South Carolina Nursing Home Blog : South Carolina Nursing Home Lawyer & Attorney : Poliakoff & Associates Law Firm : Elderly Care, Senior Care

ABC News reported a story about the deaths of residents caused by over medication and chemical restraint.  When residents at the Kern Valley Nursing Home complained or annoyed nursing director Gwen Hughes, prosecutors say she chemically restrained them with powerful anti-psychotic drugs. Her methods were so severe, three residents died.

California Attorney General Jerry Brown says that Hughes ordered one patient drugged just for glaring at her, and another for throwing a carton of milk. Some residents were left drooling, dehydrated, and dangerously thin.  According to Brown, "In a couple cases, elderly people were actually held down, restrained against their will, and given excessive amounts of medicine to keep them quiet."

Even more shocking -- Hughes had been fired for over-drugging once before, from a nursing home in nearby Fresno, Calif. The administrator of that nursing home said they told her next employer only the dates she worked there.

Three nursing home officials appeared at a hearing on charges of elder abuse at the Kern Valley facility from 2003 to 2007 -- Gwen Hughes, as well as administrator Pamela Ott and staff physician, Dr. Hoshang Pormir. The three defendants each face up to 11 years in prison, and all have pleaded not guilty. A preliminary hearing is set for March 9, 2010.

Additionally, a former pharmacist at the facility, Debbi Gayle Hayes, accepted a plea bargain on the condition that she testifies for the prosecution.

Experts say over-drugging is common nationwide, and the number of nursing home residents who are given these drugs is rising.   It has been estimated that nursing homes give anti-psychotics to one in every four patients. Some suggest that the drugs are replacing physical restraints, which are now illegal except as a last resort.

Toby Edelman, from the watchdog Center for Medicare Advocacy, says, "They're hiding the restraints. A physical restraint is visible, but a chemical restraint is not."

Using a chemical purely as a restraint is also illegal, but they are so widely used that the lawyer for Pormir, the doctor in the California case, plans to cite the drugs' widespread use as part of his defense.

His attorney, Dennis Thelen, says, "To suggest that using psychotropic medication is contrary to a patient's best interest is just flatly contradicted by what happens every day in the United States, yesterday, right now, and tomorrow."

A Food and Drug Administration official estimates that unnecessary anti-psychotics kill 15,000 nursing home patients each year, including Fannie Mae Brinkley.

There are steps you can take to make sure your loved one isn't at risk. Click the links below for more information.

Elder Justice Coalition http://www.elderjusticecoalition.gov

National Committee for the Prevention of Elder Abuse http://www.preventelderabuse.org

National Adult Protective Services Association http://www.apsnetwork.org/

National Center on Elder Abuse http://www.ncea.aoa.gov

National Association of State Units on Aging www.nasua.org

National Academy of Elder Law Attorneys www.naela.org

National Association of State Long-Term Care Ombudsman Programs http://www.nasop.org/

Nursing Home Comparison Tool from Medicare http://www.medicare.gov/NHCompare

Center for Medicare Advocacy www.medicareadvocacy.org

Directory of State Resources from the National Center on Elder Abuse http://www.ncea.aoa.gov/NCEAroot/Main_Site/Find_Help/State_Resources.aspx

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The Chicago Tribune had a good article about the use of anti-psychotic medications being overprescribed and over used in nursing homes.  Health advocates are calling for tough new rules on the use of anti-psychotic drugs in Illinois nursing homes, including tighter controls on doctors who prescribe the powerful medications. "Medical care should help you get better, not get worse," said Wendy Meltzer of Illinois Citizens for Better Care, an advocacy group for nursing home residents.

A Tribune investigation recently showed how many frail and vulnerable Illinois nursing home residents have been unnecessarily dosed with anti-psychotics, leading to harm and an increased risk of death. One psychiatrist, the Tribune found in a joint investigation with ProPublica, provided assembly-line care to thousands of mentally ill patients.

