Doctors Say Medication Is Overused in Dementia

By LAURIE TARKAN - New York Times

Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication.

Last fall her mother, Theresa Lamascola, of the Bronx, suffering from anxiety and confusion, was put on the antipsychotic drug Risperdal. When she had trouble walking, her daughter took her to another doctor — the younger Ms. Lamascola’s own physician — who found that she had unrecognized hypothyroidism, a disorder that can contribute to dementia.

Theresa Lamascola was moved to a nursing home to get these problems under control. But things only got worse. “My mother was screaming and out of it, drooling on herself and twitching,” said Ms. Lamascola, a pediatric nurse. The psychiatrist in the nursing home stopped the Risperdal, which can cause twitching and vocal tics, and prescribed a sedative and two other antipsychotics.

“I knew the drugs were doing this to her,” her daughter said. “I told him to stop the medications and stay away from Mom.”

Not until yet another doctor took Mrs. Lamascola off the drugs did she begin to improve.

The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from $4 billion in 2000, according to IMS Health, a health care information company.

Part of this increase can be traced to prescriptions in nursing homes. Researchers estimate that about a third of all nursing home patients have been given antipsychotic drugs.

The increases continue despite a drumbeat of bad publicity. A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions.

In 2005, the Food and Drug Administration ordered that the newer drugs carry a “black box” label warning of an increased risk of death. Last week, the F.D.A. required a similar warning on the labels of older antipsychotics.

The agency has not approved marketing of these drugs for older people with dementia, but they are commonly prescribed to these patients “off label.” Several states are suing the top sellers of antipsychotics on charges of false and misleading marketing.

Ambre Morley, a spokeswoman for Janssen, the division of Johnson & Johnson that manufactures Risperdal, would not comment on the suits, but said: “As with any medication, the prescribing of a medication is up to a physician. We only promote our products for F.D.A.-approved indications.”

Nevertheless, many doctors say misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Johnny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places.”

Dr. William D. Smucker, a member of the American Medical Directors Association, a group of health professionals who work in nursing homes, agreed. Though the group encourages doctors to conduct a thorough assessment and prescribe antipsychotics only as a last resort, he said, “Many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.”

Some nursing homes are trying a different approach, so-called environmental intervention. The strategies include reducing boredom, providing intellectual and physical stimulation, exercise, calming music, bringing in pets for therapy and improving how the staff approaches and talks to dementia patients.

At the Margaret Teitz Nursing and Rehabilitation Center in Queens, social workers do life reviews of patients to understand their interests, lifestyle and former occupations.

“I had a patient who used to be in fashion,” said Nancy Goldwasser, the director of social services. “So we got her fabric samples. And she’d sit and look through the books, touch the fabric, and it would calm her.”

But such approaches are time consuming, they do not help all patients, they can be prohibitively expensive and they will be more difficult to provide as Alzheimer’s continues to increase.

“Our health care system isn’t set up to address the mental, emotional and behavioral problems of the elderly,” said Dr. Gary S. Moak, president of the American Association for Geriatric Psychiatry.

Nursing homes are short staffed, and insurers do not generally pay for the attentive medical care and hands-on psychosocial therapy that advocates recommend. It is much easier to use sedatives and antipsychotics, despite their side effects.

The first generation of antipsychotics, like Haldol, carry a significant risk of repetitive movement disorders and sedation. Second-generation antipsychotics, also called atypicals, are more commonly prescribed because the risk of movement disorders is lower. But they, too, can cause sedation, and they contribute to weight gain and diabetes.

Used correctly, the drugs do have a role in treating some seriously demented patients, who may be incapacitated by paranoia or are self-destructive or violent. Taking the edge off the behavior can keep them safe and living at home, rather than in a nursing home.

If patients are prescribed an antipsychotic, it should be a very low dose for the shortest period necessary, said Dr. Dillip V. Jeste, a professor of psychiatry and neuroscience at the University of California, San Diego.

It may take a few weeks or months to control behavior. In many cases, the patient can then be weaned off of the drugs or kept at a very low dose.

Some experts say another group of medications — antidementia drugs like Aricept, Exelon and Namenda — are underused. Research shows that 10 to 20 percent of Alzheimer’s patients had noticeable positive responses to the drugs, and 40 percent more showed some cognitive improvement, even if it was not noticeable to an observer.

“Sometimes, it’s enough to take the edge off the behavioral problems, so the family and patient can live with it and you don’t expose people to much risk,” said Dr. Gary J. Kennedy, director of geriatric psychiatry at the Montefiore Medical Center in the Bronx.

