Value Assessment of Oncology Pharmacist Interventions.

A review of the published literature confirms the challenge in quantifying the value of oncology pharmacists. This editorial expands on a 2020 study by Meleis and colleagues published in the Journal of the Advanced Practitioner in Oncology and seeks to correlate pharmacist interventions to cost-saving and cost-avoidance measures to show the value of ambulatory oncology clinical pharmacists in patient care. A total of 4,686 interventions were reviewed. The 6-month intervention data demonstrate an annualized value of approximately $1.1 million dollars from nine ambulatory oncology clinical pharmacists showcasing the essential role of the clinical pharmacist in ambulatory oncology settings.

Adapting to Change: A Thoracic Oncology Team's Perspective.

With targeted therapies, outcomes for patients with NSCLC are improving, but better monitoring for AEs is needed.

Which hematology/oncology patients are high priority for ambulatory clinical pharmacist review? A three-round Delphi survey by the National Comprehensive Cancer Network.

INTRODUCTION: Prioritization and acuity tools have been leveraged to facilitate targeted and efficient clinical pharmacist interventions. However, there is a lack of established pharmacy-specific acuity factors in the ambulatory hematology/oncology setting. Therefore, National Comprehensive Cancer Network's Pharmacy Directors Forum conducted a survey to establish consensus on acuity factors associated with hematology/oncology patients that are high priority for ambulatory clinical pharmacist review. METHODS: A three-round electronic Delphi survey was conducted. During the first round, respondents were asked an open-ended question to suggest acuity factors based on their expert opinion. Respondents were then asked in the second round to agree or disagree with the compiled acuity factors, in which those with ≥75% agreement were included in the third round. The final consensus was defined as a mean score ≥3.33 on a modified 4-point Likert scale (4 = strongly agree, 1 = strongly disagree) during the third round. RESULTS: A total of 124 hematology/oncology clinical pharmacists completed the first round of the Delphi survey (invitation response rate, 36.7%), of which 103 completed the second round (response rate, 83.1%) and 84 the third round (response rate, 67.7%). A final consensus was achieved for 18 acuity factors. Acuity factors were identified in the following themes: antineoplastic regimen characteristics, drug interactions, organ dysfunction, pharmacogenomics, recent discharge, laboratory parameters, and treatment-related toxicities. CONCLUSIONS: This Delphi panel of 124 clinical pharmacists achieved consensus on 18 acuity factors that would identify a hematology/oncology patient as a high priority for ambulatory clinical pharmacist review. The research team envisions incorporating these acuity factors into a pharmacy-specific electronic scoring tool.

Antiemetics: ASCO Guideline Update.

PURPOSE: To update the guideline to include new anticancer agents, antiemetics, and antiemetic regimens and to provide recommendations on the use of dexamethasone as a prophylactic antiemetic in patients receiving checkpoint inhibitors (CPIs). METHODS: ASCO convened an Expert Panel and updated the systematic review to include randomized controlled trials (RCTs) and meta-analyses of RCTs published between June 1, 2016, and January 24, 2020. To address the dexamethasone and CPI question, we conducted a systematic review of RCTs that evaluated the addition of a CPI to chemotherapy. RESULTS: The systematic reviews included 3 publications from the updated search and 10 publications on CPIs. Two phase III trials in adult patients with non-small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen. In both studies, superior outcomes were noted in the PD-1 inhibitor-containing arms. Other important findings address olanzapine in adults and fosaprepitant in pediatric patients. RECOMMENDATIONS: Recommendations for adults are unchanged with the exception of the option of adding olanzapine in the setting of hematopoietic stem cell transplantation. Dosing information now includes the option of a 5-mg dose of olanzapine in adults and intravenous formulations of aprepitant and netupitant-palonosetron. The option of fosaprepitant is added to pediatric recommendations. There is no clinical evidence to warrant omission of dexamethasone from guideline-compliant prophylactic antiemetic regimens when CPIs are administered to adults in combination with chemotherapy. CPIs administered alone or in combination with another CPI do not require the routine use of a prophylactic antiemetic.Additional information is available at www.asco.org/supportive-care-guidelines.

