My name is Christina Rose, I'm a clinical professor at Temple University School of Pharmacy and a critical care pharmacist at Temple University Hospital in Philadelphia, Pennsylvania. Today I'll be discussing steps required to set up a pharmacy in an alternate care site, also known as an ACS. Areas I'll be focusing on in this presentation will be reviewing steps needed to be compliant with regulatory and licensing standards, creating a formulary to meet the needs of the setting, and having a pharmacy plan in place to ensure medications are available and used safely, especially during emergency situations, and maintaining safe infection control practices. Knowing the level of patient care an alternate care site is expected to provide can help with planning for the pharmacy and determining pharmacist roles and expectations. ACS level of care may range from acute or ICU care in patients that need ventilatory support and intensive care monitoring, hospital care treating moderately symptomatic patients requiring significant oxygen and needing assistance with ADLs, and non-hospital care low-level patients that are mildly symptomatic requiring low amounts of oxygen and no assistance with ADLs. The level of care will determine pharmacy staff backgrounds that are needed for non-hospital care patients, outpatient community pharmacists may be required to staff the pharmacy, but acute care and hospital care level patients may require inpatient trained hospital pharmacists as well as specialty pharmacists that have training and backgrounds in treating patients in critical care settings. Once pharmacy roles and expectations within the ACS are determined and if a pharmacy is needed on-site, licensure will need to be obtained. Determining how the ACS is licensed, such as a satellite hospital or a government-initiated facility will determine steps needed to obtain a DEA or pharmacy license. If an ACS is a satellite of a hospital or existing clinic, the DEA may grant permission to set up the pharmacy using the hospital's existing DEA license. If not, the ACS may enter into a written agreement with a neighboring hospital or file for a DEA license as an emergent request with the DEA. To obtain a State Board of Pharmacy licensure for the ACS pharmacy, there are specific licensing requirements for each state and that state's Board of Pharmacy should be contacted. Another important consideration for setting up a pharmacy in an ACS is determining an appropriate physical location for the pharmacy, and it needs to assure it meets regulatory requirements for securing drugs and having appropriate storage space, as well as space for staff to social distance. Pharmacists, medical and nursing staff should work as a team to develop a formulary to assure safe and evidence-based treatment is available while limiting the formulary to one to two drugs per drug class to keep inventory low due to limited storage space and to minimize cost. The formulary needs to be tailored to the patient population and level of acuity of patients being served. Facilities with acute care patients will require critical care pharmacotherapy made available, such as vasopressors, sedatives, paralytics, antibiotics, and anticoagulants, as well as keeping in mind that equipment will be required to safely administer these medications. A strategy that should be considered to determine what other formulary medications would be needed would be to survey feeder hospitals to determine their most common COVID-19 specific therapies being used, symptomatic treatments, as well as the most common chronic medication therapy needed to take care of their patients. This can help streamline the formulary at your alternate care site. Providing medications at an alternate care site can be complex. Oral medications can be obtained by a pharmacy distributor. Some alternate care sites may require patients to be admitted with a limited supply of their own medications in which nursing staff or patients can self-administer. Meds may be available through the strategic national stockpile. Even if IV medication therapy will be used at the alternate care site, most ACSs do not have a sterile compounding area, and IVs will need to be obtained through another source, such as through a hospital pharmacy or a contract with a compounding pharmacy. To increase patient safety and quality of care, order sets may be designed for providers that are not familiar with the formulary or ordering system at the alternate care site. Developing a process for treating common and emergent conditions, such as sepsis, hyperglycemia, pain, sleep, delirium, treatment and profession, and VTE prophylaxis can help standardize care. Strategies for managing patient emergencies is an important component of ACS planning. Roles of responders and team members should be made known ahead of time. Team members may include physicians, nursing, EMS, and pharmacist staff. Pharmacists may serve as an active member of the code team, answering drug information questions, making medication recommendations, and performing chest compressions, or may serve in a distributive role just to replenish medications being used. The level of service will depend on available trained staff. Pharmacists can also assist in making evidence-based recommendations or assuring medications are available for the treatment of other emergent situations in order to stabilize patients until they can be transported out of the facility. When planning for a pharmacy, all aspects of the medication use system should be examined to ensure safe use of medications. From procurement and limiting the formulary, if patient-supplied medications are used in the ACS facility, putting processes in place so pharmacists can identify and verify that these medications are labeled accurately for safe and secure storage of medications, automated dispensing cabinets, if available, would be ideal. Locked medication carts with patient-specific drawers that have clear labels on them can also be used to safely store patient-specific medications. If electronic medical record is available, that would be the ideal situation to limit prescribing error. Order sets can be used to standardize medication orders either in an electronic medical record system or if paper orders are available. Limiting or limiting verbal orders is always good practice to minimize prescribing error as well. If resources are available for barcoding medication administration and smart IV pumps, these technologies should be implemented for safest medication administration. If these technologies are not available, nursing competencies should be developed for IV infusion calculations as well as policies should be put in place to assure that nursing independent double checks are conducted on high alert medications or any medications that are taken out of a stock medication cart to be administered by nursing. Medication error reporting system and incident report process should also be put in place and frequently reviewed so systems can be changed to limit medication errors. Staff training on electronic medical record, any IV pumps, policies, procedures, as well as assuring that staff have access to drug information and knowing where medications should be safely disposed of can also improve staff and patient safety. Patient control precautions are critical for an ACS caring for COVID-19 patients. Any staff member that will have direct patient contact including pharmacy staff should be trained on safe donning doffing procedures of PPE. Designating one pharmacy staff member each shift to have patient exposure can limit the pharmacy staff to infected patients. This can also help to limit PPE use which is critical for all hospitals as well as alternate care sites. Other ways pharmacy can limit PPE use is to create a drop off zone for medications as well as limit medication deliveries throughout the day to specific times. Clear processes for communication procedures with the pharmacy staff should be made with the providers and nursing staff so drug information questions and medication problems could be rectified as much as possible through a phone or radio. Determining a procedure for handling contaminated medications is also something that should be determined ahead of time. Dispensing a 24-hour supply of medications could help limit waste and medications that have to be returned to the pharmacy stock. Any leftover medications from patients that are discharged can be quarantined for 72 hours and then returned to pharmacy stock safely. Wasting of any contaminated medications is a potential option but due to all the recent shortages this would not be optimal. In summary, the four most important points to consider when establishing a pharmacy in an alternate care site would be to determine licensing requirements for your specific facility, identifying a physical site for the pharmacy to ensure that there's adequate storage and security of medications as well as ability for staff to social distance, and identify education and background requirements for the pharmacy staff that's needed. Be able to develop a formulary that meets the needs of the patients in the facility, coming up with an adequate medication procurement plan, to come up with a formulary by surveying feeder hospitals to determine the most commonly used medication therapies for COVID-19 patients, and streamline the formulary by utilizing only one to two drugs per class. And always assuring that there's adequate drug therapy available to treat patients that have medical emergencies. And lastly, develop policies and procedures ahead of time to ensure there are safe processes in place for medication use and infection control practices to keep staff as well as patients safe. Thank you.

alternate care site

pharmacy plan

medication safety

patient care

licensing standards