BACKGROUND: Although bevacizumab and its biosimilars are commonly used, there are limited real-world data on bevacizumab use in the United States, especially biosimilar bevacizumab used in ophthalmologic conditions. OBJECTIVE: To evaluate use patterns and patient characteristics for the originator bevacizumab relative to its biosimilars for labeled and off-label oncology and ophthalmology conditions and characterize adverse events in patients using bevacizumab for oncologic indications. METHODS: We conducted a retrospective cohort study with the Biologics and Biosimilars Collective Intelligence Consortium-distributed database to identify patients aged 21 years and older who received bevacizumab between January 1, 2010, and June 30, 2021. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Ophthalmologic indications included neovascular age-related macular degeneration (AMD), retinal vein occlusion (RVO), choroidal neovascularization (CNV), and proliferative diabetic retinopathy (PDR). We also captured patients' demographic and clinical characteristics. RESULTS: Total bevacizumab product (originator and biosimilars) use increased over time for RVO, CNV, and PDR starting in 2015 but decreased for AMD after 2016. For ophthalmology, bevacizumab product users were primarily male (56.8%), had a mean age of 62.9 years (SD = 0.08), and had a mean Charlson/Elixhauser combined comorbidity score ranging from 0.7 (CNV) to 2.7 (PDR). Bevacizumab users for oncology indications were mostly female (61.8%), had a mean age of 62.9 years (SD = 12.2), and had a mean Charlson/Elixhauser combined comorbidity score of 7.4 (SD = 3.0). Oncologic biosimilar product use increased over time between 2019 and 2020 as follows: colon cancer, 6.2% to 49.4%; lung cancer, 1.9% to 36.2%; and gynecologic cancer, 2.4% to 38.1%. CONCLUSIONS: Bevacizumab product use increased across most indications during the study period. Use for biosimilars increased in later years relative to the originator once available on the market. Limited data are available on real-world biosimilar use in the United States; future research should include monitoring for use and adverse events of these products.

Background Real-world evidence is a valuable source of information in healthcare. This study describes the challenges and successes during algorithm development to identify cancer cohorts and multi-agent chemotherapy regimens from claims data to perform a comparative effectiveness analysis of granulocyte colony stimulating factor (G-CSF) use. Methods Using the Biologics and Biosimilars Collective Intelligence Consortium's Distributed Research Network, we iteratively developed and tested a de novo algorithm to accurately identify patients by cancer diagnosis, then extract chemotherapy and G-CSF administrations for a retrospective study of prophylactic G-CSF. Results After identifying patients with cancer and subsequent chemotherapy exposures, we observed only 12% of patients with cancer received chemotherapy, which is fewer than expected based on prior analyses. Therefore, we reversed the initial inclusion criteria to identify chemotherapy receipt, then prior cancer diagnosis, which increased the number of patients from 2,814 to 3,645, or 68% of patients receiving chemotherapy had diagnoses of interest. Additionally, we excluded patients with cancer diagnoses that differed from those of interest in the 183 days before the index date of G-CSF receipt, including early-stage cancers without G-CSF or chemotherapy exposure. By removing this criterion, we retained 77 patients who were previously excluded. Finally, we incorporated a 5-day window to identify all chemotherapy drugs administered (excluding oral prednisone and methotrexate, as these medications may be used for other non-malignant conditions) as patients may fill oral prescriptions days to weeks prior to infusion. This increased the number of patients with chemotherapy exposures of interest to 6,010. The final cohort of included patients, based on G-CSF exposure, increased from 420 from the initial algorithm to 886 using the final algorithm. Conclusions Medications used for multiple indications, sensitivity and specificity of administrative codes, and relative timing of medication exposure must all be evaluated to identify patient cohorts receiving chemotherapy from claims data.

