WFAA had an article about the continued use of dangerous medications to chemically restrain nursing home residents.  See Part 5 (See Parts 123 and 4 of WFAA’s continuing investigation of nursing home abuse and neglect.)  Despite the FDA’s warning to stop using anti-psychotics for dementia patients, the majority of nursing homes still uses them — more than 25 percent of the residents continue to take them for uses not approved by the FDA.

The story begins in 1993. Risperdal had just gained FDA approval for use in treating schizophrenia and bipolar disorder. But that’s a relatively small market. Dementia patients, however, comprise about half of nursing home residents.

Federal and state attorneys argued that Johnson & Johnson “developed a scheme to turn the drug into a blockbuster,” court documents show. In testimony, the attorneys claimed Johnson & Johnson used Texas as the “model state” to promote the drug “locally and nationally.”

The goal, according to federal and Texas attorneys: Get doctors to prescribe Risperdal over other drugs and for conditions – like dementia – for which it was not FDA-approved. It’s known as “off-label use.”

An off-label use of a drug is not illegal,” said Michael Elliott, a former assistant U.S. attorney who specialized in health care fraud. “What is inappropriate is for a drug company to market that drug for off-label uses.”

Texas court records and exhibits show Johnson & Johnson recruited influential doctors like Steven Shon, then medical director of the now defunct Texas Department of Mental Health & Mental Retardation. Texas Attorney General attorneys alleged Johnson & Johnson “made a series of illegal payments to Dr. Shon that effectively turned him into a salesman for Risperdal,” court documents show.

Dr. Shon testified in the case that the money did not influence him.  Sure….

The company also paid lucrative fees to a major pharmacy provider to promote the drug in nursing homes, court documents show.

Despite the FDA’s warning that using Risperdal to treat elderly dementia patients was dangerous, business plans in federal court filings show Johnson & Johnson created a sales force they called “ElderCare.”

The alleged objective? Target dementia patients, federal court records show.

From the late 1990’s to 2004, sales reps made thousands of calls promoting the drug “as safe and effective” for treating “behavior problems” in elderly dementia patients, court documents show.

As a result, court exhibits show, domestic sales of Risperdal increased from $892 million to $2 billion per year.

According to Johnson & Johnson’s own market research, as much as “75 percent of the prescriptions for Risperdal were for off-label uses.”

1011Now reported the arrest of nursing home employee after officials said she stole pills that were for residents.  The Lancaster County Sheriff’s Office said Joan Jilek was taken into custody and charged with acquiring a controlled substance by fraud.

According to LSO, one of Jilek’s duties at the Waverly Care Center was to distribute medicine to residents.  LSO said Jilek is suspected to have been stealing pills for about three weeks and stole 22 Oxycontin and oxycodone pills.  Eventually, other employees noticed that pill counts were off and reported prescriptions missing.

 

 

Kathryn Price’s blog had an article on the use of anti-psychotics in nursing homes despite the FDA’s black box warnings.  Human Rights Watch, a nonprofit, nongovernmental human rights organization, released a report this year that shows nursing homes are overprescribing antipsychotic drugs to manage the behavior of dementia patients even though anti-psychotic drugs are not FDA approved as treatment for dementia.

The FDA mandates that a black box warning appear on anti-psychotic medications, which cautions that they may lead to an increased risk of death for dementia patients. Additionally, research exists supporting the idea that anti-psychotics can be harmful when used for behavioral reasons alone on dementia patients, including an increased risk of deathfalls, and reduced cognitive functioning.

The federal government does have regulations aimed at preventing this. One such regulation appears in a 2016 revision to the Centers for Medicare & Medicaid Services’ (CMS) regulations for Medicare and Medicaid certified nursing facilities. The regulations state that “Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record.”

According to federal regulations, patients and/or their guardians have a right to understand the purpose of their prescribed medical treatment prior to administering, which is vital to preventing the prescription of unnecessary anti-psychotic drugs.

