EudraVigilance 中用药错误的比例失调分析和特征描述:探讨性别和年龄组的调查结果。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-09-19 DOI:10.1007/s40264-024-01478-6
Victor Pera, Jan A Kors, Erik M van Mulligen, Marcel de Wilde, Peter R Rijnbeek, Katia M C Verhamme
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引用次数: 0

摘要

背景:虽然欧洲药品管理局的 EudraVigilance 对用药错误(ME)进行了研究,但尚未尝试根据性别和年龄组进行广泛的特征描述和信号检测:本研究旨在描述 EudraVigilance 中所有与 ME 相关的个体病例安全报告的特征,并针对 30 种最常报告的药物,探讨不同性别和年龄组之间显著的报告比例失调(SDR)信号:方法:使用 EudraVigilance 在 2002 年至 2021 年间报告的单个病例安全报告。ME被定义为狭义的《监管活动标准化医学词典》(Standardised Medical Dictionary for Regulatory Activities® Query)中的任何首选术语。根据报告几率比的 95% 置信区间下限≥ 1 且至少有 3 份个体病例安全报告,选出报告比例失调的信号。分析的亚组包括女性个体、男性个体以及年龄组:0-1 个月、2 个月至 2 岁、3-11 岁、12-17 岁、18-64 岁、65-85 岁和大于 85 岁。利用热图作为视觉辅助工具来识别引人注目的特别提款权:在 9,662,345 份 EudraVigilance 报告中,267,262 份(2.8%)包含至少一个 ME,总共有 300,324 个 ME,涉及 429,554 种药物。报告最多的 ME 是 "产品给药时间不当"(52,646;17.5%),其次是 "给药剂量不正确"(32,379;10.8%)和 "产品使用过程中技术错误"(26,831;8.9%)。与 ME 有关的个体病例安全报告最常见于女性(148,009 份;55.4%),最常见于医护人员(155,711 份;58.3%),主要来自美国(98,716 份;36.9%),其次是法国(26,678 份;10.0%),报告的中位年龄为 50 岁(四分位间范围:26-68 岁)。大多数 ME 个案安全报告(158,991 份;59.5%)与严重健康后果有关。根据整个 EudraVigilance 数据库,共确定了 847 份严重健康后果报告;对于亚组,严重健康后果报告的数量从 0-1 个月年龄组的 84 份到女性个体的 749 份不等。女性和男性的报告比例失调信号非常相似。大多数 ME 报告的是人类乳头瘤病毒疫苗(解剖治疗化学[ATC]:J07BM01;11,086 个 ME,57% 为 "产品给药时间不当"),不同年龄组的报告几率比从 1.5 到 47.0 不等。带状疱疹减毒活疫苗(ATC:J07BK02)的 SDR 在所有亚组中的报告几率从 26.6 到 78.1 不等。羟考酮(ATC:N02AA05;847 例 "意外用药过量",35%)、利培酮(ATC:N05AX08;469 例 "产品给药时间不当",22.3%)和利伐沙班(ATC:B01AF01;1,377 例 "给药剂量不当",34.6%)的报告比例过高。6%)在 2 个月至 2 岁年龄组中的 SDR 值较高,报告几率范围在 8.2 至 10.7 之间,而在整个 EudraVigilance 中,相同药物的报告几率范围在 1.3 至 1.6 之间:这项探索性研究概述了 EudraVigilance 数据库中具有特征的 ME 个案安全性报告和 SDR。在特定年龄组中发现了最明显的 SDR。在疫苗、羟考酮、利伐沙班和利培酮中发现了文献中未描述过的过度报告信号,这可能会促使利益相关者进行进一步检查。报告率最高的 MEs("产品给药时间不当"、"给药剂量不正确 "和 "产品使用过程中的错误技术")成为一般优先重点,需要进一步开展由医疗服务提供者、制造商和监管机构参与的根本原因分析,以提高对 MEs 的理解和预防。
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Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups.

Background: While medication errors (MEs) have been studied in the European Medicines Agency's EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted.

Objectives: The aim of this study was to characterise all ME-related individual case safety reports in EudraVigilance and explore notable signals of disproportionate reporting (SDRs) among sexes and age groups for the 30 most frequently reported drugs.

Methods: Individual case safety reports were used from EudraVigilance reported between 2002 and 2021. An ME was defined as any Preferred Term from the narrow Standardised Medical Dictionary for Regulatory Activities® Query. Signals of disproportionate reporting were selected based on a lower boundary of the 95% confidence interval ≥ 1 of the reporting odds ratio, and at least 3 individual case safety reports. Analysed subgroups were female individuals, male individuals, and age groups 0-1 month, 2 months to 2 years, 3-11 years, 12-17 years, 18-64 years, 65-85 years, and >85 years. Heatmaps were utilised as a visual aid to identify striking SDRs.

Results: Of the 9,662,345 EudraVigilance reports, 267,262 (2.8%) contained at least one ME, with a total of 300,324 MEs, for 429,554 drugs. The most reported ME was "Inappropriate schedule of product administration" (52,646; 17.5%), followed by "Incorrect dose administered" (32,379; 10.8%) and "Wrong technique in product usage process" (26,831; 8.9%). Individual case safety reports with MEs were most frequently related to female individuals (148,009; 55.4%), most often submitted by healthcare professionals (155,711; 58.3%), originated predominantly from the USA (98,716; 36.9%), followed by France (26,678; 10.0%), and showed a median reported age of 50 years (interquartile range: 26-68). Most ME individual case safety reports (158,991; 59.5%) were associated with a serious health outcome. A total of 847 SDRs were identified, based on the entire EudraVigilance database; for subgroups, the number of SDRs ranged from 84 for the age group 0-1 month to 749 for female individuals. Signals of disproportionate reporting for female individuals and male individuals were very similar. Most MEs were reported for the vaccine against human papillomavirus (Anatomical Therapeutic Chemical [ATC]: J07BM01; 11,086 MEs, 57% being "inappropriate schedule of product administration"), with reporting odds ratios that range from 1.5 to 47.0 among age groups. The SDR for the live-attenuated vaccine against herpes zoster (ATC: J07BK02) had a reporting odds ratio that ranged from 26.6 to 78.1 among all subgroups. Signals of disproportionate reporting for oxycodone (ATC: N02AA05; 847 cases of "Accidental overdose", 35%), risperidone (ATC: N05AX08; 469 cases "Inappropriate schedule of product administration", 22.3%) and rivaroxaban (ATC: B01AF01; 1,377 cases of "Incorrect dose administered", 34.6%) stood out with higher magnitude SDRs for the age group 2 months to 2 years, with an reporting odds ratio range between 8.2 and 10.7, while for the entire EudraVigilance the reporting odds ratio ranged between 1.3 and 1.6 for the same drugs.

Conclusions: This exploratory research provides an overview of characterised ME individual case safety reports and SDRs from the EudraVigilance database. Most conspicuous SDRs were identified in specific age groups. Signals of disproportionate reporting, not described in the literature, were found for vaccines, oxycodone, rivaroxaban and risperidone, and may prompt further examination by stakeholders. Top-reported MEs ("Inappropriate schedule of product administration", "Incorrect dose administered" and "Wrong technique in product usage process") emerged as a general priority focus to perform a further root-cause analysis involving healthcare providers, manufacturers and regulatory bodies, to improve the understanding and prevention of MEs.

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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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