识别药物警戒报告系统中的妊娠不良药物反应:在 EudraVigilance 中开发的新算法。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-06-19 DOI:10.1007/s40264-024-01448-y
Cosimo Zaccaria, Loris Piccolo, María Gordillo-Marañón, Gilles Touraille, Corinne de Vries
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引用次数: 0

摘要

导言:有必要加强有关孕期用药的证据基础,并促进安全信号的早期检测。EudraVigilance (EV) 是欧洲经济区内管理和分析可疑药物不良反应 (ADR) 信息的主要系统。尽管 EudraVigilance 具有多种功能,但其目前的安全报告电子提交格式中缺少表明孕期药物暴露的特定数据元素:本文旨在通过在 EV 中开发一种基于规则的算法来解决现有方法的局限性,从而更可靠地识别真正代表孕期 ADR 的病例:该研究利用标准化 MedDRA 查询 (SMQ) "妊娠和新生儿主题"(PNT) 作为比较基准。考虑到 SMQ PNT 还能检索健康妊娠结果、避孕失败、堕胎失败以及与妊娠无关的 ADR,研究人员定制了一种新算法,以提高识别妊娠期疑似 ADR 的准确性:结果:经测试,该算法表现出卓越的性能,能正确预测 90% 的妊娠期 ADR 报告病例,而 SMQ PNT 的准确率仅为 54%。在电动车中实施该算法后,共检索到 202426 个病例:新算法的开发和成功测试标志着在 EV 中进行妊娠特异性信号检测又向前迈进了一步。由于与妊娠相关的信号在 EV 这样的大型数据库中可能会被稀释,因此本研究为今后的研究奠定了基础,以便在更精细的妊娠相关 ADR 报告子集中评估比例失调方法的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance.

Introduction: There is a need to strengthen the evidence base regarding medication use during pregnancy and to facilitate the early detection of safety signals. EudraVigilance (EV) serves as the primary system for managing and analysing information concerning suspected adverse drug reactions (ADRs) within the European Economic Area. Despite its various functionalities, the current format for electronic submissions of safety reports lacks a specific data element indicating medicine exposure during pregnancy.

Objective: This paper aims to address the limitations of existing approaches by developing a rule-based algorithm in EV that more reliably identifies cases that are truly representative of an ADR during pregnancy.

Methods: The study utilised the standardised MedDRA query (SMQ) 'Pregnancy and neonatal topics' (PNT) as a benchmark for comparison. Recognising that the SMQ PNT also retrieves healthy pregnancy outcomes, contraceptive failure, failed abortifacients as well as ADRs not associated with pregnancy, a novel algorithm was tailored to improve the accuracy of identifying suspected ADRs occurring during pregnancy.

Results: Upon testing, the algorithm demonstrated superior performance, correctly predicting 90% of cases reporting an ADR during pregnancy, compared to 54% achieved by the SMQ PNT. The implementation of the algorithm in EV led to the retrieval of 202,426 cases.

Conclusion: The development and successful testing of the novel algorithm represents a step forward in pregnancy-specific signal detection in EV. Because signals associated with pregnancy may be diluted in a large database such as EV, this study lays the groundwork for future research to evaluate the effectiveness of disproportionality methods on a more refined subset of pregnancy-related ADR reports.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
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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