The FDA has approved anti-psychotic drugs to treat serious mental illnesses, such as schizophrenia, but doctors also prescribe them to geriatric patients with other conditions, such as dementia, in a common but controversial practice called "off-label" use. Meltzer said one way to stop nursing home doctors from using the drugs to "chemically restrain" residents is for the state to refuse to pay for certain medications.  Documents show that hundreds of nursing residents have been given psychotropics without their permission since 2001. 

Nursing homes, Meltzer said, should have a formal process of explaining the benefits and risks of taking psychotropics. Right now, she said, the goal of many nursing homes is to simply get residents to sign the forms as opposed to explain the options.

Advocates also said Illinois should require drugmakers to publicly disclose payments to doctors so that their patients can be aware of possible conflicts of interest. One pharmaceutical company gave Reinstein nearly $500,000 to promote a drug that Medicaid records suggest he prescribed 41,000 times.

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As a follow up to recent posts regarding the kickback scheme involving OmniCare and Murray Forman and Leonard Grunstein, today I am going to post a well written article from the Chicago Breaking News about a doctor prescribing dangerous medications to nursing home residents.

Inside Chicago's Maxwell Manor nursing home, Dr. Michael Reinstein's patients suffered from side effects so severe that they trembled, hallucinated or lost control of their bladders. Staffers told state investigators that so many patients were clamoring to complain to Reinstein about their medications that a security guard was assigned to accompany him on his visits. In addition, staffers said Reinstein had induced patients to take powerful antipsychotic drugs with the promise of passes to leave the home.

Today he is one of the most prolific providers of psychiatric care in Chicago-area nursing homes and mental health facilities, even as he is trailed by lawsuits and complaints like the ones at Maxwell Manor.  An investigation by ProPublica and the Tribune found that Reinstein has compiled a worrisome record, providing assembly-line care with a highly risky drug.  Reinstein has been accused of overmedicating his mentally ill patients. His unusually heavy reliance on the drug clozapine -- a potent psychotropic medication that carries five "black box" warnings -- has been linked to at least three deaths.

In 2007 he prescribed various medications to 4,141 Medicaid patients, including more prescriptions for clozapine than were written by all the doctors in Texas put together. Records also show he is getting government reimbursement for seeing an improbably large number of patients. Documents filled out by Reinstein suggest that if each of his patient visits lasts 10 minutes, he would have to work 21 hours a day, seven days a week.  Reinstein sees 60 patients each day, he wrote in an audit report in 2007.

Working from a strip-mall office in Uptown, Reinstein says he is psychiatric medical director at 13 nursing facilities, seeing patients with chronic mental illness. Those include people with schizophrenia.

Autopsy and court records show that three patients under Reinstein's care died of clozapine intoxication. Alvin Essary died at age 50 at the Somerset Place nursing home on the North Side in 1999.  Medical records show that when he died his blood contained five times the toxic level of clozapine.

The "black box" warnings -- the FDA's strongest -- on clozapine's label detail serious potential side effects, from enlargement of the heart to rapid drops in blood pressure to increased seizure risk.   Doctors also are required to take regular blood samples to ensure patients' immune systems aren't shutting down.

The FDA approved the drug two decades ago for only a sliver of the population: the actively suicidal or the quarter of schizophrenic patients who do not improve on medications with lesser side effects. Yet Reinstein last year said under oath that his practice once had more than 300 patients among 415 in one Chicago nursing home on clozapine.

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Chicago Tribune had an article that is a good follow-up or counter balance to yesterday's blog entry.  The article discusses the overmedication of nursing home residents including Delores Fleming.  She moved into Heritage Manor of Mount Zion and scored 23 out of 30 on a mental exam and was deemed to be "moderately impaired," state inspection records show.  Fleming had few problems her first week in the nursing home, according to her medical records, which her family provided to the Tribune.  But after she repeatedly had crying spells and tried to wander away, the nursing home doctor prescribed two anti psychotic drugs, even though she was not psychotic. Her family had given consent for the Seroquel, but the medical records show the permission sheet erroneously described the drug as an anti-anxiety medication. Seroquel is an anti psychotic drug intended for serious mental illnesses, such as schizophrenia.

