Smilow Cancer Hospital at Yale New Haven Health System in Connecticut is 1 of 45 National Cancer Institute–designated comprehensive cancer hospitals and 1 of 27 National Comprehensive Cancer Network (NCCN) hospitals in the United States. In addition to the main cancer center, the health system has 14 cancer hospital care centers throughout Connecticut, serving patients receiving infusion and oral chemotherapy. 

At the Smilow Cancer Hospital, our oncology pharmacists play an important role in the delivery of care for patients with cancer because of the complexity of treatment regimens, the number of available medications, requirements for careful dose review and close lab monitoring, and the need for patient counseling and adverse effect monitoring. This role is even more critical with the rapid development of oral chemotherapy agents and a shift from intravenous (IV) chemotherapy to delivery of oral medications in recent years. With this shift, more of the education and monitoring requirements, self-management responsibilities for complex oral chemotherapy regimens, and adverse effect monitoring requirements are transferring from the care team to the patient.

Prior to the coronavirus disease 2019 (COVID-19) pandemic, Smilow oncology pharmacists managed care for patients receiving both infusion and oral chemotherapies in the acute care and ambulatory settings. The multidisciplinary oral chemotherapy model incorporating treatment plans for every drug, an internal specialty pharmacy hub, patient education and follow-up, monthly refill reminders, and a medication assistance program were all designed to expedite drug access, standardize the consent process, and ensure we had ongoing clinical support for patients with cancer. 

The COVID-19 pandemic has presented challenges to the care of patients with cancer, who may be at higher risk of developing severe disease. Clinicians must carefully consider whether to deliver, modify, or postpone cancer treatment, as delays or therapy changes could lead to disease progression and poor outcomes. Health systems caring for immunocompromised patients, especially those who are currently receiving chemotherapy, must devise strategies to maintain optimal clinical care for this population while decreasing the risk of exposure to the virus. 

Pivoting to Enure Critical Care 
The Smilow care teams worked collaboratively to create management strategies, including conversion from IV to oral chemotherapy, when clinically appropriate, for patients with cancer during the COVID-19 crisis. In collaboration with medical and pharmacy leadership, recommendations for changes to regimens and treatment plans, which were based on published data or expertise from the center’s disease teams, have been implemented. Several extended-interval infusion strategies have been implemented, including conversion of weekly paclitaxel to dose-dense chemotherapy for adjuvant breast cancer and every-3-week intervals for metastatic breast cancer. 

Smilow’s treatment plans for checkpoint inhibitors have been changed to allow every-4-weeks or every-6-weeks dosing. Monthly zoledronic acid or denosumab injections have been converted to every 3 months as were extended-interval leuprorelin and goserelin. 

For patients with gastrointestinal malignancies who had received 6 to 8 cycles of the folinic acid, fluorouracil, and oxaliplatin regimen, maintenance capecitabine is recommended at Smilow, resulting in a nearly 60% increase in capecitabine prescription volume at the Smilow specialty pharmacy from February to April 2020. Treatment holidays in patients who had received 6 or more months of therapy for biliary, pancreatic, or gastric cancer are considered. 

Because some surgeries were delayed as a result of the deferral of elective surgeries to reduce hospital census, induction chemotherapy is being used as an alternative. For some patient populations, including those with lymphoma, delayed treatment for those with asymptomatic disease not requiring therapy is considered. 

To decrease the risk of hospitalization and the need for urgent clinic visits because of neutropenia or transfusions, we also evaluated the center’s guidelines on using growth factors based on thand the American Society of Clinical Oncology, and we modified our treatment plans to include these agents when clinically indicated. 

Given the potential risks for disruptions to the pharmaceutical supply chain during the COVID-19 pandemic, ensuring that patients with cancer had an adequate supply of their oral chemotherapy medications at the correct time was essential. Prior to the COVID-19 crisis, the Yale health system’s specialty pharmacy staff worked approximately 5 to 7 days before the medication refill due date to ensure signed oral chemotherapy cycles, release the prescription to the appropriate pharmacy, and set up medication delivery. During the COVID-19 crisis, our pharmacy staff identified patients due for refills of their oral chemotherapy up to 2 weeks in advance and reached out to prescribers to authorize a new cycle of treatment, if clinically appropriate. 

In addition to this strategy, Smilow Cancer Center and clinical pharmacy leadership identified oral chemotherapy and oral hormonal medications that would qualify for a 60- or 90-day supply instead of the typical 1-month supply mandated by the health system and Quality Oncology Practice Initiative oral chemotherapy guidelines. Imatinib, dasatinib, nilotinib, abiraterone, and enzalutamide have been identified as agents that can be prescribed as multiple-month supplies to ensure availability to patients with cancer during the COVID-19 pandemic. 

As a result, the volume of oral chemotherapy prescriptions filled at the health system’s internal specialty pharmacy increased approximately 20% from February to March 2020, potentially because of proactive refill outreach and a change in the approach to days supplied. Smilow’s specialty clinical oncology pharmacists continued to conduct initial and ongoing patient education through telephone communications for patients receiving oral chemotherapy, remotely identifying any adverse effects or toxicities and alerting the oncology care team. 

Pharmacy staff also provided resources for patient support and referrals to a medication assistance program for patients struggling with high co-pays or lapses in insurance.
To reduce the number of high-risk patients with cancer at ambulatory infusion sites, coordination with and transition to home infusion services is facilitated by our health system. Patients with cancer receiving IV immunoglobulin therapy within the health system’s infusion centers successfully transitioned to contracted infusion pharmacies. Those receiving supportive care medications in clinic transitioned to home-administered options or home administration with nursing support. 

Our health system’s specialty pharmacy frequently assisted with benefits investigation and fulfillment of supportive oncology specialty medications as well as the identification of financial assistance options and manufacturer-provided nursing support. The move from clinic-administered supportive care oncology medications to home-administered options potentially shifted revenue from the health system’s infusion centers to the internal specialty pharmacy.

Patients receiving infusion and oral chemotherapy engaged in virtual provider visits when possible to limit exposure in clinic, and as a result, internal policies requiring signed patient consent are modified to allow remote or telephone consent during these telehealth visits. Additionally, telepharmacy staffing models are implemented for both oncology clinical pharmacists and specialty clinical pharmacists, as state regulations provided allowances for remote verification of prescriptions by pharmacists.

Conclusion
The changes implemented by our health system’s cancer center during the COVID-19 crisis demonstrated the ability to maintain access to clinical care, as well as critical medications, while limiting exposure and risk. Changes to infusion chemotherapy regimens and shifts from clinic-administered to home-administered or home infusion therapy presented financial implications to the health system. However, the changes in medication administration also presented new revenue opportunities for the health system’s specialty pharmacy. 
Clinical pharmacists and providers maintained care and close monitoring of our patients with cancer through telephone consultations, telehealth visits, and a remote staffing model that will likely sustain in the post–COVID-19 world for this high-risk population. 
 
MARTHA STUTSKY, PHARMD, BCPS is employed by Yale New Haven Health System in Connecticut; OSAMA ABDELGHANY, PHARMD, MHA, BCOP, is manager of oncology pharmacy services at Smilow Cancer Center, Yale New Haven Health System.