Advancing ambulatory pharmacy practice through a crisis: Objectives and strategies used in an ambulatory care action team's response to the ...
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Note Advancing ambulatory pharmacy practice through a crisis: Objectives and strategies used in an ambulatory care action team’s response to the COVID-19 pandemic Tina Do, PharmD, MS, BCPS, Department of Pharmacy, Yale New Purpose. The objectives and strategies used by an ambulatory care Haven Hospital, New Haven, CT, USA action team operating within a large health system’s pharmacy incident Steph Luon, PharmD, BCACP, BCPS, command structure during the initial response to the coronavirus disease Department of Pharmacy, Yale New Haven Hospital, New Haven, CT, USA 2019 (COVID-19) pandemic are discussed. Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 Kimberly Boothe, PharmD, MHA, The Kimber Boothe Group, LLC, Cincinnati, Summary. In a time of crisis, a pharmacy ambulatory action team was OH, USA formed to provide ambulatory clinical pharmacy expertise and meet an im- Martha Stutsky, PharmD, BCPS, mediate and ongoing need to limit nonemergent care during the COVID-19 Department of Pharmacy, Yale New pandemic. By building a strong communication infrastructure and part- Haven Hospital, New Haven, CT, USA nership with ambulatory care providers, clinic medical and operational Marie Renauer, PharmD, MBA, leaderships, clinical laboratory staff, and infusion centers, the team was BCACP, Corporate Pharmacy Services, Yale New Haven Health, West Haven, able to swiftly execute solutions and respond to new issues and requests. CT, USA Ambulatory care pharmacy practice continued to advance through provi- sion 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 pa- tients’ transition from in-clinic injection to home self-administration, pro- vision of medication assistance support, and management of 1,300 pa- tients 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 im- plemented 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 phar- macy ambulatory action team were essential to respond to a crisis and continue ambulatory clinical pharmacy services expansion. Keywords. ambulatory care, coronavirus, COVID-19, pharmacy practice advancement, pharmacy service Am J Health-Syst Pharm. 2021;78:720-725 T he coronavirus disease 2019 (COVID-19) pandemic has tested the emergency preparedness of healthcare had 2.4 million outpatient encounters in fiscal year 2018. The largest hospital in the system, Yale New Haven Hospital, facilities and created new challenges and houses its own retail pharmacy, and all opportunities for the delivery of ambula- YNHHS hospitals are networked to an tory care, including pharmacy services. integrated specialty pharmacy. Address correspondence to Dr. Do Yale New Haven Health System (YNHHS) Prior to the COVID-19 pandemic, (tina.do@ynhh.org). is a large academic health system con- the YNHHS pharmacy department sisting of 5 hospitals (with a total of 2,563 was implementing strategic expan- © American Society of Health-System licensed beds in fiscal year 2018) and a sion plans that aligned with American Pharmacists 2021. All rights reserved. For permissions, please e-mail: journals. physician foundation of more than 130 Society of Health-System Pharmacists permissions@oup.com. community practices in Connecticut, (ASHP) Practice Advancement Ini DOI 10.1093/ajhp/zxab063 Rhode Island, and New York. YNHHS tiative 2030 goals to ensure patients 720 AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021
AMBULATORY CARE ADVANCES DURING COVID-19 Note have access to a pharmacist in all care Communication settings.1 One of these strategies was KEY POINTS One of the first objectives assigned to integrate and advance ambulatory • The formation of a pharmacy to all the YNHHS pharmacy action clinical pharmacy services across the incident command structure teams was to establish clear and ef- health system. At the onset of the pan- and ambulatory care ac- fective channels for communica- demic, the pharmacy department’s tion team facilitated a strong tion with key stakeholders across the strategic plan projects were tempor- communication infrastructure health ecosystem. The key strategies arily halted to respond to the imme- and connection with all key were to (1) identify key partners, (2) diate need to limit nonemergent care stakeholders. confirm methods of communication, and create surge capacity for patients and (3) facilitate sharing of informa- • Ambulatory pharmacy practice with COVID-19. In response, YNHHS tion. The key partners for the ambu- can advance during a time initiated a hospital incident command latory action team were identified as of crisis through identifica- Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 structure (HICS) for system oversight the ambulatory care providers, clinic tion and closure of gaps in of system incident management (SIM). medical and operational leaderships, care management for vulner- A pharmacy incident command struc- clinical laboratory staff, and infusion able populations with chronic ture (PICS) was deployed to integrate centers. The main methods of com- conditions. with the HICS and create an infrastruc- munication were reporting at SIM am- ture