Researchers at SAIL helping to improve medicine safety in early motherhood

Researchers from SAIL and Swansea University are playing a key role in multi-million pound international project to improve the safety of medicines given to mums-to-be and breastfeeding mothers.

They have teamed up with colleagues from across Europe to produce their first publication as part of the IMI ConcePTION project.

This £28 million Europe-wide project is funded by the Innovative Medicines Initiative (IMI); a joint undertaking, which receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA (the European Federation of Pharmaceutical Industries and Associations).

IMI seeks to bridge the knowledge and data gap in the safety of medicines prescribed during pregnancy and breastfeeding. It aims to do this by creating a trusted information ecosystem using anonymised data from multi-national data sources.

In Wales, the ConcePTION team is led by Professor Sue Jordan from the Faculty of Medicine, Health and Life Science, and employs the expertise of SAIL Databank’s Analytical Services Team operating in partnership with Public Health Wales. The results of this latest study help bring together data from 21 European sources by creating a common data model.

Professor Jordan said: “Many women are concerned about the safety of medicines taken during pregnancy and while breastfeeding, and information is not always available.

“Databanks across Europe are working together to address this problem by exploring the benefits and harms to both women and children when medicines are prescribed during these critical periods.

“Our group is very pleased to contribute to the influential ENCePP guide on research methods. Our SAIL work on congenital anomalies is cited as an illustration of comprehensive identification of adverse drug reactions and other factors affecting adverse perinatal outcomes.”

The group’s findings have just been published by online journal Clinical Pharmacology & Therapeutics

Based within Population Data Science at Swansea University Medical School, the SAIL Databank team has helped develop common scripts needed to support the data analytics function. These are lines of computer code that enable the capture of routine health data stored in structured tables in databanks across Europe.

This data can then be securely accessed within each respective data repository by approved researchers and data scientists for linkage and analysis.

The findings provide information to improve medication safety for families and better inform healthcare practitioners. Results of each analysis are then pooled by ConcePTION at its Dutch HQ at University Medical Centre (UMC) Utrecht, allowing for a much larger pan-European examination.

This collaborative, federated, approach means that no ‘raw’ data is compromised and remains well-protected by each repository’s governance and data access protocols.

SAIL Databank operates as the Trusted Research Environment for Wales and is one of the best-characterised population data resources found anywhere in the world. Amongst its wealth of data assets, and those that support ConcePTION research, are its GP, hospital, births and deaths, maternity and child health datasets.

In addition, and crucial to enabling ConcePTION analyses, is the Congenital Anomaly Register and Information Service (CARIS) dataset, hosted by SAIL but gathered and supplied by Public Health Wales.

CARIS manager David Tucker said: “This has been an exciting project. It uses the routine data collected by CARIS to its full potential. This research is answering long-asked questions about children’s survival, quality of life and educational achievements. These are questions which every parent asks and now we are beginning to provide some answers.”

The SAIL Analytical Team has also made ground-breaking links between CARIS, GP prescribing and education data.

SAIL Senior Data Scientist, Dan Thayer, added: “SAIL’s uniquely rich data resources, as well as our team’s interest in developing technology to support research collaboration, make this project an ideal fit for us. ConcePTION should be an important step forward in filling critical evidence gaps around medication safety in pregnancy.”

It is now hoped the ConcePTION project will inform the development of new evidence through collaboration between industry and university partners in the Innovative Medicines Initiative.

Working alongside Professor Jordan, Dan Tucker and Dan Thayer in the Wales team are Gareth Davies, Ieuan Scanlon, Anna Rawlings, Carys Jones and Huda Abd.

The IMI Grant Agreement number is 821520.

The project follows on from EuroMediCat which explored the increased risks of congenital anomalies associated with antidepressants and anti-asthma medication. This saw Professor Jordan and the SAIL team identify reduced breastfeeding rates when antidepressants are prescribed in pregnancy.