The New Hampshire News had an interesting article about the “Battle Against Chemical Restraints in Nursing Homes”.  Nursing homes around the country are under pressure from the Federal government to reduce their use of antipsychotics.  This powerful class of prescription drug is meant for mental illnesses such as schizophrenia. But they are being used on people with Alzheimer’s Disease at startling rates.

MedPageToday also had an article stating that more than one in five U.S. nursing home residents are given antipsychotic medications — generally off-label, a national analysis revealed. In a sample of more than 1 million patients in nursing homes, 22% were given at least one prescription for an antipsychotic agent, according to Becky A. Briesacher, PhD, and colleagues from the University of Massachusetts in Worcester.  The researchers analyzed data on dispensing during 2009-2010 by the long-term care pharmacy Omnicare, which provides medication services across the country and for up to half of all residents.

The prescribing of antipsychotic medications persists at high levels in U.S. nursing homes despite extensive data demonstrating marginal clinical benefits and serious adverse effects, including death,” Briesacher and colleagues wrote in a research letter in the Feb. 6 issue of the Journal of the American Medical Association.  “The most common antipsychotics prescribed are often used for off-label indications related to dementia, and the extended durations of use raise concerns about the care of frail elders residing in [nursing homes],” the researchers stated.

In more than two-thirds of cases, the agents used were from the atypical class of antipsychotics, which are primarily indicated for the treatment of schizophrenia and bipolar disorder:

Quetiapine (Seroquel), 31.1%
Risperidone (Risperdal), 24.4%
Olanzapine (Zyprexa), 13.1%

Meanwhile, the Hartford Courant reported that the Westside Care Center nursing home in Manchester, two-thirds of long-stay residents are receiving antipsychotic drugs, even though they do not have a psychosis or related condition that regulators say warrants their use. Westside’s rate of dispensing the drugs to 68 percent of its residents without a diagnosis is the highest in the state, according to federal data — and more than double the state’s average of 26 percent, which already ranks in the top-third of states nationally.  The December data — newly disclosed by federal nursing home regulators — show that more than half of Connecticut’s nursing homes — 128 of 233 — were dispensing antipsychotics without a clinical diagnosis at rates exceeding the national average.

 

Medical Express had an interesting article  about a review in The Cochrane Library that found that education and social support for staff and caregivers can reduce the use of antipsychotics in nursing home patients with dementia.  Improved staff training and education, communication between personal and professional caregivers and support for everyone involved in the patient’s care are effective non-pharmacological methods to try before using antipsychotic medications.

Unfortunately nursing homes use antipsychotic drugs as the first line of treatment for any challenging behavior in nursing homes, despite the fact that they can have serious side effects including over-sedation, falls and cardiovascular problems.

“Despite the reduction in antipsychotic use with the behavioral interventions, none of the four individual studies found significant changes in the behavioral and psychological symptoms of dementia. I agree with the main findings but further research to study the effectiveness of non-pharmacological approaches to managing behavioral symptoms of dementia is sorely needed.”

 

 

WBIR had an article on the off label use of anti-psychotics in nursing homes.  Health officials believe that too many patients with dementia are being given antipsychotics in an “off-label” use to control behavior instead of treating their dementia symptoms through non-pharmacologic therapy. Prescribing antipsychotics – approved by the FDA to treat schizophrenia and bipolar disorder among conditions – can expose a patient to medical risks.  The FDA requires that the packaging on those drugs contain a “black box warning” that administering them to elderly dementia patients increases the chance of death and can have other harmful side effects.

State health officials in Tennessee say the overuse of antipsychotic drugs nursing homes, particularly on those diagnosed with dementia, is a huge problem. About 30 percent of long-term nursing home residents in Tennessee are given antipsychotics, according to statistics collected by the Centers for Medicare and Medicaid Services. The national average is 23.8 percent, which federal officials want cut by 15 percent by year-end.

Dispensing pills is an effort to silence residents who are “acting out” without trying to find the underlying cause.  However, this increases the risk of fatal falls.

 

Newsday reported the below Opinion of Karen Angel about the misuse and overuse of anti-psychotics in nurisng homes.

A nurse from my mother’s nursing home calls to ask if it’s OK to put her on a new drug. Just a low dose to calm her, the nurse assures me.

I agree, thinking the nurse is an expert and probably knows best. And I’ve seen my mother’s mood change dramatically for the worse as the day wanes, a phenomenon in dementia patients called “sundowning.”

The drug the nurse administers is the antipsychotic Risperdal. I later find out that the FDA has issued its strongest safety caution — known as a “black box warning” — against using this drug and similar antipsychotics in elderly dementia patients because they pose an increased risk of death, stroke, seizures and diabetes.

“They’re not supposed to be used to control dementia-related so-called bad behavior,” Richard Mollot, executive director of the Manhattan-based Long Term Care Community Coalition, told me. “A lot of family members are being told ‘we need to calm down your loved one’ when in fact this is not appropriate care for people with dementia.”

A report this month by the inspector general of the Department of Health and Human Services found that 99 percent of nursing home records show a failure to follow federal safety and quality guidelines for the use of antipsychotics, suggesting drug misuse is widespread and enforcement lax.  But along with heightened scrutiny by HHS, a recent government crackdown against drug companies for illegally marketing antipsychotics is providing a ray of hope that this could change.

