Gabriëlla von Kreijfelt, Juliëtte Zwaveling, Jette A van Lint, Loes E Visser, Agnes C Kant
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引用次数: 0
Abstract
Background: The spontaneous reporting system is the cornerstone of pharmacovigilance but is limited by substantial underreporting, which may delay safety signal detection.
Objective: The aim of this study was to evaluate the electronic health record-adverse event search method for identifying and reporting additional potential adverse drug reactions in electronic health records to strengthen routine signal detection.
Methods: Between August 2022 and August 2025, targeted searches for adverse drug reactions were conducted in approximately 2,750,000 electronic health records from two Dutch hospitals using a data collection text-mining tool. Search criteria were derived from information in spontaneous reports of specific drug-adverse event associations. Structured (e.g. laboratory results, medication prescriptions) and unstructured (e.g. clinical notes, hospital discharge letters) data were used to identify potential adverse drug reactions. Identified cases were manually verified and, when relevant, reported to the Netherlands Pharmacovigilance Centre Lareb and analysed alongside spontaneous reports for signal detection.
Results: A total of 147 electronic health record-derived cases were reported for 41 drug-adverse event associations. These contributed to 34 signal detection analyses, supporting the assessment of seven safety signals. In 75% of the cases, a suspected causal relationship was documented by healthcare professionals in clinical notes. Electronic health record-derived cases accounted for up to 73% of the reports included in the seven detected signals.
Conclusions: This study demonstrates that electronic health records can be used as an additional source of individual case safety reports in routine pharmacovigilance practice, supporting the further assessment of selected potential safety signals. Despite limitations related to efficiency, this proactive approach has potential to address underreporting and complement the spontaneous reporting system, strengthening signal detection.
期刊介绍：
Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes:
Overviews of contentious or emerging issues.
Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes.
In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area.
Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement.
Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics.
Editorials and commentaries on topical issues.
Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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