Despite these regulations, the report maintains that anti-psychotic drugs are still used to treat behavioral concerns in dementia patients due to a lack of enforcement. A 2014 NPR report indicates the penalties that exist for unnecessary prescriptions are rarely used and of the infractions reported only 2 percent were severe enough to warrant a fine.

CMS launched a program in 2012 to combat the improper usage of antipsychotic drugs in nursing homes and by late 2016, CMS announced that it met its goal of reducing the national prevalence of antipsychotic use in long-stay nursing home residents by 30 percent.

 

 

WFAA reported on the investigation into over-medication at Duncanville Healthcare and Rehabilitation Center.  Parkland Hospital investigators are conducting a review for possible over-drugging of patients in an alleged practice known as taking patients “to China.”  The reviews follow the WFAA series, “Drugged and Dying,” that investigated the unnecessary use of alleged powerful antipsychotic drugs to sedate or control patients.

In an effort to cut costs on staffing, many nursing homes drug the elderly rather than hire needed staff, patient advocates warn. They have dubbed the practice “chemical restraints.”  WFAA found in its “Drugged and Dying” series that about 70 percent of a typical nursing home expense goes to staffing.

Several witnesses have come forward stating that residents at Duncanville Healthcare and Rehabilitation were being sedated unnecessarily and inappropriately.   “They said: ‘Take this lady to China,’” the former employee told WFAA.  “It just can be any medication that will put a person to sleep,” the worker said.  “They took that lady to China, and she went to the hospital,” the worker said. “The lady never did come back from the hospital.”

The former employee claims the patient was given the antipsychotic drugs Risperdal and Seroquel. However, the patient, who had been awake and talkative – after receiving the drugs – was placed in bed and became nonresponsive, and within six hours was picked up in an ambulance – and later died, the worker said.  Advocates say the medications – particularly antipsychotics – may become another form of abuse when inappropriately and unnecessarily given. In fact, antipsychotic drugs may be potentially fatal for elderly patients.

Other patients at the Duncanville facility also may have been unnecessarily medicated, according to several workers.

 

 

 

The Chicago Tribune reported that a Cook County judge upheld a ruling from last summer, which would award $4.1 million to the family of a deceased 89-year-old woman who suffered a stroke while recuperating from an injury at a Bartlett nursing home.  Cook County Circuit Court Judge Thomas Lyons also ordered Bartlett-based Clare Oaks to pay an additional $1.5 million in attorney fees and awards to the family. Attorneys for the family said the amount is a record total issued under the Illinois Nursing Home Care Act.

In February 2011, Dolores Trendel was transferred to Clare Oaks for physical therapy after fracturing her left hip, according to court records and the family’s attorneys. Trendel’s physicians ordered various medications for Trendel to take, including Coumadin, which thins the blood to prevent clotting and strokes, according to court records.

A jury last summer agreed that the stroke contributed to Trendel’s death. The stroke caused Trendel to lose the ability to walk, talk, and enjoy life in any realistic manner.

 

U.S. News reported that Kansas may require nursing facilities to get written permission from residents or their guardians before administering antipsychotic drugs.  The federal government recently enacted similar informed consent rules that will help reduce improper antipsychotic use.

However, the powerful nursing home industry opposes the safety measure.  For years, the U.S. Food and Drug Administration has warned that antipsychotics increase the risk of falls, stroke and other potentially fatal side effects for people suffering from dementia.  Kansas has been at or near the top in percentage of medicated residents, The Kansas City Star reported.  Kansas also leads the nation in the percentage of skilled nursing facilities cited by the federal government for several medication-related violations, some of which relate to antipsychotics.

WFAA had an interesting article discussing the problem of short-staffing and chemical restraints at nursing homes.  This article was Part 4 of WFAA’s continuing investigation of nursing home abuse and neglect. (See Parts 12 and 3 ).  The ongoing WFAA investigation into Texas nursing homes has already revealed questionable practices in the hiring of criminal caregivers – and now WFAA has uncovered inappropriate and unnecessary drugging of residents.

