Standardisation of the FAERS database: a systematic approach to manually recoding drug name variants

Abstract

The millions of reports enclosed in the FAERS contain valuable information that is of interest to pharmacovigilance, toxicology and post-marketing surveillance researchers. With the standardisation of the drug nomenclature, the database can be better utilised by research groups around the world.

Systematic analysis of protein targets associated with adverse events of drugs from clinical trials and post-marketing reports

“…The FAERS AEOLUS database, containing 3,526 drugs mapped to the RxNorm drug vocabulary and 17,710 unique AE terms, was installed as a MySQL database (58). Drugs were mapped to ChEMBL parent compounds, which group different salt forms of the same drug and link to a unique molecular parent structure, using the mapping between RxNorm concepts and DrugBank identifiers provided by the RXNCONSO file from the RxNorm vocabulary (RxNorm_full_12032018, downloaded from (59)) and UniChem (60), as well as direct matches between RxNorm compound names and synonyms and ChEMBL pref_name, compound_names and synonyms.…”

Safety of Biologics Approved for the Treatment of Rheumatoid Arthritis and Other Autoimmune Diseases: A Disproportionality Analysis from the FDA Adverse Event Reporting System (FAERS)

“…The files from January/2003 to September/2012 were made available by Wong et al, who standardized the names of the drugs reported within this period [23]. The files from October/2012 to June/2016 were in turn directly downloaded from the FDA website.…”

Spontaneous Adverse Event Reports Associated with Zolpidem in the United States 2003–2012

“…To address the issue of duplicate reports and the lack of standardization of drug names, we performed a manual and detailed reorganization of drug name variants in the database. 23 The open source software, OpenRefine (previously Google Refine; version 2.5) was utilized to organize and standardize medication brand names and common misspellings to reflect their relevant active ingredients. 23 All active ingredients were defined according to the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification.…”

“…23 The open source software, OpenRefine (previously Google Refine; version 2.5) was utilized to organize and standardize medication brand names and common misspellings to reflect their relevant active ingredients. 23 All active ingredients were defined according to the World Health Organization (WHO) Anatomical Therapeutic Chemical (ATC) classification. Drugs that could not be standardized according to this classification or were not recognized as a medicinal product were left verbatim.…”

“…Drugs that could not be standardized according to this classification or were not recognized as a medicinal product were left verbatim. 23 Duplicates and follow-up reports, defined by the FDA as those with the same case number, were identified and merged. Records were excluded when details were absent for patient age, sex, drug exposure, or adverse reaction.…”