to manage long-term emergency • Focusing on patient access to bulatory action team meetings and response demanded by the pandemic. clinical and laboratory services, electronic communication via an SBAR The PICS included a commander, do- medication access, and drug (situation-background-assessment- main chiefs, and action teams. Action use policy management is im- recommendation) format. teams were diverse and functional portant in maintaining patient- workgroups formed to execute iden- centered care during a pan- Patient access tified objectives and strategies during demic. Another objective of the ambula- the pharmacy department and health- tory action team was to ensure ambu- system emergency response. latory pharmacy services supported An ambulatory action team was outpatient care as providers and nurses formed. The team comprised a team were redeployed to inpatient care areas lead, alternate lead, and membership patient care or medication concerns in response to increased surge capacity. across the system pharmacy enterprise, conveyed from the SIM structure or Prioritization was given to supporting including adult, pediatric, and on- front-line pharmacy practitioners were areas with established ambulatory cology ambulatory clinical pharmacy discussed at daily PICS meetings in pharmacy services, where existing rela- services, specialty pharmacy services, order to develop collaborative strat- tionships and infrastructure facilitated and retail pharmacy services. The lead egies and response timelines and as- operationalizing new virtual workflows. and alternate lead of the pharmacy am- sign an action team to execute them. Thus, support was provided within 1 to bulatory action team also participated A timeline for the COVID-19 response 2 weeks for requests that aligned with in the SIM ambulatory action team. To can be seen in Figure 2. current ambulatory pharmacy services plan for our response, each PICS action Though the pandemic initially offered, such as diabetes, hypertension, team, including the ambulatory action stopped ambulatory pharmacy strategic anticoagulation, and outpatient paren- team, completed comprehensive plan- expansion plans, the integration of phar- teral antibiotic therapy management. ning facilitated by the ASHP COVID-19 macy practice with the SIM structure However, new patient population or Pandemic Assessment Tool for Health- highlighted the pivotal role pharmacy service additions, such as postpartum System Pharmacy Departments2 and has in emergency response and ambu- hypertension management, were only scenario planning exercises with inci- latory patient care. This approach al- planned during the initial acceler- dent action plans. The main scenario lowed for ambulatory pharmacy practice ation phase of the pandemic, but pro- for ambulatory care was that vulner- at YNHHS to continue to advance and gram implementation did not occur able populations with chronic condi- for expansion of services to vulnerable until a recovery phase, when sufficient tions would experience gaps in care populations. In response to the COVID- pharmacist resources were available. management.3 Objectives and strat- 19 pandemic, the ambulatory action Strategies implemented by the am- egies developed from the action team team was able to execute the key object- bulatory action team to maintain pa- planning were added to a standardized ives of establishing clear and effective tient access included expansion of project plan template (Figure 1), which communication with key stakeholders, chronic disease state management and facilitated execution of strategies and ensuring patient access to clinical and anticoagulation services through use of reporting to the PICS on progress and laboratory services, and managing drug telehealth. As a result, the total number barriers. Newly identified ambulatory shortages related to COVID-19. of pharmacist visits increased from AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021 721
Note AMBULATORY CARE ADVANCES DURING COVID-19 Figure 1. Action plan implemented by ambulatory action team in response to coronavirus disease 2019 (COVID-19) pandemic. REMS indicates medications subject to risk evaluation and mitigation strategy requirements. Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 approximately 1,000 visits per month safe patient transitions and medication Anticoagulation management. to more than double that figure by July assistance program copayment support As ambulatory nurses were redeployed 2020 (Figure 3). from external, manufacturer-sponsored to meet inpatient care needs, ambu- Telehealth transition. Transi programs or grants from disease state– latory clinical pharmacists assumed tioning patient appointments to focused organizations for patients with responsibility for protocol-based war- telehealth (telephone or video visits) financial need. For medications not farin management for approximately became a priority during the initial available through our pharmacy, use of 1,300 patients. Seven ambulatory clin- pandemic response to ensure com- 340B Drug Pricing Program–contracted ical pharmacists, 2 ambulatory care pliance with the Centers for Disease pharmacies was advised. In collabor- postgraduate year 2 pharmacy resi- Control and Prevention’s