van Rijt-Weetink Yrea R J, van Gendt Jip, Egberts Toine C G, van Hunsel Florence P A M, Lewis David J, Yates Laura M, Winterfeld Ursula, van Puijenbroek Eugène P
Groningen Research Institute of Pharmacy, PharmacoTherapy, -Epidemiology and -Economics, University of Groningen, Groningen, the Netherlands.
Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands.
Pharmacoepidemiol Drug Saf. 2025 Jul;34(7):e70182. doi: 10.1002/pds.70182.
Good documentation of adverse events related to medicines is essential for the assessment of safety signals. Information on the clinical quality of primary pregnancy safety data sources is lacking. The objective of this study was to assess the differences in clinical quality of various sources of primary pregnancy pharmacovigilance (PV) data.
Fifty reports of exposures to medicines during pregnancy were collected from: spontaneous and literature reports from EudraVigilance, European Network of Teratology Information Services (ENTIS), the Dutch Pregnancy Drug Register, enhanced PV programmes (EPV), and patient support programmes (PSP). Reports were standardized and anonymized, after which their clinical quality was assessed. Mean scores per source were compared using ANOVA (analysis of variance test).
Mean clinical quality scores were 89.0% (SD 10.1%) for the Dutch Pregnancy Drug Register, 77.1% (SD 13.3%) for TIS, 64.7% (SD 20.5%) for EPVs, 49.5% (SD 16.2%) for PSPs, 40.9% (SD 21.6%) for spontaneous reports, and 38.6% (SD 18.0%) for literature reports. All were statistically significantly different (p ≤ 0.05) except for spontaneous versus literature reports (mean difference 2.2%, p = 0.99) and spontaneous reports versus reports from PSPs (-8.6%, p = 0.14).
For data sources specifically designed for pregnancy data collection, the clinical quality of information generally outweighed sources designed to capture general safety information. EPV methods showed better scores for clinical quality compared to spontaneous reporting data for pregnancy PV.
良好记录与药物相关的不良事件对于评估安全信号至关重要。目前缺乏关于初次妊娠安全性数据来源临床质量的信息。本研究的目的是评估各种初次妊娠药物警戒（PV）数据来源的临床质量差异。
从以下方面收集了50份孕期药物暴露报告：EudraVigilance的自发报告和文献报告、欧洲致畸学信息服务网络（ENTIS）、荷兰妊娠药物登记处、强化PV项目（EPV）以及患者支持项目（PSP）。报告经过标准化和匿名化处理，之后对其临床质量进行评估。使用方差分析（ANOVA）比较各来源的平均得分。
荷兰妊娠药物登记处的平均临床质量得分为89.0%（标准差10.1%），ENTIS为77.1%（标准差13.3%），EPV为64.7%（标准差20.5%），PSP为49.5%（标准差16.2%），自发报告为40.9%（标准差21.6%），文献报告为38.6%（标准差18.0%）。除自发报告与文献报告（平均差异2.2%，p = 0.99）以及自发报告与PSP报告（-8.6%，p = 0.14）外，所有差异均具有统计学意义（p≤0.05）。
对于专门为收集妊娠数据而设计的数据源，其信息的临床质量总体上超过旨在获取一般安全信息的数据源。与用于妊娠PV的自发报告数据相比，EPV方法在临床质量方面得分更高。
