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Disclaimer In an effort to expedite the publication of articles , AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose This article highlights one health system’s response to the market influx of biosimilars with the establishment of a process for formulary review and selection of preferred agents and support for therapeutic interchanges. Summary Through assessment of available literature, insurance payor coverage, and manufacturer-anticipated approvals of biosimilars, a strategic stance was developed to guide biosimilar order preparation, review, adoption, and implementation. The electronic medical record (EMR) is prepared for biosimilar implementation at least 6 to 12 months ahead of anticipated formulary review. The review includes assessment of a class (reference product and available biosimilars) after at least 2 biosimilars become available. Key health-system departments and clinicians are enlisted to support review of clinical, safety, and economic implications. Implementation of a preferred product relies on standard education, formulary availability, and staff awareness to address any perceived patient safety concerns and gather provider support. The standard steps developed now apply to all future biosimilar reviews, adoption plans, and ongoing monitoring. Barriers evaluated include changes in payor coverage and challenges in preparation of the EMR for future biosimilars, meeting precertification team education needs, and providing operational support for pharmacy inventory. Conclusion To date, use of 5 preferred biosimilar products has led to significant cost savings to the institution, and the process has been endorsed by providers. The institution’s successes can be attributed to clear communication with stakeholders and the development of a deliberate process, led by a multidisciplinary leadership team, for managing formulary, safety, and operational barriers in a thoughtful and systematic manner.

Background The 2019 American Thoracic Society and Infectious Diseases Society of America Community-Acquired Pneumonia (CAP) guidelines concluded that the major risk factors for methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa (PsA) include prior isolation of these organisms and previous hospitalization with IV antibiotic use within 90 days. However, the guidelines recognized that results may vary by region and recommended local validation of risk factors. The primary objective of this study was to determine which potential risk factors are associated with MRSA and Pseudomonas aeruginosa in CAP in our institution. This study also evaluated appropriateness of antibiotics used for empiric CAP therapy. Methods This was a single-center, retrospective cohort study performed in an urban academic medical center in Cleveland, OH. Adults hospitalized for CAP who had a respiratory culture performed between January 2016 and September 2020 were included. Patients were randomized in a 1:1:1 ratio into MRSA, PsA, and non-resistant CAP (NR-CAP) groups. Patients with bacterial co-infections or resistant pathogens other than MRSA or PsA were excluded. Results The study included 111 patients with 37 patients in each group. The median age was 61 years (IQR 52-70), and 58.6% of patients were male. There were no independent risk factors for MRSA (Table 1). Independent risk factors for PsA included prior isolation and enteral feeding (Table 2). MRSA risk factors as defined by the 2019 CAP guidelines were found in 48.6% of patients with MRSA CAP (Figure 1). Guideline-defined PsA risk factors were found in 56.8% of patients with PsA CAP (Figure 2). In NR-CAP, 62.2% received empiric MRSA coverage while only 27% had a guideline-defined risk factor; PsA coverage was administered in 78.4% of NR-CAP patients, but risk factors were found in only 24.3% of this cohort. MRSA and P. aeruginosa Risk Factor Analyses Empiric MRSA and P. aeruginosa Coverage and Guideline-Defined Risk Factors Conclusion Our findings were consistent with the risk factors identified in the 2019 CAP guidelines, but additional risk factors may be present in our patient population. Empiric coverage for MRSA and PsA was disproportionately high relative to the rate of recovery. This study encourages local validation of risk factors; however, further analyses are needed to determine the impact on empiric therapy. Disclosures All Authors: No reported disclosures