guidance for ation with the pharmacy and medical dents, and 5 pharmacy technicians social distancing, quarantine, and iso- leaderships, consensus guidance was were trained. Three to 5 pharmacists lation.4,5 With the need for rapid video developed to provide for consideration and 3 to 4 technicians were assigned visit training, one of the ambulatory of patient self-administration of medi- each day to support this patient popu- clinical pharmacists with experience cations that did not have labeled indi- lation. Assigned pharmacy staff and re- conducting video visits trained clinic cations for home self-administration maining nursing staff participated in a staff and led a virtual training for 17 am- (eg, omalizumab). daily huddle to assign roles and ensure bulatory clinical pharmacists. Within The ambulatory clinical pharma- effective communication. a week all patients were converted to cists also used the telehealth visits as The ambulatory action team created telehealth visits. a way to facilitate triage of patients for a guidance document to clearly out- Pharmacist telehealth visits were further care and assessment. If there line what action should be taken when used to provide injection training and were any concerns for COVID-19–re- patients reported urgent concerns, patient counseling for self-admin lated symptoms, patients were triaged including potential COVID-19 symp- istration of biologic therapies for 27 to the responsible provider and/or call toms. To decrease the risk of potential patients in the pulmonary clinic. center. This workflow aligned with the COVID-19 transmission, opportunities Partnering with our health system spe- SIM ambulatory action team’s COVID- to extend the International Normalized cialty pharmacy ensured efficiency in 19 symptoms triage pathway. Ratio (INR) monitoring interval to up to 722 AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021
AMBULATORY CARE ADVANCES DURING COVID-19 Note Figure 2. Timeline of ambulatory action team (AAT) strategic planning and transformation plan implementation during early months of response to coronavirus disease 2019 (COVID-19) pandemic. PICS indicates pharmacy incident com- mand structure; HVC, heart and vascular. Week of March 8, 2020 PICS formaon April 1–May 8, 2020 • AAT twice-weekly meengs • Review, reporting, and execuon of project plan March 12 Ambulatory care staff huddle started March 12–June 9, 2020 May 13–Present Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 AAT lead and alternate aend system April 6, 2020 • Review, reporting, and execuon of incident management AAT meengs Started support of HVC transformaon plan ancoagulaon services • AAT once-weekly meeng March | April | May March 16–20, 2020 All adult ambulatory pharmacists May 6, 2020 converted to work from home April 21, 2020 Transformaon plan created Peak of COVID-19 cases at Yale New March 24, 2020 Haven Hospital AAT chiefs, leads, and alternates perform COVID-19 scenario planning March 30, 2020 AAT kick-off meeng and finalizaon of project plan 12 weeks in patients with stable doses of guidance to enhance care of patients of medications. Guidelines outlining warfarin and consistently therapeutic across the health system. essential laboratory monitoring param- INRs were identified.6-8 Pharmacists Through this collaboration, op- eters and those for which testing could also identified opportunities to transi- portunities to optimize and stand- be delayed for patients with diabetes, tion patients to direct oral anticoagu- ardize workflows between departments hypertension, heart failure, and/or other lant (DOAC) therapies to decrease the managing warfarin therapy were identi- chronic diseases were created. required monitoring frequency. fied. Standardization improved efficiency An ambulatory anticoagulation and consistency through creation of 21 Medication access and drug management workflow document was documentation templates and a central- use policy prepared and disseminated across the ized workflow resource, which were con- A final objective of the ambulatory health system through the SIM ambu- tinually updated as new processes were action team was to ensure that pa- latory action team to provide multidis- implemented. This standardization jled tients retained access to critical chronic ciplinary providers with strategies for to important protocol clarifications and medications during the pandemic and management of the target population. more streamlined and consistent work- that prescribers received clear guid- It included considerations for DOAC flows across the health system. ance on drug prescribing and moni- conversion in eligible patients, INR Essential laboratory moni- toring during this period. Disruptions monitoring interval extension, options toring. To ensure effectiveness of medi- in the drug supply chain, as well as for home INR monitoring, and avail- cation therapy while minimizing risks emerging evidence supporting use of ability of laboratory testing locations of staff exposure to COVID-19, the am- approved drugs for the treatment of exclusively for patients with confirmed bulatory action team completed an as- COVID-19, led to drug shortages that or suspected COVID-19. Through this sessment of current ambulatory clinical would potentially impact patients re- communication, the ambulatory ac- pharmacy services and essential labora- ceiving chronic therapy with affected tion team had the opportunity to share tory tests for initiation and monitoring drugs. The team worked to develop AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021 723
