Aioli: Standardising Drugs in the FDA Adverse Event Reporting System (FAERS) to RxNorm and Anatomical Therapeutic...

The Food and Drug Administration Adverse Event Reporting System (FAERS) is an important source of information on suspected adverse drug reactions, but does not standardise drugs. The Adverse Event Open Learning Through Universal Standardization (AEOLUS) System Provides Standardisation of drugs in FAERS to RxNorm, but its coverage leaves room for improvement and mapping accuracy has not been established. Furthermore, drugs are not mapped to the Anatomical Therapeutic Chemical (ATC) Classification System, which is frequently used in pharmacovigilance studies. Here we develop and evaluate the Aioli system, an extension of AEOLUS, to increase the mapping of drugs in FAERS to RxNorm, and to provide mappings to the ATC coding system.

Several changes and extensions were made to the AEOLUS mapping process to increase the number of drugs standardized to RxNorm. Information in FAERS fields about ingredient, route, dose amount, dose form, and dose unit was used to map to the most appropriate ATC code. Mapping accuracy was assessed on an evaluation set of 122 FAERS records.

Aioli mapped 94.1% of drug names in FAERS to RxNorm, compared to 90.4% by AEOLUS. In addition, Aioli mapped 80.4% of drug names to ATC codes. Evaluation showed high accuracies, with 92.2% correct mappings to RxNorm and 94.0% to ATC.

We have developed and evaluated the Aioli system that maps drugs in the FAERS database to RxNorm and ATC codes. With increased coverage of drugs and the mapping to ATC, Aioli further improves the usability of FAERS data in pharmacovigilance studies.