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  1. Advancing Regulatory Science

An Electronic Approach for Post-Market Safety Monitoring for Antibiotic-Associated Adverse Events

CERSI Collaborators: Sara E. Cosgrove, MD, MS; Jerald Cherian, MD, MHS; Eili Y. Klein, PhD; MS; Pranita D. Tamma, MD, MHS

FDA Collaborators: Ramya Gopinath, MBBS; Elizabeth O’Shaughnessy, MBBChBAO; Christopher Smith, PharmD

Project Start: January 10, 2022

Regulatory Science Challenge

The discovery of antibiotics is one of the greatest advancements in modern medicine. Although the use of antibiotics can save lives, antibiotics can also cause harm due to side effects such as liver and kidney damage, diarrhea, allergic reactions, interference with blood cell production and heart rhythm disturbances. FDA strives to continuously develop and improve methods and tools for post-market evaluation of FDA-regulated products, such as evaluating the safety of FDA-approved antibiotics utilized in clinical practice using an efficient and standardized approach.

Project Description and Goals

This project seeks to develop standardized electronic methods to detect common antibiotic-associated side effects in hospitalized patients using information from the electronic health record (EHR). The side effects of interest include kidney, liver, and blood cell damage; diarrhea; rashes; severe allergic reactions; and heart rhythm disturbances. The accuracy of these electronic methods will be assessed by manual review of patient medical records and the electronic methods will be modified as needed. This work will occur in five hospitals in the Johns Hopkins Health System (JHHS). Once the electronic methods are developed and evaluated within JHHS, they will be further evaluated within the University of Virginia Health System.

This work will advance FDA’s ability to evaluate the safety of FDA-approved antibiotics by identifying the type and frequency of side effects associated with both older and newer antibiotics given in hospitals through electronic methods that can potentially be reproduced in hospitals across the United States. This work will also help hospitals and clinicians improve their ability to identify and track antibiotic-related side effects occurring in patients.

Research Outcomes/Results

To date, electronic methods to detect kidney damage in patients related to vancomycin, a commonly prescribed intravenous antibiotic, heart rhythm disturbances related to quinolone antibiotics, and liver damage related to other common antibiotics, oxacillin and rifampin, have been developed and are undergoing testing.

Publications and Meeting Abstracts

  1. Cherian JP, Jones GF, Bachina P, Helsel T, Virk Z, Lee JH, Fiawoo S, Salinas A, Dzintars K, O'Shaughnessy E, Gopinath R, Tamma PD, Cosgrove SE, Klein EY. An Electronic Algorithm to Identify Vancomycin-Associated Acute Kidney Injury. Open Forum Infect Dis. 2023 May 16;10(6):ofad264. doi: 10.1093/ofid/ofad264. Erratum in: Open Forum Infect Dis. 2023 Jul 31;10(7):ofad407. doi: 10.1093/ofid/ofad407. PMID: 37383251; PMCID: PMC10296058.
  2. Cherian J, Bjoring M, Lindsay D, Mathers A, Cox H, Park S, George J, Vorsteg A, Salinas A, O’Shaughnessy E, Gopinath R, Tamma P, Cosgrove S, Klein E. Evaluating the Generalizability of an Electronic Algorithm to Identify Vancomycin-Associated Acute Kidney Injury. Poster Presentation, Society of Hospital Epidemiology of America Spring Conference, Houston, TX, April 2024.


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