Tag: nursing facilities

12/11/18

A Reason to Cry Uncontrollably

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Danny Glover did a “public awareness” ad for pseudobulbar affect (PBA) in 2015. In the ad, he said if you have PBA, choosing to laugh or cry may not be your decision. The ad went on to note PBA is a neurological, not psychological condition that is treatable; by Avanir’s Nuedexta. You were given information to “get the facts” about PBA. But one of the facts you wouldn’t get is that almost half of Nuedexta claims filed with Medicare in 2015 “were filed by doctors who had received perks (financial or otherwise) from Avanir.”

The above quote was from an article on Nuedexta from the website Nursing Home Abuse Center that highlighted a CNN investigation into Avanir and Nuedexta. While experts say that PBA effects less than 5 % of elderly patients, CNN found that “more than half of all Nuedexta pills manufactured since 2012 have gone to nursing homes.” While Avanir claims in its ads that PBS can occur with patients having Alzheimer’s or dementia, it admits Nuedexta has not been extensively studied among elderly patients.

One study among Alzheimer’s patients found those taking Nuedexta were twice as likely to suffer a fall, not something you want to see with the elderly. “Fall risk has been a huge concern among Nuedexta users since 2013 when nursing home inspectors first started questioning use of the drug in dozens of nursing homes across the United States.”  The CNN investigation found over 80 cases through 19 states where nursing homes were cited for inappropriate use and monitoring of Nuedexta. Sometimes it was given to patients without a formal prescription or doctor approval. “Many of the cases were based on the fact that patients exhibited no signs of PBA.”

The original CNN investigation reported in October of 2017 stirred up concerns and significant interest in Avanir and its marketing tactics with Nuedexta. The same two reporters have written a series of articles on CNN since then noting how Los Angeles opened an investigation into Avanir following the CNN report; how a leading advocacy group for Alzheimer’s stopped accepting contributions from Avanir after the report; and that the US government warned insurance companies to look for suspicious prescriptions of Nuedexta. And there were several doctors with problem records, at least three had criminal convictions for illegal prescribing, promoting Nuedexta.

The Los Angeles City Attorney confirmed his office was seeking information and tips from the public to help assess whether state or federal laws were violated in the sale, marketing or prescribing of Nuedexta. The people receiving Nuedexta are vulnerable and rely on others to make decisions for them. “If there is a possibility they are being administered a medication not because it is in their best interest, but because it is in the financial interest of, say, the drug manufacturer, then it is important for us to intervene.” He said he would look for potential illegal activity including kickbacks to doctors and off-label marketing of Nuedexta, that is suggesting it as a treatment for any purpose not approved by the federal government.

This would include using it as a “chemical restraint” to sedate or control behavior problems. “State regulators … have found cases of doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.” In one LA nursing home, regulators found that 28% of its residents (46 of 162) had been placed on Nuedexta. A facility psychiatrist, a paid speaker for Avanir, had given a talk about the drug to employees.

At another facility, also in Southern California, an employee admitted to inspectors that a resident had been given a diagnosis of PBA to “somehow justify the use” of Nuedexta, even though its intended purpose was to control the resident’s “mood disturbances” and yelling out.

In order to line up prescriptions, sales people identified doctors, nurses and pharmacists who could be advocates for the drug. Then they worked closely with these advocates to identify potential patients. One salesperson worked with a doctor’s office manager to pull patient’s charts and identify those who should be screened for PBA. “CNN’s investigation also found that the sales force coached doctors and facility employees on how to fight for Medicare coverage of the drug if it was initially refused.”

Another CNN article noted that after the original CNN article on Avanir and Nuedexta, the Alzheimer’s Association said it would not accept any further funding from Avanir, pending the results of the LA City Attorney. Avanir gave the group almost $200,000 in 2017. In a statement, the association said: “We are committed to people living with the disease, and we encourage vigorous review and oversight of companies and prescribers to ensure best practices are followed for those impacted by Alzheimer’s disease.” It added the contribution by Avanir was only .056% of its annual revenue.

