Medication Administration. One nurse is dedicated to administering the monoclonal therapies scheduled at 8 am and 12 pm and another at 4 pm and 8 pm. Each appointment block is 4 hours in duration to allow adequate time for patient registration, infusion, and postinfusion observation. The nurse administers the premedications and COVID-19 monoclonal therapy, and observes the patient for the required 1-hour postadministration observation period. Nursing orders detailing monitoring parameters for mild, moderate, and severe reactions, along with associated medication orders to administer in the event they occur, are detailed in the nursing orders of the COVID-19 Monoclonal Antibody Order Set (Figure 3). Prior to administration, the nurse scans each medication and the patient’s wrist identification band, and documents the time of administration within the EHR medication administration report.
Pharmacy Department
Medication Receipt Process. Inventory is currently allocated biweekly from the state department of health and will soon be transitioning to a direct order system. The pharmacy technician in charge of deliveries notifies the pharmacy Antimicrobial Stewardship Program (ASP) clinical coordinator upon receipt of the monoclonal therapies. Bamlanivimab is supplied as 1 vial per dose, whereas casirivimab/imdevimab is supplied as 4 vials or 8 vials per dose, depending how it is shipped. To reduce the likelihood of medication errors, the ASP clinical coordinator assembles each of the casirivimab/imdevimab vials into kits, where 1 kit equals 1 dose. Labels are then affixed to each kit indicating the medication name, number of vials which equal a full dose, and pharmacist signature. The kits are stored in a dedicated refrigerator, and inventory logs are affixed to the outside of the refrigerator and updated daily. This inventory is also communicated daily to ED physician, nursing, and pharmacy leadership, as well as the director of patient safety, who reports weekly usage to the state Department of Health and Human Services. These weekly reports are used to determine allocation amounts.
Medication Verification and Delivery. The Mount Sinai Medical Center pharmacist staffing model consists of centralized order entry and specialized, decentralized positions. All orders are verified by the ED pharmacist when scheduled (not a 24/7 service) and by the designated pharmacist for all other times. At the time of medication verification, the pharmacist documents patient-specific EUA criteria for use and confirms that consent was obtained and the Fact Sheet for Patients/Caregivers was provided. A pharmacist intervention was developed to assist with this documentation. Pharmacists input smart text “.COVIDmonoclonal” and a drop-down menu of EUA criteria for use appears. The pharmacist reviews the patient care notes and medication order question responses to ascertain this information, contacting the ED prescriber if further clarification is required. This verification serves as another check to ensure processes put in place are followed. Lastly, intravenous preparation and delivery are electronically recorded in the EHR, and the medications require nursing signature at the time of delivery to ensure a formal chain of custody.
Risk Management
At Mount Sinai Medical Center, all EUA and investigational therapies require patient consent. Consistent with this requirement, a COVID-19 monoclonal specific consent was developed by risk management. This is provided to every patient receiving a COVID-19 monoclonal infusion, in addition to the FDA EUA Fact Sheet for Patients and Caregivers, and documented as part of their EHR. The questions providers must answer are built into the order set to ensure this process is followed and these patient safety checks are incorporated into the workflow.
Billing and Finance Department
In alignment with Mount Sinai Medical Center’s mission to provide high-quality health care to its diverse community through teaching, research, charity care, and financial responsibility, it was determined that this therapy would be provided to all patients regardless of insurance type, including those who are uninsured. The billing and finance department was consulted prior to this service being offered, to provide patients with accurate and pertinent information. The billing and finance department provided guidance on how to document patient encounters at time of registration to facilitate appropriate billing. At this time, the medication is free of charge, but nonmedication-related ED fees apply. This is explained to patients so there is a clear understanding prior to booking their appointment.