Emily Mackler

Institutional Experience with Voriconazole Compared with Liposomal Amphotericin B as Empiric Therapy for Febrile Neutropenia

Study Objective. To assess the effectiveness, safety, and cost of empiric treatment of febrile neutropenia before and after implementing an algorithm in which voriconazole was substituted for liposomal amphotericin B (L‐AmB).

Administration of Oral Chemotherapy: Results From Three Rounds of the Quality Oncology Practice Initiative

PURPOSE Although use of oral chemotherapy is becoming more prevalent, little is known about the quality of care that patients receive when these agents are prescribed. Moreover, few practice-level systems are in place to ensure safe management of oral chemotherapy in the vulnerable population of patients with cancer. METHODS We analyzed results from 155 practices that were voluntarily participating in the American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) program on 17 test measures of oral chemotherapy administration and management in at least one of three collection periods: spring or fall of 2012, or spring of 2013. The 17 test measures cover three domains: treatment plan documentation, patient education, and adherence/toxicity monitoring. We defined composite scores for each of the three domains. We analyzed the composite scores by secular trend and tested the difference in composite scores for the three domains. Additionally, we tested change in scores over time among practices that participated at least twice. RESULTS The majority of data was provided by QOPI-certified practices. Overall, mean practice composite scores ranged from 66% to 68% for treatment plan documentation, 51% to 57% for patient education, and 75% to 81% for adherence/toxicity monitoring. Composite scores for practices that participated more than once did not improve significantly. CONCLUSION The collection of oral chemotherapy test measure data is feasible. Composite scores for treatment plan documentation and patient education were not only lower, but had greater variability compared with adherence/toxicity monitoring. Improvement opportunities exist for patients who are prescribed oral chemotherapy.

Drug costs and utilization after implementation of a posaconazole prophylaxis protocol in adults with acute myelogenous leukemia.

PURPOSE Drug costs and utilization after implementation of a posaconazole prophylaxis protocol in adults with acute myelogenous leukemia (AML) were studied. METHODS Adult patients who initiated induction or reinduction chemotherapy for the treatment of AML between December 1, 2006, and March 31, 2008, at a tertiary care hospital were included in this retrospective cohort study. Patients were divided into two groups: preprotocol (treated before June 1, 2007) and postprotocol (treated on or after June 1, 2007). Medical charts, including pharmacy and laboratory data, were reviewed for all patients. Outcomes measured included antifungal and antibacterial drug costs and utilization and total pharmacy costs. RESULTS A total of 66 patients were evaluated (33 in each group). Baseline characteristics, except patient age, were similar between groups. Each group incurred similar costs and utilized resources for similar periods of time as evidenced by similar lengths of stay, duration of neutropenia, and mortality. Antibacterial costs, total pharmacy costs, and other utilization outcomes were also similar between the two groups. Alterations to antifungal management strategy occurred more often in the postprotocol group (33% versus 58%, p = 0.048). CONCLUSION Implementation of a posaconazole protocol did not significantly alter antifungal or antibacterial drug costs or utilization or total pharmacy costs. Prophylactic posaconazole was frequently changed to alternative antifungal therapy due to an adverse drug event, perceived lack of efficacy, avoidance of a drug interaction, or inability to tolerate oral intake.

Oncology Pharmacist Opportunities: Closing the Gap in Quality Care

PURPOSE ASCO has worked to facilitate the improvement in quality oncology care via the development of the Quality Oncology Practice Initiative (QOPI). The extent to which the ASCO QOPI identifies areas in which pharmacists may enhance care is not known. These findings are important, as pharmacists are an integral part of the care team, providing direct clinical care in addition to medication use guidelines and practice-based policies. In addition, high-performing practices may receive reimbursement from the Centers for Medicare and Medicaid Services. METHODS Three pharmacists reviewed 200 QOPI measures for potential pharmacist involvement. We used the Hematology/Oncology Pharmacy Association Scope of Practice document and a validated summary of services provided by board-certified oncology pharmacists to identify which practice domains and pharmacy services would best fit the care provided by the selected QOPI measures. RESULTS A total of 177 QOPI measures were analyzed. Potential areas of pharmacist impact were identified in 67 (38%) of the included metrics. Measures largely related to optimizing drug therapy through the development and implementation of pharmacy guidelines. Patient counseling and symptom management are services that best described the majority of QOPI measures deemed actionable by a pharmacist. We also found that several QOPI measures pharmacists can intervene upon overlap with metrics currently assessed for reimbursement via the Centers for Medicare and Medicaid Services Merit-Based Incentive Payment System. CONCLUSION Oncology pharmacists are uniquely positioned to improve the quality of care provided to patients with cancer within the team-based setting.

Association of high symptom burden with oral oncolytic agents.

