Evaluation of the Implementation of a 90-Minute Rituximab Infusion Protocol at the Richard L. Roudebush VA Medical Center

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Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

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Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

Background: The utilization of rituximab for a variety of different indications has historically been associated with logistical challenges related to time and labor. Institutions across the country have implemented protocols to shorten the infusion time of rituximab in order to help alleviate these challenges. The purpose of this study was to support the safe implementation of a 90-minute rapid infusion protocol for rituximab at the Richard L. Roudebush VA Medical Center and improve staff perception regarding similar initiatives in the future with other therapies.

Methods: Proactive measures were taken to educate physicians, pharmacists, and nurses about their role in the implementation of the protocol. A weekly report of patients receiving rituximab was generated from November 1st, 2018 to April 1st, 2019. Patients were then screened for future eligibility for rapid infusions of the drug based on prespecified criteria and providers were notified regarding potential candidates. After patients received their rapid infusions, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns.

Data Analysis: The primary endpoint for this study was the incidence of grade 3 and 4 infusion related reactions associated with the rapid infusions of rituximab based on criteria from CTCAE version 5.0. Secondary endpoints were savings in infusion clinic chair time and the proportion of patients experiencing a grade 3 or 4 infusion related reaction to the rapid infusion that received proper treatment according to the institution’s hypersensitivity protocol. All endpoints were analyzed using descriptive statistics.

Results: During the study period, 11 patients received a total of 24 rapid infusions of rituximab. One out of 24 infusions (4.17%) resulted in a grade 3 infusion related reaction. This patient was treated appropriately by nurses according to the institution’s hypersensitivity protocol. The average savings in infusion clinic chair time by rapid infusions was 39.3 minutes.

Conclusion: This study proved that a rapid infusion protocol for rituximab can be successfully implemented at the Richard L. Roudebush VA Medical Center. The proactive measures utilized to implement the protocol improved provider prescribing rates and nursing satisfaction. Future plans involve implementing a rapid infusion protocol for daratumumab.

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Clinical Impact of Biweekly Liver Function Tests During the First Three Months of Abiraterone Therapy in a Veteran Population

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Purpose: To evaluate the clinical impact of biweekly liver function tests (LFTs) during the first 3 months of abiraterone therapy in veterans with prostate cancer.

Background: Abiraterone monitoring recommendations include biweekly LFTs for 3 months, then monthly based on concerns of early hepatoxicity in a limited number of patients. Veterans at the Richard L. Roudebush Veterans Affairs Medical Center (RLRVAMC) appear to tolerate abiraterone without clinically significant hepatoxicity despite stringent monitoring. There appears to be an opportunity to improve patient satisfaction/ quality of life and decrease cost to the healthcare system.

Methods: Patients were included in this retrospective chart review if abiraterone was initiated through the RLRVAMC between May 2014 and July 2018. Exclusion criteria were discontinuation within three months due to rising prostate-specific antigen or adverse drug events unrelated to hepatotoxicity, prior abiraterone exposure, and management outside RLRVAMC. Primary outcome was incidence and severity of LFT changes. Secondary outcomes included incidence and cause of dose reduction and death. Descriptive statistics analyzed outcomes. Severity of toxicity was classified according to common terminology criteria for adverse events (CTCAE) version 5.

Results: Ninety patients were included. Across three months of treatment, 24 (26.7%), 2 (2.2%), 0, and 2 (2.2%) patients experienced maximum CTCAE grade 1, 2, 3, and 4 LFT changes, respectively. Two patients experienced grade 3 or 4 LFT changes, both with previous therapy modifications due to grade 1 or 2 LFT changes and acute illness. Therapy modifications for any reason occurred in 4.4% of patients, all due to acute illness, general tolerability concerns, or grade 1 or 2 LFT changes. Four patients experienced death. No deaths were considered directly related to abiraterone.

Implications: Need for week 10 laboratory monitoring may be determined based on patient specific criteria. Reduction in laboratory monitoring may increase patient satisfaction/quality of life and decrease unnecessary costs to the healthcare system. Patients initiated on abiraterone through the RLRVAMC will receive monthly monitoring starting at week eight in the absence of baseline risk factors for hepatoxicity, grade 2 or worsening grade 1 changes during the first two months of therapy, or new grade 1 changes identified at week eight of therapy

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Purpose: To evaluate the clinical impact of biweekly liver function tests (LFTs) during the first 3 months of abiraterone therapy in veterans with prostate cancer.

