Quality of Clinical Information in Pregnancy Pharmacovigilance Data Sources—A Contribution of the ConcePTION Project

TL;DR

This study compares the quality of clinical information from different sources used to track drug safety during pregnancy.

Contribution

The study provides the first comparative assessment of clinical quality across primary pregnancy pharmacovigilance data sources.

Findings

The Dutch Pregnancy Drug Register had the highest clinical quality score at 89.0%.

Sources designed for general safety information had lower clinical quality than those specifically for pregnancy data.

Enhanced PV programmes outperformed spontaneous reporting in clinical quality for pregnancy pharmacovigilance.

Abstract

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.

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