Pamela A. MacLean
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
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
"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.
The manual doesn't prescribe treatments; that's left to individual doctors.
But there are just 2,000 board-certified geriatric psychiatrists in the United
States, according to Dr. Dilip Jeste, president-elect of the American
Psychiatric Association and chief of geriatric psychiatry at the University of
California, San Diego. That means treatment of the elderly often falls to family
doctors or the professional staff in hospitals, nursing homes and assisted
living facilities who may have little training in the special needs of the
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.
Many of the elderly received the drugs because of "behavior
problems," not due to any diagnosis of psychosis, Edelman said.
"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
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.
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.
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.
4: Innovative programs based on environmental improvements and a
Japanese teaching program show promise in retaining quality of life for elders
PART 1 - New
PART 2 - One
SIDEBAR - Unique
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.