400 Background: Bevacizumab (Avastin), an anti-angiogenic agent, was approved for various oncologic indications in 2004 in the US. Two biosimilars, bevacizumab-awwb (Mvasi) and bevacizumab-bvzr (Zirabev), were on the market 2017 and 2019, respectively. Real-world data on adverse events for bevacizumab biosimilars is limited. Methods: We conducted a retrospective cohort study using the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) distributed database to evaluate utilization patterns, patient characteristics, and prespecified adverse events of interest for the originator bevacizumab relative to its biosimilars in oncology among users 21 years of age and older between January 1, 2010, to December 31, 2020. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Adverse events (AEs) of interest were arterial thromboembolism (ATE), congestive heart failure (CHF), gastrointestinal perforation, stroke and acute myocardial infarction (AMI), and venous thromboembolism (VTE). The study analyzed biosimilars collectively, which include bevacizumab-awwb and bevacizumab-bvzr. Results: Both bevacizumab originator and biosimilar users for colon cancer were mostly male (55%), had a mean age of 61 years, and a mean Charlson/Elixhauser combined comorbidity score from 7.0 to 8.0. Among patients with lung cancer users, 53% were female with an overall mean age of 64 years and comorbidity scores from 6.4 to 7.5. Patients with gynecologic cancers had mean age of 63 years, and comorbidity scores from 6.1 to 6.7. Overall, oncologic bevacizumab use increased by 19% over time. Of the 24,044 total episodes from 2010 to 2020, AEs included ATE (2,560 events, 11%), CHF (2,092 events, 9%), gastrointestinal perforation (2,858 events, 12%), stroke/AMI (399 events, 2%), and VTE (4,447 events, 19%). AE rates were comparable between the originator and biosimilars: 7% and 8% for ATE, 5% and 4% for CHF, 9% and 8% for gastrointestinal perforation, 0.6% and 1% for stroke and AMI, and 10% and 8% for VTE, respectively. From 2019 to 2020, biosimilar use increased from 6% to 49% of total bevacizumab utilization for patients with colon cancer, from 2% to 36% for patients with lung cancer, and from 2% to 38% for patients with gynecologic cancers. Conclusions: Bevacizumab utilization increased across all oncology indications evaluated during the study period. From 2019 to 2020, utilization for biosimilars relative to the originator increased. As there are limited data available on bevacizumab biosimilar use in real world settings, future research should be conducted to see if utilization for biosimilar products continues to rise as well as safety over time.

Background: The gut microbiome plays a critical role in modulating the therapeutic effect of immune checkpoint inhibitors (ICIs). Proton pump inhibitors (PPIs) are commonly used in cancer patients and may affect the gut microbiome by altering gut pH. Objective: To evaluate if concurrent use of PPI is associated with overall survival (OS) and progression-free survival (PFS) in patients with stage IV non-small-cell lung cancer (NSCLC), melanoma, renal cell carcinoma, transitional cell carcinoma, or head and neck squamous cell carcinoma. Methods: This was a single-center retrospective cohort study of advanced cancer adult patients who received nivolumab or pembrolizumab between September 1, 2014, and August 31, 2019. Concomitant PPI exposure was defined as PPI use 0 to 30 days before or after initiation of ICIs. Treatment outcome was OS and PFS. Results: A total of 233 patients were included in our study. Concomitant PPI use was not significantly associated with OS (hazard ratio [HR] = 1.22; 95% CI = 0.80-1.86) or PFS (HR = 1.05; 95% CI = 0.76-1.45) in patients with ICI use. The effect estimates were robust after adjusting for covariates in multivariate analysis and in patients with NSCLC. Conclusion and Relevance: Concomitant PPI use was not associated with the effectiveness of nivolumab or pembrolizumab. Certain predictors of survival outcomes related to PPI use in patients receiving immunotherapy, such as the time window and indication of PPI exposure and autoimmune disorders, should be explored in the future to better carve out the impact of PPI on the effectiveness of ICI use.