177 Background: Increasing numbers of cancer patients are being treated with oral oncolytics. This change represents a shift from frequent direct observation during intravenous therapy to periodic observation and increased necessity for improved monitoring and self-care management. Despite this shift, patients are at risk to develop many of the same chemotherapy-associated symptoms and toxicities. We sought to understand the symptom burden associated with use of oral oncolytics. METHODS Michigan Oncology Quality Consortium (MOQC) sponsored a quality improvement initiative focused on improving oral oncolytic care. Eight oncology practices participated. Patients were assessed with a modified Edmonton Symptom Assessment System (ESAS) prior to each outpatient visit. A total of 537 surveys were analyzed. 13 measures were categorized into mild (0 to 3), moderate (4 to 6), and severe (7 to 10) symptom burden. RESULTS Overall, the average ESAS symptom score was mild in 81% of patients, moderate in 13% of patients, and severe in 6% of patients. These average scores, however, obscure the significant burden in select ESAS domains. For example, 39% of patients categorized their overall well-being as being moderate/severely affected; 38% of patients felt they were moderate/severely fatigued, and 21% indicated moderate/severe neuropathy symptoms. Notably, 118/537 (24%) of the assessments had 4 or more symptoms rated moderate to severe. CONCLUSIONS Patients taking oral oncolytics experience significant symptom burden that impacts quality of life. Intolerance of oral oncolytics may lead to adherence issues, potentially affecting expected outcomes. Given the prevalence of symptoms and potential for toxicity, self-care strategies to improve early recognition and treatment of symptoms by patients taking oral oncolytics are necessary. [Table: see text].

Impact of a Statewide Oral Oncolytic Initiative on Five Participating Practices

PURPOSE The shift from infusion to oral oncolytic therapy presents challenges to oncology practitioners. The purpose of this study was to describe how a statewide quality-improvement collaborative can enhance quality of care for patients receiving oral oncolytic therapy. METHODS The Michigan Oncology Quality Consortium hosted a series of learning sessions focused on oral oncolytic quality improvement, providing multiple resources to oncology community practices. The first five participating practices reported which of the evidence-based Michigan Oncology Quality Consortium resources provided were implemented at their site. They also performed prepost self-assessments in October 2013 and April 2015 and another in December 2017 to assess sustainability. Concordance with the ASCO Quality Oncology Practice Initiative oral chemotherapy standards, including documentation (five measures), patient education (seven measures), and follow-up/monitoring (four measures), was compared. RESULTS All practices showed improvement between 2013 and 2015 in documentation (32% to 88%; P = .03), patient education (37% to 100%; P could not be calculated), and monitoring (40% to 80%; P > .2). Overall, a significant improvement in concordance was observed (36% to 91%; P = .03). Use of resources from each practice varied, and practices that used more resources showed greater improvements. There was a slight decrease in overall concordance between 2015 and 2017, which was not found to be significant (91% to 84%; P = .53). CONCLUSION Use of tools from a quality-improvement collaborative improved concordance with national standards of care. Large-scale deployment of this model program may provide a clinically efficient and effective mechanism to enhance widespread change.

Implementing a specialty pharmacy course within a professional pharmacy curriculum

BACKGROUND AND PURPOSE Specialty pharmacy is an important area of pharmacy practice where patients who are prescribed a growing number of specialty drugs receive specialized care, including: benefits investigation, financial support, side effect management, and adherence assessment. As these specialty medications continue to emerge, it is important for pharmacy students to have knowledge of this specialized practice and awareness of the opportunities that exist in this area. The objective is to describe the development of a specialty pharmacy elective course to meet this educational need. EDUCATIONAL ACTIVITY AND SETTING A one-credit specialty pharmacy elective course was created for second and third-year pharmacy students. Content experts with a variety of clinical and administrative specialty pharmacy expertise led student lectures and topic discussions. Students were assessed for baseline specialty pharmacy knowledge, knowledge at the completion of the course, and satisfaction with the course. FINDINGS Student knowledge of specialty pharmacy practice increased 27.7% when comparing baseline to post-course test scores. Students evaluated the new course positively with recommendations that the course could benefit by being expanded by an additional credit. SUMMARY The development of a specialty pharmacy elective course within a college of pharmacy curriculum improved student knowledge of specialty pharmacy practice and was well-received by students who enrolled in the course. Given the complexity and growing importance of specialty pharmacy in practice, this type of course should be considered by other colleges of pharmacy.

