指定医疗事件和非指定医疗事件信号的比较:范围审查结果。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-05-01 Epub Date: 2024-02-24 DOI:10.1007/s40264-024-01403-x
Daniele Sartori, Jeffrey K Aronson, Nils Erlanson, G Niklas Norén, Igho J Onakpoya
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引用次数: 0

摘要

引言和目的:欧洲药品管理局(EMA)有一份指定医疗事件(DME)清单,这些事件本质上是严重的,无论统计标准如何,都会优先进行信号检测。我们分析了之前发表的范围审查结果,以确定 DME 信号与其他不良事件信号在沟通时间和可疑药物不良反应支持报告的特征方面是否存在差异:对于所有信号,我们从教科书或监管机构获得了药品的上市年份,提取了 VigiBase 中首次报告的年份,并计算了首次报告与通报之间的时间间隔(通报时间,TTC)。我们进一步检索了通报前几年每个病例系列报告的平均完整性(通过 vigiGrade)。我们将涉及 EMA 列表中事件的信号归类为 DME 信号。我们用中位数和四分位数间距(IQR)来描述两组信号,并用布鲁纳-芒泽尔检验法进行比较,计算 95% 置信区间(95% CI)和 P 值:在 4520 个信号中,919 个涉及 DME,3601 个涉及非 DME。支持 DME 信号的报告中位数为 15 份(IQR 为 6-38 份),完整性评分为 0.52(IQR 为 0.43-0.62);支持非 DME 信号的报告中位数为 20 份(IQR 为 6-84 份),完整性评分为 0.46(IQR 为 0.38-0.56)。与非 DME 信号相比,随机 DME 信号得到较少报告支持的概率为 0.56 (95% CI 0.54-0.58, P < 0.001),平均完整性较低的概率为 0.39 (95% CI 0.36-0.41, P < 0.001)。DME 和非 DME 信号的中位 TTC 没有差异(10 年),但当信号(无论分类如何)得到平均完整度大于 0.80 的报告支持时,TTC 低至 2 年:与其他不良事件信号相比,指定医疗事件信号得到较少报告和较高完整性评分的支持。尽管在统计学上有意义,但两组之间的效应大小差异很小。这表明,将某些不良事件列为指定医疗事件并没有达到预期的效果,即鼓励重点报告值得特别关注的可疑不良反应类型。进一步提高支持指定医疗事件信号的疑似药物不良反应报告的完整性,可能会缩短其传播时间,并减少支持这些信号所需的报告数量。
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A Comparison of Signals of Designated Medical Events and Non-designated Medical Events: Results from a Scoping Review.

Introduction and objective: The European Medicines Agency (EMA) maintains a list of designated medical events (DMEs), events that are inherently serious and are prioritized for signal detection, irrespective of statistical criteria. We have analysed the results of our previously published scoping review to determine whether DME signals differ from those of other adverse events in terms of time to communication and characteristics of supporting reports of suspected adverse drug reactions.

Methods: For all signals, we obtained the launch year of medicinal products from textbooks or regulatory agencies, extracted the year of the first report in VigiBase and calculated the interval between the first report and communication (time to communication, TTC). We further retrieved the average completeness (via vigiGrade) of the reports in each case series in the years before the communication. We categorised as DME signals those concerning an event in the EMA's list. We described the two groups of signals using medians and interquartile ranges (IQR) and compared them using the Brunner-Munzel test, calculating 95% confidence intervals (95% CI) and P values.

Results: Of 4520 signals, 919 concerned DMEs and 3601 concerned non-DMEs. Signals of DMEs were supported by a median of 15 reports (IQR 6-38 reports) with a completeness score of 0.52 (IQR 0.43-0.62) and signals of non-DMEs by 20 reports (IQR 6-84 reports) with a completeness score of 0.46 (IQR 0.38-0.56). The probability that a random DME signal was supported by fewer reports than non-DME signals was 0.56 (95% CI 0.54-0.58, P < 0.001) and that of one having lower average completeness was 0.39 (95% CI 0.36-0.41, P < 0.001). The median TTCs of DME and non-DME signals did not differ (10 years), but the TTC was as low as 2 years when signals (irrespective of classification) were supported by reports whose average completeness was > 0.80.

Conclusions: Signals of designated medical events were supported by fewer reports and higher completeness scores than signals of other adverse events. Although statistically significant, the differences in effect sizes between the two groups were small. This suggests that listing certain adverse events as DMEs is not having the expected effect of encouraging a focus on reports of the types of suspected adverse reactions that deserve special attention. Further enhancing the completeness of the reports of suspected adverse drug reactions supporting signals of designated medical events might shorten their time to communication and reduce the number of reports required to support them.

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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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