The Food and Drug Administration has granted remdesivir emergency use authorization to treat the most severely ill COVID-19 patients. The emergency use authorization is not the same as FDA approval.  It is not considered a cure.

The FDA action specifies the drug may be used for both adults and children with suspected or confirmed COVID-19 diagnoses who are severely ill with low blood oxygen levels or who may be on a ventilator. However, that does not mean the drug should be used for all hospitalized patients.

“Given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use,” the FDA wrote in a press release.

The FDA’s decision expands doctors’ ability to use remdesivir on the most severe cases. Previously, physicians were limited to trying the drug in clinical trials or in what’s called compassionate use for patients who have no other treatment options. It has only been used for the most severe cases of COVID-19, and is only administered through an IV.

The FDA’s emergency use authorization increases access by allowing any doctor “to prescribe remdesivir for their patients who are hospitalized with COVID-19,” Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center, explained.

The FDA wrote that possible side effects include, “increased levels of liver enzymes, which may be a sign of inflammation or damage to cells in the liver; and infusion-related reactions, which may include low blood pressure, nausea, vomiting, sweating, and shivering.”

O’Day said the company hopes to expand usage for patients earlier in the course of illness, before patients become sick enough to be hospitalized. Future methods of remdesivir delivery could include an injection or inhaler, but that would likely take months or even years to develop.

President Trump has been a cheerleader for the drug hydroxychloroquine, pointing in a tweet and in person to a French study as evidence that one particular drug combination might be “one of the biggest game changers in the history of medicine.”  Once again, he is an idiot with no medical training.

Dr. Kevin Tracey, president and CEO of the Feinstein Institutes for Medical Research in New York City, gave an even more pointed assessment of the French research. “The study was a complete failure,” he said.
“It was pathetic,” added Art Caplan, head of the division of medical ethics at the New York University School of Medicine.   Leaving out the five patients who took the drug and didn’t fare well is “cherry picking,” said Caplan, the bioethicist.  “That’s not science,” he said. “You’ve got your thumb on the scale.”  Caplan added that even without the “cherry picking” issue, a study with such a small number of patients is basically meaningless.  “It’s just a jumbled mess,” he said.
The small French study of 20 people found that taking hydroxychloroquine was associated with the “viral load reduction/disappearance in COVID-19 patients,” noting that the effect was “reinforced” with azithromycin, an antibiotic better known as a Z-pack.  However, Tracey and Caplan pointed out that several patients who took the drug, and ended up faring poorly, dropped out of the trial, and their outcomes were not factored into the study’s final conclusions.
The International Society of Antimicrobial Chemotherapy published the study online in its journal, the International Journal of Antimicrobial Agents, on March 20.  The society admitted that “concerns have been raised regarding the content, the ethical approval of the trial and the process that this paper underwent to be published within International Journal of Antimicrobial Agents.”   That statement by Andreas Voss, president of the society, said the study “does not meet the Society’s expected standard” and that “although ISAC recognises it is important to help the scientific community by publishing new data fast, this cannot be at the cost of reducing scientific scrutiny and best practices.”
Despite the lack of qualification or scientific evidence, Trump decided that chloroquine was a “game changer” at a White House briefing.  Two days later, on March 21, Trump referred to the French study in a tweet, saying that the combination of hydroxychloroquine and azithromycin “have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains — Thank You!”  Trump’s enthusiasm for hydroxychloroquine hasn’t waned with time, even though it has not been proven to be safe or effective.  “We have some very good results and some very good tests. You’ve seen the same test that I have,” he said at an April 5 briefing. “In France, they had a very good test.”
Now the medical society that published the French research has issued a statement saying they’re reviewing the study again and “a correction to the scientific record may be considered.”

Another company got caught gaming the system and has to pay $15.4 million to settle the case.  Guardian Elder Care Holdings Inc. operates dozens of nursing homes throughout Pennsylvania, Ohio and West Virginia will pay more than $15.4 million to the government to settle federal whistleblower claims that it provided medically unnecessary rehabilitation therapy to residents to help meet revenue goals. Incredibly no one is going to jail for this criminal enterprise. I guess Trump would pardon them anyway.