Other experts cite a lack of research backing these drugs for behavioral problems.

If patients begin showing behavioral symptoms of dementia, doctors said, they should have complete medical and psychiatric workups first, especially if symptoms develop suddenly.

“Just because someone is 95 does not mean one should not do a workup, especially if she’s been healthy,” Dr. Kennedy said.

Common causes of the symptoms include ministrokes, reparable brain hemorrhage from a mild bump on the head, hypothyroidism, dehydration, malnourishment, depression and sleep disorders.

Some doctors point out that simply paying attention to a nursing home patient can ease dementia symptoms. They note that in randomized trials of antipsychotic drugs for dementia, 30 to 60 percent of patients in the placebo groups improved.

“That’s mind boggling,” Dr. Jeste said. “These severely demented patients are not responding to the power of suggestion. They’re responding to the attention they get when they participate in a clinical trial.

“They receive both T.L.C. and good general medical and humane care, which they did not receive until now. That’s a sad commentary on the way we treat dementia patients.”

To family members looking at a nursing home for an aging parent, experts recommend seeking out homes with low staff turnover, a high ratio of staff members to patients, and programs with psychosocial components.

The Medicare Web site has basic information on individual homes at www.medicare.gov/NHcompare. The National Citizens’ Coalition for Nursing Home Reform, at www.nccnhr.org, offers a consumer guide to choosing a nursing home.

If medications are necessary, a family member should communicate with the prescribing doctor, learn the goal of each medication and be involved in making the decision.

Dr. Moak, of the psychiatry association, emphasized seeking out the doctor. Family members, he said, “often speak through the nursing staff, and that’s a huge mistake.”

Family members who are not convinced that a relative is receiving the best care should get a second opinion, as Ramona Lamascola did.

The physician she consulted, Dr. Kennedy of Montefiore, stopped her mother’s antipsychotics and sedatives and prescribed Aricept.

“It’s not clear whether it was getting her hypothyroid and other medical issues finally under control or getting rid of the offending medications,” he said. “But she had a miraculous turnaround.”

Theresa Lamascola still has dementia, but she went from confinement in a wheelchair — unable to sit still and screaming out in fear — to being able to walk with help, sit peacefully, have some memory and ability to communicate, understand subtleties of conversations and even make jokes.

Or, as her daughter put it, “I got my mother back.”

This article has been revised to reflect the following correction:

Correction: June 25, 2008
An article on Tuesday about the use of antipsychotic drugs in dementia patients misspelled the names of two drugs in a different class, sometimes used to treat the symptoms of Alzheimer’s and Parkinson’s diseases. They are Exelon and Namenda, not Exalon and Menamda.

 

Tuesday, June 17, 2008

By KEVIN FREKING, Associated Press Writer

Patients hoping to get into nursing homes increasingly are signing away their rights to sue over poor care. That’s a problem, a number of lawmakers say, and they’re pushing legislation to make such agreements unenforceable.

The nursing homes say the arbitration arrangements that many families agree to actually lead to dispute resolutions that are more fair than court cases. Lawmakers, however, urged on by consumer advocacy groups and trial lawyers, say families shouldn’t be giving away their ability to hold the homes accountable for poor care.

A Senate committee will hear on Wednesday from the family of William Kurth, who fractured his hip and leg and contracted numerous pressure ulcers during his final months of life in a Wisconsin nursing home. When his family attempted to sue for negligence, a judge dismissed the case because Kurth’s wife had agreed, as part of her husband’s admission, to have all complaints go through an arbitrator.

The Senate panel, which is investigating the growing use of binding arbitration by nursing homes, says more than 100 lawsuits have been filed in the past five years challenging such agreements.

Arbitrators take into account federal, state and county laws when resolving legal disputes. Often, the parties are free to negotiate some of the ground rules for their case. The process has the advantage of being, faster and less expensive for both parties. It also is confidential.

However, few families are even thinking about the possibility that they might want to go to court when they admit their loved ones to nursing homes.

Kurth’s wife, Elaine, was under extreme duress and on medication when she signed the papers that allowed her husband, a stroke victim, to stay at the nursing home, said Jason Studinski, the family’s attorney.

“It was one of the most stressful days of her life,” Studinski said. “She would have never signed away her right to a trial by jury if she knew what she was doing.”

