Vaccines

Nursing Home Residents Overlooked in Scramble for Covid Antibody Treatments

 
Of the dozens of patients Dr. Jim Yates has treated for covid-19 at his long-term care center in rural Alabama, this one made him especially nervous.

The 60-year-old man, who had been fully vaccinated, was diagnosed with a breakthrough infection in late September. Almost immediately, he required supplemental oxygen, and lung exams showed ominous signs of worsening disease. Yates, who is medical director of Jacksonville Health and Rehabilitation, a skilled nursing facility 75 miles northeast of Birmingham, knew his patient needed more powerful interventions — and fast.

At the first sign of the man’s symptoms, Yates had placed an order with the Alabama Department of Public Health for monoclonal antibodies, the lab-made proteins that mimic the body’s ability to fight the virus. But six days passed before the vials arrived, nearly missing the window in which the therapy works best to prevent hospitalization and death.

“We’ve been pushing the limits because of the time frame you have to go through,” Yates said. “Fortunately, once we got it, he responded.”

Across the country, medical directors of skilled nursing and long-term care sites say they’ve been scrambling to obtain doses of the potent antibody therapies following a change in federal policy that critics say limits supplies for the vulnerable population of frail and elder residents who remain at highest risk of covid infection even after vaccination.

“There are people dying in nursing homes right now, and we don’t know whether or not they could have been saved, but they didn’t have access to the product,” said Chad Worz, CEO of the American Society of Consultant Pharmacists, which represents 1,500 pharmacies that serve long-term care sites.

Before mid-September, doctors and other providers could order the antibody treatments directly through drug wholesaler AmerisourceBergen and receive the doses within 24 to 48 hours. While early versions of the authorized treatments required hourlong infusions administered at specialty centers or by trained staff members, a more recent approach allows doses to be administered via injections, which have been rapidly adopted by drive-thru clinics and nursing homes.

Prompt access to the antibody therapies is essential because they work by rapidly reducing the amount of the virus in a person’s system, lowering the chances of serious disease. The therapies are authorized for infected people who’ve had symptoms for no more than 10 days, but many doctors say they’ve had best results treating patients by Day 5 and no later than Day 7.

After a slow rollout earlier in the year, use of monoclonal antibody treatments exploded this summer as the delta variant surged, particularly in Southern states with low covid vaccination rates whose leaders were looking for alternative — albeit costlier — remedies.

By early September, orders from seven states — Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee and Texas — accounted for 70% of total shipments of monoclonals.

Those Southern states, plus three others — Arkansas, Kentucky and North Carolina — ordered new courses of treatment even faster than they used their supplies. From July 28 to Sept. 8, they collectively increased their antibody stockpiles by 134%, according to a KHN analysis of federal data.

Concerned the pattern was both uncontrolled and unsustainable given limited national supplies, officials with the Department of Health and Human Services stepped in to equalize distribution. HHS barred individual sites from placing direct orders for the monoclonals. Instead, they took over distribution, basing allocation on case rates and hospitalizations and centralizing the process through state health departments.

“It was absolutely necessary to make this change to ensure a consistent product for all areas of the country,” Dr. Meredith Chuk, who is leading the allocation, distribution and administration team at HHS, said during a conference call.

But states have been sending most doses of the monoclonal antibody treatments, known as mAbs, to hospitals and acute care centers, sidestepping the pharmacies that serve long-term care sites and depleting supplies for the most vulnerable patients, said Christopher Laxton, executive director of AMDA, the Society for Post-Acute and Long-Term Care Medicine.

While vaccination might provide 90% protection or higher against serious covid in younger, healthier people, that’s not the case for the elders who typically live in nursing homes.

“You have to think of the spectrum of immunity,” Laxton said. “For our residents, it’s closer to 60%. You know that 4 out of 10 are going to have breakthrough infections.”

The mAb treatments have been authorized for use in high-risk patients exposed to the virus, and experts in elder care say that is key to best practices in preventing outbreaks in senior facilities. That could include, for example, treating the elderly roommate of an infected nursing home patient. But because of newly limited supplies, many long-term care sites have started to restrict use to only those who are infected.

