Utilization patterns for oral oncology medications in a specialty pharmacy cycle management program.

BACKGROUND: The cycle management program (CMP) was implemented in 2008 at a national specialty pharmacy with a focus on providing specialized counseling and monitoring for patients on select oral oncology medications. The program now includes nine medications: bexarotene, dasatinib, erlotinib, everolimus, nilotinib, pazopanib, sorafenib, sunitinib, and vorinostat. Patients receive frequent assessments to encourage adherence, identify adverse events, and track discontinuations through a pharmacist outreach at the initiation of therapy, day 10 and 20 of the first month, then monthly thereafter. The use of oral agents is increasing in cancer patients, shifting away from regimens exclusively involving intravenous chemotherapy. This offers advantages for patients in terms of convenience, but introduces risk as patients become more responsible for the administration and monitoring of the medications. PURPOSE: To evaluate utilization patterns of the oral oncology medications in the CMP including adverse event occurrence, medication discontinuations, and adherence markers. METHODS: This study is a retrospective review of patient-reported data from the CMP assessments completed in 2013. Data collected include adverse events and grades, adherence markers, and discontinuation rates. A total of 1163 assessments were reviewed from 557 patients. The assessments included in the analysis were the initial assessment, 10-day assessment, 20-day assessment, and the first monthly follow-up assessment, which encompasses the first two months of therapy. RESULTS: A total of 1453 adverse events were reported. Adverse events were cited as the reason for 39% of discontinuations and 28% of missed/held doses. A total of 101 discontinuations were reported across the nine CMP medications based on the first two months of data. Missed or held doses were reported in 130 assessments. CONCLUSIONS: Patient engagement and pharmacist interventions, through programs such as the CMP, are important to help patients manage these complex, high-risk medications.

The Role of Consumerism in Pharmacy Education.

The notion of consumerism and that students are customers of pharmacy colleges was explored by proponents and opponents of the idea. First, a working definition of a "customer" in pharmacy education is pondered with respect to the roles and responsibilities of students and schools/colleges of pharmacy. Second, the pros and cons of "student-centered" education are considered in the light of students and their families being consumers of the educational experience. Third, the duality of student-centered education is discussed including student engagement/disengagement in their learning, professional/unprofessional behaviors, and shared/individual responsibilities. Lastly, learning and teaching environment dynamics are discerned when higher education becomes more student-centric and how that may affect the overall outcome of the student and the goals of pharmacy educational programs.

Review of cyclin-dependent kinase 4/6 inhibitors in the treatment of advanced or metastatic breast cancer.

OBJECTIVE: The purpose of this study is to review CDK 4/6 inhibitors used to treat metastatic breast cancer for patient safety, cost and utilization. By evaluating patient outcomes and payer influence, this study will provide critical information to aid prescribers in therapeutic decisions. METHODS: This retrospective cohort study included patients from a national specialty pharmacy with a diagnosis of breast cancer and received either palbociclib, abemaciclib, or ribociclib for treatment. Patients were stratified into four subgroups based on their total oncolytic regimen at the time of their first eligible study medication dispense. Pharmacy claims data were reviewed to determine cost and therapy adherence. RESULTS: The mean proportion of days covered was highest in patients on combination therapy with a hormone agent, 81.0%. While secondary insurances largely affected final patient out-of-pocket costs, final copays were significantly lower than the average wholesale price (AWP) of each CDK 4/6 inhibitor. When analyzing patient reported side effects, over 60% of the study population did not experience an adverse drug event (ADE) during the study time period. Ribociclib had the fewest number of reported side effects with abemaciclib patients reporting the most. Although reported ADE profiles were similar across all three study medications, difference in frequency should be evaluated when considering medication choice with specific comorbidities. CONCLUSION: CDK 4/6 inhibitors have demonstrated safety and tolerability in HR-positive/HER2-negative breast cancer patients. Real world safety data and out-of-pocket patient costs in addition patient specific comorbidities should be considered when developing a treatment plan that includes a CDK 4/6 inhibitor selection.

