EMS and monoclonal antibodies

The FDA issued an Emergency Use Authorization (EUA) that permits the administration of co-formulated REGEN-COV and REGEN-COV supplied as individual vials of casirivimab and indevimab, which are administered together. These substances are monoclonal antibodies which are given to neutralize the COVID-19 virus and prevent the progression of SARS-CoV-2 to more serious forms of disease. Monoclonal antibodies are manmade antibodies. Human genes that produce antibodies are placed in mice or other mammals. The animal is given the antigen that makes the desired human antibody. The immune cells of the animal produce the desired human antibody. Monoclonal means the antibody is synthesized from cloned immune cells. These monoclonal antibodies attach to one type of antigen. The use of these agents will hopefully decrease hospitalizations and prevent death. EMS personnel are already involved in performing COVID testing and administering vaccines. EMS providers may be asked to administer these agents. 

Legal concerns 

There are some legal issues to consider. Since the administration of REGEN-COV is permitted under an EUA, those involved need to know when the EUA expires. Some states provide blanket authorization permitting the administration of REGEN-COV by EMS personnel, while others require specific health care provider authorization. Written protocols, training, continuing education, and quality assurance are mandated in other states. The FDA has issued a template protocol for EMS. Find it here. This seven page document provides significant food for thought. We’ll touch on a few items, but prior to implementation, review with local legal counsel, medical direction, local health care systems, and state/local public health agencies is crucial. 

Uses 

COVID positive people who weigh at least forty kilograms and are 12 years of age or older at high risk for progressing to severe symptoms or death are eligible. These are COVID positive people with mild to moderate symptoms, not requiring hospitalization for COVID and not needing oxygen or not needing to increase home oxygen. REGEN-COV is also used for post-exposure prophylaxis. It is not a substitute for vaccination, cannot be used for pre-exposure prophylaxis, and must not be used on patients who are hospitalized due to COVID-19, need to receive oxygen due to COVID-19, or require more baseline oxygen secondary to COVID. There are significant clinical considerations, beyond the scope of this article, that must be addressed. 

Logistics 

The template describes an equipment and labor intensive process. Although the template defers to local medical direction and individual medical judgment, the reasoning behind any variation from the template should be well-documented. The template basic equipment list contains three items under personal protective equipment, 14 items under infusion supplies, three under injection supplies, and under general supplies 13 items including a “locking refrigerator with temperature monitoring capability”. 

Casirivimab and imdevimab contain no preservatives. They must be stored in a refrigerator at 36°F to 46°F. They can’t be frozen, shaken, or exposed to direct light or heat. The medication may be administered either by intravenous infusion or four subcutaneous injections. Each administration route requires a time consuming process. The medication must be warmed to proper temperature (approximately 30 minute for an IV infusion and about 20 minutes for subQ injection) and prepared prior to administration. Vital signs should be taken prior to administration. The IV infusion takes 21 minutes. The subQ injections are administered consecutively. In both procedures, patients should be monitored directly for two to three  minutes for any signs of hypersensitivity or allergic reactions. Patients should have their vitals assessed for 60 minutes after completion of the infusion or injections. Hypersensitivity or allergic reactions should be addressed in compliance with local protocols, including activation of the transporting EMS agency. 

Summary 

The role of EMS in healthcare is expanding into areas that potentially enhance the scope of practice. It is critical to determine that the enhancement is legal. Those who implement the activity must be properly trained and monitored. The assessment of the impact of the new activity on the ability to complete the primary mission must be considered. Will using personnel in novel activities decrease the ability to staff ambulances?

References

• EMS Administration of Monoclonal Antibodies” Journal of Emergency Medical Services, August, 2021  
• COVID-19 and the Administration of Monoclonal Antibodies and Antiviral Agents”, Ohio Department of Public Safety, August 27, 2021  
• Erich J, COVID-19: The Battle Continues, EMS World, November, 2021 
• Zabriskie JB, Essential Clinical Immunology, Cambridge, New York: Cambridge University Press; 2009. 

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