ADS Capstone Chronicles Revised
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(FDA,2018b).Healthcareprofessionalsand consumers can voluntarily report adverse events related to suspected drug ingestion and these are called direct reports. In contrast,drugmanufacturersanddistributors are mandated reporters and must submit reports under certain circumstances. If a consumerorhealthcareprofessionalsendsa report to apharmaceuticalentity,thatentity is required to submit an exact copy of the report to FDA. In some cases, this creates duplicate reports in FDA records (FDA, 2018b).Themandatedreportsfallundertwo categories: expedited reports are those that “contain at least one adverse event that is not currently described in the product labeling and for which the patient outcome isserious”(FDA,2023b),and nonexpedited reports which include serious/expected events, nonserious/unexpected events, and nonserious/expectedevents.Thefourthtype ofreportisa BSR whichstandsforbiologic safety report. Figure 1displaystheincrease in adverse event reporting since the early 2000s, broken down by report type (figure from FAERS dashboard; FDA, 2023b). Figure 1 Report Type Frequency
downloads. For example, in 2022, there were2.3millionadverseeventsreported,of which175,000resultedindeath(figurefrom FAERS dashboard; FDA 2023b; Figure 2). At the time of this project, the database contains 28.7 million reports of which15.9 million are serious and 2.6 million are related to death (Figure 2; FDA, 2023b). Figure 2 ADR Outcomes by Seriousness
The FAERS reporting hassomelimitations. First, the data is correlational so causation cannot be inferred. The reports are not verified in any way and underlying health conditions are not assessed. Second, true rates of occurrence cannot beinferredfrom this data duetolowreportingrates.Serious or death-related incidentsarereportedmore often than nonserious events, but overall, under-reporting rates are around 94% (Hazell & Shakir, 2006). Some reporting information is ambiguous or missingwhich detractsfromtheusefulnessofthedatabase. Additionally, consumers may notknowthat this reporting system exists, and may not realizethatanadverseeventisdrugrelated, so true population rates go undetected. To overcome these limitations, additional sources of data can be combined with FAERS data to create a complete, robust datasetformachinelearningandsubsequent insights. 2.1 Problem With the rise in chronic disease (CDC, 2024) and new drug developments, the impact of drug adverse events represents a largepublichealthburdenthatwillcontinue
The FDA FAERS was modernized and developed in 2012 to track post-marketing adversereactionstoFDA-approvedproducts (e.g., drugs, devices, cosmetics) in the community (FDA, 2018b). Reports are submitted electronically and the data of adverse events related to pharmaceutical drugs(i.e.,prescribed,over-the-counter,and therapeutic biologics) is subsequently made publicly accessible via application programming interfaces (APIs) or file
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