The clinical and financial impact of remote clinical oncology pharmacist engagement in community-based practices within The US Oncology Network.

INTRODUCTION: The integration of clinical oncology pharmacists into multidisciplinary healthcare teams is not well-described in the community practice setting. This study aims to analyze the clinical and financial impact of a remote-based clinical oncology pharmacist in four community oncology practices within The US Oncology Network. METHODS: Oncology-trained clinical pharmacists electronically reviewed chemotherapy orders for clinical optimization and financial stewardship within four community oncology practices. Each pharmacist was appointed at 0.5 full-time equivalents per practice. Financial, clinical, and workload metrics were tracked to monitor the impact of pharmacist engagement. RESULTS: Over 12 months, 5716 order reviews were completed with an intervention rate of 57%. The most common interventions identified by the pharmacists were interventions with clinical impact on the patient (36%), followed by dose rounding (35%) and therapeutic interchange (30%). Overall, interventions improved the cumulative practice margins by $1,455,033 and reduced total medication costs by $5,962,551. The average program return on investment was 415% (range 100-915%). CONCLUSION: Community oncology practices seek to provide high-value care in a lean, resource-constrained model. An oncology clinical pharmacist is a cost-effective and clinically invaluable care team member in community oncology practice. Pharmacists in this setting identified opportunities to improve medication safety and regimen optimization and demonstrated a significant tremendous financial impact on small-scale budgets in community oncology.

Oncology pharmacy practice in the United States: Results of a comprehensive, nationwide survey.

Introduction: This study was designed to describe the landscape of oncology pharmacy practice at patient facing institutional healthcare organizations throughout the United States. Methods: The Hematology/Oncology Pharmacy Association (HOPA) Practice Outcomes and Professional Benchmarking Committee conducted a multi-organization, voluntary survey of HOPA members between March 2021 and January 2022. Four overarching domains were targeted: institutional description, job function, staffing, and training/certification. Data were evaluated using descriptive statistics. Results: A total of 68 responses were analyzed including 59% and 41% who self-identified their organization as academic and community centers, respectively. The median number of infusion chairs and annual infusion visits were 49 (interquartile range (IQR): 32-92) and 23,500 (IQR: 8300-300,000), respectively. Pharmacy departments reported to a business leader, physician leader, and nursing leader 57%, 24%, and 10% of the time, respectively. The median oncology pharmacy full-time equivalents was 16 (IQR: 5-60). At academic centers, 50% (IQR: 26-60) of inpatient and 30% (IQR: 21-38) of ambulatory pharmacist FTEs were dedicated to clinical activities. At community centers, 45% (IQR: 26-65) of inpatient and 50% (IQR: 42-58) of ambulatory pharmacist FTEs were dedicated to clinical activities. As many as 18% and 65% of organizations required or encouraged certification for oncology pharmacists, respectively. The median number of Board-Certified Oncology Pharmacists was 4 (IQR: 2-15). Conclusion: As the number of patients with cancer rises, the oncology workforce must grow to support this expanding population. These results describe the practice landscape of oncology pharmacy at US healthcare institutions to serve as a foundation for future research evaluating metrics and benchmarks.

Rasburicase dose optimization for tumor lysis syndrome management in a network of community oncology practices.

INTRODUCTION: Single, fixed-dose rasburicase administration has been evaluated as an effective strategy in the management of hyperuricemia in the hospital setting, but this has not yet been described within ambulatory community oncology practices. The objective of this study is to evaluate and optimize the dosing strategy for rasburicase in the management of tumor lysis syndrome (TLS)-associated hyperuricemia in The US Oncology Network (The Network). METHODS: A network-wide guideline was revised to standardize rasburicase dosing from a previous recommended fixed doses of 4.5 or 7.5 mg to either 3 or 6 mg for outpatient rasburicase use in management and prevention of TLS. The primary outcome evaluated mean dose of rasburicase among all patients before and after guideline revision. A retrospective chart review evaluated secondary endpoints. RESULTS: The primary analysis included 291 patients (128 pre-revised and 163 post-revised guideline implementation). The primary outcome, mean rasburicase dose, was reduced in the post-revision compared to the pre-revision population (mean 6.2 mg pre vs. 4.5 mg post, p < 0.00001) resulting in a reduced cost per rasburicase dose of $974. Fifty patients were included for the secondary analysis. Guideline concordance was identified in 12 (48%) and 16 patients (64%), and uric acid <8 mg/dL post-rasburicase administration occurred in 14 (56%) and 16 patients (64%) before and after guideline revision, respectively. CONCLUSIONS: Guideline revision and electronic health record modification resulted in a 27% reduction in the mean rasburicase dose and a 50% reduction in repeat rasburicase dosing without a negative impact on clinical efficacy.

