key: cord-1025725-5vjf9xkt authors: Do, Tina; Luon, Steph; Boothe, Kimberly; Stutsky, Martha; Renauer, Marie title: Advancing ambulatory pharmacy practice through a crisis: Objectives and strategies used in an ambulatory care action team’s response to the COVID-19 pandemic date: 2021-01-23 journal: Am J Health Syst Pharm DOI: 10.1093/ajhp/zxab014 sha: cfa3ff2f336217ef5ac12e233c1153a5fb434811 doc_id: 1025725 cord_uid: 5vjf9xkt DISCLAIMER: In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The objectives and strategies used by an ambulatory care pharmacy team operating within a large health system’s pharmacy incident command structure during the initial response to the coronavirus disease 2019 (COVID-19) pandemic are discussed. SUMMARY: In a time of crisis, a pharmacy “ambulatory action team” was formed to provide ambulatory clinical pharmacy expertise and meet an immediate and ongoing need to limit nonemergent care during the COVID-19 pandemic. By building a strong communication infrastructure and partnership with ambulatory care providers, clinic medical and operational leaderships, clinical laboratory staff, and infusion centers, the team was able to swiftly execute solutions and respond to new issues and requests. Ambulatory care pharmacy practice continued to advance through provision of services to vulnerable patient populations with chronic conditions that were anticipated to experience gaps in care management during the COVID-19 pandemic. These efforts resulted in expansion of pharmacists’ involvement in collaborative drug therapy management, support of patients’ transition from in-clinic injection to home self-administration, provision of medication assistance support, and management of 1,300 patients via protocol-based warfarin management. Additionally, ambulatory pharmacy services in 15 primary care, anticoagulation, and specialty clinic sites were transitioned to telehealth. The ambulatory action team also implemented several strategies to manage medication therapy associated with COVID-19–related shortages and implemented electronic decision support to guide prescribing of hydroxychloroquine and azithromycin. CONCLUSION: Building a strong communication infrastructure and a pharmacy ambulatory action team were essential to respond to a crisis and continue ambulatory clinical pharmacy services expansion. M a n u s c r i p t Prior to the COVID-19 pandemic, the YNHHS pharmacy department was implementing strategic expansion plans that aligned with American Society of Health-System Pharmacists (ASHP) Practice Advancement Initiative 2030 goals to ensure patients have access to a pharmacist in all care settings. 1 One of these strategies was to integrate and advance ambulatory clinical pharmacy services across the health system. At the onset of the pandemic, the pharmacy department's strategic plan projects were temporarily halted to respond to the immediate need to limit nonemergent care and create surge capacity for patients with COVID-19. In response, YNHHS initiated a hospital incident command structure (HICS) for system oversight of system incident management (SIM). A pharmacy incident command structure (PICS) was deployed to integrate with the HICS and create an infrastructure to manage long-term emergency response demanded by the pandemic. The PICS included a commander, domain chiefs, and action teams. Action teams were diverse and functional workgroups formed to execute identified objectives and strategies during the pharmacy department and health-system emergency response. A c c e p t e d M a n u s c r i p t An "ambulatory action team" was formed. The team comprised a team lead, alternate lead, and membership across the system pharmacy enterprise, including adult, pediatric, and oncology ambulatory clinical pharmacy services, specialty pharmacy services, and retail pharmacy services. The lead and alternate lead of the pharmacy ambulatory action team also participated in the SIM ambulatory action team. To plan for our response, each PICS action team, including the ambulatory action team, completed comprehensive planning facilitated by the ASHP COVID-19 Pandemic Assessment Tool for Health-System Pharmacy Departments 2 and scenario planning exercises with incident action plans. The main scenario for ambulatory care was that vulnerable populations with chronic conditions would experience gaps in care management. 