(128) Clinical Quality of Information of Primary Pregnancy Pharmacovigilance Data Sources – A ConcePTION Project

Publication Number: 1123

Background: Clinically well-documented reports of adverse events concerning exposure to medicinal products are more likely to support a reliable assessment of potential safety signals. An assessment tool for clinical quality, based on the presence and relevance of information elements, has recently been developed and validated to quantify the suitability of information for the purpose of safety assessment of medicinal product exposure during pregnancy. Detailed information on the clinical quality of various primary pregnancy pharmacovigilance (PV) data sources is currently lacking, but is important to highlight strengths and limitations of individual sources.

Objectives: To assess the differences in clinical quality of various sources of pregnancy PV data, and to study characteristics of the nature of information collected by the different sources.

Methods: A random selection of 50 case reports of exposures to medicinal products during pregnancy was collected from each of the following data types: spontaneous reports and reports based on cases described in literature selected from EudraVigilance, European Network of Teratology Information Services (ENTIS), the Dutch Pregnancy Drug Register, enhanced PV programmes (EPV), and industry-sponsored patient support programmes (PSP). Reports were standardized and anonymized in order to blind for details that may have revealed the data source and then assessed using the new method. A score of < 45% was considered poor, 45-65% intermediate, and ≥65% excellent clinical quality. The mean quality score was calculated per data source and compared using ANOVA (analysis of variance test). An analysis of scores for each section of the quality assessment tool was undertaken to assess for patterns in reporting of specific information that might compromise the quality of a report.

Results: Mean clinical quality scores for the various sources were 89.0% (SD 10.1%) for the Dutch Pregnancy Drug Register, 77.1% (SD 13.3%) for ENTIS, 64.7% (SD 20.5%) for EPV, 49.5% (SD 16.2%) for PSP, 40.9% (SD 21.6%) for spontaneous reports, and 38.6% (SD 18.0%) for literature reports. All were statistically significantly different (p≤0.02) except for spontaneous reports versus literature reports (mean difference 2.2%, p=0.99) and spontaneous reports versus reports from PSPs (-8.6%, p=0.14).

Conclusions: Data sources specifically designed for pregnancy data collection (the Dutch Pregnancy Drug Register and ENTIS) contain on average better clinical quality reports compared to sources designed for all clinical situations (EPV, PSP, spontaneous reports and literature reports). Also, EPV methods improve general spontaneous reporting data collection for pregnancy PV.