Expanding oncology pharmacist teams: Justifying the return on investment.

Oncology pharmacists are an integral member of the cancer care multi-disciplinary team. Despite the role being previously well defined, responsibilities continue to expand. Position justification for pharmacists is a challenge with prerequisites to optimize efficient processes, promote quality and reduce overall costs. Initiation and implementation of new oncology pharmacist services requires a clear description of value to the organization and a strong understanding of workflows. Position justifications must be data-driven and unique to the organization's need and should include physician or key stakeholder support, quality initiatives, cost-savings initiatives, and revenue-generating roles. The cases and examples described serve as a reference for individuals, teams, or organizations pursuing the value of a financial investment of an oncology pharmacist to expand or initiate new pharmacy services.

Financial Impact of an Automated Oncology Dose-Rounding Initiative: One-Year Analysis.

PURPOSE: Infusion drugs are regarded as one of the high-cost health care expenditures. One approach to decrease drug expenditures is by dose-rounding biologics and cytotoxic agents. The Hematology/Oncology Pharmacy Association recommends that biologic and cytotoxic agents are rounded to the nearest vial size if they are within 10% of the ordered dose. The purpose of this initiative is to determine the impact of an automated dose-rounding algorithm on drug expenses. METHODS: The dose-rounding algorithm was developed and integrated into the computerized physician order entry system for automated dose rounding to minimize impact on current workflow and to reduce medication errors. Twenty-four medications were preselected for dose rounding and included in the analysis. Ordered doses were automatically rounded to the nearest vial size if the dose was within 10% of the original dose. Prescribers then either reviewed and signed the rounded dose or manually entered the nonrounded dose. Cost savings were calculated as drug expense savings from doses rounded down. RESULTS: From July 2018 to June 2019, 10,206 doses of the selected medications were administered. Dose rounding occurred in 5,069 doses (49.7%). All 24 medications within the initiative were administered within the time of analysis. Of the rounded doses administered, 2,516 (49.6%) were rounded down to a commercially available vial size. Using wholesale acquisition cost pricing, the drug expense savings was approximately $3.6 million US dollars (USD). The medications with the highest savings were trastuzumab and ipilimumab, with annual savings of $756,780 USD and $494,517 USD, respectively. CONCLUSION: The automated dose-rounding algorithm at Michigan Medicine reduced drug expenditures substantially, and its integration within the computerized physician order entry system had minimal impact on current workflow.

Implementation and outcomes of a pharmacist-led collaborative drug therapy management program for oncology symptom management.

INTRODUCTION: Nausea, vomiting, constipation, and diarrhea are common cancer and cancer therapy adverse effects. Pharmacists are uniquely positioned to optimize patient symptom control and minimize excess use of hospital resources, such as emergency department visits. METHODS: Michigan Medicine oncology clinical pharmacists have been independently providing patient symptom management through a collaborative drug therapy management (CDTM) program which established guidelines for management of gastrointestinal toxicities (nausea, vomiting, diarrhea, and/or constipation) secondary to a patient's cancer diagnosis or treatment of the cancer. Patients were referred to the pharmacist by the treating oncologist or hematologist. RESULTS: From June 2019 to May 2020, there were a total of 62 patient referrals. Ten of the 62 referrals did not meet the CDTM inclusion criteria, resulting in 52 patients who were managed by the pharmacists. The total number of individual pharmacist visits was 136, with a median of 2.2 (range, 0-11) visits per patient referred. A total of 169 categorized pharmacist interventions were captured. Most interventions (100/169, 59.2%) were related to nausea/vomiting. Diarrhea-related and constipation-related interventions accounted for 10 (5.9%) and 13 (7.7%) of the total interventions, respectively. Most patients (36/52, 69.2%) had a reduction in the severity of their referral diagnosis symptom(s) based on Common Terminology Criteria for Adverse Events grading. CONCLUSION: The Michigan Medicine Pharmacist CDTM program allowed pharmacists to independently manage gastrointestinal toxicities of patients with cancer and improved patient symptom severity. The CDTM program has the opportunity to improve quality of care.