Retrospective Analysis of Medication Utilization and Clinical Outcomes in Patients With Idiopathic Pulmonary Fibrosis Treated With Nintedanib or Pirfenidone.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease which results in thickening and scarring of the interstitial tissue. As the only 2 Food and Drug Administration (FDA)-approved medications on the market, it is valuable to compare the impact of nintedanib and pirfenidone on clinical outcomes. Records of patients who started nintedanib or pirfenidone between calendar years 2015 and 2016 at a national specialty pharmacy were retrospectively reviewed. Data collection was derived from patient management applications and statistical data analysis was completed in SAS (SAS Institute Inc®). The nintedanib population contained 2605 patients and of the population completing clinical assessment surveys (n = 1343), 46% of respondents (n = 612) reported no adverse events, with the remaining 54% reporting at least 1 adverse event. Average proportion of days covered (PDC) was 84.2% (SD = 17.0). Average final monthly copay for this group was $235. The pirfenidone population had 1322 patients, and of the surveyed population (n = 764), 58% of respondents (n = 445) reported no adverse events, with the remaining 42% reporting at least 1 adverse event. Average PDC was 83.4% (SD = 17.3). Average final monthly copay for this group was $339. Outcomes in the studied IPF population were similar for nintedanib and pirfenidone.

Retrospective Analysis of the Medication Utilization and Clinical Outcomes of Patients Treated with Various Regimens for Hepatitis C Infection.

BACKGROUND: The hepatitis C virus (HCV) is the most common chronic blood-borne infection and the leading cause of liver transplantation in the United States. There are approximately 3.2 million people currently infected with HCV in the United States. In late 2013, the introduction of sofosbuvir and simeprevir represented a critical advancement in the treatment of HCV by improving sustained virologic response (SVR) rates. PURPOSE: The purpose of this study was to evaluate medication utilization and clinical outcomes of patients with HCV who were treated with any Food and Drug Administration-approved combination of ribavirin, peginterferon products, simeprevir, and sofosbuvir. METHODS: Prescription records and clinical assessment forms of patients who started HCV therapy and were eligible for SVR between January 1, 2014, and December 31, 2014, were retrospectively reviewed. Data collection included patient demographics, genotype, SVR, patient-reported adverse events, discontinuations, and adherence markers. RESULTS: A total of 367 eligible patients were identified who had initiated treatment during the study period. Genotype 1 was the most common genotype, and an overall SVR rate of 86.9% was observed. Results were similar to those seen in phase III clinical trials. In addition, adverse events of these medications were more tolerable, and discontinuation rates were lower than with previous therapies.

Development of a community residency program with a focus on specialty pharmacy.

PURPOSE: An innovative community residency program that provides training in the clinical and administrative aspects of specialty pharmacy practice is described. SUMMARY: An ongoing rapid rise in U.S. approvals of specialty therapies for chronic diseases and conditions (e.g., Crohn's disease, cystic fibrosis, infertility, hepatitis C infection, multiple sclerosis) is fueling demand for pharmacists trained to meet the complex needs of patients receiving those therapies, which are typically subject to risk evaluation and mitigation strategy (REMS) requirements and limited distribution arrangements. In 2011, Duquesne University Mylan School of Pharmacy partnered with Walgreens Specialty Pharmacy to launch a one-year community residency program designed to (1) provide enhanced education on diseases and conditions targeted by specialty therapies, (2) develop well-rounded clinicians who are fully knowledgeable of the medications used to treat those disorders, and (3) prepare trainees for the operational and business-related challenges of specialty pharmacy practice. The first half of the residency year emphasizes direct patient care experiences, with team-based rotations focusing on specific disease states and health conditions; the second half of the residency program emphasizes operational-administrative training in areas such as clinical program development, resource utilization review, REMS compliance, contracting, and navigating manufacturer-sponsored patient assistance programs. Other program components include a one-month external rotation at a managed care organization, research projects, and teaching experiences. CONCLUSION: A unique community residency program jointly developed by Duquesne University and Walgreens Specialty Pharmacy prepares trainees for careers in diverse clinical, managed care, community-based, and academic practice settings.

The impact of elective active-learning courses in pregnancy/lactation and pediatric pharmacotherapy.

OBJECTIVE: To implement and evaluate the impact of 2 elective courses, Pregnancy & Lactation and Pediatrics on student acquisition of knowledge and development of lifelong learning skills related to these special populations. DESIGN: Two 3-credit elective courses were implemented using various student-driven learning techniques, such as case-based exercises, group presentations, pro-con debates, and pharmacist "grab bag" questions. Strong emphasis was placed on medication literature retrieval and analysis, and a wiki was used to create an electronic resource for longitudinal use. ASSESSMENT: Pre- and post-course tests showed significant improvement in knowledge related to pregnancy, lactation, and pediatrics. Pre- and post-course confidence and ratings on satisfaction survey tools also revealed significant improvement in several domains relating to lifelong-learning skills, knowledge related to medication use within these special populations, use of technology to enhance learning, and overall course design. CONCLUSION: The combination of student-directed learning techniques used in 2 pediatric-concentration courses is an effective teaching model.