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Quality Control of Busulfan Plasma Quantitation, Modeling, and Dosing: An Interlaboratory Proficiency Testing Program
Jeannine S McCune1, Arjen M Punt2, Rosa F Yeh3
1Department of Hematologic Malignancies Translational Sciences, Beckman Research Institute at City of Hope, Duarte, California.
Therapeutic Drug Monitoring
|March 6, 2021
Summary
A new proficiency testing program was developed for busulfan dosing in hematopoietic cell transplant. Results show variability in busulfan quantitation and dosing, indicating a need for further education and testing to ensure patient safety.
Area of Science:
- Pharmacology
- Clinical Toxicology
- Hematopoietic Stem Cell Transplantation
Background:
- Personalized busulfan dosing is crucial for improving efficacy and reducing toxicity in hematopoietic cell transplant (HCT) conditioning regimens.
- Existing regional regulations lack standardized interlaboratory comparisons for busulfan concentration monitoring.
- A novel interlaboratory proficiency program was established to assess busulfan quantitation, pharmacokinetic modeling, and dosing protocols.
Purpose of the Study:
- To design and implement a proficiency testing program for busulfan analysis and dosing.
- To evaluate the accuracy of busulfan quantitation and pharmacokinetic modeling across participating laboratories.
- To identify areas for improvement in busulfan therapeutic drug monitoring and dose recommendations.
Main Methods:
- Development of a novel busulfan stabilization method for sample transport without dry ice.
- Participating laboratories analyzed proficiency samples and a theoretical case for pharmacokinetic modeling and dose recommendations.
- Descriptive statistics were used to evaluate performance, with accuracy defined as ±15% for concentration and ±10% for exposure/dose.
Main Results:
- Accurate busulfan quantitation (within 85%-115% of reference) ranged from 67% to 85% across proficiency samples.
- Correct dose recommendations were provided by the majority of participants (88% in round 1, 71% in round 2).
- The program successfully identified inaccuracies in busulfan quantitation, modeling, and dosing.
Conclusions:
- A proficiency testing program for busulfan analysis and dosing in HCT recipients has been successfully developed.
- Proficiency testing revealed variability in laboratory performance, highlighting the need for enhanced educational initiatives.
- Further interlaboratory proficiency rounds are recommended to ensure optimal and accurate busulfan dosing for improved patient outcomes.
