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Lawsuits challenge use of 'chemical restraints' in nursing homes.

For David Couch, an attorney in Little Rock, Arkansas, Robert Harris was "just a grumpy old man" suffering from mild dementia who should not have died eight weeks after admitting himself to a nursing home.

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Harris wanted to be around people, said Couch, and felt bored staying at the house of his daughter, who was often away at work.

"He was a very active man, set in his ways. He was complaining a lot about stuff, walking around" at Lawrence Hall Nursing Center in Walnut Ridge, Arkansas, Couch said. "Because he was so active, the people at the nursing home thought he had psychotic problems and that he needed drugs."

The complaint in the wrongful death lawsuit filed by Harris's estate against the nursing home and an adjunct hospital alleges that the drugs administered shortly after his arrival--Risperdal, a so-called atypical antipsychotic, and Haldol, an older antipsychotic--caused Harris to become "an involuntary catatonic prisoner." In detailing claims that the defendants had inadequate staff and failed to monitor his condition, the complaint alleges that after Harris started the drugs, he stopped eating and drinking normally, lost almost 10 percent of his body mass within a month, could not walk about as he did before, became confused and increasingly drowsy, and then developed incontinence that required a catheter.

The catheter was inserted improperly, puncturing Harris's urethra, Couch said. Harris died from a massive infection. (Downing v. Lawrence Hall Nursing Ctr., No. CV-2002-67 (At-k., Lawrence Co. Cir. filed June 10, 2002).)

In being treated with so-called chemical restraints, Harris was not alone: In recent years, increasing numbers of nursing home residents have been prescribed antipsychotic medications to manage their behavior. The most recent research, by Becky Briesacher at the University of Massachusetts Medical School, shows that nearly 30 percent of the nation's 1.4 million nursing home residents received the drugs in 2001, up almost 10 percent from 1999. Most, like Harris, do not have a diagnosis of psychosis but are prescribed the drugs off-label, for management of dementia. (Becky Briesacher et al., The Quality of Antipsychotic Drug Prescribing in Nursing Homes, 165 Archives Internal Med. 1280 (2005).)

Many doctors and researchers acknowledge that the drugs, approved by the FDA for use only in those suffering from schizophrenia and mania, can calm or sedate agitated or otherwise disruptive demented patients. But their use in those suffering from dementia is not without controversy.

Congress passed legislation to address the issue more than 20 years ago. The Omnibus Budget Reconciliation Act (OBRA) of 1987 contained provisions to improve nursing home care, including minimizing the use of physical and chemical restraints, with penalties for noncompliance.

"The issue was to free people from unnecessary drugs and excess dose and duration and to make sure the drugs were not being used for the convenience of staff or for punishment of patients," said Michael Harper, a doctor specializing in geriatrics at the San Francisco VA Medical Center. "With patients with difficult behaviors, one of the easiest things to do is sedate them with antipsychotics and other drugs."

Briesacher said that after OBRA was enacted, prescriptions for antipsychotics in nursing homes dropped--for a time.

"Then, in the early 1990s, this new generation of atypical antipsychotics came out. They were pushed really hard by the drug companies with the promise that they had fewer side effects" than the older generation of antipsychotics, she noted. "So people felt more comfortable using them in populations other than those who had schizophrenia, and that included nursing home residents who had dementia."

Harper said the drugs are used in nursing homes to control several different behaviors.

"Sometimes they're prescribed for patients with psychotic symptoms, sometimes for patients with violent behavior, agitation, which is very broadly defined," he said. "Most experts would say that antipsychotics are most likely to have a beneficial effect if you have a really targeted symptom that you can monitor, to see if it improves. But the problem with all these drugs is regression to the mean, so they almost always look better in people's experience because you start them when someone's at their worst and then they're likely to get better."

Despite the medical breakthrough that atypical antipsychotics represented, in April 2005 the FDA ordered a so-called "black box" warning for the drugs when used off-label in the elderly suffering from dementia. Seventeen studies of the drugs showed that the death rate in that group was higher than in those taking a placebo.

A year later, a widely cited study showed that the drugs' adverse side effects in those suffering from Alzheimer's disease outweighed their advantages in the treatment of the patients' aggression or agitation. (Lon Schneider et al., Effectiveness of A typical Antipsychotic Drugs in Patients with Alzheimer's Disease, 355 New Eng. J. Med. 1525 (2006).)

In fact, in congressional testimony in February 2007, FDA researcher David Graham estimated that as many as 15,000 elderly people die every year in nursing homes from the off-label use of antipsychotic medications.

"We have pretty strong evidence that atypical antipsychotics increase the risk for falls, fractures, and some people even say death," said Briesacher. "In the population that has dementia, the benefits are really unclear."

Finding the facts

For attorneys handling cases where chemical restraints--including tranquilizers and antidepressants as well as antipsychotics--may be a factor, figuring out how to prove negligence can be tricky.

On February 9, 2006, Helen Marciniszyn was admitted to a personal care home (also known as an assisted-living facility) with mild dementia and an unsteady gait. Two months later, she was dead from complications of a hip fracture from a fall at the home.

What happened at the home in the intervening months is central to a lawsuit against the home and its corporate owners brought by Philadelphia attorney Robert Sachs on behalf of Marciniszyn's children. (Shields v. Indep. Blue Cross, No. 07-11090 (Pa., Del. Co. Com. Pleas filed Aug. 22, 2007).)

