A curated and standardized adverse drug event resource to accelerate drug safety research

Abstract

Identification of adverse drug reactions (ADRs) during the post-marketing phase is one of the most important goals of drug safety surveillance. Spontaneous reporting systems (SRS) data, which are the mainstay of traditional drug safety surveillance, are used for hypothesis generation and to validate the newer approaches. The publicly available US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data requires substantial curation before they can be used appropriately, and applying different strategies for data cleaning and normalization can have material impact on analysis results. We provide a curated and standardized version of FAERS removing duplicate case records, applying standardized vocabularies with drug names mapped to RxNorm concepts and outcomes mapped to SNOMED-CT concepts, and pre-computed summary statistics about drug-outcome relationships for general consumption. This publicly available resource, along with the source code, will accelerate drug safety research by reducing the amount of time spent performing data management on the source FAERS reports, improving the quality of the underlying data, and enabling standardized analyses using common vocabularies.

Figure 1. AEOLUS Integration and generation process.

Figure 2. List of tables and sample data for the clean aggregation of the FDA LAERS and FAERS data.

Note that the columns in light red are added for presentation clarity and are not included as-is in the actual dataset. The human readable information can be accessed via a join on the respective concept ids.

Figure 3. List of files containing drilldown, contingency tables, counts and statistics generated from the aggregate data.

Note that the columns in light red are added for presentation clarity and are not included as-is in the actual dataset. The human readable information can be accessed via a join on the respective concept ids.