2020 was a challenging year for all of us, having an impact on our work and private lives alike. Despite adapting to a global pandemic, we have made amazing progress in our project and achieved many milestones on our way to improve the information for pregnant and breastfeeding women worldwide. With 88 partners from 22 countries, we should be proud of being part of a unique project that is set out to improve the situation in an orphan and neglected topic!

The ConcePTION management team would like to thank all partners for their commitment and hard work. The ConcePTION project wishes all of you a happy holiday season and a prosperous and happier new 2021. We hope we can all relax and come back with new enthusiasm and energy to continue the work where we left off. Next year promises publication of some of our results, the launch of a mobile app to report exposure to medicines during pregnancy, and many more exciting outputs from the ConcePTION team!

Pregnant women make decisions about medicines based on insufficient, incomplete, and randomly available information with varying quality. More than five million European women become pregnant every year. Most of them use at least one medicine during their pregnancy. A recent master thesis from the ConcePTION project shows that giving women easy access to information from sources they can trust can empower them to make decisions about medicines in pregnancy.

Women with chronic illnesses get pregnant, and women who are pregnant get ill. For every pregnancy, women and their doctors have to weigh the benefits against harms of anything from upset stomach with over-the-counter aspirin to get rid of a headache, to risking death or disability from stopping treatment for epilepsy. Most of these drugs have not been studied in pregnancy, which means that both women and their babies are potentially at risk.

“Studies on the use of drugs show that most women use medicines during pregnancy, with estimates ranging from 44-99%. Nevertheless, most medicines have not been adequately studied in pregnant women. As a consequence, these women, their partners, and their doctors take very difficult decisions based on insufficient evidence”, says Dr. David Lewis, Qualified Person for Pharmacovigilance at Novartis & Senior Visiting Research Fellow, University of Hertfordshire, who leads work to develop a ConcePTION app for patient or health professional reporting of medication use in pregnancy, and providing evidence-based information.

But how can, and how do, women access reliable information? Amalia Alexe (pictured above) recently defended her master thesis “Is my treatment harming my baby?”, where she analysed public health information from the patient’s perspective. The aim was to understand how patients can make informed choices about medicines and their use during pregnancy. The work builds on a patient survey to explore views and opinions about publicly available information of the use of medicines in pregnancy.

Her work indicates that women will be empowered by having easy access to trusted information sources through a mobile app. She is part of the team that is developing an app where women, healthcare professionals and manufacturers can report pregnancy exposures. Based on her preliminary research, she anticipates that the app will encourage women to contribute to improving the information sources that already exist by sharing information about drugs they have taken during pregnancy. The app will also support women being able to contribute to better understanding the safety of medicine use when breastfeeding by asking if women would consider donating breast milk samples to the ConcePTION biobank for analysis and assessment.

“Women will have the opportunity to participate in long-term pregnancy studies through continuous access to information on their child’s health and development via the app. By participating in the ConcePTION project through use of the App, women will also help future mothers to make well-informed health decisions for themselves, and for their children” says Amalia Alexe, EU2P Master of Science student, PV Operational and Compliance Lead, Advanced Accelerator Applications, and co-leader of the team that is developing the ConcePTION app for information sharing and reporting.

By Josepine Fernow

Many women need medication during pregnancy and breastfeeding in order to treat health conditions. However, they often choose to stop their medication. I meet these women in my clinical practice. Many of them have underlying medical problems, anything from common ailments (such as headaches or heartburn) to autoimmune diseases, to heart and kidney disease or even an organ transplant. Naturally, they worry about the medicines they are taking for fear that they might harm their baby. Leaving medical problems untreated can have serious implications for both the mother and the baby. Very often, stopping medication is more harmful than the actual risks of continuing.

Drug manufacturers cannot advise pregnant and breastfeeding women to continue taking medications that they do not know are safe for both mother and child. Almost all drug formularies and manufacturer patient-information leaflets advise women to avoid using the medicine when they are pregnant or breastfeeding. Different countries have different structures in place to provide information about medicine safety during pregnancy and breastfeeding. In some countries, teratology information services advise women and healthcare providers regarding the risks and benefits of treatment. In other countries, pregnant women can ask their doctor or midwife for this advice. Studies and reports where medicines have been successfully used in pregnancy are essential. However, we desperately need more information as there is a big knowledge gap.

I am the Head of the UK Teratology Information Service (UKTIS), which is part of a group of organisations collectively called the European Network of Teratology Information Services (ENTIS- for short). All of the services in ENTIS offer unbiased information, supporting women and their healthcare providers. Many teratology information services also provide surveillance of medication in pregnancy and breastfeeding and play an important role in contributing to the worldwide literature and knowledge.

Members of ENTIS, including UKTIS, are taking part in the IMI ConcePTION project to help improve access to pregnancy safety information for everyone. We encourage women and health providers to report pregnancies to organisations that study this type of information, to better understand the effects of medicines in pregnancy.

It is a great privilege to work with pregnant women, their babies and their families. In this work, we must strive to improve the data that we collect and provide clear, accurate and unbiased information to improve pregnancy outcome for all.

By Ken Hodson (@ken_hodson on Twitter), Head of the UK Teratology Information Service (www.uktis.org) and consultant obstetrician with a specialist interest in medical problems in pregnancy in Newcastle upon Tyne, UK.

You can find the contact details of your local teratology information service at www.entis-org.eu. If you have questions about medicines in pregnancy and your country does not have a teratology information service, you can contact your doctor or midwife for advice.