In effort to cut costs, troubled nursing homes may drug the elderly rather than hire needed staff. The practice has been dubbed “chemical restraints.” It’s a practice of using powerful drugs to sedate or quell agitated, disruptive or violent patients.  When a facility is chronically short-staffed, often the staff will administer medications that sedate the residents so the residents are easier to take care of for the overworked and burnt-out caregivers.  In the latest report, called “Drugged and Dying,” News 8 investigative reporter Charlotte Huffman found that 96 percent of Texas nursing homes admit they’re giving drugs to residents who don’t need them.

According to the FDA, unnecessary use of antipsychotic medication kills 15,000 nursing home patients every year. Of all the drugs used as chemical restraints, antipsychotics are the most widespread and may be the most dangerous.

The federal government has previously caught drug manufacturers improperly promoting their antipsychotic drugs for use in nursing homes. (See here and here.)

Before nursing homes can give residents antipsychotics, new federal guidelines require doctors to diagnose them with at least one of three mental illnesses, the most common being schizophrenia.  A WFAA analysis of nursing home data shows that, after this new rule, the number of residents diagnosed with schizophrenia has skyrocketed 26 percent.  Schizophrenia develops in a patient’s early 20s, not later in life, experts say.

Various healthcare officials and advocates, when reached for comment, have found WFAA’s findings troubling:

“There’s no doubt that it raises a big red flag,” said Amanda Fredriksen, AARP Texas director of advocacy and outreach. “It’s pretty disturbing when people are that motivated to drive their numbers down to falsify medical records or to make up diagnoses. But to the extent that that’s happening, that’s a real serious issue.”

Dr. Daniel Pearson, head of psychiatry at Methodist Hospital, questions a first-time schizophrenia diagnosis of an elderly nursing home resident. He said such a diagnosis, especially to sedate, may be inappropriate, and possibly dangerous.  “Does that surprise me? No. Are those diagnoses legitimate? Probably not,” Dr. Daniel Pearson told WFAA.  “If you are using it just to keep people quiet, there are significant risks that are associated with that…increased risk of cardiac death, increased risk of falling, breaking a hip,” added Dr. Pearson, who spent a decade as a psychiatrist in nursing homes.

About 70 percent of a nursing home’s expenses are staffing,” said attorney Ernest Tosh, who handles nursing home lawsuits. “So, if they can cut back on staffing, they can directly increase their profitability.”

Last year, the state of Texas warned nursing home administrators about inappropriately drugging residents.

That same watchdog created this brochure to inform nursing home residents about the dangers of them being inappropriately drugged.

Here is a link to federal government regulations dealing with medication administration and monitoring – see p. 505.

Watch a 2011 U.S. Senate hearing on antipsychotic drug use in nursing homes.

 

 

 

 

The Herald & Review reported the disturbing story of James Rellihan who is accused of removing opioid patches from the bodies of residents at two nursing homes, including one where he worked as a registered nurse.  Rellihan is charged with burglary and theft under $500.

In a statement read in court, Assistant State’s Attorney Jeff Horve detailed two visits Rellihan allegedly made, one on Feb. 24 to Bloomington Rehabilitation and Health Care Center, and another on Feb. 26 to Heritage Health in Normal.

At the Bloomington facility, Rellihan removed three fentanyl patches from a terminally ill man, telling the patient, “It will be OK,” said the prosecutor.   The 31-year-old nurse was seen by co-workers who questioned why he was at the facility on his day off.
On Feb. 26, Rellihan showed up at the Normal nursing home where he had worked. He went to a patient’s room where he removed a fentanyl patch from a man with dementia, according to the charges.
When questioned by police, Rellihan “denied taking, using or selling” the patches, Horve told Associate Judge Amy McFarland.