Outlining claims of negligence and wrongful death, the complaint alleges that the day after Marciniszyn was admitted, a doctor, without seeing her, prescribed Seroquel, an atypical antipsychotic, for psychosis. Less than two weeks later, another doctor prescribed a tranquilizer, Ativan, again without seeing her.

The doctors were not the only ones not seeing Marciniszyn; according to Sachs, the family was discouraged from visiting her in the first two weeks of her stay at the home.

"They were told that their mother needed to get adjusted to the facilities," Sachs said. "So the family had no idea that with these drugs that she had never taken before, she was out of it. They deprived the family of the opportunity to protect her from these medications."

Five days after the Ativan was prescribed, Marciniszyn fell, breaking her hip. The complaint alleges that the home improperly restrained her with drugs and that the medications placed her at an increased risk of falling.

"It wasn't just the use of the atypical antipsychotic, but the combination of both drugs that created a situation where it was a foregone conclusion that she would fall," said Sachs.

Memphis attorney Parke Morris is handling two cases of chemical restraints in nursing homes. His clients are suing the homes for wrongful death and negligence after the deceased were prescribed large quantities of powerful tranquilizers and antidepressants. (Stotts v. Beverly Enters., No. CT-00137603 (Tenn., Shelby Co. Cir. filed Mar. 11, 2003); Johnson v. Orion Memphis, No. CT005181-06 (Tenn., Shelby Co. Cir. filed Dec. 15, 2006).)

Morris said vigilant family members can be crucial to proving these cases, because they are often the first to notice changes in a resident's behavior. But sometimes luck, too, plays a role in determining whether chemical restraints were used.

"In one case, surgery before the patient's death showed unmetabolized pools of the tranquilizer Ativan," Morris said. "But in the other, we were lucky to have an employee come forward after the case was filed, who claimed he was fired for warning the family about chemical restraints."

Although nursing homes are required to have a pharmacist review drug use for each patient at least every 30 days, oversight is minimal, according to Armon Neel, an independent geriatric consultant pharmacist in Griffin, Georgia.

"Consultant pharmacists can make all kinds of recommendations to the physician about drug therapies and inappropriate drug doses, but if the doctor does not want to accept that, he can move right on. There is no oversight, and that is wrong," Neel said.

He also sees an inherent conflict of interest in how pharmacists review drug plans in nursing homes.

"Although a nursing home pays for a consulting pharmacist, the consulting pharmacist usually works for a pharmacy provider, often a big chain operation that the nursing home contracts with for drugs. There's a conflict of interest, because in the nursing home the intention is to keep patients away from unnecessary drugs, and the pharmacy provider wants to move market share: More drug use, larger drug costs."

In response to such critiques, Barry Straube, chief medical officer at the Centers for Medicare and Medicaid Services (CMS), which funds more than 60 percent of nursing home care, told the Wall Street Journal that the agency "has initiated a more rigorous process to oversee appropriate use of medicine" and that the number of nursing home inspections resulting in citations for drug misuse jumped nearly 50 percent between 2004 and 2007. (Lucette Lagnado, Prescription Abuse Seen in U.S. Nursing Homes, Wall St. J. A1 (Dec. 4, 2007).)

In December, Sen. Charles Grassley (R-Iowa) asked the inspector general of the Department of Health and Human Services to investigate the use of antipsychotics in nursing homes. His letter noted that Medicaid spent $5.4 billion on atypical antipsychotics in 2005, 25 percent of which was for nursing home residents.

Time and money

Lawyers say the use of antipsychotics in nursing homes is tied to the widespread problem of inadequate staffing in these facilities and the industry's focus on the bottom line. Sachs believes money is at the heart of the matter.

"Especially in for-profit homes, the nursing staff realizes that they can supervise more people if the patients are less active," he said. "They encourage the prescription of potent medications that have the effect of sedating and tranquilizing patients, thus reducing their activity level. This is important, because in a for-profit care environment, having fewer care providers improves the bottom line. So the employees look good because they are managing a higher patient load, the owners look good because they're earning greater profits, but residents suffer from reduced quality of life because when people are sedated, they are often at greater risk of falling."

Charlene Harrington, a researcher at the University of California, San Francisco, noted in congressional testimony in November 2007 that total average of staff at nursing homes has not increased since 1997, and nurse staffing hours per resident day have declined 25 percent since 2000. That decline, she said, is tied to poor quality: A 2001 study commissioned by CMS found that 97 percent of nursing homes do not meet the minimal guidelines defined by the study for the level of nurse and patient interaction needed to prevent harm. (CMS, prepared by Abt Assoc., Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes: Report to Congress Phase II Final (Dec. 2001).) And CMS currently has no numbers for minimum staff.

Couch said this problem is central to what happened to Robert Harris.

"If they had more people there to interact with him, they wouldn't have had to give him drugs. They took the easy way out, in my opinion. They just didn't have the time or inclination to deal with Harris," he said.

"I would say that 75 percent of people in nursing homes on antipsychotics shouldn't be on them. People are bored, they don't have anything to do, and they're old. Once an adult, twice a child--they' re like kindergarten kids. If what was going on in our nursing homes was going on in our kindergartens, we'd be appalled as a nation."
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Author:Jablow, Valerie
Publication:Trial
Date:Mar 1, 2008
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