Another nonprofit, the Alzheimer’s Foundation of America, said it received $60,000 from Avanir in 2016-2017. The organization declined to comment on the findings of CNN’s report, adding that it stood by its educational programs and that Nuedexta is not mentioned in Avanir presentations. Nuedexta is the only FDA approved treatment for PBA. One of its medical advisory board members said the AFA’s Educational Conferences provide caregivers an opportunity to understand and recognize PBA, “which afflicts a certain percentage of those with dementia.”

“Between 2013 and 2016, he received nearly $50,000 from Avanir, in the form of consulting and royalty or licensing fees, as well as travel and meals, according to government data.” He was also the lead author on the Avanir-funded study on Nuedexta that found patients on Nuedexta were more than twice as likely to fall (8.6% versus 3.9%) than those on a placebo. A research professor who studies the marketing tactics of pharmaceutical companies said Avanir’s ties with nonprofit dementia advocacy groups was “deeply troubling” and a conflict of interest. This was a particular concern for him “because Nuedexta has not been approved specifically for Alzheimer’s or dementia.

Between 2013 and 2016 Avanir Pharmaceuticals paid almost 500 doctors to speak or consult on Nuedexta. After reviewing the top prescribers of Nuedexta, CNN noted 12 who had been disciplined by state medical boards. Former Avanir employees said the company’s speaker program sought out doctors and pharmacists to present the drug to medical colleagues and nursing home employees. “Avanir and its parent company, Otsuka, paid doctors nearly $14 million for Nuedexta-related consulting, promotional speaking and other services.” In effect, these doctors are being used as a sales force, according to Michel Santoro, an expert in pharmaceutical industry ethics at Santa Clara University.

Many of the doctors with medical board issues identified by CNN involved other medications such as opioids. But one case centered on the use of Nuedexta. An Oregon doctor had already been banned by the state board from providing mental health treatment to inmates. Then he was summoned for his treatment of four nursing home patients. For one of his patients he attempted to prescribe Nuedexta “when there was no support for a PBA diagnosis.” The others were cases of inappropriately prescribing medications, changing doses or discontinuing drugs without explanation. Despite all these allegations, he was being paid by Avanir to speak publically about Nuedexta.

Then in June of 2018 CNN reported they had received documents through a public records request that indicated there have been complaints filed with the FDA about Avanir’s marketing and advertising dating back to 2012. BlueCross BlueShield of Arizona said Avanir was misrepresenting Nuedexta as “safe and effective” in populations it had not been approved for or adequately studied. “We believe that the manufacturer appears to be marketing Nuedexta far beyond the scope of the clinical evidence.” An individual complaint in 2016 said they had overheard a salesperson promote the drug for unapproved uses. “Specifically they are targeting [sic] residents with Dementia with Behavioral Disturbances.”

In March of 2018 CMS (Centers for Medicare & Medicaid Services) issued a memo asking Medicare insurance providers to monitor prescriptions for Nuedexta in order to ensure it was being appropriately given to patients. The memo reminded plan sponsors that Nuedexta was only approved to treat PBA and that insurers were legally required to ensure it was only being used for medically accepted uses. The agency said the memo was provided to “inform plan sponsors about increases in utilization that may not be readily discerned or may relate to potential fraud.”

Sadly, Avanir seems to have placed profits ahead of ethical medical care with the elderly. They have encouraged the use of Nuedexta in nursing facilities as a kind of chemical restraint. This seems to have partly occurred in response to the FDA tightening regulations on the use of antipsychotics for the same reason. There is a reason to cry uncontrollably, but it’s for how Neudexta has been mis-marketed and mis-prescribed. For more on Nuedexta and the use of antipsychotics in nursing homes, see “Conjuring Diagnoses for the Elderly” and “Nursing Homes Want Docile.”

11/6/18

Nursing Homes Want Docile

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The US population is aging. Between 2005 and 2015, the percentage of the population over 65 increased by 30%. “Older people now account for one in seven Americans: almost 50 million people, over 26 million women and over 21 million men.” As our population ages, the number of individuals with debilitating conditions like dementia is also increasing. By 2050, it has been estimated that as many as 15 million Americans could have Alzheimer’s. And in an average week, nursing facilities in the U.S. currently administer antipsychotic medications to over 179,000 people “who do not have diagnoses for which the drugs are approved.”