Objective. To determine the current state of employment for doctor of pharmacy (PharmD) graduates based on 5-year trends among graduates of research-intensive institutions and the Pharmacist Demand Index. Methods. Data from a cross-sectional survey of PharmD graduates from 10 research-intensive colleges of pharmacy conducted over a 5-year period were used to generate an overview of graduating students’ experiences and the outcomes of their job searches. Results. The average response rate of graduates of programs over the 5 years was 75.4%. Overall, 86% of graduates had postgraduate placements (ie, jobs, residencies, fellowships, further education) at the time of graduation. Across all years, 85% of respondents who had placements indicated they were satisfied with the postgraduation offer they received. Conclusion. An examination of postgraduate outcomes of research-intensive schools and the Pharmacist Demand Indicator over the past 5 years indicates a trend toward a balance between the supply and demand for pharmacists. Careful attention needs to be given to these two metrics moving forward.

Purpose To update guideline recommendations on the role of bone-modifying agents in multiple myeloma. Methods An update panel conducted a targeted systematic literature review by searching PubMed and the Cochrane Library for randomized controlled trials, systematic reviews, meta-analyses, clinical practice guidelines, and observational studies. Results Thirty-five relevant studies were identified, and updated evidence supports the current recommendations. Recommendations For patients with active symptomatic multiple myeloma that requires systemic therapy with or without evidence of lytic destruction of bone or compression fracture of the spine from osteopenia on plain radiograph(s) or other imaging studies, intravenous administration of pamidronate 90 mg over at least 2 hours or zoledronic acid 4 mg over at least 15 minutes every 3 to 4 weeks is recommended. Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative. Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting. The update panel recommends that clinicians consider reducing the initial pamidronate dose in patients with preexisting renal impairment. Zoledronic acid has not been studied in patients with severe renal impairment and is not recommended in this setting. The update panel suggests that bone-modifying treatment continue for up to 2 years. Less frequent dosing has been evaluated and should be considered in patients with responsive or stable disease. Continuous use is at the discretion of the treating physician and the risk of ongoing skeletal morbidity. Retreatment should be initiated at the time of disease relapse. The update panel discusses measures regarding osteonecrosis of the jaw. Additional information is available at www.asco.org/hematologic-malignancies-guidelines and www.asco.org/guidelineswiki .

Background and purpose: StrengthsFinder (R) is a widely-used assessment that can be used to help student pharmacists discover their talents (i.e., signature themes [STs]) and develop their leadership skills. The assessment has also been used in pharmacy residents, but the prevalence of various STs in that group has not been compared to those in student pharmacists. Educational activity and setting: Residents from four midwestern pharmacy institutions completed StrengthsFinder (R) 2.0 and received their top five STs. STs were organized and examined by domains (executing, influencing, relationship building, and strategic thinking). StrengthsFinder (R) data on student pharmacists were obtained from a previously published study. The distribution of the themes and domains was compared between residents and student pharmacists. Findings: Responses from 31 residency program cohorts, including 290 pharmacy residents from a pool of 304 (95.4%) possible respondents, were included in the study. The learner ST was more frequently reported in the top five in pharmacy residents versus student pharmacists (42.8% versus 35.5%, p = 0.022). The woo and communication STs were also more frequently reported in the top five, while the consistency ST was reported less frequently in the top five in pharmacy residents versus student pharmacists (p < 0.05). The executing and relationship building domains had the highest average number of STs (1.58 and 1.56, respectively). Discussion and summary: The ST profile of pharmacy residents at residency programs affiliated with four midwestern schools of pharmacy is generally similar to that of pharmacy graduates. However, several STs were more or less prevalent in pharmacy residents. Recognition of these differences may assist residency program directors in marketing and design of programs and ranking of candidates.

