Date of Conferral

10-9-2025

Degree

Ph.D.

School

Public Health

Advisor

Jennifer Oliphant

Abstract

Adverse events to medicines pose a risk to the public health of patients. Breakthrough therapy medicines are designed to address unmet medical needs and are often approved on an expedited timeline; however they are also criticized for lacking an adequate understanding of their risk profile at the time of approval. This study examined the relationship between the number of concomitant medicines, as well as the approved therapeutic indication, and the outcomes of reported adverse events associated with medicines approved under the breakthrough therapy designation. The conceptual framework applied in this retrospective, cross-sectional, quantitative study is the process of pharmacovigilance, which involves studying the postmarketing safety profile of approved medicines. Adverse event reports to non-oncology breakthrough therapy indications (n = 394,706) were obtained from the FDA Adverse Event Reporting System (FAERS) Database from the inception of the program (2012) through 2024. Adverse event report outcomes were analyzed using multinomial logistic regression. The results indicate a modest but significant relationship between the number of concomitant medicines and the reported outcome of adverse events. In addition, the approved therapeutic indication was found to be associated with the outcome of reported adverse events, indicating that the risk of experiencing an adverse event may be disease specific. The results of this study have implications for contributing to social change by protecting public health through informing patients about the potential risks associated with breakthrough therapy medicines, improving future clinical guidelines for the clinical trials of these medicines, and informing future regulatory guidelines of these medicines.

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