Many persons make the painful decision of putting a loved one into a nursing home because of the level of care the person needs. The last thing they expect is that their loved one may be improperly medicated. Yet excessive use of antipsychotic drugs in nursing homes is such a concern that the Government Accountability Office, a government agency that reports to the U.S. Congress, noted that antipsychotic drugs are prescribed to 33% of older adults with dementia who spend 100 days or more in a nursing home, as opposed to 14% of older adults with dementia in the general population who receive such medication. The GAO used Medicare Part D data from the government to arrive at these figures.
The Centers for Medicare and Medicaid Services (CMS), which is part of the U.S. Department of Health and Human Services noted in a 2015 press release that use of antipsychotic drugs in nursing homes will now be one of three factors in determining a nursing home’s “star” rating. The CMS press release said:
“Beginning today, nursing home star ratings will:
- Include use of antipsychotics in calculation of the star ratings. These medications are often used for diagnoses that do not warrant them. The two existing quality measures – for short stay and long stay patients – will now be part of the calculation for the quality measures star rating.”
(CMS.gov. Centers for Medicare and Medicaid Services, February 20, 2014. Https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-20-2.html.)
Before this change in the rating system, the CMS press release noted, about 80% of nursing homes received either a 4-star or a 5-star rating, which are the two highest ratings. After the change in the ratings system, less than 50% of nursing homes received a 4-star or a 5-star rating. Nursing homes that received only 1-star ratings doubled. (CMS.gov. Centers for Medicare and Medicaid Services, February 20, 2014. Https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-20-2.html.)
The Government Accountability Office said in its 2015 report to Congress that evidence pointed to “the number of staff at the nursing home as contributing to the decision to prescribe antipsychotic drugs to older adults” (United States Government Accountability Office, Report to Congressional Requesters, January 2015, p. 23). The report said: “Nursing home staff levels, particularly low staff levels, lead to higher antipsychotic drug use” (United States Government Accountability Office, Report to Congressional Requesters, January 2015, GAO Highlights, http://www.gao.gov/assets/670/668221.pdf).
Researchers Briesacher, Tija, Field et al. wrote a report of their study of nursing homes and antipsychotic drug use that appeared in the journal Pharmacoepidemiology and Drug Safety. The researchers found that low staff levels in nursing homes was associated with higher use of antipsychotic drugs.
Risks of Antipsychotic Drugs
The GAO report further notes that antipsychotic drugs for the older population are not FDA-approved to treat dementia behavioral symptoms, although they are often used for this purpose. Rather, antipsychotic drugs are FDA-approved to treat schizophrenia and bipolar disorder. (United States Government Accountability Office, Report to Congressional Requesters, January 2015, http://www.gao.gov/assets/670/668221.pdf, p. 2).
Antipsychotic drugs also carry health risks (United States Government Accountability Office, Report to Congressional Requesters, January 2015, http://www.gao.gov/assets/670/668221.pdf, p. 2). The report notes: “These drugs have been found to cause falls and other adverse events, including an increased risk of death, among older adults with a diagnosis of dementia” (United States Government Accountability Office, Report to Congressional Requesters, January 2015, http://www.gao.gov/assets/670/668221.pdf, p. 2).
“These drugs have been found to cause falls and other adverse events, including an increased risk of death, among older adults with a diagnosis of dementia” (United States Government Accountability Office, Report to Congressional Requesters, January 2015, http://www.gao.gov/assets/670/668221R.pdf, p. 2).
Off-label use of drugs is common medical practice. However, off-label use of antipsychotic drugs is so dangerous that in 2005 the U.S. Food and Drug Administration (FDA) mandated that “atypical” antipsychotics drugs must carry a boxed warning (United States Government Accountability Office, Report to Congressional Requesters, January 2015, http://www.gao.gov/assets/670/668221.pdf, p. 8). Then in 2008 the FDA issued a warning that included conventional antipsychotic drugs and required that these drugs also carry a boxed warning. The FDA warning read as follows:
“Considerations for Healthcare Professionals
- Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death.
- Antipsychotic drugs are not approved for the treatment of dementia-related psychosis.Furthermore, there is no approved drug for the treatment of dementia-related psychosis. Healthcare professionals should consider other management options.
- Physicians who prescribe antipsychotics to elderly patients with dementia-related psychosis should discuss this risk of increased mortality with their patients, patients’ families, and caregivers.” (FDA website, Information for Healthcare Professionals: Conventional Antipsychotics, February 16, 2008, Federal alert. Available online at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm).
A “boxed warning” is sometimes called a “black box” warning because it is bordered by black lines. According to D. W. Aaronson of the Chicago Medical School, in an article available through the National Institutes of Health, a “black box” warning is the highest level of warning that FDA gives about the danger of a drug, and such drugs should not be administered without informed consent, which includes a discussion with patients, their loved ones, or representatives, about the known dangers.
Some common names of antipsychotic drugs, both conventional and atypical, are, according to the FDA website: Compazine, Haldol, Loxitane, Mellaril, Moban, Navane, Orap, Prolixin, Stelazine, Thorazine, Trilafon, Abilify, Clorazil, FazoClo, Geodon, Invega, Risperdal, Seroquel, Zyprexa, Symbyax.
Loved ones of elderly patients would do well to visit the FDA webpage in the Source list at the end of this article to see if their elderly loved ones in nursing homes who have dementia are being prescribed these drugs or others with the same chemical composition. For example, the brand name Abilify contains the chemical aripirazole.
CMS has set up nationwide goals to reduce the use of antipsychotic drugs in nursing homes. The goal is to reduce antipsychotic drug use in such institutions by 25% by year’s end 2015, and to reduce such use by 30% by the end of the year 2016 (Government Accountability Office (GAO). (Jan 30, 2015). Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings. P. 27.)
Worthy goals, indeed.
Sources
Aaronson, D. W. (2006). The “black box” warning and allergy drugs. Journal of Allergies and Clinical Immunology. Jan;117(1):40-4. Abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/16387582.
Briesacher, B. A., Tjia, J., Field, T., Mazor, K.M., Donovan, J.L. et al. (2012).”Nationwide Variation in Nursing Home Antipsychotic Use, Staffing and Quality of Care.” Pharmacoepidemiology and Drug Safety, Vol. 21.
Centers for Medicare and Medicaid Services (CMS). CMS Strengthens Five-Star Rating System for Nursing Homes. Media Release, February 20, 2015.Available online at https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-20-2.html.
Government Accountability Office (GAO). Antipsychotic Drug Use: HHS Has Initiatives to Reduce Use among Older Adults in Nursing Homes, but Should Expand Efforts to Other Settings. GAO-15-211: Published: Jan 30, 2015. Publicly Released: March 2, 2015. Highlights available online at http://www.gao.gov/products/GAO-15-211. Full report available online at http://www.gao.gov/assets/670/668221.pdf.
U.S. Food and Drug Administration. Drugs and Drug Safety. Available online at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124830.htm.
