Methodology for Constructing Benchmark Database of Adverse Drug Reactions Based on Multi-Source Information

doi:10.19803/j.1672-8629.20240911

Abstract

Abstract: Objective To summarize the primary data sources used in constructing benchmark databases for adverse drug reactions (ADR) and to demonstrate a comprehensive, multi-source approach to building an ADR benchmark database using drug-induced thrombocytopenia (DITP) as an example so as to provide a reference for future computational modeling studies and to guide safer clinical drug use. Methods The advantages and limitations of the data sources used in existing ADR benchmark databases were compared and analyzed. A benchmark database for DITP was constructed by integrating data from multiple sources, and the consistency of these data sources was evaluated using the kappa statistic. The distribution and variability of DITP-risk drugs were analyzed based on the Anatomic Therapeutic Chemical (ATC) classification system. Results Using the FDA-recommended multi-source integration approach, a DITP benchmark database (DITPst) comprising 1 765 drugs was constructed. Analysis of the anatomical classification of drugs within the DITPst database revealed that antineoplastic and immunomodulating agents were the most frequently associated with DITP, with 77.17% (196/254) of these drugs identified as causing these ADR. Conclusion Constructing ADR benchmark databases using multi-source information provides a valuable data reference for computational modeling in drug development as well as for ensuring post-marketing drug safety and promoting rational drug use.

Key words: Adverse Drug Reaction, Drug-Induced Thrombocytopenia, Benchmark Database, Multi-Source Data, Computational Simulation Research, Antineoplastic Drug, Immunomodulating Drug, Safe and Rational Drug Use

CLC Number:

R994.1
R978

NIE Xiaolu, SUN Feng, YAN Aixia, PENG Xiaoxia, ZHAN Siyan. Methodology for Constructing Benchmark Database of Adverse Drug Reactions Based on Multi-Source Information[J]. Chinese Journal of Pharmacovigilance, 2025, 22(1): 10-15.

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https://zgywjj.magtechjournal.com/EN/Y2025/V22/I1/10

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