RESUMEN
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.