Pharmacist-Led Oral Oncology Programs

Oral anticancer agents have become a mainstay for the treatment of both solid tumors and hematologic malignancies. However, the benefit of patient convenience comes with the challenges of nonadherence, monitoring for adverse effects, and insurance restrictions. Establishing an institutional program for oral anticancer agents allows pharmacists the opportunity to provide patient education and support through a formal process. Three well-established pharmacist-led oral oncology programs are highlighted below. The authors provide insight on the formation and structure of the program, patient flow, and lessons learned.

Julia R. Kerr, PharmD

Robert S. Mancini, PharmD BCOP FHOPA

Amanda L. Wright, PharmD

Jessie L. Modlin, PharmD

Oral Oncology Medically Integrated Dispensing Program, St. Luke’s Cancer Institute, Boise, ID

The St. Luke’s Cancer Institute Oral Oncology Medically Integrated Dispensing Program began as a pilot residency project in 2009. Through the program a small subset of oral oncology prescriptions were reviewed and processed. With improved patient access, the pilot project quickly expanded in the following year to include all providers at the five oncology clinics in the health system. The first full-time oral chemotherapy pharmacist and half-time technician were hired in 2010. Since then, the program has grown to include 4 pharmacist full-time equivalents (FTEs), 5 technician FTEs, and a 0.5 FTE nurse, who manages mail orders for patients at the largest site. Prescriptions are processed in a spoke-and-wheel distribution model.

After a treatment plan has been entered into the Epic electronic health record (EHR) software, new prescriptions are sent to the pharmacy using the software’s “Send Plan” functionality. When the new prescription is received, an electronic chart is created for each patient, as well as a tracking sheet that is used for internal pharmacy processes only. The tracking sheet contains patient demographics, prescription details for each cycle of treatment, follow-up appointments, monitoring parameters, drug interactions, dispensing logistics, and other pertinent information that is sometimes not readily available in the EHR.

The pharmacist performs a clinical review of the new prescription, and initial contact is made with the patient to confirm the plan for starting treatment. The pharmacist reviews the details related to processing specialty prescriptions, such as prior authorization, referrals to financial advocates, and insurance contracts with out-of-state specialty pharmacies.

The new prescription is then sent to the pharmacy technician, who begins prior authorization and performs an insurance benefits investigation. The process for prior authorization is completed internally—in most cases, by a technician, a pharmacist, or both. After the prescription has been approved, the technician processes a test claim with the insurance to determine the patient’s out-of- pocket cost. If the cost is unaffordable, a referral is sent to the financial advocate to review options for financial assistance or to seek a free supply of the drug directly from the manufacturer.

When the prescription is ready for processing, the pharmacist will again contact the patient to obtain consent to fill it, make arrangements to dispense the medication, and provide medication counseling. A technician will close the loop to confirm that the prescription was received. For patients whose insurance requires the use of a specific specialty pharmacy, the pharmacist will trans- fer the prescription to the specialty pharmacy and provide contact information to the patient. A referral is then sent to the provider’s primary nurse for future refills.

Daily tasks are assigned using the “All Reminders” queue in Epic. Tasks are split between pharmacists and  technicians, using standardized wording for a variety of functions that direct the staff member on what needs to be done (e.g., refill, follow up,
dispense the prescription at an appointment, give assistance on pending drugs, mail the prescription, counsel the patient).

One of the biggest challenges was the rapid growth of the program. The program currently follows an average of 550 patients. Because the program expanded much more quickly than expected, balancing FTEs and workload has been a constant struggle. The workflow was greatly improved with the expansion of pharmacist services. This was done through
another residency project in which a collaborative practice agree- ment (CPA) was developed for the reordering of oral oncology medications.