 Members of the Kurth family who will appear before Congress say their father, a World War II veteran, died at age 84 from infections that occurred because excrement and urine were not cleansed from his bedsores for days at a time. David Kurth of Burlington, Wis., says arbitration has become a shield for large corporations to hide behind and decrease the quality of care.

“It is economically more profitable to let people like my father suffer than to provide proper care,” said Kurth in written testimony provided to The Associated Press. “And now that our family is trying to hold the nursing home corporation accountable for its actions, Kindredcare is trying to bury our case by forcing us into a mandatory, secret, and binding arbitration process that they chose.”

Kindred Healthcare, based in Louisville, Ky., said it would not comment specifically on the Kurth case. But it noted a judge’s decision that found the arbitration agreement was optional and not a condition for admission.

“The Kurth family has been represented by counsel throughout this proceeding and may pursue their claim under the provisions of Kindred’s Alternative Dispute Resolution program should they choose to do so,” the company said via e-mail. “We look forward to a prompt and mutually acceptable resolution of the case.”

The company said the arbitration program was designed to achieve several goals, including prompt resolution of legal disputes and lower costs to both residents and their families.

Lawmakers don’t want to preclude binding arbitration as an option, said Sen. Herb Kohl, D-Wis., and chairman of the Senate Aging Committee. But the decision has to be made by both parties after a dispute occurs.

“Many incoming residents lack the capacity to make even simple decisions, much less judge the legal significance of an arbitration agreement,” Kohl said. “Most are unaware that they are signing away their right to go to court.”

The nursing home industry emphasizes that arbitration is voluntarily agreed to and not a condition for admission. Also, nursing homes say, the process is typically quicker than a court case, so agreements can be reached while the patient can still take advantage of compensation.

Bruce Yarwood, president of the American Health Care Association, said lawsuits were driving nursing homes out of some states in the late 1990s and early 2000s, particularly Florida. He also said that jury trials can be stacked against the industry because people are inclined to want someone to pay if a mom or grandmother got hurt, even if the nursing home isn’t responsible for the injury.

“What we find is that when you get into a court structure, it’s not necessarily an unbiased structure,” Yarwood said. “What we’re looking at is something that’s a lot more fair.”

Groups including AARP and the Alzheimer’s Association support legislation, sponsored by Sen. Mel Martinez, R-Fla., that would make arbitration agreements for nursing home patients unenforceable.

Stephen Ware, a professor of law at Kansas University, urged lawmakers in his written testimony to refrain from banning arbitration for nursing homes. He said lower legal expenses can increase access to justice, especially in smaller cases where it can be difficult to attract a lawyer. Also, lower legal expenses can benefit others to the extent that a nursing home’s costs are ultimately paid for by residents and their families, or by taxpayers.

In some cases, the Federal Arbitration Act allows courts to invalidate unconscionable arbitration agreements, Ware notes.

“And this is not just a theoretical protection,” he said. “Each year, there are many cases in which courts hold particular arbitration agreements unconscionable. Among these are cases involving nursing homes.”

 

 

 

By James Drew
Baltimore Sun reporter

June 16, 2008

Alarmed that the purchase of nursing homes by larger companies could cause a decline in care, Maryland is studying whether restrictions should be placed on ownership as regulators face criticism that private equity groups make it more difficult for the public to hold nursing homes accountable for poor care.

The goal of the two bills that Gov. Martin O’Malley recently signed into law is to determine if the type of ownership - ranging from small nonprofits to corporations with worldwide holdings - has a connection with violations of state and federal regulations at nursing homes, said Wendy Kronmiller, director of the state Office of Health Care Quality.

The driving force behind the effort is the acquisition of one of the nation’s largest nursing home chains, HCR ManorCare, by the Carlyle Group for $6 billion in December. HCR ManorCare has 14 nursing homes in Maryland and 277 nationwide.

The Service Employees International Union, which represents 1,100 workers at HCR ManorCare nursing homes nationwide, including 200 in Maryland, released a study last year asserting that buyouts of two other nursing home chains have led to more violations of state and federal regulations, and new business structures to limit liability, reduce tax bills and make it more difficult to track how Medicare and Medicaid dollars are spent. Union officials have complained of violations of federal and state regulations at HCR ManorCare nursing homes in Maryland and of what they say is “inadequate staffing.”

Kronmiller said a task force formed this summer would have a wider scope than ownership by private equity firms. The group, which will include representatives of consumer groups and nursing homes, will analyze data over two years to determine whether there is a link between type of ownership and poor care.