2018-2019 Drug Updates in Solid Tumors.

Sally Barbour, PharmD, BCOP, CPP, FHOPA, updated attendees on the FDA-approved therapies for initial or expanded indications for solid tumors across the past year, as well as their supporting clinical trial data and best practices for safe and effective dosing and administration, drug monitoring, and adverse event management.

Evaluation of the Role and Impact of Ambulatory Clinical Pharmacists in an Academic Comprehensive Cancer Center.

INTRODUCTION: In recent years, there has been significant growth of ambulatory oncology pharmacy, yet there is a paucity of published studies on the clinical activities and impact of ambulatory oncology clinical pharmacists. At Duke Cancer Center, dedicated pharmacist services are embedded in specialized outpatient oncology areas. Pharmacists document their clinical and administrative activities in the electronic health record. The primary objective of this study is to quantify and assess ambulatory oncology pharmacist interventions in clinics in a large academic comprehensive cancer center. METHODS: For the purposes of this single-center, retrospective, descriptive study, pharmacist interventions were collected, quantified, and described over a 6-month period from July 1 to December 31, 2015. The study evaluated the perceived contribution and impact of a pharmacist on patient care in ambulatory oncology clinics via a survey that was distributed to providers and nurses. RESULTS: In the 6-month time period, there were 5,091 interventions spanning 3,967 patient encounters between nine ambulatory oncology clinic pharmacists. The average time per encounter in the 6-month time frame was 22.4 minutes. There were 92 respondents to the survey (61.7% response rate). Overall, responses showed that the clinical pharmacists add value to patient care and are integral members of the team. CONCLUSIONS: Although previous studies have described pharmacist activities in outpatient oncology clinics, this study showed a larger number and variety of clinical pharmacist activities in outpatient cancer clinics to improve patient care. Future directions include conducting prospective, controlled studies to link pharmacist activities to tangible outcomes.

Incidence of skeletal related events in patients with bone metastasis receiving denosumab every four weeks compared to intervals greater than every four weeks.

OBJECTIVE: Denosumab is a monoclonal antibody used for prevention of skeletal related events in patients with bone metastasis from solid tumors and is administered every four weeks. In our practice, denosumab is often given at different frequencies more similar to patient's chemotherapy regimens to decrease frequency of clinic visits. The purpose of this study is to compare the incidence of skeletal related events, incidence of hypocalcemia, and cost with denosumab given at every four weeks and denosumab given at other frequencies. METHODS: This retrospective study at Duke University Health System included solid tumor patients with an age ≥18 years who received denosumab for prevention of skeletal related events. RESULTS: A total of 94 patients were included, with 29 in the every four-week group and 65 in the greater than every four-week group. Patients who received denosumab every four weeks had a 41.4% incidence of skeletal related events compared to 26.2% incidence of skeletal related events in patients who received denosumab at intervals greater than every four weeks (OR: 0.50; p = 0.14). There was no statistically significant difference in incidence of hypocalcemia. Based on average wholesale price, when the frequency of denosumab is extended to greater than every four weeks, annual cost savings per patient ranged from $4700 (every 5 weeks) to $18,800 (every 12 weeks). CONCLUSION: While this study raises the possibility of decreasing the frequency of denosumab administration, further data are necessary to confirm that less frequent administration is non-inferior to every four-week administration.

Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update.