The settlement resolves a 2015 whistleblower complaint filed in U.S. Eastern District Court, Philadelphia, that brought the allegations to light that violate provisions of the False Claims Act. About $6.2 million of unnecessary treatment was billed to Medicare and other federal health care programs at 28 facilities operated by Guardian.  Two former Guardian employees, Philippa Kraus and Julie White, were the whistleblowers who made the claims and they will share about $2.8 million of the settlement.

Billing federal health care programs for medically unnecessary rehabilitation services not only depletes these programs’ funds but also exploits our most vulnerable citizens,” Brady said in a statement. Guardian Elder Care pressured its therapists to provide services to meet financial targets and maximize revenue without regard to the clinical need for the care. Unfortunately, this practice is wide spread in the industry base don my years of experience as a nursing home abuse and neglect lawyer.

Too much rehabilitation therapy can actually harm patients, just like giving them too many pills or too much medicine,” said U.S. Attorney William McSwain in a statement. “And of course it harms taxpayers who foot the bill for unnecessary treatment.”

Guardian is also entering into a corporate integrity agreement with the U.S. Department of Health and Human Services Office of Inspector General as part of the settlement.

Everyone knows that substance abuse among health care providers is a growing concern especially with the opioid epidemic.  Recently I read an article about an investigation into missing narcotics at the Carthage Center for Rehabilitation and Nursing. Spokesperson Jeff Jacomowitz told 7 News the drugs were discovered missing during the end of a shift.

“At the end of shift count, approximately 7 a.m. on the morning of Monday, February 3, 2020, the facility noticed that narcotics were missing from the overnight shift, which is 11 p.m. to 7 a.m. The facility immediately called Carthage Police to begin an investigation, followed protocol by notifying the Department of Health and the Narcotics Investigation Bureau,” he said.

Jacomowitz also said the missing medications were immediately replaced for the center’s residents.

“Carthage Center has zero tolerance for any employee who commits any crime at the facility, including stealing of any property including medication, bodily harm to either a resident or a staff member or anything related to destruction within the confines of the walls at Carthage Center. We are hoping in this matter that whoever committed this crime will be prosecuted to the fullest extent of the law,” he said.

 

The Opioid Crisis under the Trump Administration has gotten progressively worse.  For years, nursing homes have resisted caring for patients on medication-assisted treatment for OUD.  However, some nursing homes are at the forefront of treatment options.  For example, Cape Regency Rehabilitation & Health Care Center provides one-on-one meetings with a licensed drug and alcohol counselor and management of suboxone medication as part of the nursing home care.  Instead of chemically restraining residents, facilities are helping residents overcome their addictions. Advocates for patients with opioid use disorder say denying them access to nursing home care is discriminatory.

Cape Regency is owned by Athena Health Care Systems.  They send residents to recovery meetings on site and at a nearby church and helps residents with opioid use disorder find appropriate housing after they are discharged, including sober housing if appropriate.

John Seaman, a licensed drug and alcohol counselor, said he runs staff training sessions on caring for residents with opioid use disorder, or OUD, and wishes more nursing homes would admit patients with the disorder. Seaman, who divides his time between Cape Regency and Cape Heritage Rehabilitation & Health Care Center in Sandwich, estimates that one-third of the nursing home’s residents in the long-term care and short-term care units have substance use disorders.

“OUD patients require an additional set of services related to counseling, transportation, activities, security and other needs,” said Tara Gregorio, president of Massachusetts Senior Care, a professional organization for nursing homes, senior residences and assisted living centers. “The federal skilled nursing facility oversight regulations do not address the special needs of OUD nursing facility residents, which place nursing home facilities at great risk for enforcement actions” and deficiencies, Gregorio said in an email to Cape Cod Times.

 

 

Another sad story of an overworked nurse stealing medications from a resident.  Talisa Milam Haygood was arrested Dec. 20 on a felony charge for allegedly stealing medication from residents in October and falsifying records indicating she had given the drugs.  Haygood is charged with obtaining a controlled substance by fraud, punishable by up to 10 years in prison.

