From Mount Sinai Medical Center, Miami Beach, FL.
Abstract
Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards.
Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients. We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards. Key components of our implementation process were multidisciplinary planning involving decision makers and stakeholders; setting realistic goals in the process; team communication; and measuring and reporting quality improvement on a regular basis.
Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021. Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred. There has been no concern from staff regarding infection during the process. Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion. Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program.
Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner.
Keywords: COVID-19; monoclonal antibody; infusion; emergency use authorization.
SARS-CoV-2 and the disease it causes, COVID-19, have transformed from scientific vernacular to common household terms. It began with a cluster of pneumonia cases of unknown etiology in December 2019 in Wuhan, China, with physicians there reporting a novel coronavirus strain (2019-nCoV), now referred to as SARS-CoV-2. Rapid spread of this virus resulted in the World Health Organization (WHO) declaring an international public health emergency. Since this time, the virus has evolved into a worldwide pandemic. COVID-19 has dramatically impacted our society, resulting in more than 2.63 million global deaths as of this writing, of which more than 527,000 deaths have occurred in the United States.1 This novel virus has resulted in a flurry of literature, research, therapies, and collaboration across multiple disciplines in an effort to prevent, treat, and mitigate cases and complications of this disease.