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Lookup NU author(s): Dr Laura Yates
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2025 The Author(s). Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.Purpose: 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. Methods: 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). Results: 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). Conclusions: 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.
Author(s): van Rijt-Weetink YRJ, van Gendt J, Egberts TCG, van Hunsel FPAM, Lewis DJ, Yates LM, Winterfeld U, van Puijenbroek EP
Publication type: Article
Publication status: Published
Journal: Pharmacoepidemiology and Drug Safety
Year: 2025
Volume: 34
Issue: 7
Print publication date: 01/07/2025
Online publication date: 25/06/2025
Acceptance date: 29/05/2025
Date deposited: 09/07/2025
ISSN (print): 1053-8569
ISSN (electronic): 1099-1557
Publisher: John Wiley and Sons Ltd
URL: https://doi.org/10.1002/pds.70182
DOI: 10.1002/pds.70182
Data Access Statement: The codes and datasets for this manuscript are not publicly available because of the data protection policy of the Pharmacovigilance Centre Lareb. Requests to access the datasets should be directed to the corresponding author and will be granted on reasonable request
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