Purpose To update, in collaboration with Cancer Care Ontario (CCO), key recommendations of the American Society of Clinical Oncology (ASCO) guideline on the role of bone-modifying agents (BMAs) in metastatic breast cancer. This focused update addressed the new data on intervals between dosing and the role of BMAs in control of bone pain. Methods A joint ASCO-CCO Update Committee conducted targeted systematic literature reviews to identify relevant studies. Results The Update Committee reviewed three phase III noninferiority trials of dosing intervals, one systematic review and meta-analysis of studies of de-escalation of BMAs, and two randomized trials of BMAs in control of pain secondary to bone metastases. Recommendations Patients with breast cancer who have evidence of bone metastases should be treated with BMAs. Options include denosumab, 120 mg subcutaneously, every 4 weeks; pamidronate, 90 mg intravenously, every 3 to 4 weeks; or zoledronic acid, 4 mg intravenously every 12 weeks or every 3 to 4 weeks. The analgesic effects of BMAs are modest, and they should not be used alone for bone pain. The Update Committee recommends that the current standard of care for supportive care and pain management—analgesia, adjunct therapies, radiotherapy, surgery, systemic anticancer therapy, and referral to supportive care and pain management—be applied. Evidence is insufficient to support the use of one BMA over another. Additional information is available at www.asco.org/breast-cancer-guidelines and www.asco.org/guidelineswiki .

We conducted a nationwide survey of 583 community pharmacists in Japan and demonstrated a need for additional education and training in oral chemotherapy from a multivariate analysis.A recent study of community pharmacists in Canada reported that they required additional education. We conducted a survey of community pharmacists to evaluate the adequacy of education and training in oral anticancer agents in Japan.Between May and June 2014, community pharmacists were asked to complete a questionnaire by using two different survey strategies, one online and one via postal mail.Three hundred community pharmacists responded to an online survey and 283 community pharmacists responded to a mailed survey. Only 6-10% of respondents felt that they had received adequate education in oncology or oral chemotherapy. Although 81% of Japanese pharmacists had attended at least one continuing education event related to oncology in the past 2 years, only 54% felt comfortable dispensing oral anticancer agents and only 40% felt comfortable educating patients about oral chemotherapy. In a multivariate analysis, confidence in educating patients about oral chemotherapy was associated with an understanding of chemotherapy cycles and doses (odds ratio = 4.89, 95% confidence interval [2.53-9.45]) and the number of continuing education events they had attended (odds ratio = 1.67, 95% confidence interval [1.35-2.08]).This is the first report to evaluate whether community pharmacists are equipped to ensure the safe use of oral anticancer agents in Japan. The results are similar to those previously reported for Canadian pharmacists, namely a low rate of positive responses for education in oncology and oral chemotherapy, demonstrating a similar need for additional education and training in oral chemotherapy.

Objective. To characterize postgraduation placement plans of 2013 doctor of pharmacy (PharmD) graduates. Methods. A cross-sectional survey of PharmD graduates from 8 midwestern colleges of pharmacy was designed to capture a comprehensive picture of graduating students’ experiences and outcomes of their job search. Results. At graduation, 81% of 2013 respondents had postgraduate plans, with approximately 40% accepting jobs and 40% accepting residencies or fellowships. Eighty-four percent of graduates reported being pleased with offers received, and 86% received placement in their preferred practice setting. Students perceived that securing residencies was more difficult than securing jobs. Students who participated in key activities had a nearly sevenfold increase in successful residency placement. Conclusion. While the demand for pharmacists decreased in recent years, responses indicated successful placement by the majority of 2013 graduates at the time of graduation.

The NCCN Guidelines for Cancer-Associated Venous Thromboembolic Disease outline strategies for treatment and prevention of venous thromboembolism (VTE) in adult patients with a diagnosis of cancer or for whom cancer is clinically suspected. VTE is a common complication in patients with cancer, which places them at greater risk for morbidity and mortality. Therefore, risk-appropriate prophylaxis is an essential component for the optimal care of inpatients and outpatients with cancer. Critical to meeting this goal is ensuring that patients get the most effective medication in the correct dose. Body weight has a significant impact on blood volume and drug clearance. Because obesity is a common health problem in industrialized societies, cancer care providers are increasingly likely to treat obese patients in their practice. Obesity is a risk factor common to VTE and many cancers, and may also impact the anticoagulant dose needed for safe and effective prophylaxis. These NCCN Guidelines Insights summarize the data supporting new dosing recommendations for VTE prophylaxis in obese patients with cancer.

