Evaluating the effects of a global pandemic on the operation of an investigational drug service.

PURPOSE: This study is an analysis of the changes to workload and operations of UNC Health's investigational drug service (IDS) brought about by the coronavirus disease 2019 (COVID-19) pandemic. METHODS: Workload statistics were collected and analyzed for trend changes to illustrate operational changes necessitated by the COVID-19 pandemic within the IDS pharmacy at UNC Health. RESULTS: Multiple workload metrics declined at the beginning of the COVID-19 pandemic, followed by an increase in the metrics for many categories as the pandemic continued. Notably, monthly inventory added initially decreased by 37.5%, later leveling off but showing increased variability. Fills dispensed and monitoring visits both decreased by 34.5% from the first quarter (Q1) to Q2 of 2020. Both metrics returned to or slightly exceeded prepandemic levels by the end of the study period in March 2021. Patient enrollment decreased 76% from February to May 2020 before dramatically increasing in Q3 of 2020 and Q1 of 2021 with the initiation of COVID-19 vaccine studies. The average time to study startup increased for trials not related to COVID-19 and decreased for COVID-19-related trials. There has been no major impact on the number of open protocols throughout the course of the pandemic. CONCLUSION: Despite initial decreases in workload following the start of the COVID-19 pandemic, IDS operations returned to and, in some cases, exceeded prepandemic levels.

Identifying health-system pharmacy operational process categories and corresponding tasks across a diverse health system using a modified Delphi process.

PURPOSE: The purpose of this study was to identify and build consensus on operational tasks that occur within a health-system pharmacy. METHODS: An expert panel of 8 individuals was invited to participate in a 3-round modified Delphi process. In the first round, the expert panel independently reviewed an initial list and provided feedback. All feedback was incorporated into the second round and then reviewed and discussed as a group. The expert panel reviewed an updated list based on feedback from the second round and reached consensus on a final list of operational processes and corresponding tasks. RESULTS: All 8 participants agreed to serve on the Delphi expert panel and reviewed an initial list of 9 process categories (hazardous intravenous [IV] medications, nonhazardous IV medications, hazardous oral medications, nonhazardous oral medications, controlled substances, total parenteral nutrition [TPN]/fluid preparations, distribution and delivery, clinical tasks, and miscellaneous operational tasks) and 44 corresponding tasks. Through the Delphi process, 72 new tasks were identified in the first round, while 34 new tasks were identified in the second round. In the third and final round, the expert panel reviewed the updated list of 9 process categories and 150 corresponding tasks, made additional edits, and reached consensus on a final list of 9 processes and 138 corresponding tasks that represented operational work within a health-system pharmacy. CONCLUSION: The modified Delphi process effectively identified operational processes and corresponding tasks occurring within hospital pharmacies in a diverse health system. This process facilitated consensus building, and the findings may inform development of an operational workload model.

ASHP national survey of pharmacy practice in hospital settings: Impact of COVID-19 pandemic on pharmacy operations-2020.

PURPOSE: Results of the 2020 ASHP national survey of pharmacy practice in hospital settings pertaining to pharmacy operational changes implemented in response to the coronavirus disease 2019 (COVID-19) pandemic are presented. METHODS: Pharmacy directors at 1,437 general and children's medical/surgical hospitals in the United States were surveyed using a mixed-mode method of contact by email and mail. Survey completion was online. RESULTS: The response rate was 18.7%. Seventy-three percent of hospitals implemented changes to hospital units, including 46% that increased intensive care unit bed capacity; 94% made changes to pharmacy supply chain acquisition, changes to products, and/or increased inventory. Staffing changes were implemented by 69% of hospitals, with the most common being staffing reductions (55%) and salary reductions (16%). Medication-use changes were implemented by 86% of hospitals, with treatment guidelines for COVID-19 treatment (79%) and opening compassionate use or investigational drug studies (55%) being the most common. Changes in sterile compounding processes were implemented by 84% of hospitals. Personal protective equipment (PPE) shortages led to 71% of hospitals modifying PPE use standards in sterile compounding. Eighty-seven percent of hospitals changed operational activities, such as changing medication return practices (56%), medication reconciliation processes (46%), intravenous medication recycling (38%), and discharge counseling (37%). Hospitals experienced shortages of many medications, including albuterol inhalers (60%), sedatives and anesthetic agents (58%), neuromuscular blockers (43%), corticosteroids (34%), cardiovascular agents (24%), investigational agents (24%), and dialysis solutions (6%). CONCLUSION: The pharmacy profession responded to myriad threats to operations and patient care during the COVID-19 pandemic in 2020.

Strategies used to meet the challenges of mass COVID-19 vaccination by the pharmacy department in a large academic medical center.

PURPOSE: Highly effective coronavirus disease 2019 (COVID-19) vaccines have brought hope for ending the pandemic. Unprecedented mass vaccination started first among healthcare workers. The aim of this report is to describe key strategies undertaken by a large hospital pharmacy department to meet the challenges of preparing a large quantity of COVID-19 vaccine doses in a short period of time. SUMMARY: MedStar Washington Hospital Center (MWHC) was in the first group of hospitals in Washington, DC, to receive Pfizer-BioNTech vaccine in December 2020. The pharmacy department faced challenges including stringent vaccine storage requirements, a need for specific equipment and workflow, limited funding, and staffing constraints. The pharmacy department's senior leaders defined pharmacy responsibilities, budgeted for equipment, participated in vaccination center design, and instructed pharmacy informatics personnel. The vaccine coordinators were appointed to oversee all vaccination-related operations. An ultra-low temperature freezer was installed 2 weeks before arrival of the first shipment of vaccine. All pharmacy order entry tools and operating procedures were standardized, and staff training and schedules were finalized by December 15. The first dose of the vaccine was administered on December 16 at the vaccination center. Pharmacy staff members dispensed the vaccine doses and monitored patients. By January 6, 2021, MWHC had vaccinated 3,812 employees with their first vaccine dose, with an average of 228 doses administered daily. CONCLUSION: Key strategies such as systemic coordination, early preparation, detailed planning, operating procedure development, and staff education and engagement proved successful in facilitating preparation of thousands of COVID-19 vaccine doses for hospital employees within a short period of time.

Insights on developing a field hospital formulary and medication distribution process in preparation for a second surge of COVID-19 cases.

PURPOSE: The coronavirus disease 2019 (COVID-19) pandemic has caused health systems across the country to plan for field hospitals to care for patients outside of traditional healthcare settings in the event of a second surge. Here we describe key considerations for the implementation of pharmacy operations and a field hospital formulary at an offsite location within a 2-week time frame. SUMMARY: Development of an offsite field hospital formulary is first dependent on the location and patient population defined for the field hospital. Creation of a limited formulary for a planned field hospital in Michigan involved reviewing physical space limitations and drug distribution workflows, assessing current prescribing trends, creating drug categories, and creating formulary guidelines to limit formulary options in each therapeutic category. Ultimately, our institution developed a 140-medication field hospital formulary, a process to enable appropriate use of nonformulary drugs, and a mixed operations model including automated dispensing cabinets and a manual cart-fill process. Although the institution did not have to open the field hospital, the process used for developing the formulary and determining distribution models will allow for an immediate implementation if a second surge occurs. CONCLUSION: A methodical approach to developing limited formularies and pharmacy operations in a field hospital setting will allow health systems to establish efficient and effective medication distribution services in the event of a second surge of COVID-19 cases.