Pharmacists sign prescriptions on behalf of providers for specific adjustments outlined in the CPA. The CPA includes clinical activities such as dose rounding to the nearest tablet size; dose adjustments based on renal and hepatic function, toxicities, and specific indications; renewal of prescription refills; and ordering laboratory tests or exams recommended by guidelines. Results from the residency project showed a statistically significant improvement in the mean turnaround times for prescriptions completed per the CPA.¹ Following implementation of the CPA, it was observed that each pharmacist saves significant time each day by signing prescriptions on behalf of providers per the CPA. Further expansion of pharmacist services is under consideration, given the success of the CPA in this program. Some of the barriers encountered include insurance contracting, with many insurers still requiring contracted specialty pharmacies, and obtaining access to dispense products from pharmaceutical manufacturers. Fortunately, the program does have access to dispense the Celgene Risk Evaluation and Mitigation Strategies program drugs, and each pharmacist is a certified counselor. Since the launch of the pilot project, the
program has published more than a dozen peer-reviewed articles and has been referenced by the 2018 Hematology/Oncology Pharmacy Association’s oral oncolytic therapy practice standard² and the Standards for Medically Integrated Dispensing produced jointly by the American Society of Clinical Oncology and the National Com- munity Oncology Dispensing Association.³ In addition, the program has won a medication safety award from the American Society of Health-System Pharmacists (2012) and two innovator awards from the Association of Community Cancer Centers (2011 and 2020). The pharmacy department continues to expand and refine the delivery of patient services in its Oral Oncology Medically Integrated Dispensing Program.

References

1. Wright AL, Matta SF, Kerr JR. Expansion of pharmacist practice in oral oncolytic therapy with a collaborative practice agreement. J Oncol Pharm Pract. 2020; 1078155220905004 [published online ahead of print February 19, 2020]. doi:10.1177/1078155220905004
2. Mackler E, Segal EM, Muluneh B, Jeffers K, Carmichael, J. 2018 Hematology/Oncology Pharmacist Association best practices for the management of oral oncolytic therapy: pharmacy practice standard. J Oncol Pract. 2019;15(4):e346-e355. Available at https://ascopubs.org/doi/10.1200/JOP.18.00581
3. Dillmon MS, Kennedy EB, Anderson MK, et al. Patient-centered standards for medically integrated dispensing: ASCO/NCODA standards. J Clin Oncol. 2020;38(6):633-644.

Oral Anti-Cancer Agent Management Clinic, Malcom Randall VA Medical Center, Gainesville, FL

Kourtney LaPlant, PharmD BCOP

Paige May, PharmD BCOP

Ashley McGee, PharmD MBA BCOP

When the shift from intravenous (IV) to oral anticancer agents
began around 2008, concerns about proper utilization and toxicity management surfaced. It was recognized that these patients needed to be properly taught how to take the medications, what the common toxicities were and how to manage them, and when to call for help. The oncology pharmacy staff (three full-time oncology pharmacy specialists) at the Malcom Randall VA Medical Center in Gainesville, FL, approached the oncology physician leadership for a discussion of how the pharmacy staff could assist in managing this patient population.

Leadership buy-in from both the medical oncology and the phar- macy administration is likely the first hurdle of any proposed new clinic. Our oncology leaders were enthusiastic about a pharmacy-led initiative to support patient care. From a pharmacy standpoint, concerns are usually related to staffing. Are there enough hours to devote to clinical activities and still support oncology operations? In an examination of support staffing, we identified the availability of two advanced-practice pharmacy interns per month and several pharmacy residents who were doing oncology rotations and saw a learning opportunity. The idea of using trainees helped us obtain support from the pharmacy leadership, and our plan was bolstered by published research on the potential cost benefits of ensuring appropriate use of these high-cost drugs.^1,2

Referral to the clinic begins when pharmacy staff are notified through a consultation with oncology providers of the desire to start a patient on oral anticancer agents. The pharmacist reviews the patient’s record to ensure that the patient meets the criteria for the use of a given drug. If therapy is determined to be appropriate, a member of the pharmacy team will counsel the patient. In-person counseling is preferable, but video visits or phone calls are acceptable. Pharmacy trainees are educated by oncology pharmacists before they conduct patient education, to ensure their competency. After a patient has been counseled, a weekly follow-up phone or video call is scheduled with pharmacy for the first 3 weeks until the patient returns to the clinic in the fourth week (for monthly regimens). The oncologist orders the anticancer therapy, but the pharmacy staff's scope of practice within federal law and institu- tional credentialing procedures allows them to order supportive care medications, depending on the medication’s toxicity profile.