 She was employed at Lakewood Therapy and Living Center when the alleged theft and fraud occurred. According to the probable cause affidavit, the administrator at Lakewood filed a report with police on Oct. 10 after reviewing video surveillance footage at the center following a complaint by a resident about some missing Nexium pills.

In viewing the footage, he reportedly saw a nurse, identified as Haygood, removing a hydrocodone pill from the medication cart shortly before 1:30 p.m. on Oct. 9 and placing it in her mouth. The administrator counted the pills in the cart and compared it to the entries made by Haygood in the prescription log book.

He then spoke to the residents Haygood had indicated received their pain medication and found two residents who had not received any medication. One patient told him Haygood had refused to give her any hydrocodone at the prescribed time but instead gave her a Tylenol pill.

One patient was reportedly not capable of advising if he received any medication, but a review of the security footage showed Haygood never entered the man’s room at the time indicated and only went into his room once during her eight-hour shift for about three seconds.

The administrator noted that in the entry for that patient Haygood had indicated she had crushed the pill up in a solution and injected it into the patient, but the video showed Haygood never retrieved a syringe from the storage closet.

Police Detective Jjesus Anaya spoke to the administrator and one patient who confirmed the same information. The administrator noted he has video evidence of 17 “pill diversions” by Haygood and is still reviewing the footage to compile more evidence.

 

 

Substance abuse among health care professionals (especially nurses in skilled care facilities) has increased significantly over the last decade.  The opioid crisis has dramatically affected nurses and other caregivers. Recently another registered nurse was arrested for stealing pain mediacation and watering down morphine intended for a patient, according to court documents.  Joshua D. Williams worked at Greenbrier Regional Medical Center. He was charged with tampering with a consumer product.

The indictment says Williams was working as a supervisory registered nurse at Greenbrier Regional in August 2018 when he tampered with a bottle of liquid morphine sulfate prescribed to a patient. The indictment says he removed a quantity of the drug and replaced it with a saline solution, diluting its concentration to about 14% of what it was labeled.

Court documents don’t say why Williams allegedly diluted the morphine, but according to media reports and prosecutors in other cases, medical staff oftentimes steal the opiate for personal use.

“The morphine discrepancy … was detected during a routine audit,” R. Bruce McCorkle, Greenbrier Regional’s administrator said in a statement, indicating staff reported the situation to “the appropriate state and federal authorities.”

The department said he is authorized to work in several other states, including Maryland, West Virginia and North Carolina.

 

The Trump administration recently announced getting rid of safety regulations placed on nursing homes.  The administration states that the proposed changes would save nursing homes some $600 million a year, though as NPR noted, the proposed regulation reduction wouldn’t require that any savings be spent on improving patient care or increasing staffing.

One particular proposal, which experts and consumer advocates are concerned about is changing the rules for prescribing danagerous and deadly antipsychotic medications to patients at nursing homesConcerns stem with warnings about antipsychotic drugs – used as a chemical restraint and often off-label – can often raise the risk of death in older individuals, particularly from ones already suffering from dementia, according to the NPR report.

CMS has spent years attempting to get nursing home facilities to reduce the use of antipsychotic drugs.  Under current regulations, nursing home facilities cannot prescribe patients antipsychotic drugs for longer than two weeks without having a doctor reevaluate a patient. Under the new proposed regulations, nursing homes could go as long as one to two months without having a doctor evaluate a patient, according to the NPR report.  There is no medical or nursing rationale for this change.

Richard Mollot, Executive Director of the Long Term Care Community Coalition told NPR that his organization opposes the rule change, and cited a doctor who explained why he likewise opposed the regulation adjustment.

“What he said was that no other insurance company would ever accept that a doctor didn’t have to see a patient before continuing a prescription for medicine,” Mollot said. “But CMS is saying now that that’s okay for nursing homes in this very vulnerable population, and people die from this. They’re affected so catastrophically.”