Objective. To describe student pharmacists' Signature Themes from the Clifton StrengthsFinder across 5 Midwestern pharmacy institutions and to compare themes by gender, institution, and undergraduate population.Methods. Student pharmacists completed the StrengthsFinder 2.0 assessment and received their top 5 Signature Themes. Themes were organized and examined by domains (Executing, Influencing, Relationship Building, Strategic Thinking). The distribution of the themes was compared between student pharmacists and undergraduates and themes and domains were compared by institution and gender.Results. Although results varied by institution, the top 5 themes among the 1244 of 1250 students (99.5%) who completed the assessment were: Achiever, Harmony, Learner, Responsibility, and Empathy. Female student pharmacists had more themes in Executing and Relationship Building, while males had more themes in Influencing and Strategic Thinking. Pharmacy students exhibit more Executing domain talents and fewer Influencing domain talents compared with undergraduates.Conclusion. Signature Themes were consistent among student pharmacists across 5 Midwestern colleges of pharmacy.

The NCCN Guidelines for Cancer-Associated Venous Thromboembolic Disease outline strategies for treatment and prevention of venous thromboembolism (VTE) in adult patients with a diagnosis of cancer or for whom cancer is clinically suspected. VTE is a common complication in patients with cancer, which places them at greater risk for morbidity and mortality. Therefore, risk-appropriate prophylaxis is an essential component for the optimal care of inpatients and outpatients with cancer. Critical to meeting this goal is ensuring that patients get the most effective medication in the correct dose. Body weight has a significant impact on blood volume and drug clearance. Because obesity is a common health problem in industrialized societies, cancer care providers are increasingly likely to treat obese patients in their practice. Obesity is a risk factor common to VTE and many cancers, and may also impact the anticoagulant dose needed for safe and effective prophylaxis. These NCCN Guidelines Insights summarize the data supporting new dosing recommendations for VTE prophylaxis in obese patients with cancer.

Peripheral blood has replaced bone marrow as a source of hematopoietic stem cells for autologous rescue after high‐dose chemotherapy. Patients who receive peripheral blood stem cell (PBSC) transplants experience rapid and sustained hematopoietic reconstitution. As a result, transplant‐related mortality is now less than 5% at many centers, and the cost of high‐dose chemotherapy has decreased considerably. However, the relapse rate continues to be unacceptably high, and the collection of hematopoietic stem cells from peripheral blood is inconvenient, time consuming, and expensive. This article discusses the current status of novel technologies such as positive selection of hematopoietic stem cells, ex vivo expansion of hematopoietic progenitor cells, allogeneic PBSC transplants, and umbilical cord blood transplants. Several companies are actively developing devices that positively select hematopoietic stem cells. Because positive selection reduces the volume of infused cells, patients experience fewer adverse effects related to dimethylsulfoxide (DMSO) or lysed cells. These devices may also serve as an ex vivo method to remove (“purge”) residual tumor cells. Positively selected hematopoietic stem cells may be expanded ex vivo to produce a large number of a specific population of hematopoietic cells. By adding cytokines that stimulate and activate lymphocytes, natural killer cells, and other immune effector cells, investigators could expand the number of immune effector cells with antitumor activity and then infuse them into patients as a form of adoptive immunotherapy. Finally, peripheral blood and umbilical cord blood are promising new sources of hematopoietic stem cells for allogeneic transplants.

