The Society of Critical Care Medicine has revamped its guidelines in an attempt to keep doctors from overprescribing benzodiazepines to sedate patients. “Benzos,” as they are sometimes called, are a class of anti-anxiety drugs including Valium, Klonopin and Ativan which can bring on a nightmarish set of side effects including delirium and hallucinations, even in the most clear-minded individuals.

These drugs have a heightened effect on the elderly, and are associated with an increased risk of falling.  For patients who are under the confusing influence of these drugs, painful medical procedures may feel more like torture.  A breathing tube can be interpreted as someone choking them.  A catheter insertion may seem like rape.  Often patients in this situation will later develop post-traumatic stress disorder, suffering nightmares, flashbacks, memory loss, and lingering phobias. They may feel confused and embarrassed about what they remember from their treatment.

Some treatment centers and families in Europe keep journals for their patients so that disturbing memories of hallucinations can be cross-referenced with the actual procedures which took place. While these journals seem to speed up mental recovery after a scary medical procedure, they have been slow to take hold in the United States.

See articles here, here, and here.

WNYC also had a recent article on the overuse of antipsychotics in New York City nursing homes. “There is widespread and poorly regulated use of anti-psychotic medications by several New York City nursing homes, according to a new investigation by the Gotham Gazette.” The series found that one-in-four nursing home residents in the city were given anti-psychotics in 2011, and one-in-three homes dose more than a third of their residents.

Anti-psychotics are sometimes known as “chemical restraints” because of their sedative effect. Under federal law, anti-psychotic drugs can only be given on doctors’ orders, and not so nursing home staff can better manage difficult patients.  They are frequently prescribed for difficult patients, such as those suffering from dementia. Yet research has found that the drugs can also lead to falls, strokes and even death.

 

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 News Today reported the finding that medications are known as nonbenzodiazepine hypnotic drugs, a class of sleeping medications that includes Lunesta, Sonata, and Ambien increase the risk of falls and hip fractures.  The scientists discovered that the risk for hip fracture was greater for the residents taking a nonbenzodiazepine hypnotic drug.  The benefits do not outweigh the risks.

The finding came from new research conducted by experts from Harvard Medical School, led by Sarah D. Berry, M.D., M.P.H.

It is important to understand the relationship between sleep medication use and injurious falls in nursing home residents,” the experts wrote. A previous study demonstrated that nursing home residents with dementia are three times more likely to have an injurious fall when they take drugs to treat depression.”

The authors said:
“The risk for hip fracture is elevated among nursing home residents using a nonbenzodiazepine hypnotic drug. New users and residents having mild to moderate cognitive impairment or requiring limited assistance with transfers may be most vulnerable to the use of these drugs.”
When prescribing sleeping pills to nursing home residents, doctors should take caution, the researchers added. They concluded :

“Residents, staff, and nursing home administrators need to collaborate to create a culture change within the nursing home that increases daytime activity, improves social engagement, avoids daytime naps, and minimizes awake time in bed for residents. Physicians must also have amore active role to ensure that sleep quality and structure are not impaired by treatable medical or psychiatric conditions and that other sleep disorders commonly seen in the frail elderly (eg, central sleep apnea) are promptly diagnosed and treated.”

 

Gwen D. Hughes, who worked at Kern Valley Healthcare District’s facility in Lake Isabella, was charged in the deaths of three patients. She pleaded no contest in Kern County Superior Court to one felony count of elder abuse with a special allegation that the abuse contributed to the victim’s death. She was only sentenced to three years in state prison for overmedicating patients at a Kern County nursing home, causing at least one wrongful death.   The California Department of Public Health first began to investigate the facility in 2007, following complaints from an ombudsman that a patient at the facility had been held down and forcibly injected with psychotropic medications.  See article at SFGate here.

Hughes ordered the hospital’s director of pharmacy to write doctor’s orders for psychotropic medication for 23 patients — not for therapeutic reasons, but to keep them quiet.  Officials say the drugs were given to patients who were noisy, prone to wandering, who complained about conditions or were argumentative.  The investigation found that the drugs hastened three patients’ deaths, and all 23 suffered adverse physical reactions.

Pamela Ott, the former chief executive officer of the Kern Valley Health District, pleaded no contest to one felony count of conspiracy to commit an act injurious to the public health, based on her failure to adequately supervise Hughes. Ott was sentenced to three years of formal probation.

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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.

 

Medical Express reported: “More than one in four older veterans residing in U.S. Department of Veterans Affairs (VA) Community Living Centers received antipsychotic medications, and more than 40 percent of those veterans had no documented evidence-based reason for use, according to new research from the University of Pittsburgh and VA Pittsburgh Medical Center.”

The study, the first to address this topic in VA nursing homes, finds similar rates of antipsychotic use as studies in non-VA nursing homes. The findings will be published in the November issue of the journal Medical Care and currently are available online.

“Our study adds to the growing evidence base that antipsychotics have been overused in nursing homes, and the VA is not immune to this problem,” said lead author Walid Gellad, M.D., M.P.H., an assistant professor in Pitt’s School of Medicine and the Graduate School of Public Health’s Department of Health Policy and Management. “Behavioral symptoms in dementia patients are difficult to treat, and, in most cases, nursing home staff are doing what they can to keep patients comfortable and safe. We have to find better ways to do this, though.”

Antipsychotics have limited efficacy in alleviating behavioral problems in dementia patients, and several studies associate their use with an increased risk of mortality.

 

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The Guardian Express had a great article on the use of Selective serotonin reuptake inhibitors (SSRI) in to elderly individuals that reside in nursing homes.  SSRIs should not be prescribed according to the inference implied by two new studies.  These reports suggest that selective serotonin reuptake inhibitor has a high probability of increasing an elderly patient’s risk of falling, consequently causing injury when given to nursing home residents suffering from dementia.

The risk taken by the aforementioned patients far outweighs the benefits of the drug. A careful look into the efficacy of the drug appears to have yielded mixed results at best for the treatment of depression.  For several years, SSRIs have been widely controversial among researchers who argue that patients with mild or moderate cases have had little if any improvement from the use of the drug.

Research conducted recently by the Alzheimer’s Society has revealed that Selective Serotonin Reuptake Inhibitors are of no benefit for dementia patients living in care homes. The study reveals that the risk is dose-dependent, with those using average doses having 3 times the risk compared with nonusers.  Even at low doses, SSRIs are associated with increased risk of an injurious fall in nursing home residents with dementia.

“The Rotterdam study drew the same conclusions in their research. In their investigation they found that a person taking SSRIs falls about 248 times in a period of two years. During the period, more than 583 elderly people suffered severe injuries such as fractures, sprains, bruises, and even death to similar mishaps. As per them, there is direct association between SSRIs and falls.”  The use of an SSRI with a hypnotic or sedative (which appears to be common in most nursing homes)  increases the risk even further.

The study is published online January 18 in the British Journal of Clinical Pharmacology.  “This study is a reminder that the elderly with dementia are prone to many serious complications, such as falls, and are certainly more sensitive to polypharmacy. They are more likely to be on multiple medications. This is likely to potentiate any adverse drug reactions or side effects, including increased sedation, which can certainly predispose a patient to a fall,” Josepha A. Cheong, MD, professor of psychiatry at the University of Florida College of Medicine said.

The article concludes: “The fact that these drugs make patients more lethargic and lead a catastrophic fall is one thing, but the possibility that they may not be even helping patients with mild disorders arguably borders of criminality.”

 

 

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.