Implementing a Method for Evaluating Patient-Reported Outcomes Associated With Oral Oncolytic Therapy

INTRODUCTION The paradigm shift in health care toward value-based reimbursement has brought emphasis to providing better quality of care to patients with chronic diseases, including patients with cancer. In accordance with providing better quality of care to patients, there has been a growing interest in evaluating quality of life through patient-reported outcomes (PROs). The revised Edmonton Symptom Assessment Scale (ESAS-r) is a tool that can be used to assess PROs and has been validated for use in patients with cancer. This initiative sought to use this standard assessment tool to acquire PROs concerning symptom burden from patients prescribed oral oncolytics. PATIENTS AND METHODS Eight oncology practices in the state of Michigan used a modified ESAS-r to evaluate symptom burden of patients prescribed oral oncolytics before each outpatient visit. Thirteen symptoms were categorized as mild (0 to 3), moderate (4 to 6), or severe (7 to 10). RESULTS A total of 1,235 modified ESAS-r surveys were collected and analyzed; 82.5% of symptoms were categorized as mild, 11.9% of symptoms were categorized as moderate, and 5.6% of symptoms were categorized as severe. CONCLUSION PROs can be evaluated through the use of a standardized tool, such as the ESAS-r, in oncology patients receiving oral oncolytic therapy. Implementing such a tool in both community and academic practices is feasible and may facilitate improvements in the quality of care.

Engagement in a statewide oral oncolytic collaborative and practice impact.

89 Background: The rapid shift to oral oncolytic therapy presents challenges to oncology practitioners. The purpose of this study is to describe how participation in a statewide oral oncolytic improvement collaborative where best practices and resources were shared can readily impact quality of care as measured by national standards. METHODS The Michigan Oncology Quality Consortium (MOQC) hosted a series of learning collaborative sessions focused on topics and deployment of resources specific to oral oncolytic management and quality improvement. Participating practices performed pre/post self-assessments in Oct. 2013 and Apr. 2015 (n = 3). Concordance with national ASCO QOPI and ONS standards was compared, including documentation (5 measures), patient education (7 measures), and follow-up/monitoring (4 measures). A response scale of always, sometimes, and never was used. Specifically, practices were surveyed to assess which evidence-based MOQC resources were implemented: patient intake template, drug-specific self-management guides, start date mailer, medication calendar, primary care physician communication template, Edmonton Symptom Assessment Scale (ESAS), and patient adherence questionnaires. RESULTS Practice A showed improvement in documentation, patient education, and monitoring. This practice used the initial oral chemotherapy template, ESAS, patient education templates, and patient calendar (Table). Practice B implemented 6 resources and demonstrated improvements in 15 metrics. Practice C implemented 4 resources, namely patient-focused resources, to improve all patient education and monitoring metrics. CONCLUSIONS Use of the collaborative model and supplying oncology teams with scientific evidence, standard workflows, and resources improves concordance with national standards of care. Large-scale deployment of this model program may provide a clinically efficient and effective mechanism to enhance widespread change. [Table: see text].

Confidence in self-managing side effects from oral oncolytics among a sample of Michigan oncology practices.

68 Background: The aim of this study was to assess patient confidence to self-manage common side effects of oral oncolytic agents among cancer patients whose providers participated in the Michigan Oncology Quality Consortium (MOQC). METHODS This was a cross-sectional study conducted between August and September 2015, enrolling a convenience sample of 125 patients currently taking oral oncolytics in 10 oncology practices who completed a brief online survey. Demographics, clinical information, health literacy (3 items) and Patient Activation Measure (PAM, 13 items) were assessed. The PAM instrument assesses patient self-reported knowledge, skills and confidence for self-management. Participants were also asked to rate on a scale 0-10 how confident they felt self-managing 3 common oral oncolytic side-effects: fatigue, nausea and diarrhea. Differences by age, gender, education level, health literacy, and PAM level were examined. RESULTS Respondents were 66.2 (SD, 13.6) years old and 57.7% were female. The mean length of oral oncolytic therapy was 12.9 (SD, 13.8) months and average number of medications was 5.9 (SD, 3.2). Approximately three-quarters of patients assessed had high levels of patient activation (41.5% level 3 and 32.5% level 4), with the remaining 26.0% having low involvement in their care (17.1% level 1 and 8.9% level 2). Confidence to manage fatigue was high for 79% of patients, moderate for 12.1% and low for 8.9%. Confidence to manage nausea and diarrhea was higher with 85.5% and 88.7% patients reporting high confidence, respectively, but 6.5% and 4.8% reporting low confidence to manage these two symptoms. When combining the confidence measures to manage each of the three symptoms, patients with higher health literacy (p = 0.001), higher PAM levels (p = 0.018) and older patients (p = 0.041) exhibited higher confidence at a statistically significant degree. CONCLUSIONS Healthliteracy and PAM were associated with patient confidence to self-manage oral oncolytic side effects. Health literacy screening in clinical practice may be an efficient means to identify patients with low self-management confidence and determine needs of further education and support.