Routine proteinuria monitoring for bevacizumab in patients with gynecologic malignancies

2016 ◽  
Vol 22 (6) ◽  
pp. 771-776 ◽  
Author(s):  
Catherine S Lee ◽  
Laura M Alwan ◽  
Xiaocui Sun ◽  
Katherine A McLean ◽  
Renata R Urban
Keyword(s):  
Risk Factors ◽  
Gynecologic Oncology ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Creatinine Ratio ◽  
Gynecologic Malignancies ◽  
Urine Protein ◽  
Potential Cost ◽  
Bevacizumab Treatment ◽  
Grade 3

Background Proteinuria leading to nephrotic syndrome is a rare adverse event arising from treatment with bevacizumab. There is limited evidence to guide the frequency and appropriate test for monitoring for proteinuria. The purpose of this study was to determine the prevalence and severity of proteinuria during bevacizumab administration to patients with gynecologic malignancies, and to evaluate risk factors associated with this toxicity; a secondary objective was to evaluate the cost of routine proteinuria monitoring to assess for opportunities of cost containment that could change clinical practice. Methods A retrospective chart review was performed at an academic gynecologic oncology clinic. Women over 18 years of age with a diagnosed gynecologic malignancy were evaluated for the development of proteinuria while receiving bevacizumab treatment as measured by a urine protein-to-creatinine ratio. Patient and disease-specific risk factors were evaluated using logistic regression to determine correlations of risk factors to development of proteinuria. Cost assessment was performed using institution-specific data for urine laboratory tests. Results Eighty-nine patients were identified, and the overall prevalence of proteinuria of any grade was 35%. The mean number of bevacizumab cycles was 13 (2–64 cycles). The majority of patients experienced grade 1 proteinuria (70%, 62 patients). Grade 3 proteinuria was observed in two patients (2%). There was a trend toward increased bevacizumab cycles associated with increased grade proteinuria ( p = 0.053), however there were no factors significantly associated with the development of proteinuria as measured by urine protein-to-creatinine ratio. Conclusion Monitoring of urine protein-to-creatinine ratios with each cycle may be unnecessary due to the low prevalence of grade 3 proteinuria observed. Additionally, urine protein-to-creatinine ratios may not provide adequate assessment of proteinuria toxicity associated with bevacizumab therapy. Potential cost savings opportunities for the institution can be realized with a cost-reductive monitoring algorithm that will utilize less costly laboratory techniques for patients at high risk of developing proteinuria.

Evaluation of the dosing strategies of biologic agents and the theoretical impact of dose rounding

2016 ◽  
Vol 24 (1) ◽  
pp. 47-55
Author(s):  
Savannah Lindsey ◽  
Laura Beth Parsons ◽  
Lindsay Rosenbeck Figg ◽  
Jill Rhodes
Keyword(s):  
Monoclonal Antibody ◽  
Monoclonal Antibodies ◽  
Medical Center ◽  
Academic Medical Center ◽  
Wholesale Price ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Potential Cost ◽  
Cost Avoidance ◽  
The Cost

Introduction Monoclonal antibodies possess unique pharmacokinetic properties that permit flexible dosing. Increased use and high costs of these medications have led to the development of cost-containing strategies. This study aims to quantify the cost savings and clinical impact associated with dose rounding monoclonal antibodies to the nearest vial size. Methods This study was a single-arm, retrospective chart review assessing all monoclonal antibody doses dispensed at an outpatient community infusion center associated with an academic medical center between August 2014 and August 2015. All monoclonal antibody doses were reviewed to determine the cost of drug wasted using two methods. The waste-cost analysis described the amount of drug disposed of due to the use of partial vials. The theoretical dose savings described potential cost avoidance based on rounding the ordered dose to the nearest vial size. The theoretical rounded dose was compared to the actual ordered dose to explore clinical implications. Results A total of 436 doses were included. Of these, 237 were not rounded to the nearest vial size and included in the analysis. The cost of waste associated with these doses was $108,013.64 using actual wholesale price. The potential cost avoidance associated with the theoretical dose calculation was $83,595.53. Rounding these doses to the nearest vial size resulted in a median 6.7% (range, 1.4–20%) deviation from ordered dose. Conclusions Rounding monoclonal antibodies to the nearest vial size could lead to significant cost and waste savings with minimal deviation from the actual ordered dose.

