Optimizing formulary decisions and new drug approval through data and team collaboration
Panelists discuss the complex, systemwide stewardship considerations for incorporating new antibiotics targeting resistant pathogens, emphasizing the need for real-world efficacy data, thoughtful formulary restrictions, and tailored strategies for outpatient use to ensure safe, effective, and sustainable adoption across diverse care settings.
As new antibiotics targeting resistant organisms like metallo-β-lactamase producers emerge, stewardship programs must carefully evaluate whether and how to incorporate these agents into hospital formularies. Monica shared that formulary decisions are no longer institution-specific but systemwide, involving academic centers, community hospitals, and outpatient settings. Decisions are based on several factors, including clinical need, risk of resistance, cost, microbiological capabilities, and infrastructure for safe administration. New antibiotics are often added in a restricted manner—available only at sites treating the highest-risk patients—especially if smaller hospitals lack the resources or stewardship expertise to support their use appropriately.
Rodney emphasized the importance of generating high-quality, real-world data to support informed decisions. Although in vitro and preclinical studies are foundational, clinical efficacy data in diverse, complex patient populations—including those with renal impairment, sepsis, or immunocompromise—are critically needed. Additional priorities include studying resistance development during therapy, head-to-head comparisons between new agents, and robust pharmacokinetic/pharmacodynamic data to optimize dosing. Anita added that guidance documents, like the Infectious Diseases Society of America’s, attempt to synthesize imperfect data to offer practical, consensus-based suggestions—not firm recommendations—because real-world decision-making often occurs in the absence of definitive trials. These guidance efforts balance evolving microbiological trends and regional resistance patterns with expert judgment.
Monica also highlighted the unique data needs for outpatient parenteral antimicrobial therapy (OPAT) programs. Outpatient care requires extended drug stability (ideally 7-9 days), simplified administration (like once-daily elastomeric infusions), and easy-to-use formulations to support patient independence and adherence. Although inpatient data can often be adapted for OPAT settings, specific data on stability, infusion time, and delivery methods are still lacking. In the long run, oral options would be ideal, but until then, ensuring ease of administration and patient safety outside the hospital remains a top priority for stewardship teams managing transitions of care.
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