Still, some states have worked to ensure access to mAbs in long-term care sites. Minnesota health officials rely on a policy that prioritizes residents of skilled nursing facilities for the antibody therapies through a weighted lottery. In Michigan, state Medical Director Dr. William Fales directed emergency medical technicians and paramedics to the Ascension Borgess Hospital system in Kalamazoo to help administer doses during recent outbreaks at two centers.

“The monoclonal antibodies made a huge difference,” said Renee Birchmeier, a nurse practitioner who cares for patients in nine of the system’s sites. “Even the patients in the assisted living with COPD, they’re doing OK,” she said, referring to chronic obstructive pulmonary disease. “They’re not advancing, but they’re doing OK. And they’re alive.”

Long-term care sites have accounted for a fraction of the orders for the monoclonal treatments, first authorized in November 2020. About 3.2 million doses have been distributed to date, with about 52% already used, according to HHS. Only about 13,500 doses have gone to nursing homes this year, according to federal data. That doesn’t include other long-term care sites such as assisted living centers.

The use is low in part because the treatments were originally delivered only through IV infusions. But in June, the Regeneron monoclonal antibody treatment was authorized for use via subcutaneous injections — four separate shots, given in the same sitting — and demand surged.

Use in nursing homes rose to more than 3,200 doses in August and nearly 6,700 in September, federal data shows. But weekly usage dropped sharply from mid-September through early October after the HHS policy change.

Nursing homes and other long-term care sites were seemingly left behind in the new allocation system, said Cristina Crawford, a spokesperson for the American Health Care Association, a nonprofit trade group representing long-term care operators. “We need federal and state public health officials to readjust their priorities and focus on our seniors,” she said.

In an Oct. 20 letter to White House policy adviser Amy Chang, advocates for long-term care pharmacists and providers called for a coordinated federal approach to ensure access to the treatments. Such a plan might reserve use of a certain type or formulation of the product for direct order and use in long-term care settings, said Worz, of the pharmacy group.

So far, neither the HHS nor the White House has responded to the letter, Worz said. Cicely Waters, a spokesperson for HHS, said the agency continues to work with state health departments and other organizations “to help get covid-19 monoclonal antibody products to the areas that need it most.” But she didn’t address whether HHS is considering a specific solution for long-term care sites.

Demand for monoclonal antibody treatments has eased as cases of covid have declined across the U.S. For the week ending Oct. 27, an average of nearly 72,000 daily cases were reported, a decline of about 20% from two weeks prior. Still, there were 2,669 confirmed cases among nursing home residents the week ending Oct. 24, and 392 deaths, according to the Centers for Disease Control and Prevention.

At least some of those deaths might have been prevented with timely monoclonal antibody therapy, Worz said.

Resolving the access issue will be key to managing outbreaks as the nation wades into another holiday season, said Dr. Rayvelle Stallings, corporate medical officer at PruittHealth, which serves 24,000 patients in 180 locations in the Southeast.

PruittHealth pharmacies have a dozen to two dozen doses of monoclonal antibody treatments in stock, just enough to handle expected breakthrough cases, she said.

“But it’s definitely not enough if we were to have a significant outbreak this winter,” she said. “We would need 40 to 50 doses. If we saw the same or similar surge as we saw in August and September? We would not have enough.”

Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.

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Student Nurses Who Refuse Vaccination Struggle to Complete Degrees

Kaitlyn Hevner expects to complete a 15-month accelerated nursing program at the University of North Florida in Jacksonville in December. For her clinical training this fall, she’s working 12-hour shifts on weekends with medical-surgical patients at a hospital.

But Hevner and nursing students like her who refuse to get vaccinated against covid-19 are in an increasingly precarious position. Their stance may put their required clinical training and, eventually, their nursing careers at risk.

In early September, the Biden administration announced that workers at health care facilities, including hospitals and ambulatory surgery centers, would be required to receive covid vaccines. Although details of the federal rule won’t be released until October, some experts predict that student nurses doing clinical training at such sites will have to be vaccinated, too.