scholarly journals Pharmacist-Driven Management of Chemotherapy Induced Nausea and Vomiting in Hospitalized Adult Oncology Patients. A Retrospective Comparative Study

2011 ◽  
Vol 2 (3) ◽  
Author(s):  
Ramy Elshaboury ◽  
Kathleen Green
Keyword(s):  
Practice Guidelines ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Standard Of Care ◽  
Nausea And Vomiting ◽  
P Value ◽  
Potential Cost

Chemotherapy-induced nausea and vomiting (CINV) is a major adverse event associated with cancer treatments. There are clinical practice guidelines that assist practitioners in managing CINV. Many cancer centers develop protocols for physicians and pharmacists to guide prophylaxis and breakthrough treatments of CINV based on published guidelines. The purpose of this study was to evaluate the outcome differences between pharmacist and physician -driven management of CINV in adult hospitalized cancer patients in a large academic medical center. This is a single center retrospective chart review study. The primary outcome of the study was the number of breakthrough antiemetic doses needed throughout the hospitalization. A total of 106 adult patients receiving inpatient chemotherapy were reviewed for CINV management. Fifty-five patients (52%) were managed according to the pharmacist-driven protocol, and fifty-one patients (48%) were managed by the physician. There was no difference between the two groups in the primary outcome. Patients in the pharmacist-managed group needed 6.4 breakthrough antiemetic doses; whereas, patients in the physician managed group needed 5.9 doses throughout the hospital stay (P-value = 0.7). No difference was seen when results were adjusted for length of hospitalization. There was a difference in adherence to the institution CINV guidelines favoring the pharmacist-driven approach (85% versus 33%, P < 0.0001). In conclusion, pharmacist-run protocol for CINV management was as effective as the standard of care. Protocols that are based on practice guidelines may offer the advantage of care standardization and potential cost savings.   Type: Student Project

Assessment of rasburicase utilization for tumor lysis syndrome management in pediatric and adult patients in the inpatient and outpatient settings

2020 ◽  
pp. 107815522094536
Author(s):  
Marin I Abousaud ◽  
Marie C Rush ◽  
Michelle Rockey
Keyword(s):  
Tumor Lysis Syndrome ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Outpatient Setting ◽  
Primary Objective ◽  
Adult Patients ◽  
Potential Cost ◽  
Tumor Lysis ◽  
Laboratory Values ◽  
Outpatient Settings

Introduction At Wake Forest Baptist Health, an adult tumor lysis syndrome pocket card was created in order to optimize management of tumor lysis syndrome and outline specific recommendations for the use of rasburicase. Due to the increased use of rasburicase at our institution and its cost, the purpose of this study was to evaluate the utilization of rasburicase for the management of tumor lysis syndrome in pediatric and adult patients in the inpatient and outpatient settings. Methods This was an observational, single-center, non-randomized, retrospective chart review conducted between September 2018 and August 2019. The primary objective was to evaluate the utilization of rasburicase and appropriateness for the management of tumor lysis syndrome in pediatric and adult patients based on the Wake Forest Baptist Health tumor lysis syndrome pocket card. The secondary objectives were to assess response to prophylactic and treatment doses of rasburicase and to quantify drug cost versus expense of rasburicase utilization. Results Overall, 64 patients (57 adults and 7 pediatric patients) were included in the study. Rasburicase use for tumor lysis syndrome indication adhered to the pocket card 64% of the time. Appropriate fluids and/or allopurinol were initiated in only 34% of patients. For monitoring, 80% of patients had all necessary tumor lysis syndrome laboratory values collected after rasburicase administration. All 11 patients (17%) who received rasburicase in the outpatient setting did not have follow-up labs collected. Of the patients who had tumor lysis syndrome laboratory values collected post rasburicase, 39% were appropriately timed to accurately assess efficacy of rasburicase with the median time of laboratory monitoring after rasburicase being 6.5 h. Response was observed with rasburicase 3 mg (92%), 6 mg (100%), and weight-based dosing (100%). The wholesale acquisition cost per patient was $5203 (1101–10,406). The potential cost savings of using the 3 mg dose versus the 6 mg dose for the patients who did not meet tumor lysis syndrome treatment recommendations based on the Wake Forest Baptist Health pocket card was estimated to be $36,419.46. Conclusion There are several opportunities for improvement in tumor lysis syndrome management and rasburicase utilization at our institution. This study will lead to the implementation of formal restrictions for rasburicase use and selection of rasburicase dose. Updating the rasburicase order panel to include appropriate prophylaxis and require input of uric acid level, populating pertinent tumor lysis syndrome laboratory values on the order verification screen for pharmacists to appropriately assess if rasburicase meets the institution restriction criteria, and providing education to providers on the appropriate ordering and timing of labs.