Note AMBULATORY CARE ADVANCES DURING COVID-19 Figure 3. Ambulatory care pharmacist visits by type (10,895 visits in total) during early months of pandemic response. 2500 2000 1500 1000 Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 500 0 2020 2020 2020 2020 2020 2020 2020 January February March April May June July Office Visits Telehealth Visits Total Visits prescribing guidance, information guidance from the drug manufacturer medications be reserved for patients technology restrictions within the provided for 7 medications and a change with medical conditions for which their computerized order entry system, and from the usual REMS process for 6. use had been established and there inventory management strategies to re- Drug shortages management. were no alternatives. Dermatology and tain drug supply for the health system’s During the early weeks of the COVID- rheumatology prescribers identified patients who were receiving these 19 pandemic, several readily avail- patients whose hydroxychloroquine medications chronically. Risk manage- able medications were demonstrated therapy could be decreased via once- ment programs for frequent monitoring to have possible activity against the daily dosing to conserve supply and of some medications were modified in virus in hospitalized patients, including also recommended avoiding new-start response to the COVID-19 pandemic to hydroxychloroquine, azithromycin, and hydroxychloroquine therapy. reduce the need for patient laboratory HIV-1 protease inhibitors. The increased Implementation of electronic deci- visits, and it was essential to communi- demand and utilization of these medica- sion support for hydroxychloroquine cate these changes to prescribers. tions for the acute treatment of COVID- and azithromycin prescribing resulted Risk evaluation and mitigation 19 in hospitalized patients resulted in in generation of an advisory warning strategies (REMS) management. supply shortages in the community for upon medication prescribing that out- The US Food and Drug Administration’s outpatients receiving the medications lined restrictions on prescribing of release of the guidance document chronically. Several strategies were these medications in the outpatient “Policy for Certain REMS Requirements implemented to manage medication setting. These prescriptions also re- During the COVID-19 Public Health therapy associated with COVID-19–re- quired an associated diagnosis code Emergency” provided temporary relief lated shortages, including outpatient and contained a hard-stop limit on from selected laboratory testing require- prescribing guidance, prescriber deci- days’ supply per fill (ie, a maximum ments or days’ supply limitations for sion support within the electronic med- of 30 days). Upon receipt of any new drugs subject to REMS requirements.9,10 ical record, internal pharmacy validation hydroxychloroquine prescriptions, To provide awareness of REMS program of prescriptions, and dispensed quantity clinical pharmacists within the health- requirement changes, the team compiled limitations. Guidelines for outpatient system specialty pharmacy reviewed a list of medications subject to REMS re- prescribing of hydroxychloroquine, electronic medical record documenta- quirements prescribed within the health HIV-1 protease inhibitors, and azith tion to validate indications for use and system, the updated requirements, and romycin were developed in collabor- escalated cases to the rheumatology the manufacturers’ letters about the up- ation with members of the pharmacy leadership if compliance with the out- dates. During a 13 month period prior and medical leaderships with expertise lined guidelines was unclear. to the start of the COVID-19 pandemic, in infectious diseases, pulmonary medi- The strategies implemented to 14 such medications were prescribed cine, rheumatology, and dermatology; manage COVID-19–related drug within the health system, with formal the guidelines recommended that these supply shortages in the outpatient 724 AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021
AMBULATORY CARE ADVANCES DURING COVID-19 Note setting allowed YNHHS pharmacies Successful execution of the ac- References to continue to fill hydroxychloroquine tion plan also involved coordination 1. ASHP Practice Advancement Initiative and azithromycin prescriptions for pa- and teamwork. Therefore, equally im- 2030: New recommendations for tients chronically treated with these portant was the continual fostering of advancing pharmacy practice in health systems. Am J Health-Syst Pharm. therapies and ensured a sustained a positive environment that ensured all 2020;77(2):113-121. supply in the community. Stabilization team members were heard, involved, 2. American Society of Health-System of supply also allowed YNHHS phar- and engaged. Frontline pharmacists Pharmacists. ASHP COVID- macies to accept prescriptions for and pharmacy residents were members 19 Pandemic