Chemotherapy Remote Care Monitoring Program: Integration of SMS Text Patient-Reported Outcomes in the Electronic Health Record and Pharmacist Intervention for Chemotherapy-Induced Nausea and Vomiting.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a common cause of unplanned healthcare utilization. The University of Michigan Rogel Cancer Center initiated the chemotherapy remote care monitoring program (CRCMP) to proactively identify patients experiencing CINV and intervene before the need for urgent evaluation. METHODS: High-risk patients for CINV are identified by neurokinin-1 (NK-1) antagonist administration, enrolled in the CRCMP, and received a daily text message survey for 7 days after chemotherapy administration to report symptoms. Responses above a set threshold trigger a message to the team pharmacist for intervention. The primary outcome of 14-day unplanned healthcare use was evaluated before and after CRCMP implementation. RESULTS: In 8 months, 652 patients received an NK-1 antagonist (2,244 cycles) and 387 patients were enrolled in the CRCMP (59%). Text message response rate was 94%. Clinical pharmacists provided 248 interventions in 121 patient episodes meeting threshold criteria. Fourteen-day unplanned healthcare use was decreased in the CRCMP-enrolled NK-1 episodes (6.68% v 4.53%, P = .02). Admissions were numerically lower for those enrolling in CRCMP when only admissions for nausea were considered (0.63% v 0.35%, P = .33). CONCLUSION: The CRCMP allowed for real-time management of patient-reported CINV symptom burden based on patient-reported outcomes (PROs) and an electronic medical record-integrated SMS text questionnaire. Clinical pharmacists were key team members to manage patient symptoms. Enrollment in CRCMP significantly reduced overall unplanned healthcare utilization. Although these changes were numerically small, any reduction in unnecessary care utilizing PROs can contribute to high-value care for patients with cancer.

Trends in the delivery of care to oncology patients in the United States: Emphasis on the role pharmacists on the healthcare team.

OBJECTIVE: The purpose of this study was to identify trends in oncology care that allow one to forecast workforce supply and demand, the training and skills needed by the oncology pharmacist for the likely future of oncology care. METHODS: Interviews were conducted with experienced oncology pharmacists in leadership roles at 20 organizations balanced by geographic region and type of practice site (academic or community/ambulatory). Results were analyzed using descriptive statistics and theme identification. RESULTS: Practice sites differed widely in numbers of patient visits, practitioner/patient ratios, residency program presence, and other structural features. Despite this, the majority reported an expectation of growth in cancer patients, oncology physicians, oncology pharmacists, pharmacy technicians, oncology nurses, and advanced practice practitioners in the next two to five years. Fifty percent of sites currently support Post Graduate Year 2 (PGY2) oncology residencies. At least 50% reported routine pharmacist involvement in 12 clinical functions. More future involvement was predicted for immunotherapy (80%) and oral oncolytic therapy (90%). Interprofessional involvement was reported for a broad variety of practice-related committees and patient education teams. Limited pharmacist involvement in credentialing, quality measurement, and value-based reimbursement systems was found. CONCLUSION: Anticipated increases in demand for oncology pharmacists strongly suggest the need for more PGY2 oncology residency programs and on-the-job oncology training programs. Oncology pharmacists are currently involved in many clinical and administrative functions including multidisciplinary management. While a core set of clinical functions has been identified, oncology pharmacists must prepare for the increased use of oral oncology agents and immunotherapy. Pharmacist involvement in value-based reimbursement and other data-based quality outcome measurements should be increased to optimize involvement in team-based patient care.

Real-world comparison of immune checkpoint inhibitors in non-small cell lung cancer following platinum-based chemotherapy.

