Implementation and Evaluation of a 90-Minute Rituximab Infusion Protocol at the Richard L. Roudebush VA Medical Center
Background: The use of IV rituximab for the treatment of a variety of malignant and nonmalignant indications has been associated with significant challenges related to time and labor. To help alleviate some of these logistic challenges, institutions have implemented protocols to shorten the time in which rituximab is infused. 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 (RLRVAMC).
Methods: A 90-minute rituximab protocol was developed, and proactive measures were taken to educate physicians, pharmacists, and nurses on ordering, processing, compounding, and administering rituximab. A weekly report of patients who received rituximab at RLRVAMC was generated November 1, 2018 through April 1, 2019. Patients then were screened for rapid infusion of the drug based on eligibility criteria, and health care providers (HCPs) were notified. After each patient received a rapid infusion, a retrospective chart review was performed to evaluate patient tolerability and assess for any safety concerns that would require protocol modification. The primary endpoint for this study was the incidence of grade 3 and 4 infusion-related reactions (IRRs) associated with rapid infusions of rituximab based on the Common Terminology Criteria for Adverse Events Version 5.0.
Results: Eleven patients received 24 rapid infusions of ritux imab. Of these infusions, 1 (4.2%) resulted in a grade 3 IRR; no infusions resulted in a reaction of grade ≥ 4. The use of rapid infusion of rituximab when compared with nonrapid infusion saved 39.3 minutes on average per patient.
Conclusions: The proactive measures that were used to im plement the rapid infusion rituximab protocol improved HCP prescribing rates, nursing satisfaction, and the management of IRRs. This study confirmed appropriateness of rapid administration of rituximab in this veteran population and has increased interest in implementing other rapid infusion protocols.
Methods
Proactive measures were required before and during the implementation of the 90-minute protocol to ensure patient safety and staff satisfaction. Updates to the RLRVAMC policy for the management of medical emergencies within the infusion center were reviewed and approved by the acute care committee and nursing leadership. A protocol was developed to identify eligible patients, outline the hypersensitivity protocol, instruct pharmacy personnel on admixture preparation, and provide a titration schedule based on dose. Order sets also were created to assist health care providers (HCPs) with the prescribing of rituximab for nonantineoplastic indications. Educational materials were crafted to assist with order verification, product preparation, labeling, and programming of infusion pumps. Live education was provided for physicians, pharmacists, and nurses to ensure smooth implementation of the protocol and appropriate management of medical emergencies based on the updated policy.
Study Design
Nursing staff in the infusion clinic were surveyed once before a live education session and again after the conclusion of the study. The purpose of the survey was to assess the prior experience and current comfort level of the nursing staff with administering rituximab over 90 minutes. Nurses were asked the following questions: (1) Do you have prior experience administering rituximab via 90-minute infusion; and (2) do you feel comfortable administering rituximab via 90-minute infusion?
A weekly report of patients who received rituximab between November 1, 2018 through April 1, 2019 at the RLRVAMC was generated. HCPs were alerted to eligible patients based on protocol requirements. The HCPs then made the final determination and entered orders accordingly.
This study was a retrospective chart review of all who patients received a rapid infusion of rituximab. Patients who were included if they were aged ≥ 18 years, received rituximab infusions in the RLRVAMC infusion clinic, had an absolute lymphocyte count ≤ 5,000/mm3 at the time of their rapid infusions, had no significant baseline cardiovascular disease or respiratory compromise, and had no prior grade 3 or 4 rituximab IRRs as defined by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.9 This study was a quality improvement initiative and considered exempt by the institutional review board. All data were deidentified and secured to ensure patient privacy.
The primary endpoint for this study was the incidence of grade 3 or 4 IRRs associated with the rapid infusion of rituximab. Secondary endpoints included the proportion of patients who experienced a grade 3 or 4 infusion reaction, who received proper treatment according to the institution’s hypersensitivity protocol, savings in infusion clinic chair time, and nursing satisfaction with education and implementation of the rapid infusion rituximab protocol.
The following data were collected for all included patients: demographics, lactic acid dehydrogenase level, white blood cell count, and absolute lymphocyte count prior to rituximab infusion, indication for treatment, dose of rituximab for 90-minute infusion, date of infusion, starting time, ending time, number of previous rituximab infusions within the past 3 months, symptoms of infusion reactions during rituximab infusion, and grade of any infusion reactions that occurred.
Estimated savings in infusion clinic chair time was calculated by taking the difference in time between each completed rapid infusion and the estimated amount of time it would have taken for each patient to receive a traditional infusion. The estimated amount of time for traditional infusion was determined by following the institution’s protocol for administering rituximab to patients who previously tolerated their first dose of the drug (eg, 100 mg/h starting rate and increasing by 100 mg/h every 30 minutes to a maximum infusion rate of 400 mg/h). All endpoints were analyzed using descriptive statistics.
