Just like everyone else, pregnant women sometimes need to take medicines. Sometimes the reason has nothing to do with pregnancy, like headaches, allergies or chronic illness. Sometimes health problems start or get worse when a woman is pregnant, like diabetes, morning sickness or high blood pressure. Sometimes women take medicines before they know that they are pregnant. Often there is not enough evidence to give women trustworthy information about how her particular drug might affect the fetus. This is why women and health-care professionals should always report any medicines taken during pregnancy! Your information can help women make informed decisions about the benefits and risks of different treatments!

There are several ways to report that a woman has used a particular medicine. The different registries are interested in what is often called exposures (when a woman used a particular medicine). The ConcePTION project will build a system where this information can be with other important pregnancy information such as miscarriages, stillbirth and malformations, and how children develop. Every report counts!

If you are a pregnant woman

If you used a medicine during your pregnancy (regardless of whether there are unwanted effects or not), you can ask your doctor or midwife to report for you, or report it yourself. There are three different ways to report, but remember to only report each medicine once, and through one of the routes. If you prefer not to ask you healthcare provider, you could:

• Report that you have taken a medicine during pregnancy to the company who makes the medicine (Marketing Authorization Holder). You can find the information on where and how to notify them either in the information leaflet included in the product packaging, or by visiting the company website.
• In some Europeans countries, you can report through specialized, country specific centers called Teratology Information Services. To find out if this service is available in your country, please visit https://www.entis-org.eu/centers.
• You could also report to what is called national competent authorities, which is another name for the authorities that approve medicines (regulators). For EU & EEA countries, you can find a list here: national competent authorities of the EU and EEA on the European Medicines Agency website.

If you are a health care provider

If you prescribe a medicine to a pregnant patient, whether or not it is associated with an adverse drug reaction, you should report the exposure to either the Marketing Authorization Holder of the product, or a national Teratology Information Service centre (if there is such a service in your country). As always, you are required to report adverse events through regular routes. It is particularly important to report any problems that result in hospitalization, significant disability, or death”.

If you are reporting exposure (without adverse events), you can find a list of national competent authorities here: national competent authorities of the EU and EEA on the European Medicines Agency website. Your report will likely feed into the EudraVigilance database, a collaboration between different actors in Europe. These include the European Medicines Agency, different National Competent Authorities (national regulatory authorities), the Market Authorisation Holders (companies that make the medicines), and different sponsors of clinical trials (including physicians, academic centres, non-governmental organisations. To find out if there is a Teratology Information Service center in your country, please visit https://www.entis-org.eu/centers.

Want to know how some of these systems work?

Christine Taeter, Head of Immunology Patient Safety Unit at UCB presents the perspective of Marketing Authorization Holders on monitoring the safety of medicines use during pregnancy.

Jonathan Luke Richardson from the UK Teratology Information Service (UKTIS), Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom presents an overview of how ENTIS monitors medication use in pregnancy.

Helen Dolk, Professor of Epidemiology & Health Services Research at Ulster University presents how the EUROmediCAT network works to optimise the use of congenital anomaly registries and healthcare databases for medication safety monitoring.

Women have the same right to health as everyone. But because there is concern about safety, clinical trials rarely involve pregnant or breastfeeding women. The ConcePTION project aims to solve this problem by building a system where information from children, mothers and their doctors will help develop reliable information about how safe a medicine is for women who are pregnant or breastfeed. Making the information accessible for women and health care professionals through an online knowledge bank.

We use health data from prenatal registries and surveys to find out if a mother used a specific medicine during pregnancy. This data is combined with information about the children, looking for correlations between development, malformations and medicine use. Prospective studies and malformation registries (teratology information) provides a picture of the children’s health. Another big part to the ConcePTION project is looking at how medicines transfer to milk and to infants during breastfeeding.

But collecting information, piecing it together and turning data to evidence is a huge and complex task.  A task that requires the expertise and resources from individuals and organisations: Academic researchers, the pharmaceutical industry, the European Medicines Agency, teratology information services, research infrastructures, companies and others all have a crucial role to play.

We are developing models for how medicines transfer to breast milk. One part of this entails analyzing components from specific medicines in breast milk and blood from mothers who already use that drug. Together, we are pooling our resources to set up a first in its kind, European breast milk biobank and analysis platform for mother’s milk. Samples will be collected from breastfeeding women (who already have prescriptions for the medicine), and shipped to the milk biobank. This human data will be compared to a model where we use a combination of data: Ranging from learning how different compounds transfer in vitro (using cell lines), and in vivo (in animals) to in silico (computer) models.

The ConcePTION effort shows that together, women, health care professionals, universities, pharmaceutical companies, authorities, organisations that work with pharmacovigilance and other actors are able to form a partnership. A partnership that can deliver a European system that develops robust safety data for medicine use in pregnancy and breastfeeding! Through the Innovative Medicines initiative, we are pooling resources from the European Union’s Horizon 2020 framework programme, covering costs and salaries for academic researchers and other public partners. And through EFPIA, the Pharmaceutical Industry is contributing the same amount in costs and salaries for the experts they bring to the project.

We are working together to solve a complicated puzzle: bringing data and expertise together, turning the data into evidence for medicine safety. Allowing women to make informed decisions about their health, pregnancies and how to feed their babies!

By Josepine Fernow

Want to know more?

Watch this clip and visit our YouTube channel for more content about ConcePTION.

To be able to say that it is safe for a pregnant woman to take a particular medicine, we need to know that the safety data is robust. The ConcePTION project is piecing European data together, building a system to generate evidence on medicine safety for pregnant and breastfeeding women. A recent report provides an inventory of the core elements that are needed to generate the evidence that is required. The report guides researchers in performing high quality and meaningful population-based studies: allowing women and their doctors to make informed decisions and weigh the benefits against the risks of treatments.

The report selects, identifies and defines what we consider to be core evidence elements. These are the elements needed to assess how safe a particular medicine is to use in pregnancy. The report includes descriptions of what we call core outcome data elements, ranging from a foetus being small for its gestational age, preterm birth, stillbirth, miscarriages, malformations, the health of the mother, childhood development. It also describes how exposure of the mother to medication during pregnancy should be assessed.  The report also lists the different methods that can be used to analyse this information and describes ways to assess the quality.

This work is a result of reviews of information that has already been published, combined with the knowledge of about 20 experts in different but complementary fields, from more than 10 different countries. This work has also been reviewed, discussed and validated by external experts and stakeholders in a consultation meeting.

Want to know more? Download and read the report D1.2 Core evidence elements for generating medication safety evidence for pregnancy using population-based data