The state has anecdotal evidence that talented administrators and nursing directors, combined with little staff turnover, result in better care, but officials have not studied ownership, said Kronmiller, whose office is part of the Department of Health and Mental Hygiene.

Maryland has 233 nursing homes - about 60 percent for-profit and 40 percent nonprofit, state officials say. The study will try to determine how many are owned by private equity groups.

Of the two Maryland nursing homes that federal officials placed on a national watch list this year, both are owned by private equity groups: ManorCare- Rossville by the Carlyle Group and the Waldorf Center by Formation Capital, which last year acquired Genesis HealthCare. Genesis operates 22 nursing homes in Maryland. Manor Care-Rossville and the Waldorf Center will be inspected twice a year instead of once and face possible penalties.

Kronmiller stressed that problems at the two nursing homes were detected over three years and began before the acquisitions.

But SEIU officials warn that private equity groups hold companies in their portfolios “accountable to profits, but not quality of health care or how they treat their workers.”

“Private equity is corporate greed on steroids; how that melds with patient care is hard for us to figure out,” said Stephen Lerner, director of SEIU’s private equity campaign.

HCR ManorCare, in a written statement, said Carlyle expects to make a profit by selling its investment.

“That’s how Carlyle will make money … not by cutting costs or staffing or anything else, but by helping make HCR ManorCare a stronger care provider,” the statement said.

Advocates for nursing home residents in Maryland said they have not documented a link between ownership type and poor care, noting that the number of violations of federal and state regulations discovered during inspections varies within large corporate chains and that some nursing homes owned by nonprofits have fared poorly in recent state inspections.

“Each nursing home is a separate entity, and there are quite wide variations in care,” said Bob Bronaugh, vice chairman of Voices for Quality Care, a nonprofit group based in Leonardtown.

Charlene Harrington, a professor in the School of Nursing at the University of California-San Francisco, said studies she has helped conduct since 2000 have found that for-profit nursing homes across the nation operate with lower costs and smaller staffs than nonprofits, which provide more staff and higher quality care.

“I am not sure they need to do another study,” said Harrington, referring to Maryland officials.

Private equity firms began to buy nursing homes in 2000, according to David G. Stevenson, an assistant professor at Harvard Medical School in Boston.

Stevenson said a study he recently completed did not find that nursing home quality “worsens markedly” after purchase by private equity firms, but he said more research was needed.

In addition to studying ownership, Maryland officials are crafting regulations - based on a bill sponsored by Del. Patrick L. McDonough, a Republican who represents Baltimore and Harford counties - to require nursing home applicants to disclose to the state “any significant change in the financial condition,” including cash flow. Kronmiller said the initiative stemmed from recent financial problems at nursing homes owned by smaller nonprofits, which she said could have been resolved earlier if the state had known about them.

The state also is debating possible ways to get nursing home owners to provide more details on how they are structured. That primarily would benefit consumers, she said.

For example, members of Voices for Quality Care recently researched a St. Mary’s County nursing home after learning it had dozens of violations of federal and state regulations on its most recent inspection posted on the Web site of the Centers for Medicare & Medicaid Services. The group identified the firm managing the nursing home, researched other nursing homes across the nation run by the same company and is examining how ownership is structured.

Voices for Quality Care wants to do the same research for all nursing homes in Maryland and has been urging Congress to pass legislation to require more transparency in nursing home ownership.

“We’re interested in who owns them, because the owners often hire out-of-state management companies, and if the out-of-state management companies are failing or having problems, we want to go to the owner,” said Bronaugh, the group’s vice chairman.

Nursing homes whose ownership includes layers of limited-liability companies also threaten to make it harder for nursing home residents to sue over poor care, said Jason Frank, chairman of the elder law section of the Maryland State Bar Association.

The Office of Health Care Quality is “grossly understaffed, grossly underfunded, and so the regulatory model as an alternative to tort just does not work,” Frank said.

Kronmiller, the office’s director, said she would be a member of the committee that studies nursing home ownership, and the legislature would provide staff. She is chairing the group working on regulations to require nursing home to provide earlier warnings about financial problems and more information about ownership.

“It will require more work on our end, but this is what we are supposed to be doing,” she said.

Kronmiller said she hoped the nursing home ownership study would help guide the legislature as it grapples with the controversy over private equity groups.

“Certainly the goal is to provide good care, but aren’t they all trying to get money out of it? Why would this be different?” she asked.