On January 20, 2020, the first US case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, later defined as coronavirus disease 2019 (COVID-19), was confirmed.1 COVID-19 vaccines and therapies have since become available to improve patient care and outcomes. On September 9, 2021, the Department of Health and Human Services (HHS) amended the COVID-19 Public Readiness and Emergency Preparedness Act (PREP Act) to allow licensed pharmacists to order and administer COVID-19 therapeutics.2 This authority was recently nullified when the Food and Drug Administration (FDA) chose to exclude pharmacists from having the ability to independently prescribe emergency use authorization (EUA) oral antivirals. However, these outpatient therapies are plagued with complex drug-drug interactions (DDIs) that warrant taking a robust medication history and careful evaluation before prescribing. Pharmacists have been challenged with similar barriers in caring for patients with other disease states and have proven themselves to be an active part of healthcare teams to overcome these barriers.3,4 As a result of the increasing number of available COVID-19 therapies along with a surge in COVID-19 cases, the pharmacy department at Boston Medical Center (BMC) recognized the need to implement a novel multidisciplinary system to rapidly increase appropriate prescribing of, safe dispensing of, and adequate access to these advanced therapies. This article provides an outline of the processes our institution put in place to organize a multidisciplinary approach to improving COVID-19–related patient care and lessons learned to aid other institutions in organizing similar efforts.
The role of pharmacy leadership.
In early January 2022, the omicron variant of SARS-CoV-2 caused a sudden surge in case numbers and hospitalizations across the nation. Pfizer’s oral combination packaged product nirmatrelvir/ritonavir (Paxlovid), Merck’s oral medication molnupiravir, and GlaxoSmithKline’s intravenous monoclonal antibody, sotrovimab, recently received FDA EUA.5-7 Due to limited supply nationally, the Massachusetts Department of Public Health (DPH) allocated a supply of these medications to our institution. The supply was to be used for prescribing in the outpatient clinics and emergency department (ED). Pharmacy leadership recognized the organizational challenges of limited supply, increasing demand, and the complexity of and lack of prescriber experience with the therapeutic regimens. Under the direction of our institution’s chief pharmacy officer, the clinical pharmacy managers developed and proposed a primarily pharmacist-driven workflow that prioritized patients at highest risk for COVID-19–related health decline. The assessment and prescribing of COVID-19 therapies by physicians and advanced practice practitioners (APPs) was to be augmented by clinical pharmacists under a scope of practice agreement. The scope of practice agreement allowed for pharmacists to develop, document, and execute a plan of care utilizing the most appropriate medication treatment, as per established protocol, under the supervision of an infectious diseases (ID) attending physician. During the COVID-19 surge, our ED resources were limited and the available resources needed to be fully utilized in the short term while a long-term transitional plan could be developed. For this reason, the ED implemented our pharmacist-led protocol with the long-term goal of transitioning the process to be provider driven. The leadership team rapidly and cohesively brought together inpatient, outpatient, ambulatory, and residency pharmacy teams to increase patient assessments and prescribing and to meet the unique needs of our patient population.
The role of infectious diseases providers and pharmacists.
ID providers have been at the forefront of the pandemic for nearly 2 years. We turned to our ID physician colleagues to provide expert opinion and recommendations for proper use of the EUA COVID-19 therapies. An ID physician served as the supervising physician for a scope of practice that allowed clinical pharmacy specialists (CPSs) (including residents) to order COVID-19 therapeutics for patients meeting DPH and BMC-specific high-risk criteria in both the ambulatory setting and ED. The ID team developed the initial treatment algorithm to guide therapy decision-making using the DPH framework.8 ID providers and pharmacists utilized EUA criteria,5-7 National Institutes of Health (NIH) guidance,9 and DPH restrictions to establish BMC-specific use criteria for outpatient clinics and the ED. Patients were immediately considered ineligible if they were asymptomatic, required hospital admission, or had increasing oxygen requirements. The eligibility criteria can be seen in Figure 1.
Flowchart depicting COVID-19 treatment eligibility criteria used in outpatient clinics of Boston Medical Center. OP indicates outpatient. aUnvaccinated, immunosuppression (including HIV/AIDS, T- or B-cell malignancy, hematologic malignancy, use of biologics), sickle cell disease, 65 years of age or older, diabetes mellitus, chronic kidney disease, chronic liver disease, cardiovascular disease, neurological disorder, chronic lung disease, substance use disorder, mental health disorders, smoker, pregnancy, body mass index of >30, stroke and/or cerebrovascular accident, or tuberculosis.bMolnupiravir may be considered in patients who cannot receive Paxlovid (eg, those with estimated glomerular filtration rate of <30 mL/min or significant drug-drug interactions) and/or those who do not want to receive intravenous therapy.
