Nearly all pregnant women use at least one medicine. After all, becoming pregnant doesn’t magically cure people of any existing health conditions they might already have, or make them immune from any that they might develop. But pregnant women are generally excluded from clinical trials, and most of the knowledge we have about whether medications are safe to take during pregnancy is gleaned from observing women taking medications during their pregnancies.
However, there’s no standardised or systematic approach to collecting this type of data, which means that it takes longer for the medical community to agree that a particular medication can be deemed safe.
Many countries hold data on medication exposure during pregnancy (so-called PregPV datasets) however the format of these data and the way that they are collected vary from country to country. This impedes progress as it’s more difficult to compare and combine the data.
The IMI ConcePTION project sought to change that by developing a series of recommendations to optimise and standardise data collection techniques, analysis and reporting. They outlined a reference framework of core data elements recommended for data collection in pregnant women, and published their work in the journal Drug Safety.
A scoping review was carried out to see what kind of data collection methods were used in different parts of the world, and what kinds of international organisations and networks were involved. Using that information and following an expert review of the key statistics needed to assess the safety of medicine in pregnancy, core data elements (CDEs) were identified and then defined.
The CDE recommendations framework produced by the project is comprised of 98 individual datasets arranged into 14 tables. 63 of them were identified as essential for studying the risk of adverse outcomes, whether for the pregnant woman, the fetus or the infant. 71 were considered essential for studying longer-term childhood outcomes.
The next step is to promote and disseminate the framework worldwide to ensure that it will be implemented globally.
ConcePTION is supported by the Innovative Medicines Initiative (IMI) programme, a partnership between the European Union and the European pharmaceutical industry.