Purpose To update the ASCO guideline for antiemetics in oncology. Methods ASCO convened an Expert Panel and conducted a systematic review of the medical literature for the period of November 2009 to June 2016. Results Forty-one publications were included in this systematic review. A phase III randomized controlled trial demonstrated that adding olanzapine to antiemetic prophylaxis reduces the likelihood of nausea among adult patients who are treated with high emetic risk antineoplastic agents. Randomized controlled trials also support an expanded role for neurokinin 1 receptor antagonists in patients who are treated with chemotherapy. Recommendation Key updates include the addition of olanzapine to antiemetic regimens for adults who receive high-emetic-risk antineoplastic agents or who experience breakthrough nausea and vomiting; a recommendation to administer dexamethasone on day 1 only for adults who receive anthracycline and cyclophosphamide chemotherapy; and the addition of a neurokinin 1 receptor antagonist for adults who receive carboplatin area under the curve ≥ 4 mg/mL per minute or high-dose chemotherapy, and for pediatric patients who receive high-emetic-risk antineoplastic agents. For radiation-induced nausea and vomiting, adjustments were made to anatomic regions, risk levels, and antiemetic administration schedules. Rescue therapy alone is now recommended for low-emetic-risk radiation therapy. The Expert Panel reiterated the importance of using the most effective antiemetic regimens that are appropriate for antineoplastic agents or radiotherapy being administered. Such regimens should be used with initial treatment, rather than first assessing the patient's emetic response with less-effective treatment. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

NCCN Guidelines Insights: Antiemesis, Version 2.2017.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Antiemesis address all aspects of management for chemotherapy-induced nausea and vomiting. These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines for Antiemesis, specifically those regarding carboplatin, granisetron, and olanzapine.

Management of Patients With Chemotherapy-Induced Nausea and Vomiting.

Despite advances in the management of chemotherapy-induced nausea and vomiting (CINV), clinical management remains a challenge and CINV continues to be a side effect that patients fear most. Advanced practitioners can play a major role in evidence-based interventions for prevention and management of these side effects of treatment.

Board-Certified Oncology Pharmacists: Their Potential Contribution to Reducing a Shortfall in Oncology Patient Visits.

PURPOSE: With an aging US population, the number of patients who need cancer treatment will increase significantly by 2020. On the basis of a predicted shortage of oncology physicians, nonphysician health care practitioners will need to fill the shortfall in oncology patient visits, and nurse practitioners and physician assistants have already been identified for this purpose. This study proposes that appropriately trained oncology pharmacists can also contribute. The purpose of this study is to estimate the supply of Board of Pharmacy Specialties-certified oncology pharmacists (BCOPs) and their potential contribution to the care of patients with cancer through 2020. METHODS: Data regarding accredited oncology pharmacy residencies, new BCOPs, and total BCOPs were used to estimate oncology residencies, new BCOPs, and total BCOPs through 2020. A Delphi panel process was used to estimate patient visits, identify patient care services that BCOPs could provide, and study limitations. RESULTS: By 2020, there will be an estimated 3,639 BCOPs, and approximately 62% of BCOPs will have completed accredited oncology pharmacy residencies. Delphi panelists came to consensus (at least 80% agreement) on eight patient care services that BCOPs could provide. Although the estimates given by our model indicate that BCOPs could provide 5 to 7 million 30-minute patient visits annually, sensitivity analysis, based on factors that could reduce potential visit availability resulted in 2.5 to 3.5 million visits by 2020 with the addition of BCOPs to the health care team. CONCLUSION: BCOPs can contribute to a projected shortfall in needed patient visits for cancer treatment. BCOPs, along with nurse practitioners and physician assistants could substantially reduce, but likely not eliminate, the shortfall of providers needed for oncology patient visits.

Safety and tolerability of eribulin mesylate in patients with pretreated metastatic breast cancer.