Pharmacists specializing in ID at BMC were also involved in development of the pharmacist-driven workflow. The pharmacists reviewed dosing of EUA therapies, as well as associated adverse events and DDIs, to compose a guidance document to be utilized by prescribers. This document was approved by an attending ID physician. The ID pharmacy group also helped develop a uniform documentation note in the electronic medical record (EMR) to capture important information and avoid duplicated work amongst healthcare practitioners. The note included:
Patient demographics (age, gender identity, address, and contact information)
COVID-19 vaccination status
Date of symptom onset
Date of last positive SARS-CoV-2 test
Location of last SARS-CoV-2 test
Treatment-qualifying high-risk conditions
Contraindications to treatment
The ID pharmacy group created an additional internal documentation, visible only to pharmacy staff, with details including renal dose adjustments, potential DDIs, dispensing pharmacy, and a list of a patient’s current medications.
The role of ambulatory care pharmacists.
Ambulatory care CPSs at BMC work under a scope of practice under physician supervision. To meet the demand of the COVID-19 surge, ambulatory care CPS expanded their scope of practice to encompass COVID-19 therapeutics under an ID physician. Alongside other APPs, they responded to positive SARS-CoV-2 test results by contacting patients, assessing symptoms, and determining eligibility for outpatient treatment (Figure 1). If a patient was eligible, the pharmacist ordered appropriate oral antiviral therapy at an outpatient pharmacy or coordinated an on-site infusion of a monoclonal antibody. Given that the medications being prescribed were all under EUA, CPSs were required to obtain verbal consent from the patient prior to initiation of treatment. Additionally, ambulatory CPSs provided follow-up telephone calls at day 5 of therapy to assess adherence, toxicity, completion of therapy, and/or worsening symptoms of COVID-19 for those patients who did not have primary care established at BMC. This was to ensure that all patients had follow-up irrespective of their primary care being within our health system. Under the CPS scope of practice, telephone encounters also provided additional supportive care such as nonprescription medication recommendations and triage of high-acuity care to urgent/emergency care based on patients’ reports of symptom severity. All telephone encounters were documented within the EMR.
The role of ED pharmacists.
BMC’s ED is the busiest level 1 trauma center in New England and serves a large population of underserved patients. During the omicron surge, our ED was at capacity, with limited resources resulting in lower than anticipated outpatient COVID-19 therapy screening and prescribing relative to screening and prescribing in confirmed cases. We proposed a pilot project utilizing 2 pharmacists to screen patients and order COVID-19 therapies. Two pharmacy residents working under a scope of practice (similar to the one for ambulatory care CPSs) along with an ID physician provided services in the ED Monday through Friday from 8 am to 10 pm. CPSs were available for backup support.
All patients presenting received a rapid polymerase chain reaction (PCR) SARS-CoV-2 test unless they had tested positive within the past 30 days. ED pilot project pharmacists screened patients with confirmed positive SARS-CoV-2 tests for treatment eligibility. Evaluation of eligibility included determination of symptom onset within the past 10 days and hospital disposition. At the time of this ED pilot project, sotrovimab was the monoclonal antibody under EUA for use against the omicron variant, and the criteria for use included symptom onset within 10 days. (Since that time, new monoclonal antibodies with differing criteria for use have been approved through EUA, so evaluations should be dependent on the therapy options available at the time.) If a patient was deemed eligible, the pharmacist used past medical history, relevant laboratory results, and a comprehensive medication reconciliation to guide selection of the appropriate outpatient COVID-19 therapy based on Figure 1. Similar to the ambulatory CPS process, the ED pilot project process specified that pharmacists obtain verbal consent. Pharmacists ordered appropriate therapy, counseled, and ensured the patient was set up to receive the medication.
BMC serves a high-risk population that encounters many types of barriers (eg, language, social, financial) to appropriate healthcare. Addressing these barriers was an important aspect of the pilot project. Our inpatient and outpatient pharmacy teams arranged for home delivery of medications and transportation to infusion clinics and provided language-specific medication counseling sheets to overcome any obstacles.
In addition to direct patient care, ED pilot project pharmacists provided 24/7 on-call pager coverage for COVID-19–related clinical questions and assisted in refining COVID-19–related clinical support materials such as a built-in EMR assessment tool and treatment algorithm. It was a process of continuous quality improvement based on multidisciplinary input and firsthand experiences, with real-time workflow improvements implemented to optimize patient care. ED pilot project pharmacists evaluated the processes and recommended necessary changes in real time to improve workflow and patient care. Additionally, ED providers were educated on operationalizing the assessment tool, therapies available, and appropriate therapeutic decision-making. Provider education was ongoing as many physicians in training rotated through the ED.
