An innovative mobile app for the provision of medical information and collection of safety data on exposure to medicines during pregnancy or breastfeeding: An IHI ConcePTION contribution

Abstract

To increase the volume, quality, and comprehensiveness of pregnancy and breastfeeding reports related to medication exposure.Innovative Health Initiative (IHI) ConcePTION, in collaboration with the Medicines and Healthcare products Regulatory Agency (MHRA), has developed a mobile application designed for exchange of safety information for pregnancy and breastfeeding. The users will also be able to report medication exposure during pregnancy and breastfeeding, regardless of the outcome, by answering simple questions, tailored for their level of medical knowledge.Through the first version of the app, the users will receive trusted safety information on their medication of interest, from the Health Authority (RSS feeds, tagged for ‘pregnancy’ and ‘breastfeeding’). By using the app, women and healthcare providers will also be able to help future mothers, by reporting the events they experienced following the utilization of medications during pregnancy and breastfeeding. These will be analyzed by MHRA to further characterize the safety profiles of the medications required to be used in these situations.Collection of pregnancy outcomes after exposure to medications during pregnancy is limited by under‐reporting and focused on reporting of harms. By developing the app, ConcePTION brings reliable safety information closer to healthcare professionals and pregnant and breastfeeding women and proposes an easy‐to‐use, general data protection regulation‐compliant, secure tool tailored for safety in pregnancy and breastfeeding.