The danger of Risperdal for elderly residents

The Milwaukee-Wisconsin Journal Sentinel had an interesting article about Bruce Bowman.  He was a resident at a nursing home facility who was given Risperdal, an anti-psychotic medication.  Normally it is used to control agitation and aggression but many nursing homes use it and other medications as a chemical restraint to "quiet" the residents.

Mr. Bowman had adverse reactions to the Risperdal.  These reactions were well known to his health care providers but the nursing home never warned the family of any possible side effects.  Mr. Bowman's throat swelled up. His body went rigid. He got pneumonia from lack of mobility. The once strong former logger withered away. Two weeks before he died June 19, Bowman weighed only 112 pounds.

Six months before he died, Bowman was given Risperdal by the nursing home. his children insist they were never told by the nursing home staff that Risperdal has a black-box warning that reads: "Increased mortality in elderly patients with dementia-related psychosis." They didn't know that in clinical trials for Risperdal, most patient deaths occurred from cardiovascular or infectious complications, such as pneumonia. The drug's listed side effects also include vomiting, weight loss and muscle stiffness, among many others.

"I'd never give any kind of consent for any of that," said Martin Bowman, Bruce's son, who was the legal guardian of his father's care and needed to approve any changes in medication.

The black-box warning for Risperdal was issued by the Food and Drug Administration in 2005. The drug is only approved for use in people with schizophrenia, bipolar disorder and some irritability associated with autism. Martin Bowman never saw that warning because the nursing home was using 7-year-old medication consent forms, Public Investigator found.

The old forms didn't have the paragraphs of warnings about Risperdal because the warnings hadn't been issued in 2001, when the forms apparently were printed.  The nursing home should have downloaded an updated form from the state Department of Health Services Web site.

Anti-psychotic drugs often are prescribed to elderly patients with dementia to control their agitation and outbursts.  Many researches believe that anti-psychotic drugs are overprescribed to subdue nursing-home patients. The consequences can be deadly.

Many nursing homes use medications as a restraint so they can save money on staff.  The less vocal a resident is or the more they are asleep, the less the staff has to do for them.  Nurses are happy because of less work, and the corporation who owns and operates the facility gets more profit.

Overmedicating Demented Residents

NY Times had an article about the overuse of certain medications in elderly residents.  Below are excerpts of the article.

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.  [Blogger's note: Typically these medications are used as "chemical restraints" to quiet the residents down--a sure sign of understaffing.]

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.”

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. 

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

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.

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.


Use of chemical restraints in nursing homes

 Warren Wolfe of the Star Tribune in St. Paul, Mn. wrote a great article on the overuse of medications in the nursing home population.

Thousands of nursing homes nationwide are using powerful antipsychotic drugs to quiet disruptive people with mild dementia -- at times a step that's easier and cheaper than training staff to fix the problem.   The practice is alarming Medicaid officials so they ordered state nursing home inspectors to crack down on it. 

The Food and Drug Administration requires some to carry a "black box warning" that they heighten risk of death for older patients, a warning that it might extend to all antipsychotic drugs. They also increase the risk of confusion and falling.   The drugs often are prescribed whether the resident is psychotic or not.

Antipsychotic drugs have become the No. 1 drug paid for by Medicaid, which regulates and pays for nursing home care.  It's easy to understand why an overworked and burnt out nurse might want a resident drugged as a chemical restraint.  However, unless the resident is combative because of a mental illness such as paranoia, there's always a better way to control disruptive behavior in someone with dementia than with drugs, said John Brose, a Minneapolis psychologist who consults at more than 100 nursing homes, including Hopkins.

"Usually, that person is trying to communicate something -- I'm too cold, too hot, constipated, frightened, tired, thirsty," he said. "Figure that out, then deal with the real problem."


Sedatives increase risk of falls in elderly

Journal of Clinical Nursing has an article about a recent study linking the use of sleeping pills containing benzodiazepines to increase falls in nursing homes.
Older patients taking benzodiazepines were 2.9 times more likely to fall   Obviously, patients who fall suffer severe injuries.   Some older patients have impaired cognitive function or limited functional ability and physical strength stemming from chronic physical ailments, increasing their risk of a fall, often when walking or being moved.

In addition, older patients are take multiple medications, whose side effects increase the patients' chances of a fall.  Physical restraints may be used to decrease the possibility of falling and being injured.

"Even if no physical injury occurs, fall victims may develop a fear of falling again and thus reduce their activities as a result," the authors wrote. "This can lead to unnecessary dependency, loss of function, decreased socialization, and a poor quality of life."

The researchers found that use of sleeping pills containing benzodiazepines was significantly associated with fractures supporting the findings of most previous studies.

Patients using wheelchairs and bed rails were less likely to fall, but neither of the associations reached statistical significance. Nevertheless, "the use of these might be regarded as protective or preventative strategies," the researchers said.

Bed rails can cause injuries if patients climb over them, and physically restraining an already agitated individual can increase fear and worsen behavior, they said.   "In addition, restraints can lead to serious complications, including circulatory obstruction, skin tears, incontinence, fractures, and dislocations," they wrote. "These restraints should be used with care and consideration." 

The Study recognized that restraints cannot completely eliminate falls in nursing homes and that they may not be appropriate in every situation, but concluded that "our results support the hypothesis that they might be protective when used selectively together with fewer sedatives, especially benzodiazepines."

Primary source: Journal of Clinical Nursing
Source reference:
Fonad E, et al "Falls and fall risk among nursing home residents"J Clin Nurs 2008; 17: 126-134.


Allegations of rape in Kansas nursing home

Kansas City, Missouri Police are investigating the alleged rape of an 80-year-old woman at a Northland nursing home.   While management vehemently denies anything happened, a medical examination shows otherwise. 

The 80-year-old woman was found naked from the waist down Wednesday afternoon.

According to the police report, the victim's daughter noticed bruising in her private area and asked if anyone touched her there. The victim replied, "Yes, it was hell."

Police said they have not had a chance to talk to the victim because the nursing home has given her sedatives.  They hope to speak with her soon.


Investigation related to death at nursing home

Here is an interesting article about an investigation at a nursing home involving a resident who died from suffocation. 

It was Friday, September 7 when authorities say Stephanie Galletti who lived at the Taylor Nursing Home and Rehabilitation Center got tangled in some bed rails and suffocated.   According to a search warrant, it is part of a neglect investigation into Galletti's death. She was an Alzheimer's patient with a history of falling out of bed.

Court papers reveal a housekeeper "found Ms. Galletti's head wedged between her bed rail and her mattress."   Included in the evidence seized from the nursing home Wednesday were medical records and an air mattress from Galletti's bed.

According to court papers, the elderly woman died at 7:40 a.m., but her death was not reported to police until 9:48 a.m.   No one can explain the two hour delay.

In the affidavit investigators said, "No explanation was given as to the two hour delay in reporting the incident."  Authorities are also investigating a bed alarm that is supposed to sound if a patient falls out of bed. Detectives said Galletti's bed alarm was turned off.

The bed alarm should not have been off according to the physician's orders.  Clearly, the home did not have the bed alarm on and did not properly supervise the resdient.











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