The scope of this topic is to better inform the use of medicines during pregnancy and breastfeeding. To change current practices, the overall objective is to provide improved tools and methods to generate more valuable, reliable and timely information to HCPs and pregnant and lactating women to enhance optimal care.
Information to guide decision making for the safe and effective use of medications during pregnancy and breastfeeding is a large unmet need that hinders optimal care of women of childbearing potential. Pregnant women with serious illness need medicines, to treat conditions in order to prevent irreversible damage to their health and the health of their unborn child. These patients, together with their healthcare professionals (HCPs), are invariably interested in better information on the risks that their disease and/or medication can pose to the foetus as well as to babies during breastfeeding.
There is therefore an unmet need for a science and data driven approach to define the standards for generating data on medicines used during pregnancy and breastfeeding. It will result in better and more complete scientific information on drug effects on pregnancy and lactation and this will be used to inform treatment decisions and will increase the quality of care for women.
The project is expected to deliver scientifically sound and validated way of producing data to assess medication-related adverse pregnancy outcome and to better characterise and predict the excretion of medicines in breast milk. This will enable regulatory bodies to assess data and include enhanced information in the labels, providing prescribers and patients with much needed information to guide treatment decisions for the benefit of women and children. It will generally improve the health of our next generation. In the absence of the information generated through the project, the diseased pregnant and breastfeeding population will continue to be underserved.