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headshot of Ashley Marx, PharmD
Ashley Marx, PharmD
Lindsay Daniels, PharmD, MPH

Carolina Antimicrobial Stewardship Program (CASP) is carrying out intensive stewardship in the realm of COVID-19. The work is a natural extension of its mission to improve the use of antimicrobials (which include antibiotics, antivirals, antifungals, and antiparasitics). In addition to CASP’s daily stewardship to ensure patients receive antimicrobials only when needed, with the right drug, right dose, and right duration, team members are overseeing a painstaking process of making a new treatment available to hospitalized COVID-19 patients.

In May 2020, UNC Medical Center (UNCMC) was among the first hospitals to receive a batch of the first proven treatment for COVID-19 via the North Carolina Department of Health and Human Services (NCDHHS). Remdesivir is a broad-spectrum antiviral created through a partnership between UNC epidemiologist Ralph Baric’s Lab at the University of North Carolina at Chapel Hill and Gilead Sciences. It shortens the average duration of COVID-19 symptoms by four days and shows a trend for decreased mortality.

Remdesivir is not yet approved by the Food and Drug Administration (FDA) but has been available to patients since May under an Emergency Use Authorization (EUA). During an emergency such as the COVID-19 pandemic, an EUA makes treatments available prior to FDA approval b­­­ased on limited but promising scientific evidence ­­when there are no better alternatives available. The UNC Health Anti-Infective Subcommittee developed clinical guidance for physicians to help guide decisions about which patients are most likely to benefit from remdesivir, in accordance with strict EUA and NC DHHS rules.

CASP’s antimicrobial stewardship pharmacists Lindsay Daniels, PharmD, MPH and Ashley Marx, PharmD manage remdesivir approvals, distribution, and tracking across all UNC Health system’s hospitals statewide in collaboration with members of UNC Health’s Departments of Pharmacy. Together with CASP physicians, they review each request for the drug in detail and determine if the patient meets the stringent EUA guidelines. If so, Daniels and Marx communicate the approval to the patient care team and to the service pharmacist who enters and verifies the drug order.  Operational pharmacy teams prepare the drug for dispensing. Under the EUA, there are extra layers of assurances and reporting the Pharmacy Department undertakes to ensure that drugs are used appropriately, as UNCMC must provide a full accounting to NCDHHS for each dose administered.

“We all want to advocate for the patients, and each of us lends our expertise to ensure we’re taking all factors available into account to make the best treatment decisions,” Marx explained.

As the global race forges ahead to identify safe and effective therapeutics, all hope that additional treatments will soon be added to the arsenal to help Marx and colleagues do just that.

Jonathan Parr, MD, MPH, a CASP team member who also directs the Division of Infectious Diseases inpatient COVID-19 service, praised the remdesivir roll-out, saying, “This is an extremely impactful activity and requires a tremendous amount of detailed, thoughtful work. Dr. Daniels and Dr. Marx have excelled in developing and implementing a system that supports patients, their loved ones, and their care teams across the state.”