Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources—A Contribution of the ConcePTION Project: A Contribution of the ConcePTION Project
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| Název: | Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources—A Contribution of the ConcePTION Project: A Contribution of the ConcePTION Project |
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| Autoři: | Yrea R. J. van Rijt‐Weetink, Jip van Gendt, Toine C. G. Egberts, Florence P. A. M. van Hunsel, David J. Lewis, Laura M. Yates, Ursula Winterfeld, Eugène P. van Puijenbroek |
| Zdroj: | Pharmacoepidemiol Drug Saf Pharmacoepidemiology and Drug Safety, vol. 34, no. 7 |
| Informace o vydavateli: | Wiley, 2025. |
| Rok vydání: | 2025 |
| Témata: | Factual/standards, Registries/statistics & numerical data, Netherlands/epidemiology, Drug-Related Side Effects and Adverse Reactions/epidemiology, Data Accuracy, Pharmacovigilance, Databases, Pregnancy Complications/epidemiology, Pregnancy, Humans, Female, Information Sources, Original Article, Adverse Drug Reaction Reporting Systems/standards |
| Popis: | 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. |
| Druh dokumentu: | Article Other literature type |
| Popis souboru: | application/pdf |
| Jazyk: | English |
| ISSN: | 1099-1557 1053-8569 |
| DOI: | 10.1002/pds.70182 |
| Přístupová URL adresa: | https://research.rug.nl/en/publications/cdecb08e-9456-4405-8c0a-56d73f35e02d https://hdl.handle.net/11370/cdecb08e-9456-4405-8c0a-56d73f35e02d https://doi.org/10.1002/pds.70182 https://research-portal.uu.nl/en/publications/61f171eb-2a9a-4df6-b889-1ecd5a093da0 https://doi.org/10.1002/pds.70182 https://serval.unil.ch/resource/serval:BIB_2F87CE98019E.P001/REF.pdf http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_2F87CE98019E6 https://serval.unil.ch/notice/serval:BIB_2F87CE98019E |
| Rights: | CC BY |
| Přístupové číslo: | edsair.doi.dedup.....65f76b39a4199269eff4e136e17a3bf4 |
| Databáze: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | 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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| ISSN: | 10991557 10538569 |
| DOI: | 10.1002/pds.70182 |