Abstract

Abstract Background In December 2020, ceftolozane/tazobactam (CT) was voluntarily recalled due to failed sterility tests. With this recall, clinicians were forced to utilize alternatives for multi-drug resistant (MDR) Pseudomonas (PSA) infections until CT returned in late December, 2021. While many studies have examined the impact of medication shortages, few have evaluated the impact of antimicrobial shortages. We evaluated the impact of the CT recall by assessing cost, clinical outcomes, and utilization of novel alternative agents. Methods This multi-site retrospective cohort study compared patients treated for MDR PSA prior to the CT recall (Jan-Jul 2020) to patients treated during the CT recall (Jan-Jul 2021) across seven AdventHealth Central Florida (AHCF) adult hospitals. The primary outcome was percentage of patients treated with novel therapies (CT, ceftazidime/avibactam, or cefiderocol). Secondary outcomes included length of therapy (LOT), inpatient mortality, 30-day readmissions, length of say (LOS), pharmacy expenditures, and average cost per case. Results A total of 203 patients with MDR PSA were evaluated: 100 in the pre-recall cohort and 103 in the post-recall cohort. The majority (58%) of patients were male with an average age of 64 years. The most common source of infection in both cohorts was pneumonia, followed by complicated urinary tract infection. Significantly more patients were treated with novel agents as definitive therapy in the post-recall cohort (65% vs. 29%, p< 0.0001). Average LOT for all anti-PSA therapy was 12 days in the pre-recall cohort compared to 14 days in the post-recall cohort (p=0.1753). Inpatient mortality and 30-day readmissions were not statistically different between groups. Hospital LOS was significantly different between the two groups (18 days vs. 25 days, p=0.006). Significantly higher pharmacy expenditures were found in the post recall cohort (Figure 1) and the average cost per case was significantly higher in the post-recall cohort ($125,254 vs. $62,249). Figure 1:Pharmacy Expenditures for Novel Agents Novel agents: cefiderocol, ceftazidime/avibactam, ceftolozane/tazobactam Conclusion The CT recall had a significant impact on both economic and clinical outcomes, particularly increased length of stay, length of therapy, and cost to both the patient and health system. Higher utilization of novel agents is concerning given rising rates of PSA resistance. Disclosures Amy L. Carr, PharmD, BCIDP, Shionogi: Advisory Board.

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