Evaluation of chemotherapy preparation processes: Volumetric method reliability and gravimetric method utility within 5 US hospitals

Abstract

Abstract Purpose The primary aim of this study was to investigate the accuracy of the volumetric method for intravenous (IV) preparations and explore the utility of gravimetric methods in the medication preparation process within multiple institutions. Secondary outcomes of this study were syringe size percent variations and impact on drug expenditures. Methods A prospective, noninterventional, multisite study was conducted between March 2015 and December 2016 to generate baseline estimates of accuracy and precision in the volumetric medication preparation process. Five hospitals in the United States were recruited for study participation. During the data collection process, technicians were required to measure the syringe at 3 different points: when the new empty syringe was connected to a closed-system transfer device (CSTD), when the filled syringe containing the prepared dose of medication was connected to a CSTD, and when the used syringe with residual medication was connected to a CSTD. The actual dose of drug dispensed (in mg) was divided by the specific gravity of the medication to determine the actual volume of medication dispensed. Results A total of 4,443 compounded sterile products representing 60 medications across 5 hospitals were eligible for the study. Of the evaluated preparations, 91.92% were within 5% of the prescribed dose and 96.56% were within 10% of the prescribed dose. The outliers ranged from –144.10% to 233.72%. Conclusion The potential for significant over- and undertreatment of an individual patient receiving IV chemotherapy exists, indicating the need for an additional measurement method, such as real-time gravimetric verification, to ensure an accurate dose is administered to every patient.