Venous Thromboembolic Events With Chemotherapy Plus Bevacizumab: A Pooled Analysis of Patients in Randomized Phase II and III Studies

2011 ◽  
Vol 29 (13) ◽  
pp. 1757-1764 ◽  
Author(s):  
Herbert I. Hurwitz ◽  
Leonard B. Saltz ◽  
Eric Van Cutsem ◽  
James Cassidy ◽  
Jonas Wiedemann ◽  
...  
Keyword(s):  
Risk Factors ◽  
Performance Status ◽  
Anticoagulation Therapy ◽  
Pooled Analysis ◽  
Severe Bleeding ◽  
Tumor Type ◽  
Bevacizumab Treatment ◽  
Venous Thromboembolic Events ◽  
Venous Thromboembolic ◽  
Grade 3

Purpose Thromboembolism is a major source of morbidity and mortality in patients with cancer. The contribution of anti–vascular endothelial growth factor therapy to these events remains controversial. Patients and Methods Individual patient data were available for 6,055 patients in 10 randomized studies. Unadjusted and exposure-adjusted incidence of venous thromboembolisms (VTEs) was estimated for the overall population and by tumor type. Multivariate analysis was performed to identify risk factors for development of VTE. The safety of anticoagulant therapy in patients undergoing bevacizumab treatment was also examined. Results There were no statistically significant increases in the unadjusted or exposure-adjusted incidences of all-grade VTEs for bevacizumab versus controls in the overall population or by tumor type. The unadjusted incidence in the overall population was 10.9% with bevacizumab versus 9.8% with controls (odds ratio, 1.14; 95% CI, 0.96 to 1.35; P = .13); the rate per 100 patient-years was 18.5 for bevacizumab and 20.3 for controls (rate ratio, 0.91; 95% CI, 0.77 to 1.06; P =.23). Incidences of grade 3 to 5 events were similar in both groups. Several risk factors for VTEs were identified, including tumor type, older age, poorer performance status, VTE history, and baseline oral anticoagulant use. No interactions between bevacizumab treatment and these factors were observed. For patients who had a VTE and received full-dose anticoagulation therapy, the risk of severe bleeding was low (< 1%) and unaffected by bevacizumab treatment. Conclusion The addition of bevacizumab to chemotherapy did not statistically significantly increase the risk of VTEs versus chemotherapy alone. The risk for VTEs is driven predominantly by tumor and host factors.

A randomized pilot study comparing aprepitant to olanzapine for treatment of chemotherapy-induced nausea and vomiting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9633-9633 ◽  
Author(s):  
N. M. Shumway ◽  
S. E. Terrazzino ◽  
C. B. Jones
Keyword(s):  
Pilot Study ◽  
Daily Diary ◽  
Cost Savings ◽  
Complete Response ◽  
Similar Efficacy ◽  
Nausea And Vomiting ◽  
Potential Cost ◽  
Double Blind ◽  
Acute Period ◽  
Grade 3