Pharmacotherapy: The Journal of Human Pharmacology and Drug TherapyVolume 34, Issue 8 p. 769-770 Editorial Standards of Practice for Clinical Pharmacists: The Time Has Come Gary C. Yee, Corresponding Author Gary C. Yee College of Pharmacy, University of Nebraska Medical Center, Omaha, NebraskaAddress for correspondence: Gary C. Yee, University of Nebraska Medical Center, 986045 Nebraska Medical Center, Omaha, NE 68198-6045; e-mail: [email protected]; or download from http://www.accp.com.Search for more papers by this authorCurtis E. Haas, Curtis E. Haas Department of Pharmacy, University of Rochester Medical Center, Rochester, New YorkSearch for more papers by this author Gary C. Yee, Corresponding Author Gary C. Yee College of Pharmacy, University of Nebraska Medical Center, Omaha, NebraskaAddress for correspondence: Gary C. Yee, University of Nebraska Medical Center, 986045 Nebraska Medical Center, Omaha, NE 68198-6045; e-mail: [email protected]; or download from http://www.accp.com.Search for more papers by this authorCurtis E. Haas, Curtis E. Haas Department of Pharmacy, University of Rochester Medical Center, Rochester, New YorkSearch for more papers by this author First published: 11 August 2014 https://doi.org/10.1002/phar.1450Citations: 12Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL No abstract is available for this article.Citing Literature Volume34, Issue8August 2014Pages 769-770 RelatedInformation

Objective. To describe the current status and developing trend of clinical pharmacy education in China. Methods. Descriptive analysis of data and information about the clinical pharmacy specialty, pharmacy colleges, and curriculum from literature, college websites, and statistics from the Ministry of Health (MOH) and Ministry of Education (MOE) websites was conducted. Results. Clinical pharmacy programs were established in China in 1989 but developed more fully after 2006. In 2012, there were 30 pharmacy colleges with clinical pharmacy undergraduate programs, which included a bachelor’s degree in clinical pharmacy and a clinical pharmacy concentration within the BS programs of pharmacy or medicine. More than 40 colleges within the university system offer 4 types of master’s degree programs in clinical pharmacy. Five universities offer a PhD program in clinical pharmacy. Three postgraduate programs exist, which train hospital pharmacists and clinical pharmacists: the 3+2 year Hospital Pharmacist Standardized Training Program at Peking hospitals; the 1-year Clinical Pharmacist Training Program sponsored by the MOH; and the 2-year Clinical Pharmacist Residency Program provided by West China Hospital at Sichuan University. Conclusion. A growing clinical pharmacy education system has been established and has become an important subfield in Chinese pharmacy education. Measures should be taken to further promote the development of clinical pharmacy education in China.

Venous thromboembolism (VTE) remains a common and life-threatening complication among patients with cancer. Thromboprophylaxis can be used to prevent the occurrence of VTE in patients with cancer who are considered at high risk for developing this complication. Therefore, it is critical to recognize the various risk factors for VTE in patients with cancer. Risk assessment tools are available to help identify patients for whom discussions regarding the potential benefits and risks of thromboprophylaxis would be appropriate. The NCCN Clinical Practice Guidelines in Oncology for VTE provide recommendations on risk evaluation, diagnosis, prevention, and treatment of VTE in patients with cancer.

Purpose To update the recommendations on the role of bone-modifying agents in the prevention and treatment of skeletal-related events (SREs) for patients with metastatic breast cancer with bone metastases. Methods A literature search using MEDLINE and the Cochrane Collaboration Library identified relevant studies published between January 2003 and November 2010. The primary outcomes of interest were SREs and time to SRE. Secondary outcomes included adverse events and pain. An Update Committee reviewed the literature and re-evaluated previous recommendations. Results Recommendations were modified to include a new agent. A recommendation regarding osteonecrosis of the jaw was added. Recommendations Bone-modifying agent therapy is only recommended for patients with breast cancer with evidence of bone metastases; denosumab 120 mg subcutaneously every 4 weeks, intravenous pamidronate 90 mg over no less than 2 hours, or zoledronic acid 4 mg over no less than 15 minutes every 3 to 4 weeks is recommended. There is insufficient evidence to demonstrate greater efficacy of one bone-modifying agent over another. In patients with a calculated serum creatinine clearance of more than 60 mg/min, no change in dosage, infusion time, or interval of bisphosphonate administration is required. Serum creatinine should be monitored before each dose. All patients should receive a dental examination and appropriate preventive dentistry before bone-modifying agent therapy and maintain optimal oral health. Current standards of care for cancer bone pain management should be applied at the onset of pain, in concert with the initiation of bonemodifying agent therapy. The use of biochemical markers to monitor bone-modifying agent use is not recommended.