Introduced in the 1990s, these “second-generation” antipsychotics have largely replaced drugs created in the 1950s to treat schizophrenia, in part because the newer medicines have been considered safer, with fewer troubling side effects. Almost 40 percent of nursing-home residents with dementia received the drugs in 2010, according to the Center for Medicare and Medicaid Services. Partly as a result, antipsychotics are now the top-selling class of pharmaceuticals, with yearly revenue of about $14.6 billion — despite their approval for only about 1 percent of the population.

The federal Nursing Home Reform Act of 1987 established “the right to be free of unnecessary and inappropriate physical and chemical restraints” — but the government has failed to enforce this. In fact, as a campaign against physical restraints has all but eradicated them over the past two decades, chemical restraints have become more entrenched — even as the issue has been hotly debated in Congress.

“The way antipsychotic drugs are used in nursing homes is a form of elder abuse,” Patricia McGinnis, executive director of California Advocates for Nursing Home Reform, told the Senate Special Committee on Aging in 2010. “Instead of providing individualized care, many homes indiscriminately use these drugs to sedate and subdue residents.”

 

The largest study of the use of such antipsychotics, conducted by Harvard Medical School and published earlier this year, found that elderly dementia patients using them are almost twice as likely to die as those on a placebo. David Graham, associate director of the Food and Drug Administration’s Office of Drug Safety, has estimated that 15,000 elderly people die in nursing homes every year as a result of the off-label prescription of these antipsychotics.

Last year, a report by the inspector general found that 88 percent of successful Medicare payment claims for antipsychotics were for nursing-home residents with dementia, despite the documented risk of death, and 22 percent of patients were on the drugs for too long or at too high a dose, violating federal rules on unnecessary drug use. The report condemned nursing homes’ failure “to comply with federal regulations designed to prevent overmedication.”

Fifty-one percent of the claims in the study didn’t meet the government’s Medicare reimbursement rules — but were paid anyway. This means the Medicare system is shelling out hundreds of millions a year to pay for these drugs, with taxpayers footing the bill. If nothing changes, costs will explode over the next two decades as 10,000 baby boomers a day become eligible for Medicare.

No enforcement action was taken as a result of the report, the inspector general’s office said, because the data were drawn from a random nationwide sample and weren’t sufficient to establish patterns at particular nursing homes.

Beyond their physical risks, antipsychotics are problematic because they not only suppress dementia patients’ agitation, they wipe out pleasurable emotions, too. “They turn people into zombies,” Mollot says.

Patients on these drugs sleep a lot. Now it’s clear to me why my mother would be in bed by 6 p.m. at the nursing home, while since moving back home and stopping the drug, she often stays up watching classic movies past 9.

 

Though the government hasn’t gone after nursing homes, it has recently won four big settlements against drug giants for illegally marketing antipsychotics. Last year, Eli Lilly and Pfizer paid the largest criminal fines in U.S. history — $515 million and $1.3 billion, respectively — for deceptive promotion. In a case in Arkansas last April, Johnson & Johnson was fined $1.1 billion for misleading doctors about Risperdal’s risks.

Meanwhile, a federal case is pending against Johnson & Johnson for allegedly paying millions in kickbacks to Omnicare, the nation’s largest long-term-care pharmacy, to recommend Risperdal for nursing-home patients.

In another promising reform initiative, the Center for Medicare and Medicaid Services has launched a campaign against antipsychotic use in nursing homes, with the goal of reducing it by 15 percent by 2013 through alternatives such as increased staffing and better pain management.

Yet, though commendable, these efforts have done little so far to change practices on the ground level for a population that has no time to spare.

I recently asked my mother if she still gets pleasure out of life, even though in the past year, she has gone from being independent to relying on a full-time caretaker for all her basic needs. She replied, “Absolutely!”

All elderly deserve that chance. But until nursing homes face greater scrutiny and sanctions, our elderly will continue to languish in chemical restraints.

 

There were several articles the past couple of weeks regarding Illinois’ new  law improving the safety and staffing in nursing homes. Lawmakers unanimously approved legislation that would raise the standards of care and safety in Illinois’ troubled nursing homes. See articles from the Chicago Tribune here and here.  The law reflects the 38 recommendations of Quinn’s Nursing Home Safety Task Force, which was formed last fall in response to a Tribune investigation into attacks, rapes and murders in the subset of facilities that mix aggressive and vulnerable residents.

The law would require nursing homes to increase staffing levels, meet higher standards before admitting patients with serious mental illness, tighten existing criminal background checks, psychological screenings of incoming nursing home residents, and segregate the most dangerous residents in secure units where they should receive more monitoring and treatment. 

Among the bill’s other key provisions is a mandate that nursing homes admitting people with serious mental illness obtain a new certification demonstrating that they can and will effectively monitor and treat those residents. The new standards for those homes would require the homes to have sufficient staff, including psychiatric professionals, on a 24-hour basis; training of staff on "managing aggression and crisis prevention"; and substance abuse programs.

The bill also would establish a database that would track violent incidents inside the homes. It would add safeguards to ensure the informed consent of residents administered psychotropic drugs. And it would expand the state’s ability to deny operators permits to open new homes if they run facilities that have repeatedly violated safety standards.

Lobbyists for the nursing home industry agreed to increase nursing staff levels in the next four years to 3.8 hours of daily nursing care for each resident who needs skilled care, up from the current minimum of 2.5 hours. Quinn’s task force had recommended 4.1 hours.

It took tense negotiations and an eleventh-hour deal to strike a historic bill that aims to undo a half-century of failed policies and end a legacy of violence in which nursing home residents were raped, assaulted and murdered.

 

I wish South Carolina lawmakers were open to the idea of protecting residents and reforming nursing home care.

 

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.

 

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.

Read More →

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.
 

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.