“It’s a big deal. This is different than all the other drugs you’ve heard about. This drug does make a difference in survival rates,” said J. Doug Nelson, MD, a family physician and medical director in Hickory, NC, about monoclonal antibodies (mAbs) and their use in treating COVID-19. Early evidence suggests that mAbs treatment can reduce the viral load — the amount of coronavirus in a person’s body — which may lead to milder symptoms and help speed recovery. “For every 12 patients who qualify for this treatment, at least one will be able to keep from going to the hospital. When hospitals are overwhelmed and an admission can put frail elderly at risk for a variety of issues and problems, this is significant.”
Chad Worz, PharmD, BCGP, executive director of the American Society of Consultant Pharmacists (ASCP), agreed. “It is a huge deal to avoid hospitalizations,” he said, not just for the individual but for long-term care facilities, which are trying to prevent outbreaks, and hospitals, which are stretched thin with resources and running short on beds, staffing, and supplies. “If you can treat someone early in the infection, you can potentially prevent an outbreak. We have weekly calls with over 200 people each week, and we keep hearing, ‘This is like a miracle,’” said Dr. Worz. “We would love more data, but anecdotally it’s tremendously promising.”
Two antibody products received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration late last year. Bamlanivimab (Eli Lilly) and casirivimab/imdevimab (Regeneron) are indicated for “high-risk” patients such as nursing home and assisted living residents. To date, of the two, only bamlanivimab is available to long-term care pharmacies. On February 9, the FDA issued an EUA for bamlanivimab and etesevimab (Eli Lily) administered together to treat mild to moderate COVID-19 in adults and pediatric patients (12 years old or older weighing at least 88 pounds). The authorized use includes treatments for people 65 years old or older.
None of these products are authorized for use in patients who are hospitalized with COVID-19, those who require oxygen therapy for COVID-19, or individuals on chronic oxygen therapy who require an increase in baseline oxygen rate because of COVID-19.
A Little Background
In mid-December 2020, the chief medical officer of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services (HHS/ASPR) sent a message to all state and territorial health officials concerning their oversight of the allocation and distribution of COVID-19 therapeutics administered under EUA. At the same time HHS/ASPR implemented a new federal allocation program called the Special Projects for Equitable and Efficient Distribution (SPEED). This was designed to help states and authorities identify and allocate mAbs to nonhospital facilities that service priority populations, including nursing homes.
Two SPEED initiatives started immediately. One was to enable home infusion providers in 46 states and the District of Columbia to dispense to and provide nursing support to administer mAbs to nursing home and assisted living facility residents. The other was to directly allocate mAbs to long-term care pharmacies for ready deployment when COVID-19 cases occur in the nursing homes and assisted living communities served by each pharmacy. Although mAbs require a prescriber’s order, there is no cost for the product to patients.
Johnson Abraham, PharmD, BCGP, director of clinical services at Forum Extended Care Pharmacy in Illinois, said, “The mAbs can only be administered in settings where health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system, as necessary.” At the same time, mAbs have specific conditions of use. They require infusion, plus one hour of monitoring after the infusion for possible adverse reactions.
“Nurses are needed to administer an [intravenous] product to utilize mAbs,” said Dr. Abraham. In most states, this means a registered nurse; however, some states allow a licensed practical nurse with training to perform this activity. The monitoring during and after infusion does not need to be performed by a nurse; non-nurse staff need to be trained to identify the signs and symptoms of an adverse medication reaction. However, Dr. Nelson said, “We need to figure out a way to do this when we have staffing shortages.” To overcome this challenge, Dr. Abraham said, some facilities designate a staff member to check vitals every 15 minutes.
Use of mAbs requires a little preparatory work with the patient or his/her activated power of attorney. As Dr. Abraham explained, “Before administration, they have to be informed that this treatment doesn’t have formal FDA approval and just EUA based on limited data.”
The key is to get mAbs started as quickly as possible before the virus progresses in the patient. Dr. Abraham said, “The longer you wait, the more likely the patient will need oxygen therapy if they’re not on it, or if they are on it currently, they will need more. At the same time, the longer you wait to begin treatment, the more likely it is that symptoms will worsen.”
There is no question that mAbs use, as effective as it seems to be for the post-acute and long-term care patient population, isn’t without challenges. This is especially true during a time when facilities may be short staffed, every team member is overburdened, and few have the skills or ability to administer the drugs intravenously. Dr. Nelson had a few ideas to address this. He suggested bringing a nurse from the hospital to handle the administration or partnering with a local hospice to have their nurses assist with the procedure. Both options were shot down by legal counsel as too risky, he recalled. “Once again, legal and regulatory red tape interfered with our ability to get our patients the right medications at the right time,” he said.
AMDA and ASCP Collaborate on Readiness Document
AMDA – The Society for Post-Acute and Long-Term Care Medicine and ASCP recently collaborated on a readiness document that outlines the steps for long-term care pharmacies to acquire the treatments and provide them to capable providers as well as the eligibility, administration, and monitoring requirements for facility medical and nursing staffs.
Among the contents of this document:
Medicare Monoclonal Antibody COVID-19 Infusion Program instruction
Fact sheets on EUAs related to mAbs
COVID-19 Outpatient Monoclonal Antibody Infusion Orders
Fact sheets for patients, parents, and caregivers about mAbs
“We were pleased to work with AMDA on this. It really is a matter of awareness. We need to get the word out,” said Dr. Worz. “Once they get over the hump of understanding how to use this treatment, facility leaders become more comfortable with it, and it’s being ordered more and more.”
Moving Forward: Lesson Learned
So far, mAbs do not seem to be subject to the same hesitancy and questions that plague the COVID-19 vaccine. “We haven’t gotten feedback regarding any questions or concerns on the part of patients or families,“ said Dr. Worz. He suggested that there may be some confusion about the relationship between antibody treatment and the vaccine. However, there is a simple answer to this. A patient can’t receive the vaccine for 90 days after they are treated with mAbs. “We just have to educate everyone about this,” he said. It also may be helpful to explain to patients and families that vaccines provide active immunity by triggering a natural immune response whereas antibody treatments give the body the antibodies it needs to protect itself from an active virus.
Dr. Nelson said, “We need to figure out a way to use this when we have staffing shortages. Hopefully, the vaccine will keep staff healthy if there is a new outbreak in three months, so this won’t be an issue. But we need to prepare for various scenarios.” He added, “We also need to continue to work on breaking down barriers between settings to maximize win-win situations regarding COVID-19 treatment and prevention.”
Senior contributing writer Joanne Kaldy is a freelance writer in Harrisburg, PA.