Precluding the need for IV access and infusion center or hospital visits, oral chemotherapy treatment proves beneficial; patients often prefer oral chemotherapy over its IV counterpart due to its convenience. Therefore, it is not surprising that oral chemotherapy treatment is increasingly common. In 2017, eight of the 16 new chemotherapy drugs approved by the US FDA were oral agents,1 and oral formulations now comprise up to 35% of all oncologic agents in development.2,3 Oral chemotherapy use is accompanied by unique concerns, including ensuring patient adherence, managing side effects, educating patients on safe handling requirements, and avoiding food and drug interactions.3 However, according to a survey of 42 US cancer centers, the majority do not have a system in place to monitor and manage these drugs.4
Taking oral chemotherapy as prescribed is essential to effectively combatting disease. Adherence results when the health care provider’s recommendations and the patient’s subsequent behavior are in alignment. Unlike IV chemotherapy, oral formulations require that the patient assume responsibility for medication compliance, manage complex treatment regimens, and maintain an awareness of potential side effects. Although patients taking oral chemotherapy encounter many of the same challenges that affect patients taking oral medications to treat other chronic disease states, adherence to the treatment regimen is especially important to prevent the serious consequences of cancer progression. Because safe use of oral chemotherapy requires robust oversight, pharmacists, as the medication experts, should take a leadership role in managing use, including counseling patients, assessing adherence, managing side effects and drug-drug interactions (DDIs), and developing a positive relationship with the patient that facilitates excellent care.
Implementing an Oral Chemotherapy Clinic
Baptist Health Lexington in Lexington, Kentucky, implemented a pharmacist-run oral chemotherapy clinic in 2017 to support patients receiving oral chemotherapy. See the SIDEBAR for more information about the clinic’s work.
The Role of the Pharmacist
Patient Education and Counseling
Because of their knowledge base, pharmacists are in a prime position to counsel patients prescribed oral chemotherapy. The pharmacist should ensure that the patient understands the treatment regimen, including which medications they are taking and what those medications do. In addition, the patient must have an organized plan to manage these medications and should know when to request assistance. Pharmacists must collaborate with the health care team to address individual patient barriers, particularly ways to help the patient organize for successful administration (for example, using pill boxes and medication calendars), as well as manage side effects that may occur.
Pharmacists should play a central role in assessing patient adherence. Factors affecting adherence to oral chemotherapy include high cost, the patient’s level of health literacy, the quality of the health care provider’s counseling, and the trust level developed between the patient and the health care team. Even when covered by insurance, oral chemotherapy often places a high financial burden on patients. In response, some patients may alter their medication schedule in order to extend their therapy.5 Patients must have adequate health literacy, be properly educated regarding how to take their medications correctly, and have a support system at home.
Managing Side Effects and DDIs
Patients with cancer are at particular risk for DDIs because they are usually taking several medications for the management of both their cancer and comorbidities. Elderly patients face additional concerns involving DDIs and the normal physiologic changes of aging. Studies show that 27% to 58% of ambulatory cancer patients had at least one potential DDI6,7; another study found that 14% of DDIs included an anticancer therapy. DDIs were related to a number of factors, including the patient’s total number of medications, treatment type, cancer type, and the presence of comorbidities.8
It is important to note that while some patients may be non-adherent due to side effects, others may be reluctant to report side effects to the oncologist or other health care practitioners for fear that they may stop their oral chemotherapy. This behavior could cause worsening side effects and demonstrates the importance of following up with patients and providing resources for side-effect management. In one study, 87% of patients said that they would continue treatment even if a serious side effect occurred, with or without consulting their oncologist.9 Careful monitoring may identify side effects earlier so they can be addressed before they worsen or become irreversible. To monitor side effects in patients taking oral chemotherapy at home, the provider-patient relationship must be strong, and communication regarding when to contact the provider must be clear.
Developing a Relationship of Trust and Communication
Pharmacists must develop a trusting relationship with patients to ensure sufficient communication about the importance of the oral chemotherapy, the regimen, and its role in their disease state, as well as to motivate medication compliance and prompt frank discussions of side effects.5 The pharmacist should consistently follow up with the patient, and actively communicate their availability to discuss patient concerns. A pharmacist can foster a trusting relationship by demonstrating empathy through minimizing distractions during counseling sessions, engaging in active listening, and including the patient in the education by asking open-ended questions. If possible, include a caregiver or family member in the conversation.
Proper management of oral chemotherapy agents ensures that patients prescribed these medications adhere to treatment, receive timely assistance with side effects, and avoid DDIs. Pharmacists should assume a leadership role in providing oversight of oral chemotherapy drugs. As more oral chemotherapy medications enter the market, implementing a pharmacist-led oral chemotherapy clinic is one option to provide robust oversight, ensuring safe and effective use.
