Introduction: Melphalan is often part of the standard conditioning regimen for autologous stem cell transplantation (SCT) for multiple myeloma (MM). Due to the short stability time for IV admixtures of traditional propylene glycol-containing melphalan products, careful alignment is required between pharmacy, nursing, and patients to ensure timely dose delivery. Propylene glycol-free (PGF) melphalan (Evomela®) has improved stability that may allow for greater medical staff flexibility for scheduling, reconstitution, admixture delivery, and infusion to patients. The aim of this study was to document the steps, time and resource burden incurred when preparing generic propylene glycol containing melphalan and estimate the benefits of stable PGF melphalan.
Methods: A survey was conducted with healthcare providers (HCPs) specializing in the care and management of MM patients. HCPs (5 oncology pharmacists, 5 oncology nurses, 5 oncology pharmacy technicians) included those involved in the preparation, administration and monitoring of melphalan when used as a conditioning agent for SCT. HCPs were selected based on a purposeful sampling design to capture a geographically representative sample among US SCT centers. Part 1 of survey consisted of an exploratory qualitative interview with each HCP to capture insights on preparing oncology treatments for administration as well as melphalan-specific insights related to preparation, administration and monitoring. Part 2 of the survey consisted of a quantitative evaluation based on the insights from part 1 of the survey. The quantitative portion focused on capturing facility characteristics as well as melphalan utilization patterns as well as timing and resource consumption related to the preparation, administration, and monitoring of generic melphalan. Additionally, HCPs provided their attitudes towards the potential time benefits of a more stable form of melphalan as it relates to alignment between the pharmacy and the nurses managing the patients during treatment with melphalan. Results are presented as descriptive statistics with mean and standard deviation for continuous variables and counts and percentages for categorical variables.
Results: Sixty percent of those surveyed utilized generic melphalan. The steps involved in the preparation of melphalan (generic or PGF) included 1) verification of melphalan prescription, 2) preparation and release of melphalan admixture, 3) delivery of melphalan to the floor, 4) preparation of the patient for administering melphalan, 5) setup and verification of the melphalan pump and administration, and 6) patient monitoring during administration. The total time from start to finish averaged 75.3 (standard deviation: 46.7) minutes (min). The total time spent varied, but the cumulative total time spent incurred across all provider average times was 108.2 min (Table 1). On average, the time of 2.1 pharmacists, 0.9 technicians and 1.5 nurses were utilized in the preparation, administration and monitoring of a melphalan prescription (Table 1). Forty percent of those surveyed had changed from generic to PGF melphalan for the following reasons: convenience for a more stable product (61.5%); convenience for pharmacy preparation planning (46.2%); convenience for patient scheduling (38.5%); improved safety for staff rushing due to risk of precipitation (30.8%); and to reduce the risk of lost treatment due to precipitation (15.4%). HCPs also estimated the potential time benefits of PGF melphalan, which included reducing preparation time by a mean of 4.96 min for pharmacy and nurse alignment to initiate preparation, 3.77 min for pharmacy and nurse to align on pick up, 8.34 min due to nurse time waiting to pick up and 9.77 min for the pharmacy technician or runner to deliver directly to the floor.
Conclusions: In this survey of healthcare providers involved in the preparation, administration and monitoring of melphalan as a conditioning treatment for SCT among MM patients, the total time spent was ~1.8 hours for preparing generic melphalan with a potential opportunity to reduce the time by ~0.45 hours when using a PGF melphalan. There may be a potential time and convenience benefit to oncology pharmacists, technician and nurses. Future comparative effectiveness research is needed to confirm these findings in a larger sample of SCT centers using melphalan as a conditioning regimen for SCT among MM patients.
Acosta:Acrotech Biopharma: Employment. Darban:BluePath Solutions: Consultancy. Gitlin:BluePath Solutions: Consultancy.
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