PURPOSE: The safety and tolerability of eribulin mesylate for the treatment of metastatic breast cancer (MBC) are examined. METHODS: This retrospective analysis used pooled safety and tolerability data from three Phase II trials and one Phase III trial of eribulin in patients with MBC. In these studies, patients with pretreated MBC received eribulin mesylate 1.4 mg/m(2) as a two- to five-minute i.v. infusion on days 1 and 8 of a 21-day cycle. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events, version 3.0. RESULTS: Across the four trials, 908 patients received eribulin and were assessed for safety. Aside from anthracyclines and taxanes, the most common prior chemotherapy agents were capecitabine, vinorelbine, and gemcitabine. Patients had received a mean of 3.7 (range, 1-11) prior chemotherapeutic regimens. Dose delays, reductions, and interruptions due to treatment-emergent adverse events occurred in 35.0%, 17.3%, and 2.9% of patients, respectively. Treatment was discontinued in 12.3% of patients due to adverse events, regardless of whether the adverse event was considered treatment related. The most common grade 3 or 4 treatment-related adverse events were neutropenia (52.4%) and leukopenia (19.3%). Serious adverse events occurred in 26.1% of patients, with the most common being febrile neutropenia (3.6%) and pyrexia (2.3%). Peripheral neuropathy was seen in 30.6% of patients, with 6.6% experiencing grade 3 or 4 reactions. CONCLUSION: Despite heavy pretreatment with anthracyclines, taxanes, and capecitabine, eribulin was well tolerated in this pooled analysis of patients with MBC.

Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV).

PURPOSE: Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT3 RAs in preventing CINV associated with moderately or highly emetogenic chemotherapy. METHODS: Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 µg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0-24 h), delayed (>24-120 h), and overall (0-120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity. RESULTS: CR rates were significantly higher for palonosetron (n = 1,787) versus older 5HT3 RAs (n = 1,175) in the delayed (57 vs 45 %, P < 0.0001) and overall periods (51 vs 40 %, P < 0.0001); odds ratios (95 % CI) in the acute, delayed, and overall periods were 1.15 (0.98-1.34), 1.62 (1.40-1.88), and 1.56 (1.34-1.81), respectively. Significant differences in CC rates and nausea severity were observed for the delayed and overall periods and in emetic episodes for all three periods. The incidence of treatment-related adverse events was similar with palonosetron (0.25 mg, 20.0 %; 0.75 mg, 26.5 %) and older 5HT3 RAs (27.5 %). CONCLUSIONS: Palonosetron is more effective than older 5HT3 RAs for controlling CINV in the delayed and overall postchemotherapy periods.

Palonosetron versus older 5-HT3 receptor antagonists for nausea prevention in patients receiving chemotherapy: a multistudy analysis.

BACKGROUND: No clinical standard currently exists for the optimal management of nausea induced by emetogenic chemotherapy, 7particularly delayed nausea. OBJECTIVES: To compare the effcacy and safety of palonosetron with older 5-HT3 receptor antagonists (RAs) in preventing chemotherapy-induced nausea. METHODS: Data were pooled from 4 similarly designed multicenter, randomized, double-blind, clinical trials that compared single intravenous doses of palonosetron 0.25 mg or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 µg/kg, administered 30 minutes before moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). Pooled data within each chemotherapy category (MEC: n = 1,132; HEC: n = 1,781) were analyzed by a logistic regression model. Nausea endpoints were complete control rates (ie, no more than mild nausea, no vomiting, and no rescue medication), nausea-free rates, nausea severity, and requirement for rescue antiemetic/antinausea medication over 5 days following chemotherapy. Pooled safety data were summarized descriptively. RESULTS: Numerically more palonosetron-treated patients were nausea-free on each day, and fewer had moderate-severe nausea. Similarly, usage of rescue medication was less frequent among palonosetron-treated patients. Complete control rates for palonosetron and older 5-HT3 RAs in the acute phase were 66% vs 63%, 52% vs 42% in the delayed phase (24-120 hours), and 46% vs 37% in the overall phase. The incidence of adverse events was similar for palonosetron and older 5-HT3 RAs. LIMITATIONS: This post hoc analysis summarized data for palonosetron and several other 5-HT3 RAs but was not powered for statistical comparisons between individual agents. Because nausea is inherently subjective, the reliability of assessments of some aspects (eg, severity) may be infuenced by interindividual variability. CONCLUSION: Palonosetron may be more effective than older 5-HT3 RAs in preventing nausea, with comparable tolerability. DISCLOSURES AND FUNDING: Dr Schwartzberg is a consultant to and Dr Cox an employee at Esai. Mr Ballinari is a member of staff at and Dr Thorn consults for Helsinn Healthcare SA. Funding to support this study and the preparation of this manuscript was provided by Eisai Inc.

