Building evidence for medicine safety in pregnancy requires large sets of high quality data, but until now there were no tools available for grading pregnancy pharmacovigilance data. One of the challenges lies in the fact that a lot of pregnancy pharmacovigilance information is collected in individual case reports, not designed for drug use during pregnancy. The ConcePTION project has developed a four-step process to assess the quality of the information in case reports, listing the elements that are essential for assessing the quality of information used to evaluate the risks associated with medicinal products used during pregnancy.
Evaluating the risk of exposure to a medicinal product during pregnancy builds on access to information that is comprehensive and clearly explained. A paper just published in Frontiers in Drug Safety and Regulation reports on a ConcePTION project process to assess case report information. The work builds on an expert focus group discussion to identify the different kinds of information that could form the basis for a quality assessment, followed by two surveys and focus group discussions to do a final selection. The work resulted in a list of twenty-one information elements. The authors categorised these elements into into seven groups: information pertaining to the association itself, the event, exposure to the medicinal product, maternal factors, pregnancy, labour, and the child.
According to Eugène van Puijenbroek, clinical pharmacologist at the Netherlands Pharmacovigilance Centre Lareb and Professor of Pharmacovigilance at the University of Groningen, this study is a first step in the development of a validated method for evaluating the clinical quality of case reports and other information sources on pregnancy pharmacovigilance data. The study aimed to identify the elements that are needed if we are to assess the quality of information. In turn allowing us to use them for risk assessment.
The study is published Open Access in Frontiers in Drug Safety and Regulation
van Rijt-Weetink, Y.R.J., Chamani, K., Egberts, A.C.G., van Hunsel, F.P.A.M., Lewis D.J., Yates, L.M., Winterfeld, U., van Puijenbroek, E.P. (2023) Elements to assess the quality of information of case reports in pregnancy pharmacovigilance data—a ConcePTION project, Frontiers in Drug Safety and Regulation 3, DOI: 10.3389/fdsfr.2023.1187888