9633 Background: Chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) is prevalent. The NK1antagonist, aprepitant (APR), has been shown to decrease CINV and with increased use, cost of supportive care is rising. Recent studies have shown that olanzapine (OLN) is safe and effective for CINV when used in combination with dexamethasone and palonosetron. We conducted a randomized, double-blind, placebo controlled pilot study to evaluate the use of OLN compared to APR for prevention of CINV in patients receiving HEC. Methods: Chemotherapy naïve patients receiving HEC were randomized to an APR containing arm or an OLN containing arm [see Table ] for the first 2 cycles of treatment. Patients recorded episodes of emesis and use of rescue meds using a daily diary and symptoms using the M.D. Anderson Symptom Inventory(MDASI). 18 patients consented to the protocol and 17/18 (OLN=8, APR=9) patients were evaluable (1 lost daily diary) with a median age 60 (range 24–71) 11/18 were females. Results: Chemo regimens for OLN group included (AC=50%, cisplatin=25%, ABVD=25%, and ifos=25%) and for APR (AC=55%, cisplatin=33%, and ABVD=11%) For both cycles (C1+C2) the complete response (CR=no emesis, no rescue) during the anticipatory period (D-2, D-1) was 87.5% in the OLN group compared to 77.8% in the APR group. Acute period (D1) CR rates were 75% in OLN vs. 44% in the APR group. Delayed (D2–4) CR rates were 62.5% in OLN vs. 55.6% in the APR group. Rates of nausea (score ≥ 1 on scale of 0–10, MDASI) were 25% OLN vs. 22.2% APR for anticipatory period, 62.5% OLN vs. 44.4% APR for acute period, and 62.5% OLN vs. 66.7% APR for delayed period. There were no grade 3 /4 toxicities. Conclusions: OLN containing antiemetic regimens were well tolerated and offered similar efficacy as APR containing regimens in preventing CINV in patients receiving HEC. Larger studies are needed to evaluate non-inferiority and potential cost savings of OLN containing regimens. [Table: see text] No significant financial relationships to disclose.

Proteinuria monitoring in patients receiving bevacizumab at a community cancer center.

2014 ◽  
Vol 32 (30_suppl) ◽  
pp. 13-13
Author(s):  
Amin Benyounes ◽  
Sherry Pomerantz ◽  
Ann Christian ◽  
Gentry Teng King ◽  
Nancy Leahy ◽  
...  
Keyword(s):  
Retrospective Chart Review ◽  
Albert Einstein ◽  
Cancer Center ◽  
Primary Endpoints ◽  
Routine Monitoring ◽  
Bevacizumab Treatment ◽  
Progression Of Disease ◽  
Grade 3 ◽  
The Cost ◽  
Nephrotic Range Proteinuria

13 Background: The use of bevacizumab has been associated with the development of proteinuria. The manufacturer suggests monitoring for proteinuria with serial urine dipsticks. We set to evaluate the relevance and cost of this practice in a Community Cancer Center in Philadelphia. Methods: We performed a retrospective chart review at Albert Einstein Cancer Center. Consecutive patients treated with bevacizumab from January 2011 to March 2014 were included in the study. Primary endpoints were the incidence and grade of proteinuria under bevacizumab therapy and the implication of proteinuria in treatment (holding or cessation of bevacizumab). Secondary objectives included the association between the number of bevacizumab infusions or patient’s comorbidities (diabetes, hypertension, chronic kidney disease) and the development or worsening of proteinuria. We also calculated the cost of monitoring for proteinuria in our cohort. Results: 71 patients were screened. A total of 66 patients (corresponding to 738 infusions) were included in the analysis. Typical monitoring interval was every 2 cycles. None developed nephrotic range proteinuria. One patient (1.5%) developed grade 2 proteinuria. Bevaciuzumab was discontinued due to proteinuria in 2 patients (3%): neither of them developed permanent kidney damage or required an intervention as a consequence of the proteinuria. The most common reason of bevacizumab discontinuation was progression of disease (75%). Neither the number of infusions nor concomitant comorbidities were significantly associated with the development or worsening of proteinuria (p=0.8, p>0.05 respectively). The cost of monitoring for proteinuria in our cohort was estimated at $3980. Conclusions: These results show that the development of grade 2 proteinuria, let alone grade 3, with bevacizumab is uncommon and rarely affects treatment decisions in our Community Cancer Center. We therefore question the necessity of routine monitoring for proteinuria during bevacizumab treatment.