 

 

 

One of the major issues with America’s health care system is how we treat people with addictions.  Anyone who has been affected by the ongoing opioid crisis can attest to the lack of resources for those addicted to the deadly scourge.  Many are stuck in nursing homes.  This is not an ideal situation for numerous reasons.  Rehabilitation hospitals work with patients to achieve therapy goals. But for long-term care, if a patient isn’t able to live independently in the community, the patient typically goes to a nursing home.

Athena Health Care Systems, a privately owned long-term care company based in Connecticut, has become one of the health care providers to offer programs to care for patients who have a history of addiction on top of the physical care diagnosis for which they are referred.  However, nursing homes are licensed by the state Department of Public Health and are surveyed by DPH to certify that they comply with federal Medicare and Medicaid regulations. They are not regulated as detoxification or addiction recovery centers. Athena-owned facilities are the only ones that have developed partnerships with drug treatment centers and in-house programs to train staff and support patients who also have substance use disorders.

“It’s an excruciating problem,” Peter Zawrotniak, program manager in addiction counseling services at UMass Memorial Medical Center, said about placing patients with substance use disorders in appropriate aftercare, particularly if they need methadone treatment.

Zawrotniak said none of the long-term care facilities in the area is equipped to address the full range of services needed for treatment and recovery. Suboxone, as long as it is prescribed by a physician with a waiver to do so, can be dispensed by nursing home staff and is easier to manage, Zawrotniak said.

Methadone, another form of medication-assisted treatment for opioid addiction, can only be administered to patients at a licensed methadone clinic. Patients must be registered with the clinic, a bureaucratic process that can be time consuming to coordinate. One patient waited in a hospital bed for two weeks. The nursing home must then transport the patient to the methadone clinic every day for their dose.

The state DPH’s Bureau of Health Care Safety and Quality issued a letter in 2016 about admission of residents on medication-assisted treatment for opioid use disorder. According to the letter, patients who have completed detoxification and are receiving medication-assisted treatment, and are otherwise eligible for admission to the long-term care facility, are expected to be admitted and have their treatment continued as prescribed by the patient’s physician or opioid treatment program.

There is no federal guidance on what reasonable accommodations need to be made for patients with substance use disorders. And extra services such as addiction counselors and enhanced security measures are not reimbursed by Medicare or Medicaid.

 

Medication errors are a serious problem in the nursing home industry. Federal law requires skilled nursing facilities to keep errors within a 5% margin. This margin is broadly defined, but includes errors such as not mixing medication as directed, giving medications at the wrong time, or not dosing the last small portion of a medication. Consumer advocates and experts estimate that at least 7 million Americans experience a medication error each year. These mistakes are preventable and costly – estimated at over $21 billion.  Errors within this 5% window don’t impact licensing and they’re the types of medications many people make at home when administering their own medications.

Nursing homes which are often understaffed, medication errors are rampant. Errors are likely underreported and that the medical coding system makes it easy to cover up error-related deaths. Under a different system, the CDC argues that medication errors might be the third most common cause of death among nursing home patients.

If you’re responsible for the health and safety of an older adult,you need to understand medication administration, particularly within nursing home settings.  By building good habits around medication preparation and administration, nursing facilities can improve patient outcomes and help minimize error rates at their facilities.

Given the potential problems stemming from improper medication administration, nursing homes need to invest in better prevention practices. That starts with increasing staffing level, a strategy that could also help prevent nursing home abuse. These facilities are chronically understaffed because of low pay and poor management and have a high rate of turnover. That means staff also aren’t familiar with patients’ care regimens and are more likely to make mistakes.

In addition to increasing staffing levels, nursing homes can decrease error rates by adopting a strong medication reconciliation program.  Reconciliation processes are especially important in nursing homes, as many patients are unable to verify their medications.

Finally, as part of reducing error rates, nursing homes should minimize high-risk behaviors, such as not properly disposing of discontinued medications or medications from discharged patients, improperly transporting medications, or administering medications without fully reviewing the label directions.

Nursing home residents are the most vulnerable members of our community and they deserve safe, careful, and appropriate treatment.