Assessment of technology-assisted technician verification of compounded intravenous sterile preparations versus pharmacist verification.

Abstract

This study is an evaluation of technology-assisted technician verification (TATV) of the compounded sterile product (CSP) preparation process as an alternative to final verification by a pharmacist. A 2-phase, single-center noninferiority study was conducted to assess the accuracy and CSP processing time with TATV versus pharmacist verification. Phase I of the study was a validation of the internal pharmacist accuracy rate in which 2 pharmacists checked each CSP. In phase II, prepared CSPs were first checked by a technician and then checked by a pharmacist. Technicians were required to complete baseline credentialing and training requirements to participate in the study. The primary outcome was the error rate for the pharmacist check in phase I and the error rate of the technician check in phase II. Secondary outcomes included total verification time and total dose processing time in each phase. The Farrington-Manning test was used for noninferiority assessment of accuracy, and the Wilcoxon rank sum test was used to detect a difference between the processing times. A total of 4,000 doses were checked in each phase. Pharmacist accuracy was 99.600% in phase I, compared to TATV accuracy of 99.575% in phase II. TATV of CSPs was noninferior to pharmacist verification (absolute difference in accuracy, 0.025%; 95% CI, -0.26% to 0.31%; P = 0.0016). Total verification time and total dose processing times were significantly lower in Phase II. This study showed that TATV of CSPs is noninferior to pharmacist final verification and does not negatively impact the time to check CSPs or total CSP processing time.