| アブストラクト | 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. |
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| 投稿者 | 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, Eugene P |
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| 組織名 | 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.;Department of Clinical Pharmacy, University Medical Centre Utrecht, Utrecht, the;Pharmacovigilance Centre Lareb, 's-Hertogenbosch, 's-Hertogenbosch, the;Global Drug Development, Novartis Pharma GmbH, Wehr, Germany.;School of Life and Medical Sciences, University of Hertfordshire, Hatfield, UK.;KRISP, University of Kwazulu-Natal, Durban, South Africa.;Northern Genetics Service, Newcastle-upon-Tyne Hospitals NHS Foundation Trust,;Newcastle upon Tyne, UK.;Swiss Teratogen Information Service and Clinical Pharmacology Service, Centre;Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne,;Switzerland. |
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