The impact of medicine use in pregnancy is difficult to study. There has been increasing attention to how particular medicines can affect children’s neurodevelopment. The ConcePTION project recently published an inventory of European data sources that can support research on the neurodevelopmental effects of exposure to medicines in pregnancy. 

The route to establishing whether a medicine is safe is complex. Determining neurodevelopmental safety is complicated by the wide range of neurodevelopmental outcomes and the length of follow-up that is needed to catch difficulties in relation to skills that develop as the child is growing up. A group of researchers from ConcePTION have developed an inventory of 90 European data sources across 14 countries that can be used to study neurodevelopment.

According to Joanne Given, Faculty of Life and Health Sciences at Ulster University and first author, the inventory covers five domains of neurodevelopment: infant development, child behaviour, cognition, educational achievement, and diagnostic codes for neurodevelopmental disorders.

“The inventory is invaluable to future studies planning to investigate the neurodevelopmental impact of medication exposures during pregnancy”, says Joanne Given.

The inventory that was published in PLoS ONE is a useful resource for evaluating perinatal and long-term childhood risks associated with in-utero exposure to medication.

Read the paper here: Given J, Bromley RL, Coste F, Lopez-Leon S, Loane M (2022) An inventory of European data sources to support pharmacoepidemiologic research on neurodevelopmental outcomes in children following medication exposure in pregnancy: A contribution from the ConcePTION project. PLoS ONE 17(10): e0275979. https://doi.org/10.1371/journal.pone.0275979

By Josepine Fernow

Interested in the ethics of research on medications during pregnancy? Marieke Hollestelle will be presenting her talk, “Ethical Considerations When Using Real World Data for Research on Medication Safety in Pregnancy” at an event on 1 December 2022, organised by Harvard Program on Perinatal and Pediatric Pharmacoepidemiology (H4P). Her presentation will be followed by discussion with Drs. Krista Huybrechts, Ameet Sarpatwari, and Sonia Hernandez-Diaz.

H4P is a collaboration between Harvard T.H. Chan School of Public Health and Brigham and Women’s Hospital.

Not there on the day? Join online via Zoom on this link https://lnkd.in/dzqeDbdi.

Today marks the start of #MedSafetyWeek, putting the spotlight on how patients and health care providers can make safety work! One challenge for pregnancy and breastfeeding is the fact that pharmacovigilance data is heterogenous and scattered, making it hard to generate evidence. Another is the fact that the information that is out there about what is safe and what is not is often conflicting. Making it difficult for women and their doctors to make informed decisions about medicines in pregnancy. But 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. If women and health-care professionals report medicine use during pregnancy, that information can help women make informed decisions about the benefits and risks of different treatments!

The way this reporting is done is different in different countries. And 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 compared 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 centre 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.