Development and Evaluation of a Pharmacist-Driven Screening Tool to Identify Patients Presenting to the Emergency Department Who Are Eligible for Outpatient Treatment of Deep Vein Thrombosis

2019 ◽  
pp. 089719001987258
Author(s):  
Shaina E. Musco ◽  
Shannon M. Smallwood ◽  
Jill Gossard
Keyword(s):  
Emergency Department ◽  
Deep Vein Thrombosis ◽  
Outpatient Treatment ◽  
Screening Tool ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Inpatient Setting ◽  
Potential Cost ◽  
Vein Thrombosis ◽  
Deep Vein

Background: Deep vein thrombosis (DVT) is a critical and costly health issue. Treatment in the outpatient setting is preferred compared to the inpatient setting. However, there is a lack of evidence regarding how best to identify patients who are ideal for outpatient DVT treatment. Objective: To design and evaluate a pharmacist-driven screening tool for the identification of patients presenting to the emergency department (ED) at a community hospital with DVT who are appropriate for outpatient treatment. Methods: This study was conducted in sequential phases: compilation and vetting of screening criteria, descriptive evaluation of criteria through retrospective chart review, and quantification of potential cost savings by avoiding admissions. Criteria were collected via literature search and assembled into a screening tool, which was applied retroactively to a cohort of ED patients admitted with DVT diagnosis. Results: A screening tool was developed with multidisciplinary input and consisted of 5 categories with individual patient and disease state criteria. The majority (91%) of patients reviewed would not have qualified for outpatient DVT treatment based on the retrospective application of the screening tool. The most common disqualification criteria category was high risk of bleeding/clotting (n = 81), and the most frequently represented parameter within that category was antithrombotic therapy prior to admission (n = 53). Conclusion: A screening tool may not be the most efficient method for health-care practitioners such as pharmacists to identify ED patients appropriate for outpatient management of DVT. Other avenues should be explored for improving the cost-effective management of these patients.

Assessment of extended urine protein monitoring frequency in patients receiving bevacizumab

2020 ◽  
pp. 107815522094395
Author(s):  
Molly Schiffer ◽  
Lejla Zukovic ◽  
Sophia Hall ◽  
Man Yee Merl
Keyword(s):  
Package Insert ◽  
Patient Characteristics ◽  
Urine Collection ◽  
New Haven ◽  
Urine Protein ◽  
Medication History ◽  
Negative Results ◽  
Monitoring Frequency ◽  
Bevacizumab Treatment ◽  
Grade 3

Purpose Proteinuria monitoring is required for patients receiving bevacizumab. Nonetheless, the frequency of monitoring is not specified in the package insert. A 2014 quality improvement study performed at Yale New Haven Health System (YNHHS) found that proteinuria occurred in 15% (all grade) of the 162 patients evaluated. These results led to decreasing the frequency of proteinuria monitoring from every treatment to every other treatment. The objective of this study is to assess the safety of the extended interval for urine protein (UP) monitoring. Methods Patients receiving at least four bevacizumab treatments at YNHHS from January to June 2017 were randomly selected and retrospectively reviewed. The following data were collected: baseline patient characteristics, comorbidities, medication history, and proteinuria monitoring. The grade, prevalence and management of proteinuria were evaluated. The minimum necessary sample size was determined to be 384 treatments to achieve a 95% confidence interval. Results Fifty-five patients and 388 bevacizumab treatments were evaluated. Urine protein was assessed in 52.5% of treatments. The incidence of proteinuria among patients was 7.2% (grade 2) and 0% (grade 3). Cumulative dose and the number of total bevacizumab doses did not affect the timing for onset or severity of proteinuria. Two patients with UP ≥ 2+ were further monitored using a 24-h urine collection test with negative results. No treatments were held due to proteinuria. Conclusion Monitoring proteinuria every other treatment does not increase the frequency of adverse events. Urine protein is now monitored prior to every third bevacizumab treatment, reducing unnecessary labs and chair time.

