ArticlePharmacoepidemiology and drug safety2025
Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources-A Contribution of the ConcePTION Project.
Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands-A contribution of the ConcePTION project.British journal of clinical pharmacology · 2026Article
- Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources-A Contribution of the ConcePTION Project.Pharmacoepidemiology and drug safety · 2025Article
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Authors and funding
8 authors.
Funding
Abstract
purposeGood 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.
methodsFifty 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).
resultsMean 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).
conclusionsFor 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.
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