Benyam Muluneh, Pharm.D., BCOP, CPP, Molly Schneider, Pharm.D., Aimee Faso, Pharm.D., BCOP, CPP, John Valgus, Pharm.D., BCOP, M.H.A., Lindsey Amerine, Pharm.D., M.S., BCPS, Rowell Daniels, Pharm.D., M.S., Scott Savage, Pharm.D., M.S.
University of North Carolina Medical Center, Chapel Hill, North Carolina
A paradigm shift is occurring in the management of patients with cancer as treatment moves away from the infusion clinic to the patient's home with oral chemotherapy. Twenty-five percent of all chemotherapy agents in development are oral. Although convenience and tolerability are improved, oral chemotherapy adds new complexities including establishing accurate prescription generation and delivery, ensuring affordability, monitoring and managing adverse drug reactions, and optimizing adherence. Non-adherence is a major challenge and has been demonstrated to compromise efficacy. With the goal of reducing non-adherence, we built an integrated, closed-loop, pharmacy-led oral chemotherapy program.
Prior to implementation, 93 patients were surveyed on their oral chemotherapy experience. Adherence rates were low; 30% of patients admitted to forgetting to take their medication and 21% intentionally cut back because of toxicities or delays in receiving refills from specialty pharmacies. Our program entailed building an off-site pharmacy that was able to provide URAC accredited specialty pharmacy services. We also embedded specialized clinical pharmacists in the oncology clinics who saw patients for education, adherence monitoring, and adverse effect management. Clinical pharmacists managed patient toxicities through collaborative practice agreements covering gastrointestinal complications, anticoagulation, pain management, and antimicrobial prophylaxis. Adherence to oral chemotherapy was measured with patient surveys and the medication possession ratio (MPR).
After implementation, 107 patients were enrolled into our program. All patients were educated prior to starting on oral chemotherapy. Oral chemotherapy understanding increased from 43% to 95% assessed using pre- and post-tests. Patient reported adherence was 86% and 94.7% for the GI/Breast and malignant hematology patient populations, respectively. These adherence rates were validated with MPR which revealed rates of 85% and 93.9%, respectively. These met the evidence based, pre-specified targets for adherence. There were 350 encounters with a clinical pharmacist and 318 adverse effects reported which led to 235 interventions including side effect management/supportive medication initiation (n=133), dose modification (n=37), lab/level order/assessment (n=24), referral to primary oncologist or other provider (n=16), and drug-drug interactions assessment/intervention (n=24). The pharmacy-driven oral chemotherapy program led to a higher major molecular response (MMR) rate (83%) in our chronic myeloid leukemia (CML) population compared with published clinical trials (average MMR rates 40% and 60% with one year and two year follow up, respectively). Also, in fiscal year (FY) 2015, the estimated annual potential revenue for oral chemotherapy distribution from the Hematology/Oncology service line was $4 million. Actual revenue earned exceeded expectation for this FY.
We developed an innovative model which resulted in improved patient knowledge regarding oral chemotherapy, improved adherence rates to exceed nationally established thresholds of excellence, and superior major molecular response outcomes for CML patients compared to published literature. While providing these clinical benefits, our program has also contributed positively to the financial goals of the department of pharmacy and the health system overall.
References:
- Weingart SN, Brown E, Bach PB et al. NCCN Task Force Report: oral chemotherapy. J Natl Compr Canc Netw. 2008; 6(suppl 3):S1–S14.
- Zerillo JA, Pham TH, Kadlubek P et al. Administration of oral chemotherapy: results from three rounds of the quality oncology practice initiative. J Oncol Pract. 2015; 11:e255-62.
- Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol. 1997; 50:105-16.
- 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; 28:2381-8.
- Partridge AH, Archer L, Kornblith AB et al. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104. J Clin Oncol. 2010; 28:2418-22.
