AARP reported on CNN’s investigation into Nuedexta. “A “little red pill” being aggressively marketed to long-term care residents is bringing in more than $100 million a year in Medicare money for its manufacturer, even though it “may be unnecessary or even unsafe,” CNN is reporting.”

“The drug, Nuedexta, is approved to treat pseudobulbar affect (PBA), a relatively rare condition marked by uncontrollable laughing or crying. However, the pill “is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments” from manufacturer Avanir Pharmaceuticals, CNN reported.”

The full report, which also contains details about possible health risks of Nuedexta, can be found at CNN.com.

The Washington Post reported how Big Pharma bullied and bought the Federal Drug Administration and Drug Enforcement Administration.  In April 2016, Congress stripped the DEA of its most potent weapon against large drug companies suspected of spilling prescription narcotics onto the nation’s streets.  For years, some drug distributors were fined for repeatedly ignoring warnings from the DEA to shut down suspicious sales of hundreds of millions of pills, while they racked up billions of dollars in sales. One internal DEA memo obtained by The Post and “60 Minutes” noted that the bill essentially eliminates the agency’s power to file immediate suspension orders of drug shipments. The new law “is fixing a problem that doesn’t need fixing,” a DEA official wrote.

The new law made it virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies. That powerful tool had allowed the agency to immediately prevent drugs from reaching the street.  The chief advocate of the law that hobbled the DEA was Rep. Tom Marino, a Pennsylvania Republican who is now President Trump’s nominee to become the nation’s next drug czar.

Political action committees representing the industry contributed at least $1.5 million to the lawmakers who sponsored or co-sponsored four versions of the bill, including nearly $100,000 to Marino and $177,000 to Hatch. Overall, the drug industry spent $106 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.

“The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.”

By then, the opioid war had claimed 200,000 lives. Overdose deaths continue to rise. There is no end in sight.  Drug industry officials and experts blame the origins of the opioid crisis on the overprescribing of pain pills by doctors.

CNN had a great article on the menace of a “little red pill” pushed on nursing home residents.  “The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe, a CNN investigation has found.”

“The pill, called Nuedexta, is approved to treat a disorder marked by sudden and uncontrollable laughing or crying — known as pseudobulbar affect, or PBA. This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker’s own figures, and it is most commonly associated with people who have multiple sclerosis (MS) or ALS, also known as Lou Gehrig’s disease.”

“Nuedexta’s financial success, however, is being propelled by a sales force focused on expanding the drug’s use among elderly patients suffering from dementia and Alzheimer’s disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company, CNN found.”

“Since 2012, more than half of all Nuedexta pills have gone to long-term care facilities. The number of pills rose to roughly 14 million in 2016, a jump of nearly 400% in just four years, according to data obtained from QuintilesIMS, which tracks pharmaceutical sales. Total sales of Nuedexta reached almost $300 million that year.”

“Nuedexta is being increasingly prescribed in nursing homes even though drugmaker Avanir Pharmaceuticals acknowledges in prescribing information that the drug has not been extensively studied in elderly patients — prompting critics to liken its use to an uncontrolled experiment. The one study the company conducted solely on patients with Alzheimer’s (a type of dementia) had 194 subjects and found that those on Nuedexta experienced falls at more than twice the rate as those on a placebo.”

“There has to be a diagnosis for every drug prescribed, and that diagnosis has to be real … it cannot be simply made up by a doctor,” said Kathryn Locatell, a geriatric physician who helps the California Department of Justice investigate cases of elder abuse in nursing homes. “There is little to no medical literature to support the drug’s use in nursing home residents (with dementia) — the population apparently being targeted.”

“Medicare is supposed to pay for drug uses that have been proven safe and effective for the population they are intended to treat or that have been otherwise supported by a specific collection of medical research. Nuedexta is currently only approved by the FDA for patients who have PBA. So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition. So-called “off-label” prescribing, in which doctors use the drug to treat patients who have not been diagnosed with PBA, would typically not be covered.”

ABC Action News reported the controversy surrounding a nursing home’s refusal to provide certain medicine to one of their residents. Zephyrhills Health and Rehab Center, which is operated by Adventist Health System, refuses to allow Charlotte Simpson pain relief by refusing to allow her to have the medical marijuana she has a legal prescription to take.  Simpson is confined to a wheelchair and suffers Parkinson’s Disease, arthritis and other ailments.

“You should see the condition she’s in. It’s horrible,” said Bert Greene, describing his mother Charlotte Simpson. “She’s got uncontrollably shaking, excruciating pain.”

Greene said after medical marijuana became legal in Florida, a doctor prescribed it for his mother and she applied for a compassionate use permit.

