of 17 placebo-controlled trials, elderly patients on one or more of these medications demonstrated a 1.6- to 1.7-fold increase in mortality, typically due either to heart-related events or infections.
Particularly in older adults, these drugs often cause falls leading to hip fractures, nerve problems such as tardive dyskinesia (involuntary movements of the lips; tongue; and sometimes the fingers, toes and trunk) and drug-induced drops in blood pressure that may result in injury, heart attacks or strokes.[5] Other serious side effects include substantial weight gain and type 2 diabetes.[6] Some of these reactions, such as worsening confusion and sedation, can mimic the symptoms of dementia in certain patients.[7]
Off-label use and promotion
Although the FDA has never approved the use of atypical antipsychotics for dementia treatment in the elderly, such off-label use of these medications doubled between 1995 and 2008. Sales of the drug in 2008 were estimated at $6 billion.[8]
Physicians are allowed to prescribe medications outside of a drug’s specific indications, but it is illegal for pharmaceutical companies to promote these drugs for this purpose. This has not stopped the major pharmaceutical manufacturers from doing just that. Between 2009 and 2012, Pfizer, Eli Lilly, AstraZeneca and Abbott paid a combined $5.7 billion in fines related to off-label marketing of their drugs to treat dementia.[9] These illegal practices were not isolated to drug companies: The nation’s largest nursing home pharmacy, Omnicare Inc., paid $98 million in fines in 2009 related to kickback schemes aimed at increasing risperidone use among nursing home patients.[10]
CMS recommendations
The recent CMS report provides much-needed guidance for discouraging the use of antipsychotics in nursing home patients. The primary recommendation focuses on a patient-centered approach, highlighting the creation of a supportive environment that recognizes the individual needs and preferences of elderly patients. Research shows that much safer nonpharmacologic approaches should be the preferred, first-line treatment for the management of behavioral symptoms of dementia.[11] Antipsychotic drugs should be used only if clinically indicated for the treatment of a specific condition, and a plan should be developed to gradually reduce the dosage or stop the medication whenever possible.
The report states:
Antipsychotic medications may be considered for elderly residents with dementia but only after medical, physical, functional, psychological, emotional psychiatric, social and environmental causes have been identified and addressed. … Antipsychotic medications must be prescribed at the lowest possible dosage for the shortest period of time and are subject to gradual dose reduction and re-review.
In addition to providing guidance regarding treating dementia in elderly patients, the CMS has included the measurement of atypical antipsychotic use in nursing homes as an indicator of the quality of a given nursing home facility. You can compare the rate of antipsychotic use among short-stay and long-stay residents at www.medicare.gov/nursinghomecompare.
What You Can Do
It is known that antipsychotic use among elderly patients is associated with increased chances of death, as well as other serious side effects.
If one of these medications is prescribed for you or your loved one, it is important to talk to your doctor to understand why the drug has been prescribed and to make a plan for decreasing the dosage or stopping the medication.
You also should discuss other treatment options, such as an increase in skilled nursing care.
As a general rule, if any elderly person on any psychoactive medication — sleeping pills, antianxiety tranquilizers, antidepressants or antipsychotic drugs — appears to be doing poorly, think about reducing the dosage or stopping the drug rather than adding another drug.[12]
References
[1] Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality /Survey and Certification Group. Advanced copy: Dementia care in nursing homes: Clarification to Appendix P, State Operations Manual (SOM) and Appendix PP in the SOM for F309 – Quality of Care and F329 – Unnecessary Drugs. May 24, 2013. http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-35.pdf. Accessed September 12, 2013.
[2] Department of Health & Human Services. Medicare atypical antipsychotic drug claims for elderly nursing home residents. May 2011. http://oig.hhs.gov/oei/reports/oei-07-08-00150.pdf. Accessed September 12, 2013.
[3] WorstPills.org. Antipsychotic drugs: Dangerously overused. /chapters/view/21. Accessed September 12, 2013.
[4] Food and Drug Administration. Public health advisory: Deaths with antipsychotics in elderly patients with behavioral disturbances. April 11, 2005. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm053171.htm. Accessed September 12, 2013.
[5] WorstPills.org. Antipsychotic drugs: Dangerously overused. /chapters/view/21. Accessed September 12, 2013.
[6] Kaiser Health News. Off-label use of risky antipsychotic drugs raises concerns. March 12, 2012. http://www.kaiserhealthnews.org/stories/2012/march/13/off-label-use-of-risky-antipsychotic-drugs.aspx. Accessed September 12, 2013.
[7] Neff D., Walling A. Dementia with lewy bodies: An emerging disease. Am Fam Physician. 2006 Apr 1;73(7):1223-1229.
[8] Alexander, G.C., Gallagher, S.A., Mascola, A., Moloney, R.M., and Stafford, R.S. Increasing off-label use of antipsychotic medications in the United States, 1995–2008. Pharmacoepidem. Drug Safe., 20: 177–184. doi: 10.1002/pds.2082.
[9] ProPublica. Big pharma’s big fines. March 11, 2013. http://projects.propublica.org/graphics/bigpharma. Accessed September 12, 2013.
[10] U.S. Department of Justice. Nation’s largest nursing home pharmacy and drug manufacturer to pay $112 million to settle false claims act cases. November 3, 2009. http://www.justice.gov/opa/pr/2009/November/09-civ-1186.html. Accessed September 12, 2013.
[11] Gitlin, LN, Kales, HC, Lyketsos, CG. Nonpharmacologic management of behavioral symptoms in dementia. JAMA. 2012;308(19):2020-2029. doi:10.1001/jama.2012.36918.
[12] Increased personal care provides alternative to antipsychotic drugs for elderly dementia patients. Worst Pills, Best Pills News. 12(7). /newsletters/view/476. Accessed September 13, 2013.
