Avoiding rash decisions with penicillin allergy labels among immunocompromised patients

About This Grant

PROJECT ABSTRACT Reported penicillin allergies affect over 10% of patients (greater than 34 million patients in the United States), yet over 95% of affected patients can tolerate penicillin. These largely inaccurate labels are termed penicillin allergy labels (PALs). PALs are associated with increased utilization of second-line antibiotics, multidrug- resistant infections, and mortality. Guidelines recommend PAL evaluation as a part of antimicrobial stewardship programs, and the recent development of clinical decision rules facilitates PAL testing in a variety of clinical settings. Removing the label, or “delabeling” through penicillin allergy evaluation immediately improves utilization of first-line antibiotics. Patients who have received hematopoietic stem cell transplants (HCTs) are likely particularly vulnerable to harms associated with PALs, as they are immunocompromised, with a high incidence of infection- and disease-related complications that are affected by antibiotic selection (e.g., multidrug-resistant infections, graft-versus-host disease). Yet, to date, there have been few efforts to understand and address PALs in this high-risk population, despite evidence that PALs are a widespread and modifiable driver of poor outcomes in the general population. To address this gap in actionable knowledge, we will quantify risks associated with having a PAL at the time of HCT, and use implementation science framework to guide a qualitative study to inform an intervention. Aim 1 will utilize data from the Center for International Blood and Marrow Transplant Research (CIBMTR), a National Institutes of Health-supported research organization, to investigate whether having a PAL at the time of HCT increases the risk for bloodstream infections, graft-versus-host disease, and mortality. Aim 2 will examine preferences for, barriers to, and facilitators of PAL evaluation in the transplant center using the integrated- Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. Aim 3 will evaluate the acceptability and feasibility of a pharmacist-led strategy using the clinical decision rule PEN-FAST to guide a penicillin allergy testing approach at Yale New Haven Hospital, which performs 170+ HCTs yearly. The PI, Ami Belmont, MD, is an allergist and immunologist, with relevant experience in health services and drug allergy epidemiology research. Her committed mentorship team brings expertise in clinical epidemiology, data registries, implementation science, qualitative and mixed methods, clinical trials, drug allergy, stem cell transplantation, and infectious disease to support the interdisciplinary training and study aims. The advanced training proposed in this award will support Dr. Belmont to develop expertise in advanced clinical epidemiology, implementation science and mixed methods, and clinical trials. Upon completion of this award, Dr. Belmont will be prepared to successfully transition to an independent Physician-Scientist focused on developing novel, scalable strategies to promote antibiotic allergy testing and optimization of first-line antibiotic utilization to improve patient outcomes among high-risk populations, including patients undergoing HCTs.