Dr. Jim Yates has seen many patients with covid-19 at his long term care center in rural Alabama. But this one was the most frightening.
In late September, the breakthrough infection was discovered in a 60-year-old man who had been fully vaccinated. He required supplemental oxygen and lung exams revealed ominous signs that his condition was worsening. 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. The vials were not delivered for six days, which was almost enough time to miss the window where the therapy is most effective in preventing 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.
Doctors and other healthcare providers could order the antibodies treatments directly from AmerisourceBergen prior to mid-September. The doses would be delivered within 24 to 48 hours. The original authorized treatments required infusions of up to an hour at specialty centers or by trained staff, but a newer approach allows for injections. This has been quickly adopted by nursing homes and drive-thru pharmacies.
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. According to a report by a, their collective antibody stockpiles increased by 134% from July 28 through Sept. 8. KHNAnalysis of federal data.
Concerned that the pattern was uncontrolled and unsustainable, given the limited national supplies, officials from the Department of Health and Human Services intervened to equalize distribution. HHS prohibited individual sites from placing orders for monoclonals directly. Instead, they took control of distribution, basing allocations on hospitalizations and case rates, and centralizing the process through state-run 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.
According to Christopher Laxton (executive director of AMDA), the Society for Post-Acute and Long-Term Care Medicine (SPHTM), states have been sending large amounts of monoclonal antibodies treatments, known collectively as mAbs, to hospitals and other acute care centers. This is bypassing pharmacies that provide long-term care and depleting supplies for the most fragile patients.
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 are available. been authorized For high-risk patients who have been exposed to the virus. Experts in elder care state that this is an important step in preventing spread in senior facilities. This could include, for instance, the treatment of an elderly roommate who is infected at a nursing home. Many long-term care facilities are now limiting their supply to only infected patients due to a shortage of supplies.
However, some states still work to ensure access to mAbs at long-term care sites. Minnesota health officials rely on a policy It prioritizes residents in skilled nursing facilities for antibody therapies through a weighted lotto. Michigan’s state Medical Director Dr. William Fales directed paramedics and emergency medical technicians to the Ascension Borgess Hospital in Kalamazoo to administer doses during recent outbreaks at 2 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.”
A small fraction of monoclonal treatment orders have been placed at long-term care centers, which were authorized in November 2020. According to HHS, approximately 3.2 million doses have already been distributed, with 52% of them being used. According to HHS, only 13.500 doses have been distributed to nursing homes this past year. federal data. That doesn’t include other long-term care sites such as assisted living centers.
Because the original IV infusions were used to administer the treatments, there is a low use. 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.
Federal data shows that nursing home use rose to over 3,200 doses in August, and almost 6,700 in September. The HHS policy change resulted in a sharp drop in weekly usage from mid-September to early October.
Cristina Crawford, a spokesperson of the American Health Care Association, a non-profit trade association representing long term care operators, stated that nursing homes and other long term care sites seemed to be left behind in this new allocation system. “We need federal and state public health officials to readjust their priorities and focus on our seniors,” she said.
In Oct. 20 letter Amy Chang, White House policy advisor, said advocates for long-term care pharmacists called for a coordinated federal approach in order to ensure access to the treatments. Worz from the pharmacy group said that such a plan could allow for the use of a specific type or formulation of the product only for long-term care settings.
Worz said that so far, neither HHS or the White House have responded. 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.
The demand for monoclonal antibody treatment has declined as covid cases have dropped across the U.S. An average of almost 72,000 daily cases was reported in the week ending October 27, a decrease of 20% over the previous two weeks. The week ended Oct. 24, saw 2,669 confirmed cases and 392 deaths among nursing home residents. Centers for Disease Control and Prevention.
Worz suggested that monoclonal anti-body therapy could have prevented at least some of these deaths.
According to Dr. Rayvelle Stallings of PruittHealth, the corporate medical officer, the solution to the access problem will be key in managing outbreaks as the nation enters another holiday season. PruittHealth serves 24,000 patients at 180 locations in the Southeast.
PruittHealth pharmacies keep a dozen to twenty-four doses of monoclonal antibodies in stock, just enough for breakthrough cases, she stated.
“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. Were we to experience the same or a similar surge in August and Sept? We would not have enough.”
Phillip Reese, an assistant professor of journalism at California State University-Sacramento, contributed to this report.