The ConcePTION Meds4Mus2B [Meds for mums to be] app, developed in partnership with the UK regulatory agency MHRA, will launch in the United Kingdom in spring 2024. It is the first of its kind, and will help share and collect vital safety information about medicine use during pregnancy and breastfeeding. With this dual mission, the app will help change how we approach healthcare for expectant and nursing mothers.
Women and their partners are an important source of information for what is referred to as pregnancy pharmacovigilance, monitoring safety and collecting information on medicines that the foetus was exposed to in the womb, and how the child develops. This approach also allows us to see if there are any effects at birth and in the long term. This first iteration of the app is developed in English, feeding into the UK regulatory agency. But more language versions are in the pipeline.
“The majority of pregnant women use at least one medicinal product during their pregnancy. Sometimes for an acute condition, such as a headache, or an infection, sometimes for a chronic condition that needs continuous treatment. By using the app, patients and healthcare professionals will gain access to trusted and verified safety information. Additionally, users will contribute to the well-being of future mothers by reporting their experiences of medicine use during pregnancy and breastfeeding.” says Amalia Alexe, EFPIA Deputy Lead for the ConcePTION work to improve the collection, analysis and interpretation of pregnancy pharmacovigilance data and the project’s App Development Lead.
Pregnant and breastfeeding women, their partners, and healthcare professionals will be able to submit reports, including both adverse events and normal outcomes. These reports will be carefully analysed to further refine the safety profiles of medications used in these contexts. Notably, all adverse events reported through the app will be integrated into the MHRA database, contributing to routine signal detection activities.
The app ensures accessibility and compliance…
- User inclusivity: Pregnant women, their partners, and healthcare professionals can all sign up and benefit from the resource.
- User-friendly interface: Users will receive tailored safety information and can report medication exposure through straightforward, customised questions that are aligned with their medical knowledge.
- Privacy assurance: The app is compliant with EU Privacy Policies and the General Data Protection Regulation (GDPR), and users can trust their data will be handled with care.
- Free download: The app will be available for free download and use, ensuring that critical medical information is accessible to all.
This is only part of ConcePTION’s efforts to bridge the knowledge gap regarding medicine safety in pregnancy and breastfeeding. For more information about the app, please contact Amalia Alexe.
By Anna Holm Bodin
