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

From 6 to 12 November, ConcePTION will take part in the global #MedSafetyWeek campaign, a collaboration involving more than 80 medicines regulatory agencies and several non-governmental organisations, to raise awareness about the importance of reporting side effects of medicines. And for pregnant women to report every time they are exposed to a medicine, to help close the knowledge gap in medicine safety for pregnancy and lactation. With the theme ‘Who can report?’, this year’s campaign will focus on the key role of every patient, woman, doctor, nurse, and pharmacist who reports a side effect or exposure and contributes to safe medicine use.

All medicines agencies operate systems to detect and analyse side effects of medicines. The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and act to minimise harm.

There are several ways to report that a pregnant 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!

How can we stimulate reporting of medicine use in pregnancy & breastfeeding? We have developed a step-by-step guide for developing communications campaigns to stimulate reporting of medicine use during pregnancy and breastfeeding. The toolkit provides hands-on guidance for TIS-centres, health authorities and other stakeholders to support them in setting up their local, tailored campaigns.

#MedSafetyWeek is an international campaign led by Uppsala Monitoring Centre (UMC), the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. The campaign is supported by WHO and by members of the International Coalition of Medicines Regulatory authorities (ICMRA). ConcePTION’s participation to the campaign has been an annual occurrence, and an important tool to connect our messaging about pregnancy and breastfeeding to the overarching discussions about medicine safety in the global community.

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There is a growing number of human data catalogues. As the European Health Data Space (EHDS) is developing its vision for a joint European descriptive metadata catalogue to help enable secondary use of the data in these catalogues, the experience of developing the ConcePTION data catalogue can be of great relevance. A recent opinion review shares several recommendations on what is needed to make human data catalogues work better together.

Human data catalogues are like libraries for researchers, making it easier for them to find, share and analyse this data for scientific and medical studies in a standardised manner. This allows the continued advancement of various different fields of scientific and medical research. In recent years, there’s been a push to make research data more “FAIR” – Findable, Accessible, Interoperable, and Reusable. This is to boost scientific progress. However, different fields have their own specific data needs, and with so many data catalogues around, navigating them can become very complicated.

The ConcePTION data catalogue in and of itself is a collection of different data sources in different data banks, hosted by different organisations operating in different fields. It is a good example of the complexities involved in streamlining information across data providers and in data catalogues. From their experiences in ConcePTION and other projects, the authors of the opinion review provide a list of recommendations.

Among their recommendations, the authors suggest letting motivated catalogue teams work independently and encouraging their cooperation through some basic standardisation. This could involve clear rules for sharing data, using unique identifiers to link records between catalogues, defining common data elements, setting up systems for data sharing, and keeping clear records of data sources and contributors. They also recommend creating spaces where catalogue developers can collaborate and share resources. This can be done through international networks like OpenAIRE and the research data alliance, as well as domain-specific groups like BBMRI and ELIXIR.

“We need a more cohesive and collaborative approach to human subject data cataloguing. By harmonizing underlying concepts, encouraging autonomy within catalogue teams, and investing in standardization efforts and cross-domain interactions, the research community can create a more integrated and accessible ecosystem for human subject data, where strengths and limitations of data for secondary use can be assessed. It’s a lot of work but will have great benefits in the end, as more robust evidence can be generated with yields more benefits perhaps especially to patients, and in the case of ConcePTION to pregnant and breastfeeding women,” says Rosa Gini, head of the Pharmacoepidemiology Unit of ARS Toscana, Italy, co-lead of ConcepTION’s work package 7, and one of the authors of the opinion review.

By Anna Holm Bodin

Swertz M, Enckevort E van, Oliveira JL, Fortier I, Bergeron J, Thurin NH, et al. Towards an Interoperable Ecosystem of Research Cohort and Real-world Data Catalogues Enabling Multi-center Studies. Yearb Med Inform. 2022 Aug;31(1):262–72.