An extensive Human Rights Watch report, “They Want Docile,” described the inappropriate use of antipsychotics in older people with dementia in U.S. nursing facilities. The report found these dangerous medications were used without valid medical reasons, for the convenience of the staff, and without informed consent. Their use was often inconsistent with federal regulator requirements for the nursing facility industry. “They Want Docile” quoted a state inspector with a long career in long-term care as saying: “I see way too many people overmedicated. The doctor signs off and the nurse fills the prescription. They see it as a cost-effective way to control behaviors.”

Older people receive long-term care in various settings ranging from at home to institutional facilities. In-between settings like assisted living facilities, senior housing and retirement communities also exist. “The proportion of people living in institutional settings increases with age because care needs become more intensive.” Of the 6 million older people who receive long-term care around 4 million receive that care at home. Another 1.2 million live in nursing facilities and around 780,000 people live in other residential care communities.

The nursing facility industry is big business and Medicare and Medicaid is the financial foundation that supports it. “In 2015, the nursing facility industry, assisted living, and other types of long-term care recorded annual revenues of $156.8 billion, 41 percent of which came from Medicaid and 21 percent from Medicare.”  The Nursing Home Reform Act of 1987 requires the nursing facility industry to meet certain standards, including certification of the care facility, to be paid by Medicare and Medicaid. CMS, the Centers for Medicare & Medicaid Services, contracts with state agencies to certify facilities and to guarantee “substantial compliance.”

With the growth in older populations and the increases in debilitating conditions such as dementia, the need for long-term care and support services will grow rapidly. Although some forms of dementia have earlier onset, the disease is associated with older age: increasing age is the “greatest known risk factor” for Alzheimer’s disease. Experts estimate that approximately 70 percent of people aged 65 and over will require long-term services and support, ranging from limited support in their own homes and communities to around-the-clock care in institutional settings.

The American Psychiatric Association (APA) has “Practice Guidelines” for the use of antipsychotics to treat agitation or psychosis in patients with dementia that indicated they should only be used as a last resort to minimize the risk of violence, patient distress and care giver burden. The APA then referenced two studies finding  “the benefits of antipsychotic medications are at best small.” Contrary to these guidelines, nursing facility staff, individuals living in facilities, their families and others told Human Rights Watch “antipsychotic drugs are used sometimes almost by default for the convenience of the facility, including to control people who are difficult to manage.”

One facility social worker said that one of the most common “behaviors” leading to antipsychotic drug prescriptions was someone constantly crying out, “help me, help me, help me.” An 87-year-old woman reflected that at her prior facility, which gave her antipsychotic drugs against her will, “they just wanted you to do things just the way they wanted.” A social worker who used to work in a nursing facility said the underlying issue is that “the nursing homes don’t want behaviors.”

Among the people living in nursing homes interviewed by Human Rights Watch, a 62-year-old woman reported she had been given Seroquel without her knowledge or consent. She said it knocked her out; leading her to sleep all the time. She claimed the facility would crush and mix it in her food so she would refuse to eat food she suspected of having the drug. “Ms. D continued to object as well as she could to being administered antipsychotic drugs until her discharge from the nursing facility the day after Human Rights Watch interviewed her.”

Madeline C., an 87-year-old woman in a facility in Illinois, described the effect of antipsychotic medications administered in a prior nursing facility. She had been placed in a dementia unit. The woman said that when she “just about went crazy” from being in a locked unit with no activities, she “started speaking out, saying things were not right.” After that, she said, “suddenly I was very sleepy,” adding, “you feel like you’re going to die there.” She said she later learned that the facility had given her an antipsychotic drug. At the time of the interview, the woman was in a different facility that had discontinued the drug. “The fog lifted…. There’s the old Madeline again.” Being at the prior facility was “a very traumatic time.”Alma G., the sister and power of attorney of Mariela O., an 84-year-old woman with dementia who died in 2017, said that her sister’s nursing facility gave her an antipsychotic drug to ease the burden of bathing her. She said, “They give my sister medication to sedate her on the days of her shower: Monday, Wednesday, Friday—an antipsychotic. They give her so much she sleeps through the lunch hour and supper.”

