Chicago, IL—Pharmacy-led oral chemotherapy programs lead to improved patient adherence and satisfaction, according to Benyam Muluneh, PharmD, BCOP, CPP, Oncology Clinical Pharmacist Practitioner, University of North Carolina (UNC) Medical Center, Malignant Hematology Clinic, Chapel Hill.
Dr Muluneh and colleagues at UNC established a successful pharmacy-led oral chemotherapy program that earned UNC’s Cancer Hospital the American Society of Health-System Pharmacists National Best Practices Award.
“When pharmacists are present and managing patients and their toxicities, it does translate to improved clinical outcomes. We were excited to illustrate that and validate what we already knew,” Dr Muluneh told attendees at the 4th Annual Hematology/Oncology Pharmacy Association Oncology Pharmacy Practice Management Program.
The Problem of Nonadherence
In recent years, the medication management of patients with cancer has shifted away from infusion clinics and toward oral chemotherapy administered at home, and approximately 33% of chemotherapy drugs available now are oral drugs.
“These agents have really transformed how we manage our patients. Now patients with chronic myeloid leukemia can live as long as their age-matched counterparts without chronic myeloid leukemia, and this is a disease that was a death sentence back in the 70s and 80s,” Dr Muluneh said.
Although oral chemotherapy is convenient and empowering to patients, nonadherence remains the single most modifiable risk factor for poor patient outcomes, he added. Therefore, Dr Muluneh and his team at UNC built an integrated, closed-loop, pharmacy-led oral chemotherapy program in which the clinical pharmacist served as the liaison between the medical team and the specialty pharmacy interacting with patients.
In a needs assessment of 95 patients receiving oral chemotherapy at UNC’s Cancer Hospital, the team identified poor adherence rates. Of the patients taking oral chemotherapy drugs that had a significant food–drug interaction, 44% did not always think about the last time they ate, and 14% were taking their oral drugs incorrectly with regard to food. Thirty percent were sometimes forgetting to take their oral chemotherapy, 21% deliberately cut back on their oral drugs at times because of adverse effects or refill delays, and, of the patients cutting back, 38% did not tell their physician.
Dr Muluneh and colleagues then conducted an analysis and identified 2 major gaps: lack of communication from the external specialty pharmacy, and the absence of a clinical pharmacist on-site to monitor adherence and manage adverse drug reactions. They hypothesized that these 2 factors were leading to decreased patient benefit from oral chemotherapy.
“It became evident that these patients needed someone following them during their entire oral chemotherapy treatment. We’re spending a lot of energy getting medications to these patients, so we have to make sure they’re staying on them and tolerating them,” Dr Muluneh noted.
Intervention Leads to Improved Adherence
The study included 107 patients with varying malignancies, and there were 350 documented patient encounters with clinical pharmacists.
When a physician made a referral for an oral chemotherapy drug, the clinical pharmacist conducted a drug–drug interaction check and educated the patient on proper administration, toxicity, and management. The clinical pharmacist also worked with the medication assistance team to conduct an investigation of benefits and copay assistance. Once these cost-related barriers were overcome, the prescription was sent to the specialty pharmacy and patients received their medications.
Clinical pharmacists conducted regular patient follow-ups every 2 to 4 weeks, coupled with physician assessment beginning at 4 to 6 weeks, until an assessment of adherence and toxicities at 3 months postinitiation. If, at that point, the patient was deemed stable, follow-up continued every 3 months via phone call, and every 6 months in the clinic. If the patient was deemed unstable, checkups were scheduled every 2 to 4 weeks, as needed.
In the malignant hematology population, the goal for adherence was >90%, and extrapolated from chronic myeloid leukemia literature, which demonstrated that major molecular response rates in patients with chronic myeloid leukemia are highly correlated with adherence; in the breast and gastrointestinal population, the goal was >80% adherence, based on breast cancer literature defining that figure as optimal, Dr Muluneh explained. After the program was implemented, 94% of patients with hematologic malignancies were adherent, as were 85% of patients in the clinic for breast and gastrointestinal cancers.
The team used a simple questionnaire and found that patients’ understanding of their oral chemotherapy went from 43% preintervention to 95% postintervention.
“Looking at patient understanding is an easy way to track impact. It’s a very nice way to validate that a pharmacist providing education brings about significant impact in terms of patient understanding of how they’re supposed to take their medications,” Dr Muluneh told attendees.
Achieving early molecular response by 3 to 6 months after starting therapy is associated with increased overall survival in patients with chronic myeloid leukemia, he said. The pharmacy-driven oral chemotherapy program led to higher early molecular response rates (pathologic complete response <10%) than in published clinical trials (93% vs 66%, respectively).
Major molecular response rates (pathologic complete response <0.1%) were also superior to clinical trial data (79% vs 60%, respectively). In addition, 100% adherence rates in the chronic myeloid leukemia population rose from 52% preintervention to 74% postintervention.
The intervention also led to positive financial outcomes. The clinic exceeded their $4 million in expected revenue, which allowed for physical expansion at an off-site location with new automation.
“I do think that having an internal specialty pharmacy dispensing all oral chemotherapy agents improves communication and leads to better patient outcomes. And when I’m having conversations with manufacturers about access, I tell them this is best practice and what’s best for patients,” said Dr Muluneh.