3 Objectives and strategies developed from the action team planning were added to a standardized project plan template (Figure 1 ), which facilitated execution of strategies and reporting to the PICS on progress and barriers. Newly indentified ambulatory patient care or medication concerns conveyed from the SIM system or front-line pharmacy practitioners were discussed at daily PICS meetings in order to develop collaborative strategies and response timelines and assign an action team to execute them. A timeline for the COVID-19 response can be seen in Figure 2 . Though the pandemic initially stopped ambulatory pharmacy strategic expansion plans, the integration of pharmacy practice with the SIM system highlighted the pivotal role pharmacy has in emergency response and ambulatory patient care. This approach allowed for ambulatory pharmacy practice at YNHHS to continue to advance and for expansion of services to vulnerable populations. In response to the COVID19 pandemic, the ambulatory Another objective of the ambulatory action team was to ensure ambulatory pharmacy services supported outpatient care as providers and nurses were redeployed to inpatient care areas in response to increased surge capacity. Prioritization was given to supporting areas with established ambulatory pharmacy services, where existing relationships and infrastructure facilitated operationalizing new virtual workflows. Thus, support was provided within 1 to 2 weeks for requests that aligned with current ambulatory pharmacy services offered, such as diabetes, hypertension, anticoagulation, and outpatient parenteral antibiotic therapy management. However, new patient population or service additions, such as postpartum women and hypertension management, were only planned during the initial acceleration phase of the pandemic, but program implementation did not occur until a recovery phase, when sufficient pharmacist resources were available. Strategies implemented by the ambulatory action team to maintain patient access included expansion A c c e p t e d M a n u s c r i p t of chronic disease state management and anticoagulation services through use of telehealth. As a result, the total number of pharmacist visits increased from approximately 1,000 visits per month to more than double that figure by July 2020 (Figure 3 ). Transitioning patient appointments to telehealth (telephone or video visits) became a priority during the initial pandemic response to ensure compliance with the Centers for Disease Control and Prevention's guidance for social distancing, quarantine, and isolation. 4, 5 With the need for rapid video visit training, one of the ambulatory clinical pharmacists with experience conducting video visits trained clinic staff and led a virtual training for 17 ambulatory clinical pharmacists. Within a week all patients were converted to telehealth visits. Pharmacist telehealth visits were used to provide injection training and patient counseling for self-administration of biologic therapies for 27 patients in the pulmonary clinic. Partnering with our health system specialty pharmacy ensured efficiency in safe patient transitions and medication assistance program copayment support from external, manufacturer-sponsored programs or grants from disease state-focused organizations for patients with financial need. For medications not available through our pharmacy, use of 340B Drug Pricing Program-contracted pharmacies was advised. In collaboration with the pharmacy and medical leaderships, consensus guidance was developed to provide for consideration of patient self-administration of medications that did not have labeled indications for home self-administration (eg, omalizumab). The ambulatory clinical pharmacists also used the telehealth visits as a way to facilitate triage of patients for further care and assessment. If there were any concerns for COVID-19related symptoms, patients were triaged to the responsible provider and/or call center. This completed an assessment of current ambulatory clinical pharmacy services and essential laboratory tests for initiation and monitoring of medications. Guidelines outlining essential laboratory monitoring parameters and those for which testing could be delayed for patients with diabetes, hypertension, heart failure, and/or other chronic diseases were created. A final objective of the ambulatory action team was to ensure that patients retained access to critical chronic medications during the pandemic and that prescribers received clear guidance on drug prescribing and monitoring during this period. Disruptions in the drug supply chain, as well as emerging evidence supporting use of approved drugs for the treatment of COVID-19, led to drug shortages that would potentially impact patients receiving chronic therapy with affected drugs. The team worked to develop prescribing guidance, information technology restrictions within the computerized order entry system, and inventory management strategies to retain drug supply for the health system's patients who were receiving these medications chronically. Risk management programs for frequent monitoring of some medications were modified in response to the COVID-19 pandemic to A c c e p t e d M a n u s c r i p t reduce the need for patient laboratory visits, and it was essential to communicate these changes to prescribers. Drug Administration's release of the guidance document "Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency" provided temporary relief from selected laboratory testing requirements or days' supply limitations for drugs subject to REMS requirements. 