Background: Abiraterone monitoring recommendations include biweekly LFTs for 3 months, then monthly based on concerns of early hepatoxicity in a limited number of patients. Veterans at the Richard L. Roudebush Veterans Affairs Medical Center (RLRVAMC) appear to tolerate abiraterone without clinically significant hepatoxicity despite stringent monitoring. There appears to be an opportunity to improve patient satisfaction/ quality of life and decrease cost to the healthcare system.

Methods: Patients were included in this retrospective chart review if abiraterone was initiated through the RLRVAMC between May 2014 and July 2018. Exclusion criteria were discontinuation within three months due to rising prostate-specific antigen or adverse drug events unrelated to hepatotoxicity, prior abiraterone exposure, and management outside RLRVAMC. Primary outcome was incidence and severity of LFT changes. Secondary outcomes included incidence and cause of dose reduction and death. Descriptive statistics analyzed outcomes. Severity of toxicity was classified according to common terminology criteria for adverse events (CTCAE) version 5.

Results: Ninety patients were included. Across three months of treatment, 24 (26.7%), 2 (2.2%), 0, and 2 (2.2%) patients experienced maximum CTCAE grade 1, 2, 3, and 4 LFT changes, respectively. Two patients experienced grade 3 or 4 LFT changes, both with previous therapy modifications due to grade 1 or 2 LFT changes and acute illness. Therapy modifications for any reason occurred in 4.4% of patients, all due to acute illness, general tolerability concerns, or grade 1 or 2 LFT changes. Four patients experienced death. No deaths were considered directly related to abiraterone.

Implications: Need for week 10 laboratory monitoring may be determined based on patient specific criteria. Reduction in laboratory monitoring may increase patient satisfaction/quality of life and decrease unnecessary costs to the healthcare system. Patients initiated on abiraterone through the RLRVAMC will receive monthly monitoring starting at week eight in the absence of baseline risk factors for hepatoxicity, grade 2 or worsening grade 1 changes during the first two months of therapy, or new grade 1 changes identified at week eight of therapy

Purpose: To evaluate the clinical impact of biweekly liver function tests (LFTs) during the first 3 months of abiraterone therapy in veterans with prostate cancer.

Background: Abiraterone monitoring recommendations include biweekly LFTs for 3 months, then monthly based on concerns of early hepatoxicity in a limited number of patients. Veterans at the Richard L. Roudebush Veterans Affairs Medical Center (RLRVAMC) appear to tolerate abiraterone without clinically significant hepatoxicity despite stringent monitoring. There appears to be an opportunity to improve patient satisfaction/ quality of life and decrease cost to the healthcare system.

Methods: Patients were included in this retrospective chart review if abiraterone was initiated through the RLRVAMC between May 2014 and July 2018. Exclusion criteria were discontinuation within three months due to rising prostate-specific antigen or adverse drug events unrelated to hepatotoxicity, prior abiraterone exposure, and management outside RLRVAMC. Primary outcome was incidence and severity of LFT changes. Secondary outcomes included incidence and cause of dose reduction and death. Descriptive statistics analyzed outcomes. Severity of toxicity was classified according to common terminology criteria for adverse events (CTCAE) version 5.

Results: Ninety patients were included. Across three months of treatment, 24 (26.7%), 2 (2.2%), 0, and 2 (2.2%) patients experienced maximum CTCAE grade 1, 2, 3, and 4 LFT changes, respectively. Two patients experienced grade 3 or 4 LFT changes, both with previous therapy modifications due to grade 1 or 2 LFT changes and acute illness. Therapy modifications for any reason occurred in 4.4% of patients, all due to acute illness, general tolerability concerns, or grade 1 or 2 LFT changes. Four patients experienced death. No deaths were considered directly related to abiraterone.

Implications: Need for week 10 laboratory monitoring may be determined based on patient specific criteria. Reduction in laboratory monitoring may increase patient satisfaction/quality of life and decrease unnecessary costs to the healthcare system. Patients initiated on abiraterone through the RLRVAMC will receive monthly monitoring starting at week eight in the absence of baseline risk factors for hepatoxicity, grade 2 or worsening grade 1 changes during the first two months of therapy, or new grade 1 changes identified at week eight of therapy

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