Pharmacy trainees, when available, conduct most of the follow-up visits, using a templated toxicity assessment form (the form has been previously published in a more comprehensive review of our clinic³). The pharmacist then develops a plan for any needed toxicity management and implements any changes to the drug therapy. Additional supportive care medications, monitoring devices such as blood pressure monitors, and lab tests can be ordered by the pharmacist if necessary. If changes to the anticancer therapy regimen are needed, pharmacy staff will instruct patients to withhold their medication and will contact the provider to discuss the plan, making changes as needed.

Following the initial month (which we felt to be the most crucial period for ensuring compliance), the responsibility for follow-up is returned to the oncology provider. Pharmacy may be asked to conduct additional interim follow-up on certain issues. Institutional policy calls for monthly visits and labs for the first 6 months when a patient is taking a new medication. An oncology pharmacy staff member reviews the patient’s labs before processing each refill. We are also field testing a population management tool to help track patients on oral chemotherapy agents and identify patients who are overdue for refills, may have abnormal labs, or may have been lost to follow-up. After a patient has been stable on one dose for 6 months, up to two refills are allowed. If a patient is stable on a dose for a year or more, 6-month follow-up may be considered on a case-by-case basis.

The pharmacy-led oral chemotherapy management clinic has been operating since 2009. One lesson learned in the beginning was the importance of formally establishing proper follow-up to help ensure accountability. Adaptations have included increasing the clinical time devoted to management of oral anticancer agents and incorporating video follow-ups to allow for visual assessment of skin toxicities and overall improvement of patient assessment capabilities. As the use of oral anticancer agents continues to expand and evolve, we see a continued future for the clinic. Future directions, if staffing allows, could include the use of oncology phar- macy specialists to conduct follow-up (in lieu of a physician visit) for stable patients receiving oral chemotherapy.

References

1. Goodin S, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents in clinical practice: recommendations from an international pharmacy panel. J Oncol Pract. 2011;7(1):7-12. doi:10.1200/jop.2010.000068
2. Mancini R, Wilson D. A pharmacist-managed oral chemotherapy program: an economic and clinical opportunity. Oncol Issues J. 2012 January/ February;27(1):28-31. https://doi.org/10.1080/10463356.2012.11883635
3. May P, LaPlant K, McGee A. Practice model: establishing and running an oral chemotherapy management clinic. Asia Pac J Oncol Nurs. 2017;4:299-303.

Comprehensive Oral Chemotherapy Management Program, University of North Carolina, Chapel Hill, NC

Benyam Muluneh, PharmD BCOP CPP

Since the World Health Organization released its landmark analysis of medication adherence, “Evidence for Action,” in 2003, the approval of oral chemotherapy drugs (OCs) has exploded.¹ In the wake of that explosion, patients’ nonadherence to taking OCs has become a significant barrier to achieving clinical outcomes, creating an opportunity for clinical pharmacy services.² For that reason, we implemented our comprehensive OC management program at the University of North Carolina in 2014.

Our first step was to survey 95 patients to understand the patient-perceived barriers to adherence.³ We found that 30% of respondents forget to take their OC as prescribed, and 21% of patients deliberately cut back on their OC primarily because of adverse effects or specialty pharmacy delays.³ Subsequently, we established an OC management program with an embedded clinical pharmacist and our own specialty pharmacy. We hypothesized that a closed-loop system where patients received their OCs from an institutional pharmacy would yield better adherence, provide better access, and be financially viable.