Groups representing the nursing profession say “students should be vaccinated when clinical facilities require it” to complete their clinical training. In a policy brief released Monday, the National Council of State Boards of Nursing and eight other nurse organizations suggested that students who refuse to be vaccinated and who don’t qualify for an exception because of their religious beliefs or medical issues may be disenrolled from their nursing program or be unable to graduate because they cannot fulfill the clinical requirements.

“We can’t have students in the workplace that can expose patients to a serious illness,” said Maryann Alexander, chief officer for nursing regulation at the national council. “Students can refuse the vaccine, but those who are not exempt maybe should be told that this is not the time to be in a nursing program.”

“You’re going to go into practice and you’re going to be very limited in your jobs if you’re not going to get that vaccine,” Alexander said.

Kaitlyn Hevner, a nursing student at the University of North Florida, has opted not to get vaccinated against covid even though many medical facilities require it. She questions whether “we give up our own religious rights and our own self-determination just because we work in a health care setting.” (Robert Working)

Hevner, 35, set to finish her clinical training in early October, said she doesn’t feel it’s acceptable to benefit from a vaccine that was developed using fetal cells obtained through abortion, which she opposes. (Development of the Johnson & Johnson covid vaccine involved a cell line from an abortion; the Pfizer-BioNTech and Moderna mRNA vaccines were not developed with fetal cell lines, but some testing of the vaccines reportedly involved fetal cells, researchers say. Many religious leaders, however, support vaccination against covid.)

With vaccines for nursing students still optional in many health care settings, nursing educators are scrambling to place unvaccinated students in health care facilities that will accept them.

Down the coast from Jacksonville in Fort Pierce, Florida, 329 students are in the two-year associate degree nursing program at Indian River State College, said Roseann Maresca, an assistant professor who teaches third-semester students and coordinates their clinical training. Only 150 of them are vaccinated against covid, she said.

Not all of the eight medical facilities that have contracts with the school require student nurses to be vaccinated.

“It’s been a nightmare trying to move students around this semester” to match them with facilities depending on their vaccination status, Maresca said.

Commonly, health care facilities have long required employees to be vaccinated against various illnesses such as influenza and hepatitis B. The pandemic has added new urgency to these requirements. According to a September tally by FierceHealthcare, more than 170 health systems mandate covid vaccines for their workforces.

In May, the federal Equal Employment Opportunity Commission made it clear that under federal law employers can mandate covid vaccinations as long as they allow workers to claim religious and medical exemptions.

Under the Biden administration’s covid plan, roughly 50,000 health care facilities that receive Medicare or Medicaid payments must require workers to be vaccinated. Until the administration releases its draft rule in October, it is unclear how nursing students assigned to health care sites for clinical training will be treated.

But the federal rule published in August that lays out regulations for government hospital payments in 2022 offers clues. It defined health care personnel that should be vaccinated as employees, licensed independent contractors and adult students/trainees and volunteers, said Colin Milligan, director of media relations at the American Hospital Association.

In addition to staff members, the Biden plan says mandates will apply to “individuals providing services under arrangements” at health care sites.

A spokesperson for the Centers for Medicare & Medicaid Services declined to clarify who would be covered by the Biden plan, noting the agency is still writing the rules.

Nonetheless, vaccination mandates threaten to derail the training of a relatively small proportion of nursing students. A recent survey by the National Student Nurses’ Association reported that 86% of nursing students and 85% of new nursing graduates who responded to an online survey said they had been or planned to be vaccinated against covid.

But the results varied widely by state, from 100% in New Hampshire and Vermont on the high end to 63% in Oklahoma, 74% in Kentucky and 76% in Florida on the low end. The survey had 7,501 respondents.

Students who don’t want to be vaccinated are asking schools to offer them alternatives to on-site clinical training. They suggest using life-size computer-controlled mannequins or computer-based simulations using avatars, said Marcia Gardner, dean of the nursing school at Molloy College in Rockville Centre, New York.

