Parry Rowan E, Pera Victor, Verhamme Katia M C, de Wilde Marcel, van Mulligen Erik M, Kors Jan A
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, the Netherlands.
Pharmacoepidemiol Drug Saf. 2025 Sep;34(9):e70216. doi: 10.1002/pds.70216.
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.
美国食品药品监督管理局不良事件报告系统（FAERS）是疑似药物不良反应信息的重要来源，但未对药物进行标准化处理。通过通用标准化进行不良事件开放式学习（AEOLUS）系统将FAERS中的药物标准化为RxNorm，但它的覆盖范围仍有改进空间，且映射准确性尚未得到验证。此外，药物未映射到药物警戒研究中常用的解剖学治疗学化学（ATC）分类系统。在此，我们开发并评估了艾奥莉系统（Aioli），它是AEOLUS的扩展，用于增加FAERS中药物到RxNorm的映射，并提供到ATC编码系统的映射。
对AEOLUS映射过程进行了若干更改和扩展，以增加标准化为RxNorm的药物数量。利用FAERS字段中有关成分、给药途径、剂量、剂型和剂量单位的信息来映射到最合适的ATC代码。在122条FAERS记录的评估集上评估映射准确性。
与AEOLUS的90.4%相比，艾奥莉系统将FAERS中94.1%的药物名称映射到RxNorm。此外，艾奥莉系统将80.4%的药物名称映射到ATC代码。评估显示准确率很高，映射到RxNorm的正确率为92.2%，映射到ATC的正确率为94.0%。
我们开发并评估了艾奥莉系统，该系统将FAERS数据库中的药物映射到RxNorm和ATC代码。随着药物覆盖范围的增加以及到ATC的映射，艾奥莉系统进一步提高了FAERS数据在药物警戒研究中的可用性。