Outpatient Parotidectomy, a Safety and Financial Review

2021 ◽  
pp. 000348942110167
Author(s):  
Maxwell Scher ◽  
Claudia I. Cabrera ◽  
Yida Cai ◽  
Akina Tamaki ◽  
Shawn Li ◽  
...  
Keyword(s):  
Postoperative Complications ◽  
Demographic Data ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Tumor Type ◽  
Potential Cost ◽  
Patient Demographics ◽  
Academic Center ◽  
Inpatient Procedure ◽  
Mean Cost

Objective: The objective of this study is to investigate the safety, efficacy, and potential cost-savings of the outpatient parotidectomy procedure. Methods: This is a retrospective chart review of all patients who underwent a parotidectomy at a large academic center from 2015 through 2019 including demographic data, postoperative complications, drain placement, readmission, and financial cost. A comparison was performed between patients who underwent an outpatient vs inpatient parotidectomy. Results: A total of 335 patients underwent parotidectomy (136 outpatient; 199 inpatient). Comparison of patient demographics, common comorbidities, tumor size, tumor type, postoperative complications, and readmission rate was similar between the inpatient and outpatient cohorts. The overall mean cost difference between inpatient parotidectomy and outpatient parotidectomy for all years was $1528.58 (95%CI: $1139-$1916). Conclusion: The outpatient parotidectomy procedure has a comparable safety profile to the inpatient procedure while providing a significant cost-savings benefit.

scholarly journals 625. The Hidden Cost of Dalbavancin: OPAT-RN Time Spent on Coordination for Patients with Substance Use Disorder

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S416-S417
Author(s):  
Alyse Douglass ◽  
Heather Mayer ◽  
Kathleen Young ◽  
Amber C Streifel ◽  
Jina Makadia ◽  
...  
Keyword(s):  
Substance Use ◽  
Substance Use Disorder ◽  
Discharge Planning ◽  
Panel Member ◽  
Cost Savings ◽  
Retrospective Chart Review ◽  
Potential Cost ◽  
Outpatient Parenteral Antimicrobial Therapy ◽  
Time Required ◽  
Treatment Settings

Abstract Background The use of dalbavancin (DAL) enhances the management of serious gram-positive infections in people with substance use disorder (SUD) by eliminating the need for central lines, weekly lab monitoring, and may decrease length of hospitalizations. Though administered weekly, care coordination for DAL is often complex, due to variable access to resources, insurance variation and treatment settings. Our institution uses OPTIONS-DC, a multi-disciplinary discharge planning conference facilitated by an outpatient parenteral antimicrobial therapy (OPAT) registered nurse (RN) to determine safe treatment plans while emphasizing patient preference for hospitalized patients with SUD and serious infections. When DAL is selected for treatment, patients are enrolled in the RN-led OPAT program for coordination and monitoring. DAL has been shown to result in monetary savings but these estimates have yet to incorporate the true cost of coordination. Methods We conducted a retrospective chart review of OPAT staff interventions required to coordinate DAL doses for patients with SUD (identified via ICD-10 code or chart notes). Additionally, we recorded in real time, the amount of time spent per intervention over a one month period for 7 additional patients. Results 53 courses of DAL in patients with SUD were included with a variety of dosing regimens and treatment settings (Table 1). 41 (77%) patients endorsed IV substance use. 68% of patients received DAL for osteomyelitis or endocarditis. The majority were insured by Oregon Medicaid (70%). The number of RN interventions per course averaged 3.35 with the most common being coordinating with patients and vendors (Table 2). The average time spent per patient course during a one-month sample was 39.4 minutes (range 15 – 58 minutes). The most time-consuming interventions were conducting the OPTIONS-DC conferences and attempting to reach patients after hospital discharge. Readmission for adverse effects or infection occurred for 4 (8%) patients. Conclusion The OPAT-RN time required to coordinate outpatient DAL for patients with SUD is substantial. This enhanced coordination allows for potential cost savings to health systems. Disclosures Amber C. Streifel, PharmD, BCPS, Melinta (Advisor or Review Panel member) Monica K. Sikka, MD, FG2 (Scientific Research Study Investigator)

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