200 million women get pregnant each year, most of them use at least one medication during pregnancy, but safety data are lacking!  The ConcePTION project is developing an ecosystem to generate robust evidence on medicines safety information in pregnancy and breastfeeding. Because of the diversity of data across many sites and countries, the ConcePTION common data model is an important part of this safety evidence ecosystem. It enables consistent research approaches to be applied to a large number of datasets across Europe. Something that is needed to fill the knowledge gap regarding medicine safety in pregnancy and breastfeeding. The common data model, and how to harmonize data to support knowledge generation on the safety of medicines for pregnant and breastfeeding women, is described in a paper recently published in Clinical Pharmacology & Therapeutics.

“We need to reduce the uncertainty that is currently surrounding medicine safety for pregnant and breastfeeding women. There is a societal obligation to do so and to do it quickly. We have looked at how to preserve, leverage and report on information held within existing European data sources. And how that can support our pharmacoepidemiological analyses of medicine safety in pregnancy and lactation,” says Miriam Sturkenboom, ConcePTION coordinator and one of the authors.

The ConcePTION common data model is an important tool for knowledge generation and a key part of the infrastructure that transforms data into the evidence needed to fill existing knowledge gaps. The common data model was designed based on data availability and content analysis of 21 European data sources. 10 years of experience in building European common data models went into the design of the ConcePTION model. A model that will allow for capturing data from routine healthcare, public health surveillance measures, registers and teratology data.

Within the first few years of ConcePTION, the common data model has already been applied in 13 of the 21 European data sources and allows research study designs and common analytical scripts to be run consistently and efficiently.  So far, it has contributed to major EU-projects related to COVID-19 disease, pregnancy or vaccines and facilitates effective and transparent analytics to address questions about utilization, effectiveness, and safety of medicines in particular populations. Among them pregnant and breastfeeding women.

“Our strategy has been to develop a novel generation of a common data model that can preserve the heterogeneity of European data and its details, that can be implemented within time and budget constraints, and that can conduct distributed analyses transparently and efficiently. Our work to achieve this is what we outline in this paper,” Nicolas Thurin, pharmacoepidemiologist at the University of Bordeaux, and another one of the co-authors concludes.

By Anna Holm

Thurin NH, Pajouheshnia R, Roberto G, From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding, Clinical Pharmacology & Therapeutics, First online 26 November 2021

On 25 January 2022, the IMI ConcePTION project is organising an online workshop on improving how we collect information to understand the risks and benefits of medicine use in pregnancy and breastfeeding. We invite women, their partners, health care professionals, researchers and representatives from companies that develop medicines and authorities that approve them to join us. Your input will help us fill some of the knowledge gaps on the safety of medicines in pregnancy and breastfeeding, and help us to understand where there are barriers and problems with the existing systems!

Despite widespread initiatives to collect information on the safety of medicines in pregnancy & breastfeeding, the evidence is still either lacking or incomplete. To improve pregnancy pharmacovigilance and ensure that health care professionals and the women themselves have access to trustworthy, updated and accurate information, we need to understand what barriers they face and work to fill gaps in the existing systems. But to succeed in developing a sustainable system for pharmacovigilance in pregnancy, we need input from the women who use medicines, the health care professionals that prescribe them, the companies that manufacture them, and the regulators that approve them.

As part of our efforts to collect better information on medication use during pregnancy and breastfeeding, the ConcePTION project will conduct a multi-stakeholder workshop. We need your feedback on our proposals!

This is an open online event. To join us on 25 January between 11-13 CET, we need you to register. The event is free of charge. The event is open to all stakeholder groups and organised so that anyone can contribute, regardless of how much you know about the topic beforehand. We are particularly interested in hearing from women who have used medicines during pregnancy, and health care professionals. Presentations will be recorded, and a report will be published on the ConcePTION website.

The workshop will address:

• Findings from the ConcePTION project which illustrate why the systems for collecting information on medicines use in pregnancy and breastfeeding need to be improved
• The ConcePTION project approach
• Our proposal for a pregnancy and breastfeeding pharmacovigilance system for the future!

Register to join the workshop >> 

This week is Safe Motherhood Week, the annual awareness week on maternal and neonatal health. This year’s theme is the impact of COVID-19 on maternal health and reproductive care, and the need to reduce the information gap on the safety of medication during pregnancy and breastfeeding. Highlighting the importance of maternal health, especially in light of the current pandemic, and aiming to raise awareness of the persistent information gap.

As a follow up to a 2020 ConcePTION survey on understanding the needs and preferences of women and health care professionals about information on medicine use during pregnancy and breastfeeding, last year Safe Motherhood Week conducted a survey. 416 women and 88 health care providers replied and helped identify how needs and preferences in reproductive care have been changing since the Coronavirus outbreak. The survey was translated into eight languages to reach women from a variety of backgrounds. According to Helena Harnik at the Synergist, one of the driving forces behind Safe Motherhood Week, they managed to collect heartfelt responses from women in over 30 countries around the world who wanted their stories to be heard.

“We were looking for insight into changes in the reproductive care of women during the pandemic. Remote contact with doctors and midwives increased, which many women reported had a significant impact on their experience. Many were unhappy with the way things had gone, and we received several heart-breaking stories about the difficulties they faced, too often alone,” Helena Harnik describes.

65% of women reported increased use of the internet as a source of reproductive care information compared to before the outbreak. Virtual support groups, like on Facebook or WhatsApp, were often utilised during this time and nearly half of women used these support groups for information or support as a replacement to asking their doctor, midwife, or pharmacist directly.  The survey findings support the need for better online information on the safe use of medicines during pregnancy and breastfeeding and the creation of a knowledge bank.

“The lack of information available on the safety of medicines used during pregnancy and breastfeeding is a real problem for real women. Through Safe Motherhood Week, we are also helping to raise awareness of this important gap in reproductive care, and the significance of the ConcePTION project, which is indeed a landmark public-private partnership. Working together to reduce uncertainty about the effects of medicines used during pregnancy and breastfeeding for women and healthcare professionals,” Helena Harnik concludes.

Learn more about Safe Motherhood Week