COVID-19 vaccine development and administration have been a central focus in response to the pandemic. And rightly so.
The three vaccine products currently out in the market are highly effective and help prevent disease spread as well as patient hospitalizations and deaths.
While the COVID-19 vaccines have deservedly been in the limelight, healthcare providers are also looking at promising therapeutics that may be effective in reducing virus transmission or decreasing severity of symptoms.
Here we’ll explore one such treatment that’s seeing strong results to date – monoclonal antibody therapy – and how one health system is leading the way in its adoption and administration.
Monoclonal antibodies (mAbs) are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses – and in this case, COVID-19.
Each therapeutic is administered as a single infusion for high-risk patients with mild to moderate COVID-19, with these experimental drugs blocking the virus’ attachment and entry into human cells.
Currently, the following mAbs treatments are available under emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA):
- A combination of bamlanivimab and etesevimab, administered simultaneously, manufactured by Eli Lilly & Co. (Per a recent update from The Assistant Secretary for Preparedness and Response (ASPR) and the FDA, bamlanivimab is no longer being distributed alone due to COVID-19 variant resistance).
- A combination of casirivimab and imdevimab, administered simultaneously, manufactured by Regeneron.
Overall, new and emerging data is pointing to mAbs therapy as an effective tool in our arsenal to fight COVID-19, showing a 70 percent reduction in both hospitalizations and deaths for patients receiving these treatments. EUA approval for additional mAb therapeutics is also expected.
Since November 2020, more than 900,000 mAbs courses have been distributed through Operation Warp Speed to more than 5,000 locations across the U.S. – including to Baptist Health South Florida.
Baptist Health South Florida is a leader in the delivery of COVID-19 therapeutics.
Early in the pandemic, Premier member Baptist Health South Florida (BHSF) recognized the importance of mAbs therapies to provide patients with the highest-quality care and ease potential strains on the health system.
BHSF primarily serves the Miami area across 11 hospitals and with 1.5 million patient visits annually. Overall, this region has been hard hit by the pandemic and has seen more than 450,000 total cases as of April 7, 2021.
With COVID-19 cases on the rise in the spring of 2020, BHSF was able to operationalize mAbs infusion efforts in just four days. The health system has since successfully treated thousands of patients with mAbs.
Below are the key takeaways and best practices that enabled its success in mAbs rollout and administration.
1. Pharmacy at the Center
BHSF’s internal reporting structure enabled the health system to thoughtfully, and quickly, operationalize its mAbs infusions strategy:
- The pharmacy leader reports directly to the chief clinical officer, allowing for pharmacy’s holistic system-wide view as well as the ability to move and flex quickly.
- Infectious disease pharmacists are vital to the BHSF team, providing specialized expertise and coordinating infusion strategy from the corporate perspective.
- A multidisciplinary team led by pharmacy – including clinicians, emergency department (ED) and urgent care center leaders, and C-suite representation – meet regularly to discuss mAbs efforts as well as roadblocks and areas of promise.
- Pharmacy’s partnership with case management as well as call center staff who centralize mAbs infusions scheduling is also key. mAbs treatment must be given soon after a person has tested positive (ideally 48-72 hours upon symptom onset), and the team’s collaboration allows for an expeditious transition from diagnosis to treatment.
“With new data on both COVID-19 therapeutics and disease variants released almost daily, it takes a strong, aligned and cross-functional team to overcome challenges and provide the highest-quality care for patients,” said Madeline Camejo, Pharm.D., BHSF chief pharmacy officer and vice president of pharmacy services.
2. Space and Staffing
mAbs appointments typically last three to four hours per patient, and because COVID-19 patients are highly contagious, they must be separated from other patients in acute care and outpatient settings.
BHSF was able to do so by taking advantage of its outpatient infusion centers and coordination between infusion and hospital staff:
- Prior to the pandemic’s onset, the BHSF pharmacy team led the organization’s strategic plan on outpatient infusion centers, and they were able to quickly pivot to use these centers to accept COVID-19-positive patients requiring infusions from ED or inpatient settings.
- For example, one of the health system’s offsite infusion campuses instituted “COVID-19 Days,” wholly dedicating the facility to mAbs treatments twice per week with top-to-bottom disinfecting in between. Another offsite infusion campus was operational for just one month prior to COVID-19, and with increasing disease spread in the community, the decision was made to dedicate this facility to mAbs infusions exclusively.
- BHSF’s outpatient mAbs infusion center is staffed with a lean team of nurses, pharmacists and support staff who treat up to 10 patients a day.
- Advance nurses in the ED and urgent care settings coordinate with call center and infusion center staff to identify mAbs-eligible persons early on, enabling greater and speedier access for patients.
3. A Focus on Patient Experience and Education
As of April 7, across the U.S. overall reported mAbs utilization is still low at 395,000 courses or 41 percent of total courses distributed, according to the U.S. Department of Health and Human Services (HHS). This is due, in part, to a lack of awareness among both patients and providers that these treatments are available.
For some patients, mAbs hesitancy is also a concern, or logistical problems, including transportation to infusion centers for those with active COVID-19, get in the way.
From the beginning of the pandemic and as new COVID-19 therapeutics come online, BHSF’s pharmacy team and infectious disease experts have worked tirelessly to vet treatment information and educate both frontline providers and patient populations on mAbs availability and effectiveness. The health system also conducts ongoing quality assurance audits on these treatments and related patient experience.
In addition to BHSF’s efforts, mAbs education is a key focus of HHS, including a public education campaign and locator on healthcare providers carrying product. The Biden administration also recently announced an investment of $150 million to expand mAbs treatment access to underserved communities across the country.
As mass vaccination efforts continue, monoclonal antibody therapies are giving patients and providers a way to get ahead of COVID-19 and help manage strain on hospital intensive care services.
“I couldn’t be prouder of the BHSF pharmacy team – and all pharmacy leaders and staff across the country – who have stepped up in this once-in-a-lifetime pandemic,” said Camejo. “To utilize these treatments for our high-risk patients, and then seeing them recover and thrive, those moments bring an overwhelming sense of pride for BHSF and our team.”
And Premier is proud of our member health systems across the nation who are working to expand mAbs access for patients in their communities. The work of BHSF and all Premier members in administering mAbs is contributing to improved patient outcomes across the U.S.
As we move forward, Premier will continue to support the uptake of effective COVID-19 therapeutics – through advocacy, convening our members to share data and best practices, and facilitating vital information exchange between members and various federal agencies.
Learn more about our response to COVID-19.
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