Our program is structured to ensure that our clinical pharmacists are involved throughout the continuum of the patients’ care. Patients receive education on their OC from a pharmacist after a referral is made by the oncologist. Clinical pharmacists are stationed in the clinic, facilitating a seamless (often informal) referral process. The education encounter contains a comprehensive medication review, discussion of common and serious adverse effects and the importance of medication adherence, and an explanation of the drug access process. The majority of prescriptions are sent by physicians (MDs), nurse practitioners (NPs), and physician assistants (PAs), but clinical pharmacists also occasionally prescribe, as permitted through the Clinical Pharmacist Practitioner licensure by the North Carolina Medical Board. A limited number of refills are given, and patients are followed closely by both specialty and clinical pharmacists for adverse effects.

Initially, patients have frequent visits with the clinical pharmacist so that toxicities from the new OC and adherence can be assessed. Typically, a pharmacist encounter (telephone or in-person) occurs at 2 weeks and 4 weeks after the patient starts the OC. The patient is also often seen by the MD (or NP or PA)  at the 4-week visit; the patient’s time with the clinical pharmacist is scheduled first. This allows the pharmacist to address OC-related concerns so that the MD, NP, or PA can focus on follow-up of disease status. A satisfaction survey of our physicians showed that they appreciated the involvement of the pharmacist in this follow-up approach.⁴

Based on the first 3 months of treatment, patients are given a more intensive or a less intensive follow-up plan. Patients who have a medication possession ratio <80%–90%, who experience adverse drug reactions or have abnormal laboratory values, or who have an MD request for more frequent follow-up are followed closely with pharmacist visits every 1–2 weeks. Patients deemed to be at lower risk of nonadherence (not falling within any of the high-risk parameters) would have a visit with the pharmacist every 3–6 months while they were on therapy.

Our comprehensive OC management program improved patient outcomes. During the first 10 months, 107 patients were enrolled, for a total of 350 pharmacist encounters during which 318 adverse events were reported and 235 interventions were implemented. We observed increased rates of patient understanding of OCs, high rates of adherence, and high rates of patient and provider satisfaction. In addition, major molecular response rates increased in our chronic myeloid leukemia patients compared with those in our historical control (pre: 58% vs. post: 83%).⁴

After implementation, we faced notable challenges in ensuring the sustainability of the program. First, because pharmacists were embedded in the clinic, they became core members of the clinical team and were addressing not only concerns with OC, but also concerns about supportive care, anticoagulation, transitions of care, infectious complications, and more. This expanded field of responsibility may have contributed to less intensive follow-up of patients on OC in some clinics. The continued increase in the approval of OCs also makes it challenging for the clinical pharmacy staff to own the entire drug-access program. Our institution has therefore embedded disease-specific medication access specialists who work alongside clinical pharmacists to expedite prior authorizations and applications for copay assistance. Significant challenges have also occurred with reimbursement and contracting. Unfortunately, limited distribution models sometimes prevent our pharmacy from serving our own patients.⁵ To deal with this problem, staff members are currently developing a more comprehensive workflow addressing the needs of patients who have their drugs filled through external channels.

Overall, implementation of a structured OC management program has yielded positive clinical, humanistic, and financial outcomes for our patients. We continue to modify our internal processes in order to adapt to the increasing number of OC approvals and a challenging limited-distribution landscape. 

References

1. Burkhart PV, Sabaté E. Adherence to long-term therapies: evidence for action. J Nurs Scholarsh. 2003;35(3):207.
2. Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010;28(14):2381-2388.
3. Muluneh B, Deal A, Alexander MD, et al. Patient perspectives on the barriers associated with medication adherence to oral chemotherapy. J Oncol Pharm Pract. 2018;24(2):98-109.
4. Muluneh B, Schneider M, Faso A, et al. Improved adherence rates and clinical outcomes of an integrated, closed-loop, pharmacist-led oral chemotherapy management program. J Oncol Pract. 2018;14(6):e324-e334.
5. Savage SW, Bates JS, Muluneh B. Challenges continue for true patient-centered access. 2016. Pharmacy Times. June 2, 2016. https://www.pharmacytimes.com/publications/specialty-pharmacy-times/2016/June-2016/Challenges-Continue-for-True-Patient-Centered-Access