Last year, when the pandemic led hospitals to close their doors to students, many nursing programs increased simulated clinical training to give nursing students some sort of clinical experience.

But that’s no substitute for working with real patients in a health care setting, educators say. State nursing boards permit simulated clinical study to varying degrees, but none allow such instruction to exceed 50% of clinical training, said Alexander. A multisite study found that nursing students could do up to half their clinical training using simulation with no negative impact on competency.

The policy brief by the council of state nursing boards states that nursing education programs “are not obligated to provide substitute or alternate clinical experiences based on a student’s request or vaccine preference.”

As more nursing students become vaccinated, the issue will grow less acute. And if the Biden plan requires nursing students to be vaccinated to work in hospitals, the number of holdouts is likely to further shrink.

Hevner, the University of North Florida student, said she’s not opposed to vaccines in general and would consider getting a covid vaccine in the future if she could be assured it wasn’t created using aborted fetal cells. She filed paperwork with the college to get a religious exemption from vaccine requirements. It turned out she didn’t need one because Orange Park Medical Center, where she is doing her clinical training, doesn’t require staffers or nursing students to be vaccinated against covid “at this time,” said Carrie Turansky, director of public relations and communications for the medical center, in Orange Park, Florida.

Although Hevner opposes getting the vaccine, “I take protecting my patients and protecting myself very seriously,” she said. She gets tested weekly for covid and always wears an N95 mask in a clinical setting, among other precautions, she said. “But I would ask: Do we give up our own religious rights and our own self-determination just because we work in a health care setting?”

She hopes the profession can accommodate people like her.

“I’m concerned because we’re in such a divisive place,” she said. But she is eager to find a middle ground because, she said, “I think I would make a really great nurse.”

Source

Mandatory Vaccines for Health Care Workers Might Upend Nurses’ Training

Kaitlyn Hevner expects to complete a 15-month accelerated nursing program at the University of North Florida in Jacksonville in December. For her clinical training this fall, she’s working 12-hour shifts on weekends with medical-surgical patients at a hospital.

But Hevner and nursing students like her who refuse to get vaccinated against covid-19 are in an increasingly precarious position. Their stance may put their required clinical training and, eventually, their nursing careers at risk.

In early September, the Biden administration announced that workers at health care facilities, including hospitals and ambulatory surgery centers, would be required to receive covid vaccines. Although details of the federal rule won’t be released until October, some experts predict that student nurses doing clinical training at such sites will have to be vaccinated, too.

Groups representing the nursing profession say “students should be vaccinated when clinical facilities require it” to complete their clinical training. In a policy brief released Monday, the National Council of State Boards of Nursing and eight other nurse organizations suggested that students who refuse to be vaccinated and who don’t qualify for an exception because of their religious beliefs or medical issues may be disenrolled from their nursing program or be unable to graduate because they cannot fulfill the clinical requirements.

“We can’t have students in the workplace that can expose patients to a serious illness,” said Maryann Alexander, chief officer for nursing regulation at the national council. “Students can refuse the vaccine, but those who are not exempt maybe should be told that this is not the time to be in a nursing program.”

“You’re going to go into practice and you’re going to be very limited in your jobs if you’re not going to get that vaccine,” Alexander said.

Kaitlyn Hevner, a nursing student at the University of North Florida, has opted not to get vaccinated against covid even though many medical facilities require it. She questions whether “we give up our own religious rights and our own self-determination just because we work in a health care setting.” (Robert Working)

Hevner, 35, set to finish her clinical training in early October, said she doesn’t feel it’s acceptable to benefit from a vaccine that was developed using fetal cells obtained through abortion, which she opposes. (Development of the Johnson & Johnson covid vaccine involved a cell line from an abortion; the Pfizer-BioNTech and Moderna mRNA vaccines were not developed with fetal cell lines, but some testing of the vaccines reportedly involved fetal cells, researchers say. Many religious leaders, however, support vaccination against covid.)

With vaccines for nursing students still optional in many health care settings, nursing educators are scrambling to place unvaccinated students in health care facilities that will accept them.