Records show that Fleming briefly improved on the Seroquel, but over the next three months she had episodes of extreme anxiety.  The doctor doubled the dosage of one medication no fewer than four times, putting her above the recommended limit.  Once she thought she was possessed, nursing notes state. Another time she thought her brother had left her $50 million.

Her doctor ordered multiple injections of the anti psychotic drug Haldol and the anti-anxiety medication Ativan, state inspection records show. Fleming's dose of Seroquel also was repeatedly doubled, putting her above the recommended limit for that drug.

After Fleming's family complained that she had grown lethargic, the staff referred her to a neurologist. According to a state inspection report, the neurologist found her catatonic and believed she had developed tremorlike "Parkinson's symptoms, due to the Haldol."  When he gave her the same mental exam she had previously taken, she scored zero out of 30. The neurologist recommended that her drugs be curtailed, and her condition dramatically improved. When she retook the test, she scored a 30 out of 30.

Both her family and the facility decided she should live elsewhere. The family wanted her in a home that specialized in Alzheimer's care; Heritage Manor believed Fleming was endangering other residents, records show, and gave her 30 days to leave.

When the Tribune reviewed 40,000 state and federal inspection reports filed since 2001 on 742 Illinois nursing homes, numerous instances emerged in which regulators cited facilities for misusing psychotropics even though the patients' doctors had created the problems.

When physicians or psychiatrists prescribe a drug for a patient, facilities must administer it as long as the order is consistent with state and federal nursing home regulations. If inspectors determine a violation occurred, they cite the nursing facility, not the doctor.

The Tribune found that inspectors documented many cases in which doctors prescribed powerful anti psychotic drugs without adequate justification or in doses that were too high.  The doctors also sometimes failed to provide adequate follow-up care, the inspection records show. They are required to see their nursing home patients only once every 60 days, though some do not visit even that often.  Several nursing home owners interviewed by the Tribune said they have struggled with doctors who rarely make time to visit patients.

Nursing homes are required to have pharmacists visit the facilities regularly and review prescriptions. If they discover irregularities, such as a patient placed on a drug without cause, they notify the nursing staff and doctor. But the Tribune found that when pharmacists recommended that a psychotropic be discontinued or the dosage reduced, physicians sometimes ignored the advice.

The difficult task of monitoring for side effects is left to nurses who are poorly trained in the use of psychotropic drugs. Experts say the situation can affect quality of care, and the Tribune's review of inspection reports shows that is true -- sometimes with tragic consequences.

The Chicago Tribune has done a great job researching, investigating, and writing about the use and abuse of anti-psychotics in nursing homes. See full article here.
 

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BakersfieldNow.com had another article about the criminal prosecutions of nursing home employees who drugged against their will.  The article mentions that Kern Valley Hospital administrator Pamela Ott was charged Tuesday on eight felony counts of elder abuse for allowing staff to forcibly administer psychotropic medications to patients for their own convenience, rather than for their patients' therapeutic needs.  The druggings led to the deaths of three nursing home residents.  Medical complications, including lethargy and the inability to eat or drink properly, resulted from the forced medications.  Twenty-two patients were given high doses, and one surviving patient was greatly harmed, the investigation determined.  Three other people were charged in February for their alleged roles in the case. All of the defendants worked for Kern Valley Healthcare District's skilled nursing facility including the former director of nursing Gwen Hughes, former pharmacist Debbi Hayes and staff physician Dr. Hoshang Pormir.

Management at the nursing home ordered staff to give high doses of psychotropic medications to Alzheimer's and other dementia patients to make them more tranquil and easier to control.  The medications were given to patients who argued, made noise or were otherwise disruptive.

"As hospital administrator, Pamela Ott was ultimately responsible for safeguarding the welfare of her patients," Attorney General Jerry Brown said in a news release. "Instead, Ott abdicated her responsibility and allowed the staff of the Kern Valley Hospital to forcibly sedate patients who questioned their care."

Prosecutors said last month that former pharmacist Hayes was placed on probation and agreed to cooperate with the attorney general's office in its prosecution of the other defendants.

