Pamela A. MacLean
RedwoodAge.com

In a nursing home on the southern end of California's Central Valley, three elderly dementia patients died during 2007. Normally, that would not make the headlines. But these patients died after being given powerful antipsychotic drugs to control their behavior despite warnings the drugs increase the risk of death in elders with dementia. 

Mae Brinkley, 91, and Joseph Shepter, 76, and Alexander Zaiko, 85, died at the Kern Valley Hospital, a 74-bed skilled nursing facility in rural Lake Isabella, about 30 miles northeast of Bakersfield. Their cases came to light after an ombudsman reported to the state Department of Public Health that a patient had been held down and forcibly injected with an antipsychotic medication. 

Investigators later found the nursing facility had given 22 patients, some with Alzheimer's - the most common form of dementia - high doses of  antipsychotic medications to control them for the convenience of staff, according to court papers and the Center for Medicare Advocacy. Now Dr. Hoshan Pormir, their physician, Gwen Hughes, director of nursing, and Debbi C. Hayes, a pharmacist, face criminal charges that include three counts of elder abuse resulting in death, five counts of non-fatal elder abuse and two counts of assault with deadly weapons - the psychotropic medications Zyprexa and Risperdal, according to the state's criminal complaint.

The case, set for trial this spring, is California's first use of criminal elder abuse law in this context.  But across the country the use of drugs as chemical straight jackets in nursing homes and hospitals is a growing problem.  

"There are dozens of Kern Valley Hospitals that drug with impunity," said Tony Chicotel, an attorney with the California Advocates for Nursing Home Reform (CAHNR).  A December report, "In a Stupor," by CAHNR alleged the "misuse of antipsychotic drugs is the leading form of elder abuse in nursing homes."

The rising concerns of the abuse of medications in nursing homes comes as the psychiatric profession reviews its definitions of mental illness. The Diagnostic and Statistical Manual of Mental Illness guides mental health professionals in identifying nearly 300 different mental disorders. Its fifth edition, DSM-5, is due out next year. As it stands now, the new guidelines could classify millions of elders as mentally ill for such conditions as bereavement and "mild cognitive disorder," a heightened level of forgetfulness that many psychiatrists see as a possible precursor to dementia. 

Dr. Dilip Jeste

Of the nearly 305,000 elderly nursing home residents nationally, about 14 percent received antipsychotic drugs in just the first six months of 2007 at a cost of hundreds of millions of dollars, according to Toby S. Edelman, senior policy attorney for the Center for Medicare Advocacy. She told a congressional hearing in November that 83 percent of Medicare claims for use of the drugs on the elderly were for off-label conditions, meaning the drugs were used in ways they were not intended. A startling 88 percent were conditions specifically cited as dangerous by the Food and Drug Administration, according to a government study.

Congressional testimony

"Medications are used often as the first intervention because family members, caregivers, nurses and doctors in all settings lack information or training regarding alternatives," said Dr. Cheryl Phillips, a geriatric doctor and senior vice president for advocacy at LeadingAge, an association of homes and services for the aged.  She joined Edelman in testifying to the Senate's Special Committee on Aging on reducing inappropriate use of these drugs in nursing homes.

Phillips said in a recent interview that the drugs don't do anything to treat dementia.  "They don't improve life.  They sedate or calm people so they are not as aggressive," she said.

To be sure, the medications do have a place in some instances, for limited periods and with close monitoring. "Without a doubt there are demented individuals who have so much agitation and are delusional that their quality of life can be improved," she said. "But the drugs also increase other risks."  Striking the right balance is a "profound challenge" for long-term care facilities and the families and seniors affected, she said.

Eight antipsychotic drugs have been approved by the Food and Drug Administration to treat schizophrenia and bipolar disorder: Aripiprazole, Clozapine, Olanzapine, Fluoxetine, Paliperidone, Quetiapine, Risperidone and Ziprasidone. Side effects include liver damage, a life-threatening nervous system problem, high blood sugar and diabetes, and low blood pressure that can cause fainting. In 2005, the FDA required a specific warning on the drug boxes that elderly patients with dementia-related psychosis had an increased risk of death using these drugs.

Improper Marketing
The financial incentives to promote the off-label use of these drugs can be tempting.  Eli Lilly Co. pled guilty in Pennsylvania federal court and agreed to pay $1.4 billion in 2009 for promoting its drug Zyprexa for unapproved uses, including the treatment of agitation, aggression, hostility, dementia, Alzheimer's and depression, according to the Justice Department. 

The same year, Omnicare, which supplies nursing homes with medicine, agreed to pay federal authorities $112 million to settle claims it accepted kickbacks from drug companies to prescribe antipsychotic drug Risperdal to nursing homes.  In January 2012, Johnson & Johnson agreed to pay $1 billion to settle claims of alleged Medicare fraud by a dozen states in marketing its schizophrenia drug Risperdal. The government accused J&J of selling Risperdal for dementia, mood and anxiety disorders and other unapproved uses.

In California, CANHR found that one in four of the state's 25,000 nursing home residents receive antipsychotic drugs, the majority are off-label uses for patients with dementia the group reported in January. 

Mark Zahner, the state attorney general's chief of prosecutions for the Bureau of Medicare Fraud and Elder Abuse, oversees the team that is prosecuting the Kern Valley staff. He says the case is unusual. The Department of Public Health is responsible for monitoring and referring potential violations.  "But we don't see a lot of chemical restraint cases come our way.  I would like to see more," he said, noting that medical privacy concerns often leave investigators' hands tied.

Budget Cutbacks
Back in 2000, former California Attorney General Bill Lockyer began a joint state and local surprise inspection program to spot nursing home abuse and neglect called Operation Guardians, but the program has been cut back in the wake of the state's budget woes.  Peggy Osborn, head of the current Operation Guardians inspection team in Sacramento, said they still conduct surprise early morning inspections.  

"It's sad. We did 70 to 90 a year when Lockyer began it. Now it is significantly reduced," she said. "We're still out there. But this is not a popular thing for the nursing industry."

California has more nursing facilities than any state but Florida.  "The city of Sacramento has more nursing facilities than the entire state of Arkansas," said Osborn.

The number of nursing homes has remained stable for more than a decade while the number of assisted living facilities, where government oversight is far less stringent, has skyrocketed.  There are 15,000 assisted living centers in California alone.  Although residents are more independent and physically fit, the potential for similar abuses increases as the residents age.

In other parts of the country, creative programs have begun to look at alternatives to use of antipsychotic medications to calm and control residents.  In Cleveland and in Shoreview, Minn., two innovative programs have found success in new approaches.

PART 4: Innovative programs based on environmental improvements and a Japanese teaching program show promise in retaining quality of life for elders with dementia

PART 1 - New Mental Disorders  

PART 2 - One Woman's Family 

SIDEBAR - Unique Elder Court 

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Pamela A. MacLean wrote this article for RedwoodAge.com as part of the MetLife Foundation Journalists in Aging Fellowship, a project of New America Media and the Gerontological Society of America.