“When she was finally approved, and the medicine was delivered, they gave it to me and told me I had to take it home with me,” Greene said.

 

 

Dove Press had clinical guidelines on prescribing psychotropic medication for nursing home residents with dementia on their website.

Objective: The aim of this study was to identify factors influencing the prescribing of psychotropic medication by general practitioners (GPs) to nursing home residents with dementia.

Subjects and methods: GPs with experience in nursing homes were recruited through professional body newsletter advertising, while 1,000 randomly selected GPs from south-eastern Australia were invited to participate, along with a targeted group of GPs in Tasmania. An anonymous survey was used to collect GPs’ opinions.

Results: A lack of nursing staff and resources was cited as the major barrier to GPs recommending non-pharmacological techniques for behavioral and psychological symptoms of dementia (BPSD; cited by 55%; 78/141), and increasing staff levels at the nursing home ranked as the most important factor to reduce the usage of psychotropic agents (cited by 60%; 76/126).

Conclusion: According to GPs, strategies to reduce the reliance on psychotropic medication by nursing home residents should be directed toward improved staffing and resources at the facilities.

The Santa Fe New Mexican reported that Casa Real nursing home in Santa Fe owned and operated by Preferred Care Partners Management Group has at least temporarily improved persistent quality-of-care problems enough to resume billing Medicare and Medicaid for newly admitted residents.  Casa Real is one of only two homes in Santa Fe that accept Medicare and Medicaid patients.

For more than two months, Casa Real had been barred from charging Medicare or Medicaid for new residents after the Centers for Medicare and Medicaid Services found the nursing home wasn’t in compliance with federal care standards.

Inspections this year turned up a long list of problems, including medication errors, expired food and drugs on shelves, unreported resident injuries and assault, poor care of bed sores, nursing understaffing and inadequate safeguards against the spread of dangerous infections.

The former director of nursing at Casa Real from May to August has accused management of forging patient records in an attempt to show the facility was in compliance with care standards dealing with monitoring of medication effects on residents.  Of course, she was soon fired.

The August inspection found residents weren’t receiving medications as directed by their physicians and that the nursing home wasn’t doing enough to ensure that residents didn’t receive unnecessary drugs, including psychotropic medications.

The federal agency in May designated Casa Real as a “special focus facility” because of its poor record of complying with care standards, and it said the nursing home would be subject to more frequent inspections. The designation is given to the nation’s poorest-performing nursing homes and is meant to address the “yo-yo” problem of facilities routinely falling in and out of compliance with care standards.

The state Attorney General’s Office is suing Preferred Care, alleging it has defrauded Medicaid by having insufficient staff to meet the needs of residents at its Santa Fe nursing homes, as well as its facilities in five other New Mexico communities. Preferred Care has denied the allegations.

St. Louis Today reported the tragic and preventable death of Robert L. Baehr.  Baehr died in November 2015 of low blood sugar about two weeks after nurses at Bent-Wood Nursing and Rehab Center mistakenly gave him a prescription drug used to treat diabetes, which Baehr did not have.  Baehr also received one dose of an antibiotic and four doses of a drug to lower blood pressure that he was not prescribed, the investigative report shows.

The drug was intended for another resident of the nursing home, and a nurse mixed up their records, according to an investigation by the U.S. Centers for Medicare and Medicaid Services.  After Baehr’s death, the federal agency cited Bent-Wood for placing residents in immediate jeopardy, putting its funding at risk.

 Baehr’s widow and daughter filed a lawsuit last year in St. Louis County Circuit Court against Bent-Wood claiming negligence by the nursing home; its owner, MGM Healthcare of Creve Coeur; and Dr. John Laird, who was Robert Baehr’s doctor.

Baehr’s drug list got switched with another resident’s who was admitted the same day, according to investigators’ interviews with nursing staff.  Investigators discovered that Baehr was given seven doses of glyburide, used to treat high blood sugar, one on Nov. 5 and two on each of the next three days. On Nov. 8, Baehr was found unresponsive and had a blood sugar level of 33 (normal levels are 70 to 100). He was revived with a sugar solution and orange juice. The next day he again became unresponsive with a blood sugar level of 33, and the sugar solution did not revive him. He never regained consciousness and died on Nov. 22. Federal records show the cause of death was profound hypoglycemia, or low blood sugar.

 

 

The Post and Courier reported the lawsuit filed by South Carolina against Purdue Pharma which is one of the largest pain pill manufacturers in the nation.  The complaint filed is aimed at Connecticut-based Purdue Pharma, the maker of OxyContin — one of many synthetic opioids that have been manufactured, shipped, prescribed and sold throughout the United States.