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The Bakersfield Californian had an article about one of the defendants charged with over drugging patients at a nursing home causing three deaths.  Debbi Gayle Hayes, a former pharmacist at a Lake Isabella nursing facility, has accepted a plea bargain that involves testifying against director of nursing and the nursing home doctor.   All three worked at the Kern Valley Healthcare District's skilled nursing facility until they were arrested in February on charges of elder abuse and causing harm or death.  Hayes pleaded no contest last week to conspiracy to obstruct justice. She was sentenced to three years probation and one year in jail, but the jail sentence won't be imposed if she cooperates truthfully in the case and completes her probation with no further problems.

The California Attorney General's Office alleged the trio played an instrutmental role in providing unnecessary drugs on at least 22 elderly residents as a means to control them.  The mood-altering medications were used to stop their complaints and control them.

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The Philadelphia Inquirer had an interesting article about the increased use of anti-psychotics in nursing home residents. Sales of atypicals rose to $14.36 billion in 2008 from $8.4 billion in 2003, according to data provider IMS Health. Elderly patients have been a major source of that growth. Studies suggest that 20 percent to 30 percent of nursing-home residents take an atypical, despite not having a psychosis diagnosis.

This is a dangerous treatment since these medications have terrible side effects such as constipation, loss of appetite, lethargy, and increased risk of falls.  I always worry that their use is more to make thing easy for the staff then to help the residents. Nursing homes provide these medications because they may calm people and help them sleep.  Families of residents need to worry staff using these medications as a chemical restraint to subdue residents who complain about the poor care they are receiving.  The article discusses two specific residents and how one benefited and the other did not.

 Risperdal, Seroquel, Zyprexa, Abilify, and Geodon are atypical antipsychotics, a category of psychotropic drugs. These drugs are approved to treat schizophrenia and bipolar disorder despite mixed evidence that they help and ample evidence that they hurt. The drugs have life-threatening side effects, especially in the elderly. Several studies report they increase the risk of heart attacks, stroke, and premature death in this group. The atypicals now carry a so-called black box warning - the most serious required by the U.S. Food and Drug Administration - saying patients with dementia who take them are "at increased risk of death."

In February, California's attorney general charged three nursing home employees with using Risperdal and Zyprexa to sedate patients and make them easier to manage. In a separate case in January, Lilly agreed to pay the federal government $1.4 billion to settle charges that it illegally marketed Zyprexa for use by the elderly.  As evidence surfaced that some elderly patients were being medicated into submission, Congress passed laws making overuse of psychiatric drugs, or "chemical restraint," illegal.

Laws trying to ensure proper use of psychiatric drugs require that nursing homes carefully monitor them, checking to see how patients respond and trying to reduce the dose or wean patients off them.  However, this is hardly ever done by well-trained or qualifed nurses.

Elaine Leventhal, director of the Gerontological Institute at the University of Medicine and Dentistry of New Jersey, said caregivers should try to manage behavior before turning to medications. She recommends that the family stay for dinner the day a relative is admitted to a nursing facility and visit as often as possible to ease the transition.

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N.Y. Newsday had an article about a nursing home employee abusing an 80-year-old female patient by tying her legs together during an eight-hour shift, without supervision or authorization.   CNA Candice Pelzer was assigned to care for the patient on the midnight to 8 a.m. shift in November 2008.  Pelzer bound the woman "without advising anyone of [the] restraint.   Pelzer, who was working at the Berkshire Nursing and Rehabilitation Center, surrendered to Medicaid fraud unit, and was charged with endangering the welfare of a physically disabled or incompetent person and violating the public health law. 

"The conduct alleged in today's arrest is despicable - a disheartening violation of the trust Long Islanders put in health care professionals to care for their loved ones,"  Attorney General Cuomo said in a statement.

The worst and most intriguing part of the article is the fact that several unnamed witnesses saw the elderly patient with her legs tied together but did nothing to assist her or intervene on her behalf.    Pelzer initially admitted tying a sheet around the woman but later said she only used it to wrap her legs.
 

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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.

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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.

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