PURPOSE: Immunotherapy is a relatively new treatment modality for advanced non-small cell lung cancer following platinum-based chemotherapy. Nivolumab, pembrolizumab, and atezolizumab demonstrated superior outcomes and improved tolerability compared to standard treatment in randomized controlled trials; however, these studies vary significantly in inclusion criteria and study design. To our knowledge, the efficacy and safety of nivolumab and atezolizumab following platinum-based chemotherapy have not been directly compared to one another in a real-world clinic setting. METHODS: We retrospectively compared immunotherapy response rates and toxicity in patients with stage IV or recurrent non-small cell lung cancer following progression during or after platinum-based chemotherapy. RESULTS: Among 124 eligible patients, the objective response rate was 14.8% in the nivolumab group (n = 81) vs. 13.9% in the atezolizumab group (n = 43) (p = 0.897). Median overall survival was 8.4 months with nivolumab (95% confidence interval (CI), 6.3 to 11.2) vs. 6.5 months with atezolizumab (95% CI, 4.7 to not reached). Median progression free survival was 2.2 months (95% CI, 1.7 to 2.8) and 2.0 months (95% CI, 1.8 to 2.7) in the nivolumab and atezolizumab groups, respectively. Treatment-related adverse events occurred in 70.4% of patients in the nivolumab group and 65.1% in the atezolizumab group. CONCLUSIONS: There was no statistically significant difference in efficacy outcomes in patients with non-small cell lung cancer who received atezolizumab or nivolumab after progression during or after platinum-based chemotherapy. Response rates in this study were numerically lower than response rates observed in the landmark randomized controlled trials leading to approval of immunotherapy in this setting. Rates of treatment-related adverse events were similar between groups.

Clinician Report of Oral Oncolytic Symptoms and Adherence Obtained via a Patient-Reported Outcome Measure (PROM).

PURPOSE: Patient-reported outcome measures (PROMs) for symptom monitoring during cancer therapy have been shown to have a positive impact on outcomes. These findings have primarily been shown for patients receiving intravenous chemotherapy. In addition, there is known discordance between physician reporting of symptoms and patient self-report. This initiative sought to describe patient-reported symptom burden and medication adherence and to indicate the degree of PROM results being discussed with the provider as indicated by documentation in the medical record for patients taking oral oncolytic therapy. METHODS: The Michigan Oncology Quality Consortium (MOQC) PROM, which included symptom ratings, medication adherence, and patient confidence in self-management, was completed during outpatient visits and compared with corresponding data documented in the electronic medical record (EMR). RESULTS: There were 82 completed PROMs. Approximately half included at least one symptom rated as severe (46%). Sixty-five percent of reported severe symptoms were documented in the EMR. Patient-reported moderate-to-severe pain was most likely to be documented in the EMR (100%), whereas patient-reported moderate-to-severe depression and anxiety were least likely to be documented (21%). Of the total symptoms documented, grading of symptom severity matched that of the patients' own report for 11% of severe symptoms. Adherence to oral oncolytics was excellent for 63% of patients, and patient adherence was documented in 7% of provider notes. CONCLUSION: Patients frequently reported moderate-to-severe symptoms, and approximately 40% of patients reported nonadherence. Clinician report (documented in the EMR) of the patient symptom burden, symptom severity, and adherence to oral oncolytic therapy was not consistent with the patients' self-report. Use of a PROM for patients taking oral oncolytics has the opportunity to improve symptom management and medication adherence.

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.

Rational use of rasburicase for the treatment and management of tumor lysis syndrome.

Purpose There is a lack of high-level evidence identifying meaningful outcomes and the optimal place in therapy of rasburicase in patients with, or at high risk for tumor lysis syndrome. The primary objective of this study was to evaluate and characterize outcomes resulting from an institution-specific guideline emphasizing supportive care, xanthine oxidase inhibitors, and lower doses of rasburicase. Methods In this retrospective chart review, we compared conservative rasburicase dosing, in accordance with newly developed UMHS tumor lysis syndrome guidelines, with aggressive rasburicase in adult patients (≥ 18 years of age) with hematological or solid tumor malignancies, and a uric acid level between 8 and 15 mg/dL. The primary efficacy outcome assessed the difference in the proportion of patients achieving a uric acid level <8 mg/dL within 48 h using a one-sided noninferiority test. The principle safety outcomes analyzed included incidence of acute kidney injury and hemodialysis requirement. Results One hundred sixty-one patients met inclusion criteria and were included in the study. Within 48 h of an elevated uric acid level, treatment was successful in 97.03% of patients in the conservative group, as compared with 98.33% in the aggressive group (difference, 1.3 percentage points; 95% confidence interval [CI], -3.33 to 5.93). Furthermore, there was no difference in the proportion of patients requiring hemodialysis (2.97% vs. 10.0%, p-value 0.079), or incidence of acute kidney injury (4.0% vs. 12.5%, p-value 1.00) between the treatment group and control group, respectively. Conclusions Conservative rasburicase use was noninferior to aggressive rasburicase use in patients with or at high risk for tumor lysis syndrome.