The lawsuit accuses Purdue of failing to comply with a 2007 agreement it signed with South Carolina over allegations of its promotion of OxyContin. The State accuses the drug manufacturer of encouraging doctors to prescribe pain pills for unapproved uses and downplaying how addictive the company’s prescriptions are.

Opioid addiction is a public health menace to South Carolina,” AG Wilson said as family members of overdose victims and addiction survivors stood behind him. “We cannot let history record that we stood by while this epidemic rages.” Wilson said the scourge has cost South Carolina billions of dollars.

More than 565 South Carolinians died of an overdose tied to highly addictive opioids in 2015, the most recent year that data is available.  Opiods are the leading cause of death for Americans under the age of 50.

 

State Medicaid data shows that 1,855 prescriptions — or more than $1 million worth — of OxyContin reimbursed under the state-run insurance program last year. That number is down from the 3,620 prescriptions worth more than $2 million that were reimbursed in 2012.

 

 

Health in Aging reported on new research published in the June 2017 issue of the Journal of the American Geriatrics Society.

Medical experts know that older adults who have dementia or other mental health concerns that impact thinking or decision making should avoid certain “potentially inappropriate medications” (PIMs). PIMs can worsen confusion and raise the risks for falls, fractures, and even death, particularly for people with complex health needs.

PIMs may include treatments like:

  • Benzodiazepines (medications sometimes called “tranquilizers” and used to treat sleep problems, anxiety, or to relax muscles)
  • Antipsychotics (medications sometimes used to address mental health conditions)
  • H2-blockers (medications sometimes used to decrease the production of stomach acid)
  • Anticholinergics (medications that block a substance called acetylcholine, a “neurotransmitter” that transfers signals between certain cells to impact how your body functions. Anticholinergics have been used to treat several different conditions, including incontinence and chronic obstructive pulmonary disorder, or COPD).

Researchers investigated how often healthcare providers prescribed PIMs to older adults living with dementia or other mental health concerns in nursing homes. The research team discovered that 44 percent of people with dementia or cognitive impairment were taking a PIM. The frailer the person, the more likely they were to be taking a PIM.

After admission to a nursing home, many residents who were initially prescribed PIMs stopped taking PIMs:

  • 5 percent stopped taking antipsychotic medications.
  • 3 percent stopped taking benzodiazepines.
  • 9 percent stopped taking H2-blockers.
  • 2 percent stopped taking medications with anticholinergic properties that worsen memory or thinking.

A smaller percentage of study participants–from 1.2 percent to 10.9 percent, depending on the specific medication–were newly started on PIMs in the nursing home. Antipsychotics and benzodiazepines were the most frequently prescribed PIMs.

The researchers concluded that many nursing home residents with dementia or other cognitive impairments enter nursing homes on PIMs. They also concluded that PIMs are more likely to be prescribed for frail older adults after admission. The researchers suggested that strategies for a person-centered approach to discontinuing PIMs should be encouraged, especially for frail older adults.

It’s also important to remember that “potentially inappropriate medications” are just that: potentially inappropriate. They should be considered carefully before use, but that doesn’t mean that they should never be used in all cases or for all older people. If you have been prescribed a PIM or if you’re concerned about the way a treatment may affect your health, be sure to speak with your healthcare provider first before changing your routine or stopping the use of specific medications.

A former nurse, who previously pled guilty to tampering with a consumer product, was sentenced to imprisonment for a term of 48 months.  Christina Lovern Calloway, while working as a nurse in a nursing home, diverted liquid morphine intended for patients to her own use. The defendant, on more than one occasion, took some of the liquid morphine from a bottle and used it herself. She then used tap water to refill the bottle in an attempt to hide her crime. The diluted morphine was then administered to patients.

 

KTLO reported that additional charges have been filed against a nurse who fled from law enforcement officers earlier this month following a traffic stop after police responded to a complaint of an intoxicated driver on July 16. When they located the vehicle and attempted to conduct a traffic stop, the driver refused to stop, and a short pursuit ensued.

The driver, Geneva Liveley, was apprehended and taken into custody. An inventory of the vehicle revealed numerous prescription medications belonging to other individuals, a loaded firearm, drug paraphernalia and cash totaling $1,110.

Liveley was charged with simultaneous possession of drugs and firearms, possession of a controlled substance (Hydrocodone), both felony counts, as well as misdemeanor charges.

Chief Manuel says an investigation began into Liveley’s possession of prescription medications belonging to other individuals. It was learned she worked at a local nursing home and stole medications from residents. The medications in her possession were logged by her as being received by the residents.

Liveley was arrested again and charged with four felony counts of controlled substances-fraudulent practices and six misdemeanor offenses.