During our 2-week ED pilot project, we assessed 118 patients and deemed 9 patients eligible for therapy. This was an improvement from prior to the pilot project, when our ED was at maximum capacity and provider workload did not allow time to complete assessments on all patients positive for SARS-CoV-2. One eligible patient declined therapy, 6 patients were prescribed nirmatrelvir/ritonavir, 1 patient was prescribed molnupiravir, and 1 patient received a sotrovimab infusion. The reasons for ineligibility of the remaining 109 patients can be seen in Figure 2. A majority of patients were ineligible due to lack of symptoms or requiring hospital admission. However, due to the frequency of ED presentation in our patient population, the COVID-positive result in the EMR that triggered assessment may have been a previous positive result within the preceding 30 days; these patients were classified as “other” (Figure 2). In mid-February 2022, the number of patients positive for SARS-CoV-2 rapidly declined and workflow was transitioned to ED providers. Providers were informed of their responsibilities and provided with a treatment algorithm handout (Figure 1). We were able to successfully execute and accomplish this transition after the end of the 2-week pilot period.
Reasons for ineligibility for COVID-19 therapy during the pilot project.
The role of outpatient pharmacists.
BMC’s network of outpatient pharmacies provides services including retail sales, specialty drugs, mail-order delivery, online refilling, adherence/blister packaging, and inpatient medication-to-bedside delivery. One outpatient retail pharmacy served as the sole, centralized repository for DPH-provided oral COVID-19 therapies for BMC. BMC healthcare practitioners, BMC-associated community health centers, and outside hospital system prescribers were instructed to send prescriptions for nirmatrelvir/ritonavir or molnupiravir to this pharmacy location on both weekdays and weekends.
Several lead outpatient pharmacists (OPs) were trained on COVID-19 therapies and organized the day-to-day processes for managing prescriptions. OPs conducted an independent assessment of eligibility based on EUA prescribing criteria and BMC-specific high-risk criteria, using EMR documentation if available. For patients prescribed nirmatrelvir/ritonavir, renal function was evaluated to assess the need for any dose adjustments. OPs utilized EMR data, prescription insurance claim information, and patient interviews (if necessary) to determine the current medication list. OPs utilized the NIH resources and the University of Liverpool’s online COVID-19 DDI tool10 to evaluate the presence of clinically significant DDIs that could affect concomitant therapies. OPs reached out to the ordering prescriber or an ID CPS with questions or concerns regarding eligibility and clinically significant DDIs.
Once deemed clinically appropriate, a prescription was prepared for dispensing. Molnupiravir was dispensed in a single container containing 40 capsules. Nirmatrelvir/ritonavir was dispensed in a carton of 5 blister cards with 2 doses per blister card—an am and a pm dose. Each dose consisted of 2 pink nirmatrelvir tablets and 1 white ritonavir tablet. If the patient required renal dose adjustment, 2 pink tablets were removed (one each from the am and pm dose supplies) and an auxiliary label was placed to signify a dosage modification; this was done for each of the 5 blister cards, and the auxiliary label was also affixed to the outside of the carton. COVID-19 therapies prescribed during ED pilot project hours were delivered by inpatient medication-to-bedside delivery or same-day courier service to the patient’s preferred location. Prescriptions sent after outpatient pharmacy hours were filled and delivery was coordinated the following morning. OPs called patients within 4 hours of drug receipt to counsel on medication adherence, potential adverse effects, and when to hold and resume home medications if necessary. OPs also counseled patients on continued self-isolation and steps to take if symptoms became worse. OPs collected patient demographics and dispense history. Patients were triaged and flagged for a telephone follow-up by a BMC ambulatory CPS upon completion of therapy if the patient did not have primary care at BMC.
In summary, a multidisciplinary approach to the constantly evolving COVID-19 therapy landscape allowed for rapid development and implementation of a clinical assessment tool and medication dispensing process across a large healthcare system. While this article is specific to the development and execution of a COVID-19–related workflow, the methods and concepts can be used to develop processes for similar endeavors. The utilization of pharmacists may be considered in similar healthcare contexts.
Multidisciplinary efforts are necessary to recognize a need and subsequently develop, implement, and execute novel solutions to rapidly developing healthcare problems.
Thoughtful allocation of resources in a high-volume setting allows for improved patient care and outcomes.
The utilization of pharmacists across all areas of a health system can serve as a model to deliver complex drug therapies to an overburdened healthcare system.
Disclosures: The authors have declared no potential conflicts of interest.
The Frontline Pharmacist column gives staff pharmacists an opportunity to share their experiences and pertinent lessons related to day-to-day practice. Topics include workplace innovations, cooperating with peers, communicating with other professionals, dealing with management, handling technical issues related to pharmacy practice, and supervising technicians. Readers are invited to submit manuscripts, ideas, and comments to AJHP, at [email protected].
Comments