Axios reported that “the pharmaceutical industry is livid about a surprise change to Medicare drug policy that was slipped into the Senate budget deal. The bill would close the Medicare Part D “donut hole” in 2019, a year earlier than previously scheduled, and force drug companies to shoulder most of the cost.”

 Medicare’s donut hole puts seniors and disabled people on the hook for a large chunk of their prescription costs. It’s supposed to go away in 2020, as part of the Affordable Care Act. Beneficiaries would pay no more than 25% of brand-name drug costs, while health plans would cover 25% and drug companies would cover the remaining 50% through discount payments.

But the Senate bill would end the coverage gap a year earlier, and change the ratios. Drug companies would be responsible for 70% of the costs instead of 50% — a move that would cost drug companies billions of dollars.

New York Magazine had an article on Trump’s lack of response to the opioid crisis.  His indifference is killing people.  Since taking office, Trump has put far more effort into promoting policies that would exacerbate the opioid epidemic than into ones that would mitigate it.

“The year Donald Trump was elected president, drug overdoses killed 63,600 Americans. That was 21 percent more drug deaths than America had seen in 2015, which had been the worst year for such fatalities in our nation’s history. It was also more unnatural deaths than gun violence, HIV/AIDS, or car accidents had ever caused in the United States in a single year. The scale of devastation wrought by the opioid epidemic was so vast, life expectancy in the United States fell for the second consecutive year — the first time that had happened since the early 1960s.”

The death toll will grow in 2017, according to preliminary data from the Centers for Disease Control and Prevention.  If the use of synthetic opioids like fentanyl continues to grow at its current rate, Stat News forecasts that more than 650,000 Americans will die from drug overdoses over the next decade.  In 2015 alone, the opioid crisis cost the American economy $504 billion, according to the White House Council of Economic Advisers.

“The drug-overdose crisis is concentrated in white, rural America (a.k.a. Trump Country). And on the campaign trail, the GOP nominee pledged to make ending the drug crisis a top priority of his administration. But since taking office, he has put far more effort into promoting policies that would exacerbate the epidemic than into ones that would mitigate it.”

“The president has tried to pass trillion-dollar cuts to Medicaid, one of the top sources of funding for addiction treatment in the United States; called for reducing spending on preventative anti-drug measures; proposed slashing the budget for the Office of National Drug Control Policy by 95 percent; neglected to nominate anyone to lead the Drug Enforcement Agency; declined to implement the vast majority of his own opioid-commission’s recommendations; declared the opioid crisis a “public health emergency” — but refused to ask for a single penny in additional funding to combat the crisis, even as he called on Congress to add $1.5 trillion to the deficit for the sake of cutting taxes; and put Kellyanne Conway, a career pollster and pundit — with no experience in public health — in charge of his administration’s opioids agenda.”

• Lawmakers “who have been leaders on opioid policy,” like West Virginia senator Shelley Moore Capito, “haven’t seen outreach from Conway or her cabinet.”

• One of the few people working on Trump’s “public education campaign” is “Andrew Giuliani, Rudy Giuliani’s 32-year-old son, who is a White House public liaison and has no background in drug policy.”

• The office’s big idea for combating the drug-overdose crisis is a “just say no”–style ad campaign, which would have premiered during the Super Bowl broadcast, if Conway’s staff hadn’t failed to put it together in time.

There is a long list of evidence-based reforms that he could implement to save thousands of Americans from its ravages. To take just one example, the most effective remedy for opioid addiction, bar none, is medication-assisted treatment (MAT). Under MAT, addicts are provided with methadone and buprenorphine — less powerful opioids that satiate most addicts’ cravings, and arrest their withdrawal symptoms, without inducing heroin’s debilitating, euphoric high. Decades of research, the World Health OrganizationCDC, and National Institute on Drug Abuse have all demonstrated MAT’s efficacy. Some studies suggest that the treatment reduces mortality among drug addicts by more than 50 percent. And yet, the therapy is only available in about 10 percent of America’s conventional drug-treatment facilities.