“They Want Docile” described many additional examples of the misuse of antipsychotic medications at nursing facilities. The authors said many of their interviews supported the statement that antipsychotic medications were often given to nursing home residents for no valid reason. Some nursing home staff told Human Rights Watch antipsychotics were prescribed for screaming or calling out. A long-term care pharmacist said he regularly sees medication requests without an appropriate diagnosis—things like “‘Seroquel for dementia,’ or ‘Seroquel for anxiety,’ or ‘Seroquel for behavior dysfunction.’”

The report is disturbing and I’ve only scratched the surface of what it describes. It also had several recommendations to federal and state legislatures, and agencies. Here are just a couple. The CMS (Centers for Medicare & Medicaid Services) should strengthen the enforcement of existing regulatory requirements to end all inappropriate use of antipsychotics in nursing facilities, including when their use would amount to being used as a “chemical restraint.” It should also strengthen enforcement of existing regulatory requirements for informed consent and appropriate medication administration. Care planning should include the right of patients to refuse treatment; to be involved in their care planning; to be free from unnecessary drugs and chemical restraints. Medicaid fraud units should be required to investigate and prosecute abuse, including the use of chemical restraints, and neglect in nursing facilities.”

The Washington Post published an article, Why are nursing homes drugging dementia patients without their consent?, that was written by an individual who was part of the Human Rights Watch research. She noted how the use of antipsychotics as chemical restraints in nursing homes has a long history. A 1975 Senate report documented some of the same issues occurring today. While there are federal regulations stating residents have the right to be fully informed of their treatment and even to refuse treatment, nursing homes regularly ignore the rules because they are rarely held accountable.

Human Rights Watch found that in 97 percent of citations for violations related to antipsychotic drugs, the incidents were determined to have caused “no actual harm” to residents. As a result, in almost no cases did the government impose financial penalties, which correspond to the severity of harm caused by the noncompliance. The prospect of enforcement actions, and the rare sanctions issued, unsurprisingly had little deterrent effect, our analysis found. Nursing homes cited for antipsychotic-drug-related issues did not reduce their rates of drug use any more than facilities not cited.

Further limitations on holding nursing facilities accountable have ironically come as a result of the Trump administration’s Patient’s Over Paperwork deregulatory efforts. In response to an industry request, the instances in which inspectors can assess the heaviest fines was limited. That guidance now favors one-time sanctions rather than per-day sanctions, leading in many cases for facilities to face less significant consequences. And since November of 2016, “CMS imposed an 18-month moratorium on Obama-era revisions to some regulations — not updated since 1991 — intended in part to protect residents whose psychotropic medications are prescribed on an “as needed” basis.”

A JAMA Psychiatry study showed how a peer comparison letter could reduce off-label prescribing of an antipsychotic in older adults. The researchers found that “a peer comparison letter randomized across the 5055 highest Medicare prescribers of the antipsychotic quetiapine fumarate [Seroquel] reduced prescribing for at least 2 years.” The effects were larger than those found with large-scale behavioral interventions, possibly because the content of the peer letter “mentioned the potential for a review of prescribing activity.” Writing for Mad in America about the study, Bernalyn Ruiz said:

This study provides some hopeful evidence that a simple intervention that can reach a large group of prescribers effectively. Given the high rates of overprescribing, especially within this vulnerable population, effective ways of addressing this issue are needed.

In another article reflecting on the study by Ina Jaffe for NPR, Dr. Helen Kales, the head of the University of Michigan’s Program for Positive Aging, said stopping the overmedication of dementia patients was just the beginning. She pointed out how the use of mood stabilizers with dementia patients has also accelerated. “So any kind of fixation on one [drug] — it’s maybe winning the battle, but not the war.” Dr. Kales chaired an international committee of dementia specialists who published a consensus statement on the ways to treat dementia behaviors like agitation and wandering, and said it’s better to find out what triggers the behavior or modify the patient’s environment instead of prescribing medication. “The highest ranked and endorsed treatments are all non-pharmacological approaches.”

In closing, consider the following. The graphic below by Human Rights Watch shows the proportion of nursing home residents across the U.S. on antipsychotic drugs. The more intensely red areas indicate a higher percentage of antipsychotic use, with 45% being the highest. If you or a loved one were in a nursing home somewhere in the U.S. would you want it to be using antipsychotics to chemically manage you and your behavior?