Corticosteroids in the treatment of chemotherapy-induced nausea and vomiting.

Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared side effects of cancer treatment, despite the advances over the past decades. Corticosteroids have been shown to be effective in the management of CINV. These agents are usually used in combination with serotonin antagonists and neurokinin-1 antagonists for highly or moderately emetogenic chemotherapy or as monotherapy for low-emetogenic chemotherapy. Consensus guidelines provide guidance regarding the scenarios in which corticosteroids are recommended. This article reviews the mechanism of action, role, and safety of corticosteroids in the management of CINV.

American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients.

BACKGROUND: Optimal performance of bronchoscopy requires patient's comfort, physician's ease of execution, and minimal risk. There is currently a wide variation in the use of topical anesthesia, analgesia, and sedation during bronchoscopy. METHODS: A panel of experts was convened by the American College of Chest Physicians Interventional/Chest Diagnostic Network. A literature search was conducted on MEDLINE from 1969 to 2009, and consensus was reached by the panel members after a comprehensive review of the data. Randomized controlled trials and prospective studies were given highest priority in building the consensus. RESULTS: In the absence of contraindications, topical anesthesia, analgesia, and sedation are suggested in all patients undergoing bronchoscopy because of enhanced patient tolerance and satisfaction. Robust data suggest that anticholinergic agents, when administered prebronchoscopy, do not produce a clinically meaningful effect, and their use is discouraged. Lidocaine is the preferred topical anesthetic for bronchoscopy, given its short half life and wide margin of safety. The use of a combination of benzodiazepines and opiates is suggested because of their synergistic effects on patient tolerance during the procedure and the added antitussive properties of opioids. Propofol is an effective agent for sedation in bronchoscopy and can achieve similar sedation, amnesia, and patient tolerance when compared with the combined administration of benzodiazepines and opiates. CONCLUSIONS: We suggest that all physicians performing bronchoscopy consider using topical anesthesia, analgesic and sedative agents, when feasible. The existing body of literature supports the safety and effectiveness of this approach when the proper agents are used in an appropriately selected patient population.

Role of oncology clinical pharmacists in light of the oncology workforce study.

To date, the information published regarding workforce implications has focused on physicians, nurse practitioners, and physician assistants. But oncology clinical pharmacists also can assist with direct patient care and patient education activities.

Quality management of potential chemotherapy-induced neutropenic complications: evaluation of practice in an academic medical center.

GOALS: Management of the risk of potential chemotherapy-induced neutropenic complications such as febrile neutropenia (FN) and severe neutropenia (SN) is a quality of care priority. How frequently does care at our institution conform to established guidelines? MATERIALS AND METHODS: This retrospective chart review study included a random sample of 305 cancer patients receiving care at a single US academic medical center. Abstracted data included demographics, risk factors, and outcome variables (e.g., development of FN/SN, administration of myeloid growth factors). To evaluate quality of care, we assessed conformance between actual practice and established clinical practice guidelines for the use of myeloid growth factors from the National Comprehensive Cancer Network (NCCN). MAIN RESULTS: Of the 305 cases reviewed, 8% were classified as low risk (<10%), 48% as intermediate risk (10-20%), and 44% as high risk (>20%), using the risk classifications in the NCCN guidelines modified to accommodate illness and other risk factors. Thirty-four percent received prophylactic administration of myeloid growth factors. Half of the cases had adequate documentation of mid-cycle absolute neutrophil count to determine whether FN/SN developed. Among these cases with adequate documentation, 21% developed FN/SN. Use of growth factors did not conform to established quality guidelines. Overall, 77 of 133 (58%) high-risk cases received myeloid growth factors, whereas six of 25 (24%) low-risk cases received myeloid growth factors. CONCLUSIONS: Routine clinical practice in this academic oncology setting was poorly aligned with established guidelines; there is substantial opportunity to standardize clinical strategies and increase conformance with evidence-based guidelines.