9 To provide awareness of REMS program requirement changes, the team compiled a list of medications subject to REMS requirements prescribed within the health system, the updated requirements, and the manufacturers' letters about the updates. During a 13 month period prior to the start of the COVID-19 pandemic, 14 such medications were prescribed within the health system, with formal guidance from the drug manufacturer provided for 7 medications and a change from the usual REMS process for 6. The strategies implemented to manage COVID-19-related drug supply shortages in the outpatient setting allowed YNHHS pharmacies to continue to fill hydroxychloroquine and azithromycin prescriptions for patients chronically treated with these therapies and ensured a sustained supply in the community. Stabilization of supply also allowed YNHHS pharmacies to accept prescriptions for new-start hydroxychloroquine therapy or for patients receiving chronic hydroxychloroquine therapy who had previously filled prescriptions specifying certain approved indications at outside community pharmacies. A c c e p t e d M a n u s c r i p t The COVID-19 pandemic has presented an unprecedented crisis, which has required the YNHHS ambulatory pharmacy team to respond in a nimble manner. The unique challenges encountered have tested our ability to adapt, accelerated timelines, changed previous workflows, and led to creation of new processes. During the initial response to the pandemic, we identified that there was a need for a new communication infrastructure that spanned across all levels to allow for clear coordination and to facilitate collaboration. To ensure the success of the PICS and the ambulatory action team, they were introduced to the pharmacy staff at town halls and huddles. The ambulatory action team and pharmacy leadership also reminded staff of the correct method of escalation if there was a deviation in the process. The ambulatory action team became the hub of all ambulatory care-related issues, improvements, and opportunities by receiving and relaying new information and data related to ambulatory care. This approach allowed the team to pivot strategically to address each new or evolving issue with modified tactics or strategies in a short time frame; it also prevented any duplication of efforts in the pharmacy department. Thus, a key to the ambulatory action team's successful execution and implementation of the objectives in the action plan was to create and maintain a robust communication framework. Successful execution of the action plan also involved coordination and teamwork. Therefore, equally important was the continual fostering of a positive environment that ensured all team members were heard, involved, and engaged. Frontline pharmacists and pharmacy residents were members of the ambulatory action team and were a part of executing and implementing the action plan. Use of the diverse skill sets and clinical expertise of the entire team enabled quick execution of the action plan. The project tracker and action plan were useful tools for organizing the objectives and tactics during the initial phase of the pandemic. Towards the subsequent recovery and practice transformation phase, these tools were used to plan some of the pharmacy department's strategic initiatives. Strategies that required further resource assessment, modification of workflow, and A c c e p t e d M a n u s c r i p t maintainence, such as the anticoagulation management and postpartum hypertension management strategies, were added to the 2021 strategic plan for implementation by separate project teams. Ambulatory care pharmacy plays an essential role by providing support to the community, patients, department, and multidisciplinary team. The formation and work of the ambulatory action team was critical for the continued advancement of YNHHS' ambulatory pharmacy practice during the early weeks of the COVID-19 pandemic. The experiences gained during the COVID-19 pandemic have made the YNHHS ambulatory pharmacy team better prepared for future crises and equipped the team with new tools and skills that will remain in a transformative state. A c c e p t e d M a n u s c r i p t New recommendations for advancing pharmacy practice in health systems ASHP COVID-19 Pandemic Assessment Tool for Health-System Pharmacy Departments Coronavirus scenario planning: 12 situations hospital leaders should prepare for COVID-19): social distancing COVID-19): quarantine and isolation Twelve-month outcomes and predictors of very stable INR control in prevalent warfarin users Extended international normalized ratio testing intervals for warfarin-treated patients The authors acknowledge the members of the YNHHS COVID-19 ambulatory action team. The authors have declared no potential conflicts of interest. A c c e p t e d M a n u s c r i p t  Transition appointments to telehealth  Support anticoagulation management  Assess essential labs for ambulatory treatment initiation and A c c e p t e d M a n u s c r i p t A c c e p t e d M a n u s c r i p t MonthYear