- US Department of Health and Human Services. Food and Drug Administration. Novel Drug Approvals for 2017. www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm. Accessed January 16, 2018.
- Mancini R, Wilson D. A pharmacist-managed oral chemotherapy program. Oncol Issues. 2012;27(1):28-31.
- Pharmacist’s Letter. Oral Oncology Drugs: Addressing the Challenges. Course No. 216 (2013). http://pharmacistsletter.therapeuticresearch.com/ce/cecourse.aspx?pc=13-216&AspxAutoDetectCookieSupport=1. Accessed January 16, 2018.
- Ma CSJ. Role of pharmacists in optimizing the use of anticancer drugs in the clinical setting. Integ Pharm Res Pract. 2014;3:11-24.
- McCue DA, Lohr LK, Pick AM. Improving adherence to oral cancer therapy in clinical practice. Pharmacotherapy. 2014;34(5):481-494.
- Riechelmann RP, Tannock IF, Wang L, et al. Potential drug interactions and duplicate prescriptions among cancer patients. J Natl Cancer Inst. 2007;99:592-600.
- van Leeuwen RW, Swart EL, Boven E, et al. Potential drug interactions in cancer therapy: a prevalence study using an advanced screening method. Ann Oncol. 2011;22:2334-2341.
- van Leeuwen RW, Brundel DH, Neef C, et al. Prevalence of potential drug-drug interactions in cancer patients treated with oral anticancer drugs. Br J Cancer. 2013;108(5):1071-1078.
- Bourmaud A, Henin E, Tinguat F, et al. Adherence to oral anticancer chemotherapy: what influences patients’ over or non-adherence? Analysis of the OCTO study through quantitative-qualitative methods. BMC Res Notes. 2015;8:291. doi: 10.1186/s13104-015-1231-8.
Megan May, PharmD, BCOP, is a clinical oncology pharmacy specialist at Baptist Health Lexington in Lexington, Kentucky.
Case Study: Baptist Health Lexington’s Pharmacist-Run Oral Chemotherapy Clinic
Implementing a pharmacist-run oral chemotherapy clinic is an excellent way for pharmacists to provide cutting-edge treatment to their patients with cancer, implement processes that directly benefit the patient, and promote the profession of pharmacy. Patients typically have many questions and concerns regarding the initiation of an oral chemotherapy agent. The goal of the Baptist Health Lexington oral chemotherapy clinic is to provide counseling, education, and monitoring parameters for patients as they begin treatment to help ease this transition of care.
Clinic workflow is centered around patient convenience. Pharmacists are specially trained in all aspects of medication therapy. The provider notifies the pharmacist when a patient will begin treatment with an oral chemotherapy agent. The pharmacist, in collaboration with a financial counselor, processes the prescription, including (but not limited to): identifying the pharmacy that will provide the medication, completing prior authorizations and appeals, ordering the medication, registering the patient for assistance programs, providing the initial in-person education sessions, and completing follow-up calls throughout the course of treatment. The pharmacist provides information about the chemotherapy agent(s), written calendars, recommendations for adherence, and answers any patient questions. After the prescription has been processed and the patient has received counseling, the patient begins their oral chemotherapy regimen. Thereafter, the pharmacist provides intermittent follow-up phone calls to assess medication adherence, identify side effects, and monitor for any DDIs.
The impact of the clinic pharmacist’s interventions with patients prescribed oral chemotherapy was evaluated via a retrospective chart review. All patients (n=125) who received pharmacist-based oral chemotherapy education and follow-up at the cancer center, in person or via telephone, from September 1, 2015 to February 1, 2016, were enrolled in the study. Patients must have received initial education with a clinic pharmacist to be included in the evaluation. Charts were reviewed at week 1 and at months 1, 2, and 3. The pharmacist’s notes were reviewed to identify interventions, including those for side effect management, DDIs, and adherence. Other interventions documented included the provision of a medication calendar, medication reconciliations, or recommendations to the patient or provider for over-the-counter or prescription medications.
The results demonstrated that the clinic pharmacist performed an intervention 74% of the time; the most common interventions were for side effect management (54%) and adherence concerns (21%). The most prevalent side effects noted were fatigue/drowsiness (24%), nausea/vomiting (18%), and diarrhea/constipation (14%). For each patient encounter, the pharmacist spent approximately 26 minutes (range of 10 to 60 minutes) for preparation and counseling.
This study emphasizes the impact the pharmacist has on side-effect management, providing critical interventions, and improving adherence. Implementing the oral chemotherapy clinic is a powerful example of the health system’s commitment to continuous quality improvement. The pharmacist-led clinic has significantly increased oversight of patients receiving oral chemotherapy agents, improving the transition of care to the outpatient setting.
The positive results of this study helped us secure funding for an additional full-time oncology pharmacist and a full-time financial counselor devoted to the oral chemotherapy clinic.
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