CHICAGO—The pace of U.S. Food and Drug Administration approval of oral anticancer medications has rapidly increased, from less than one a year at the turn of the century to 10 in 2018. While patients generally prefer taking oncolytics by mouth at home to intravenous infusions at clinics, lower rates of adherence and the greater responsibility placed on patients and caregivers associated with oral administration have forced oncology clinics to rethink how they manage patient care.

A recent article in Pharmacy by Gennaro Paolella, PharmD, of the Naval Medical Center San Diego and colleagues at the University of Illinois at Chicago provides suggestions for how oncology teams can use the skills of clinical pharmacists to better manage patient administration of cancer drugs.1

The move from clinic-based to home-based oncology care requires new ways of structuring patient interactions to ensure optimal care, creating increased opportunity and demand for pharmacists with training in oncology, the authors said.

“The expectations for communication, motivation and context of the patient, providers and support team are all completely different and need to be evaluated to ensure the new model is successful,” said co-author Andrew Boyd, MD, associate professor in the College of Applied Health Sciences at the University of Illinois at Chicago.

Adherence poses a significant challenge when patients take these medications at home. While patients with cancer typically have significant motivation to take oral anticancer medications as directed, estimates for adherence typically range from 20% to 90%, with about 10% of patients never picking up their first prescription to start treatment, the researchers noted.

The reasons for failing to follow the recommended therapeutic regimen include confusion over complex dosing and timing requirements, concern over proper handling of medications, intolerable side effects, lapsed refills, poor communication, difficulty getting to a clinic for follow-up, inadequate social support and economic challenges.

The greater responsibility given to patients means “you are even more dependent on the patient to be active partners in their care. You need more communication with the patients to ensure adherence,” Boyd told U.S. Medicine.

For many oncology teams, much of the responsibility for communication, ongoing education and monitoring falls to pharmacists.

Pharmacists must “engage your patient population to better understand their struggles and understanding of the new OAM models and use technology as appropriate to assist the new models of care,” Boyd said.

Pharmacy-Managed OAM Clinic

In recognition of the need to improve communication with patients on OAMs, the Malcom Randall VAMC in Gainesville, FL, created a pharmacy-managed oral chemotherapy clinic nearly a decade ago. The oncology team recognized that many patients were not taking medications as directed or failed to communicate serious adverse effects to their care team between clinic visits and saw the need for more in-depth counseling and monitoring by oncology pharmacy staff.

In an article in the Asia-Pacific Journal of Oncology Nursing, Paige May, PharmD, BCOP, oncology pharmacy specialist at the Gainesville VAMC and clinical assistant professor at the University of Florida College of Pharmacy, and her colleagues explained how the clinic runs and offered tips for VAMCs and other organizations that want to establish similar operations.2

To ensure that all patients receiving oral anticancer medications received education and were monitored by the pharmacy team, all oral chemotherapy drugs were tagged “pharmacy-only entry,” so that one of the clinic’s three oncology pharmacists had to review and enter the order prior to dispensing. An oncology pharmacist or pharmacy intern trained on oral chemotherapies provided initial in-depth counseling and worked with patients to establish medication routines that worked with their lives and preferences.

While more comprehensive initial counseling helped patients better understand how to take and handle the drugs, the team quickly realized the need to determine how well patients retained the information and followed the treatment regimen once they returned home. Consequently, they implemented a weekly phone call to patients for the first three weeks of care, with patients scheduled to return to the clinic in the fourth week.

The phone call included an oral chemotherapy assessment questionnaire to verify adherence and proper administration, check for side effects and suggest ways to manage any issues that have arisen. The team built the questionnaire template into the electronic medical record to simplify documentation and provide all team members access to the information.

“It is important to note that such a clinic is not taking the place of regularly scheduled oncology visits. It is meant to supplement these visits in order to provide safe and effective oncology care for patients who are prescribed oral anticancer medications,” May and her colleagues emphasized.

Other VA oncology pharmacists offer telehealth appointments for virtual visits that might allow better evaluation of side effects and patient assessment, said Julia Hammond, PharmD, BCOP, an oncology clinical pharmacy specialist at the Durham VAMC. Other technology such as dashboards that simplify tracking patients, performing follow ups, and monitoring side effects have also increased efficiency, she told U.S. Medicine.

Despite the increased use of technology, the Gainesville team anticipated a need to expand the size of the clinic as the number of patients taking oral oncolytics continues to rise.

They Gainesville team noted, as well, that the number of pharmacists trained in oncology would likely not keep pace with demand.

Need for Training

While pharmacists play a growing role in managing patients taking OAMs, relatively few have received specific training in oncology.

“Typically only about 30% are exposed to oncology practice through four-to-six week Advanced Pharmacy Practice Experience clerkship electives,” Paolella and his colleagues noted and fewer complete specialized postgraduate pharmacy residency training or other structured traineeships. Less than 1% of U.S. pharmacists have achieved the highest level of credentialing in the field and become board-certified oncology pharmacists.

“Oncology pharmacists have the ability to play a central role in the management of OAMs due to their extensive knowledge in medication administration, monitoring and reimbursement,” but their limited numbers require other ways to leverage those skills, they said. “To help meet patient demand, the oncology pharmacist workforce needs to help educate non-specialist pharmacists and other healthcare professionals.”

The VA offers a number of ways for pharmacists involved in oncology medication management to learn from each other. “Networking within the VA is above and beyond the most helpful aspect for this. We work together via Skye, phone, on the listserv and through email to stay in contact with each other and to share tools and information,” Hammond said.

Pharmacists without oncology training always have a back up, Hammond added. “If any pharmacist needs help in these situations, they can identify an oncology pharmacist within their VISN through the pharmacy SharePoint site and reach out to them with any questions.”

1 Paolella GA, Boyd AD, Wirth SM, Cuellar S, Venepalli NK, Crawford SY. Adherence to Oral Anticancer Medications: Evolving Interprofessional Roles and Pharmacist Workforce Considerations. Pharmacy (Basel). 2018 Mar 8;6(1). pii: E23.

2 May P, LaPlant K, McGee A. Practice Model: Establishing and Running an Oral Chemotherapy Management Clinic. Asia Pac J Oncol Nurs. 2017;4(4):299–303. doi:10.4103/apjon.apjon_9_17

FDA Announces Cancer Drug Approvals So Far This Year

As of April 19, the Food and Drug Administration announced the following approvals/safety notifications in the hematology/oncology category for this year:

  • pembrolizumab (KEYTRUDA, Merck & Co. Inc.) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC) and for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation or metastatic NSCLC. Patients’ tumors must have no EGFR or ALK genomic aberrations and express PD-L1 (Tumor Proportion Score [TPS] ≥1%) determined by an FDA-approved test.  The FDA also approved the drug for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. 
  • atezolizumab (TECENTRIQ, Genentech Inc.) in combination with carboplatin and etoposide, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), as well as for PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer.  
  • trastuzumab and hyaluronidase-oysk injection, for subcutaneous use (Herceptin Hylecta, Genentech Inc.). Herceptin Hylecta is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase, for the treatment of HER2 overexpressing breast cancer. 
  • trifluridine/ tipiracil tablets (LONSURF, Taiho Pharmaceutical Co., Ltd.)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. 
  • caplacizumab-yhdp (CABLIVI, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
  • cabozantinib (CABOMETYX, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.