Pregnant and breastfeeding women are rarely part of clinical trials, which means we don’t have enough data to know how safe medicines are. To be able to develop evidence, we need to obtain the information straight from the women who take the medicines! ConcePTION is developing an app that will allow women to report the medicines they use, and also provide pregnancy information: using a simple and straightforward interface. The first version of the app will be launched in the UK in the second half of 2022, in collaboration with the UK Medicines and Healthcare products Regulatory Agency, MHRA. Versions for other European languages and countries will follow!
We need good quality information to fill knowledge gaps on the safety profiles of particular medicines during pregnancy or breastfeeding. But it is not always clear to women how and where they can report. Or which system is specifically designed to make best use of the information they are providing. Amalia Alexe, a qualified clinical pharmacist at Novartis, is leading ConcePTION’s work to develop an app that will allow women to report the medicines they use during pregnancy and breastfeeding.
It is possible to ask your doctor to report on your behalf but information reported directly by women contains important details that healthcare providers do not always have. An important and novel feature of the app is its capacity to enable women to continue to provide updates on the longer-term health of the child beyond birth. The app is also designed to provide updates on safety information via news feeds.
“This means the app will be able to support and enhance post-marketing pregnancy safety data collection. Collecting information on side-effects, but also about healthy births and normal childhood development is critical to identify medicines suitable for women who need treatment whilst pregnant or breastfeeding in the future, says Amalia Alexe.
This is important, because we don’t always know how medicines taken by the mother could affect the health and (neuro-) development of the baby later on. By sharing information through the app, parents will be able to help women who become pregnant in the future to make better-informed choices on medical treatment for both themselves and their babies.
The app builds on the MedSafety app, developed in another Innovative Medicines Initiative project, WEB-RADR. Together with MHRA, we have optimised it for pregnancy. Development will continue, based on feedback received during meeting with healthcare professionals, patients, regulators, scientists, and industry representatives in January this year. According to Amalia Alexe, the feedback that the team received is in perfect alignment with the ConcePTION project’s vision for an information-exchange app for pregnancy and breastfeeding that can play an important part in improving the current safety environment for women and their babies.
“We were happy to learn that stakeholders see a need for the app, and many of them highlighted the need for access to trusted safety information on pregnancy and breastfeeding through digital tools that are both easy to understand and to access”, says Amalia Alexe.
The app will be available for both Android and iOS, with an interface that works on both mobile and tablet. It is designed to work offline, allowing women to create and save reports in the app even when not connected to the Internet. The app will be launched in English, mainly for a UK audience first to ensure it is functioning optimally. All information will be collected following GDPR regulations, and will reside with MHRA, the Health Authority in UK.
Not in the UK? You can always ask your doctor, nurse, midwife, or pharmacist to report that you are using a particular medicine. You can also inform a teratology information service, your national health authority, or the manufacturer of the medicine.
By Josepine Fernow