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An Exploratory Study of the Food and Drug Administration Adverse Events Reporting System (FAERS)

Garcia, Lauren (2022) An Exploratory Study of the Food and Drug Administration Adverse Events Reporting System (FAERS). Master Essay, University of Pittsburgh.

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Adverse drug events (ADEs) are an unfavorable or unintended response to a pharmaceutical product. Adverse drug reactions (ADRs) are a subset of ADEs which imply causality. Approximately 2 million ADRs occur in the United States annually and cost the healthcare system over $130 billion. ADRs can be voluntarily reported to the Food and Drug Administration (FDA) Adverse Event Reporting Systems (FAERS) by healthcare professionals and consumers. A subset of ADRs for certain drugs are recognized as preventable as they have genetic risk factors (variants) which can be identified using pharmacogenomic testing. Pharmacogenomic guidelines are publicly available from the Clinical Pharmacogenetics Implementation Consortium (CPIC); approximately 97% of the population has at least one genetic variant that would benefit from pharmacogenomic testing. Understanding if a patient has a genetic predisposition for an ADR can have direct impact on patient care and healthcare costs by adjusting the drug dose or prescribing an alternate drug for efficacy or safety.
This study analyzed the CPIC pharmacogenomic guidelines and case reports from the FAERS database between January 2018 and December 2019 to better understand which therapeutic areas might be underutilizing pharmacogenomic guidelines and how it may be affecting public health and healthcare costs. Analysis revealed that the most common therapeutic area with available pharmacogenomic guidelines was psychiatry. Most of these psychiatric drugs were identified as selective serotonin reuptake inhibitors (SSRIs) used to treat major depressive disorder (MDD). Given that citalopram, escitalopram, and sertraline are first line SSRIs for MDD and have well established ADRs, these FAERS case reports were selected for further investigation. Analysis indicated that most case reports were serious ADRs (84.9%) and an average of 26.2% of all cases required hospitalization. The average percent of cases resulting in death was 10.3%, with citalopram having the highest incidence of death (18.4%). Gastrointestinal distress, therapeutic failure, and somnolence or sleep disorder were determined to be the most frequent ADRs, all recognized as preventable using pharmacogenomic testing. The estimated annual cost of these ADRs is estimated to be $23.4 million. Together, these results suggest a need for more informed drug prescribing for MDD to protect public health.


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Item Type: Other Thesis, Dissertation, or Long Paper (Master Essay)
Status: Unpublished
CreatorsEmailPitt UsernameORCID
Garcia, LaurenLAG150@pitt.eduLag150
ContributionContributors NameEmailPitt UsernameORCID
Committee ChairDurst, Andreaadurst@pitt.eduadurstUNSPECIFIED
Committee MemberKrier, Sarahsek29@pitt.edusek29UNSPECIFIED
Date: 1 July 2022
Date Type: Completion
Submission Date: 22 June 2022
Access Restriction: No restriction; Release the ETD for access worldwide immediately.
Number of Pages: 54
Institution: University of Pittsburgh
Schools and Programs: School of Public Health > Public Health Genetics
Degree: MPH - Master of Public Health
Thesis Type: Master Essay
Refereed: Yes
Uncontrolled Keywords: pharmacogenomics, pharmacogenomic guidelines, pharmacogenetics, adverse drug reactions, adverse drug events, depression, major depressive disorder, Food and Drug Administration Adverse Events Reporting System, FAERS
Date Deposited: 01 Jul 2022 18:51
Last Modified: 01 Jul 2022 18:51


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