Promoting Antimicrobial Stewardship and Patient Safety by Implementing Interventions to Evaluate and De-label Penicillin Allergy

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BACKGROUND: Penicillin allergy is the most commonly reported drug allergy and significantly impacts antibiotic prescribing practices and patient safety. Although 10% of the U.S population are reported as penicillin allergic, studies have shown that up to 90% of these patients can in fact tolerate the drug. This mislabeling of approximately 32 million Americans adversely affects antimicrobial prescribing practices and increases health care costs and the risk of antibiotic resistant infections. SIGNIFICANCE/IMPACT: To promote patient safety and improve health related outcomes related to antibiotic use, there is an urgent need to create and implement processes that efficiently de-label penicillin allergy in appropriate patients. The William S. Middleton Memorial Veterans Hospital reports a higher prevalence of penicillin allergy as compared to the general population (22.6% vs 10% respectively), and penicillin allergy is associated with increased use of broad-spectrum antibiotics. Implementing processes to de-label patients misdiagnosed with penicillin allergy will decrease non- concordant antibiotic use, improve patient safety, and advance our goals as a high reliability organization (HRO). INNOVATION: The goal of our pilot study is to apply the Consolidated Framework for Implementation Research (CFIR) to study the contextual factors influencing the evaluation of penicillin allergy in the Veteran population. Knowledge gained will be used to develop an implementation package that identifies, evaluates and de-labels patients inappropriately labeled as penicillin allergic. This effort will address a national patient safety issue of antibiotic resistance and provide a usable intervention to promote the judicious use of antibiotics advocated by the VHA Office of the Inspector General, Infectious Disease of America (IDSA), the American Academy of Allergy, Asthma and Immunology (AAAAI) and the Centers of Disease Control (CDC). We will incorporate feedback from Veterans as well as key frontline physicians, pharmacists, primary care providers and nurses to develop a comprehensive implementation package and data extraction tool to study the impact on key clinical outcomes. SPECIFIC AIMS: We hypothesize that determining and addressing the principal factors influencing access to penicillin allergy evaluation will reduce the number of Veterans designated as allergic to penicillin and in turn, decrease the use of broad-spectrum antibiotics in these patients. We will test this hypothesis with the following aims: (1) Using the CFIR framework, we will study the systems level barriers and key facilitators to evaluating patients with penicillin allergy. The CFIR framework offers a validated implementation science approach that optimizes a mixed methods approach with equal value for qualitative and quantitative data. (2) Develop a penicillin allergy evaluation implementation package that effectively identifies, and de-labels patients misdiagnosed with penicillin allergy. (3) Develop a data extraction tool that establishes a comprehensive database of patients in the following groups: patients labeled with an active penicillin allergy, patients who have been de-labeled of penicillin allergy, patients with confirmed penicillin allergy who have undergone recent evaluation. The data extraction tool will track clinical outcomes of these groups using SQL queries of the national VHA Clinical Data Warehouse. METHODOLOGY: We will use a mixed methods approach focused on the generation of qualitative data from focus groups of Veterans, physicians, pharmacists, and nurses and use this information to develop a penicillin allergy implementation package. Quantitative metrics obtained related to the successful de-labeling of penicillin allergy, future antibiotic prescribing practices, rates of drug resistant infections, hospitalizations and survival will be collected via a data extraction tool that will be developed as part of this pilot study. IMPLEMENTATION/NEXT STEPS: The knowledge, implementation package and data extraction tool developed through this pilot will lead to an investigator initiated research proposal (IIR) to test our implementation package in multiple VHA hospital and ambulatory settings.