Assessment Tool new-start hydroxychloroquine therapy of the ambulatory action team and were for Health-System Pharmacy Departments. Accessed March 18, or for patients receiving chronic a part of executing and implementing 2020. https://www.ashp.org/-/ hydroxychloroquine therapy who had the action plan. Use of the diverse skill media/assets/pharmacy-practice/ previously filled prescriptions speci- sets and clinical expertise of the entire resource-centers/Coronavirus/docs/ Downloaded from https://academic.oup.com/ajhp/article/78/8/720/6154001 by guest on 30 August 2021 fying certain approved indications at team enabled quick execution of the ASHP_COVID19_AssessmentTool. outside community pharmacies. action plan. ashx?loc=ashphero3-covid19assessm enttool-03182020 The project tracker and action plan Discussion were useful tools for organizing the object- 3. Advisory Board. Coronavirus scenario planning: 12 situations hospital leaders The COVID-19 pandemic has pre- ives and tactics during the initial phase of should prepare for. Accessed March sented an unprecedented crisis, which the pandemic. Towards the subsequent 16, 2020. https://www.advisory.com/-/ has required the YNHHS ambulatory recovery and practice transformation media/Advisory-com/Research/HCAB/ pharmacy team to respond in a nimble Resources/2020/Coronavirus-scenario- phase, these tools were used to plan some planning-HCAB-2020.pdf manner. The unique challenges en- of the pharmacy department’s strategic 4. Centers for Disease Control and countered have tested our ability to initiatives. Strategies that required fur- Prevention. Coronavirus disease 2019 adapt, accelerated timelines, changed ther resource assessment, modification (COVID-19): social distancing. Accessed previous workflows, and led to creation of workflow, and maintainence, such as March 1, 2020. https://www.cdc.gov/ of new processes. During the initial re- coronavirus/2019-ncov/prevent-getting- the anticoagulation management and sick/social-distancing.html sponse to the pandemic, we identified postpartum hypertension management 5. Centers for Disease Control and that there was a need for a new commu- strategies, were added to the 2021 strategic Prevention. Coronavirus disease 2019 nication infrastructure that spanned plan for implementation by separate pro- (COVID-19): quarantine and isolation. across all levels to allow for clear coord- ject teams. Accessed March 1, 2020. https://www. ination and to facilitate collaboration. cdc.gov/coronavirus/2019-ncov/if-you- are-sick/quarantine-isolation.html To ensure the success of the PICS and Conclusion 6. Witt DM, Delate T, Clark NP, et al. the ambulatory action team, they were Ambulatory care pharmacy plays an Twelve-month outcomes and predictors introduced to the pharmacy staff at essential role by providing support to of very stable INR control in prevalent town halls and huddles. The ambula- the community, patients, department, warfarin users. J Thromb Haemost. tory action team and pharmacy leader- 2010;8(4):744-749. and multidisciplinary team. The for- 7. Barnes GD, Kong X, Cole D, et al. ship also reminded staff of the correct mation and work of the ambulatory ac- Extended international normalized method of escalation if there was a de- tion team was critical for the continued ratio testing intervals for warfarin- viation in the process. The ambulatory advancement of YNHHS’ ambulatory treated patients. J Thromb Haemost. action team became the hub of all am- pharmacy practice during the early 2018;16(7):1307-1312. bulatory care–related issues, improve- 8. Schulman S, Parpia S, Stewart C, et al. weeks of the COVID-19 pandemic. The Warfarin dose assessment every 4 weeks ments, and opportunities by receiving experiences gained during the COVID- versus every 12 weeks in patients with and relaying new information and 19 pandemic have made the YNHHS stable international normalized ratios. data related to ambulatory care. This ambulatory pharmacy team better pre- Ann Intern Med. 2011;155:653-659. approach allowed the team to pivot pared for future crises and equipped 9. US Food and Drug Administration. FDA’s strategically to address each new or Policy for certain REMS requirements the team with new tools and skills that during the COVID-19 public health evolving issue with modified tactics or will remain in a transformative state. emergency. Published March 2020. strategies in a short time frame; it also Accessed March 30, 2020. https://www. prevented any duplication of efforts in Acknowledgments fda.gov/media/136317/download the pharmacy department. Thus, a key The authors acknowledge the members of the 10. Bosentan REMS Program. Important to the ambulatory action team’s suc- YNHHS COVID-19 ambulatory action team. program update (as of 04/07/2020). Published April 7, 2020. Accessed cessful execution and implementation April 12, 2020. https://www. of the objectives in the action plan was Disclosures bosentanremsprogram.com/ to create and maintain a robust com- The authors have declared no potential con- BosentanUI/rems/pdf/resources/ munication framework. flicts of interest. Bosentan_REMS_IPU_for_COVID-19.pdf AM J HEALTH-SYST PHARM | VOLUME 78 | NUMBER 8 | April 15, 2021 725
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