Myeloid Growth Factors, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.

Myeloid growth factors (MGFs) are given as supportive care to patients receiving myelosuppressive chemotherapy to reduce the incidence of neutropenia. This selection from the NCCN Guidelines for MGFs focuses on the evaluation of regimen- and patient-specific risk factors for the development of febrile neutropenia (FN), the prophylactic use of MGFs for the prevention of chemotherapy-induced FN, and assessing the risks and benefits of MGF use in clinical practice.

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.

Clinical developments in the treatment of relapsed or relapsed and refractory multiple myeloma: impact of panobinostat, the first-in-class histone deacetylase inhibitor.

BACKGROUND: Panobinostat is a new agent for the treatment of relapsed and refractory multiple myeloma (rrMM) as part of a combination regimen. This article presents an overview of the mechanism of action, pharmacokinetics, safety, efficacy, patient care strategies, and role of the agent in treating rrMM patients. RESULTS: Panobinostat belongs to the class of drugs known as histone deacetylase inhibitors, and has high activity against Class I, II, and IV nonhistone deacetylases and histone deacetylases. It represents the first of its class to receive approval for use in MM, and received priority review and orphan drug status in both US and Europe, when used in combination with bortezomib and dexamethasone in the treatment of rrMM. Approval of panobinostat was based on subgroup analysis of Phase III data obtained in the PANORAMA trial program for evaluation of the combination of panobinostat, bortezomib, and dexamethasone. Additional clinical trials have continued to explore optimal dosing regimens and novel combination regimens to further clarify the optimal role of panobinostat in the arsenal of drugs for rrMM. Panobinostat has shown a manageable safety profile characterized primarily by hematologic toxicities (thrombocytopenia, neutropenia, lymphopenia, and anemia), gastrointestinal toxicities, notably diarrhea and nausea, as well as fatigue/asthenia, electrolyte abnormalities, and less commonly cardiac toxicities. CONCLUSION: Panobinostat represents an important addition to the treatment armamentarium for patients with rrMM, and studies are underway evaluating its optimal dosing strategy and role in combination with other drugs used to treat this patient population.

Risk factors for piperacillin/tazobactam-resistant Gram-negative infection in hematology/oncology patients with febrile neutropenia.

PURPOSE: Febrile neutropenia (FN) is a life-threatening complication of cancer therapy, and initial ineffective therapy is associated with poor outcomes. Piperacillin/tazobactam (PTZ) is a commonly used empiric antibiotic for the treatment of FN, but resistance among Gram-negative pathogens is well described. We conducted a retrospective case-control study to identify risk factors for PTZ-resistant (PTZ-R) Gram-negative isolates. METHODS: Hematology/oncology patients with FN from November 2007 to November 2013 with a positive culture for Gram-negative bacilli were divided into two groups: PTZ-sensitive (PTZ-S) and PTZ-R. A multivariable model using logistic regression was constructed to identify risk factors for PTZ-R. RESULTS: A total of 171 patients were included (25 PTZ-R, 146 PTZ-S), yielding a 14.6 % resistance rate. Thirty-day all-cause mortality was significantly higher in the PTZ-R group (29 vs 11 %, P = 0.024). Multivariable analysis yielded intensive care unit (ICU) status (odds ratio (OR) 20.18; 95 % confidence interval (CI) 1.03-397.35; P = 0.048), antibiotics for > 14 days in the previous 90 days (OR 6.02; CI 1.17-30.93; P = 0.032), and respiratory source (OR 13.65; CI 1.14-163.57; P = 0.039) as significant risk factors for PTZ-R, and the receiver operating characteristic area under the curve of the model was 0.894. Among PTZ-R isolates, 88 % were sensitive to meropenem and 100 % were sensitive to amikacin. CONCLUSIONS: Given the high mortality rates in the PTZ-R group, a risk-factor-guided approach driven by this multivariable model may help identify patients that could benefit from amikacin combination therapy to help optimize empiric therapy in this setting.