Down the coast from Jacksonville in Fort Pierce, Florida, 329 students are in the two-year associate degree nursing program at Indian River State College, said Roseann Maresca, an assistant professor who teaches third-semester students and coordinates their clinical training. Only 150 of them are vaccinated against covid, she said.

Not all of the eight medical facilities that have contracts with the school require student nurses to be vaccinated.

“It’s been a nightmare trying to move students around this semester” to match them with facilities depending on their vaccination status, Maresca said.

Commonly, health care facilities have long required employees to be vaccinated against various illnesses such as influenza and hepatitis B. The pandemic has added new urgency to these requirements. According to a September tally by FierceHealthcare, more than 170 health systems mandate covid vaccines for their workforces.

In May, the federal Equal Employment Opportunity Commission made it clear that under federal law employers can mandate covid vaccinations as long as they allow workers to claim religious and medical exemptions.

Under the Biden administration’s covid plan, roughly 50,000 health care facilities that receive Medicare or Medicaid payments must require workers to be vaccinated. Until the administration releases its draft rule in October, it is unclear how nursing students assigned to health care sites for clinical training will be treated.

But the federal rule published in August that lays out regulations for government hospital payments in 2022 offers clues. It defined health care personnel that should be vaccinated as employees, licensed independent contractors and adult students/trainees and volunteers, said Colin Milligan, director of media relations at the American Hospital Association.

In addition to staff members, the Biden plan says mandates will apply to “individuals providing services under arrangements” at health care sites.

A spokesperson for the Centers for Medicare & Medicaid Services declined to clarify who would be covered by the Biden plan, noting the agency is still writing the rules.

Nonetheless, vaccination mandates threaten to derail the training of a relatively small proportion of nursing students. A recent survey by the National Student Nurses’ Association reported that 86% of nursing students and 85% of new nursing graduates who responded to an online survey said they had been or planned to be vaccinated against covid.

But the results varied widely by state, from 100% in New Hampshire and Vermont on the high end to 63% in Oklahoma, 74% in Kentucky and 76% in Florida on the low end. The survey had 7,501 respondents.

Students who don’t want to be vaccinated are asking schools to offer them alternatives to on-site clinical training. They suggest using life-size computer-controlled mannequins or computer-based simulations using avatars, said Marcia Gardner, dean of the nursing school at Molloy College in Rockville Centre, New York.

Last year, when the pandemic led hospitals to close their doors to students, many nursing programs increased simulated clinical training to give nursing students some sort of clinical experience.

But that’s no substitute for working with real patients in a health care setting, educators say. State nursing boards permit simulated clinical study to varying degrees, but none allow such instruction to exceed 50% of clinical training, said Alexander. A multisite study found that nursing students could do up to half their clinical training using simulation with no negative impact on competency.

The policy brief by the council of state nursing boards states that nursing education programs “are not obligated to provide substitute or alternate clinical experiences based on a student’s request or vaccine preference.”

As more nursing students become vaccinated, the issue will grow less acute. And if the Biden plan requires nursing students to be vaccinated to work in hospitals, the number of holdouts is likely to further shrink.

Hevner, the University of North Florida student, said she’s not opposed to vaccines in general and would consider getting a covid vaccine in the future if she could be assured it wasn’t created using aborted fetal cells. She filed paperwork with the college to get a religious exemption from vaccine requirements. It turned out she didn’t need one because Orange Park Medical Center, where she is doing her clinical training, doesn’t require staffers or nursing students to be vaccinated against covid “at this time,” said Carrie Turansky, director of public relations and communications for the medical center, in Orange Park, Florida.

Although Hevner opposes getting the vaccine, “I take protecting my patients and protecting myself very seriously,” she said. She gets tested weekly for covid and always wears an N95 mask in a clinical setting, among other precautions, she said. “But I would ask: Do we give up our own religious rights and our own self-determination just because we work in a health care setting?”

She hopes the profession can accommodate people like her.

“I’m concerned because we’re in such a divisive place,” she said. But she is eager to find a middle ground because, she said, “I think I would make a really great nurse.”

Source