On 25 January, we invited women, their partners, health care professionals, researchers and representatives from companies that develop medicines and authorities that approve them to join a workshop. The topic of discussion was improving how we collect information to understand the risks and benefits of medicine use in pregnancy and breastfeeding.
With over 500 registrants from 49 countries, we were happy to see nearly 400 of them join throughout the workshop. This offered a unique opportunity to introduce the ConcePTION project and gain feedback from a large group of stakeholders. The workshop concentrated on the aims and outputs of work package 2 of ConcePTION and their work to improve the collection, analysis and interpretation of pregnancy pharmacovigilance data. David Lewis, EU & UK QPPV (Qualified Person for Pharmacovigilance) Head at the QPPV Office of Novartis welcomed participants and introduced participants to the ConcePTION project. Stakeholders were parents, regulators, health care professionals and researchers, while just over half of those who joined work in companies that develop medicines.
Pregnancy pharmacovigilance is important to allow women and health professionals to weigh up the risks and benefits of taking a medicine during pregnancy, taking into account their personal health. Laura Yates, Consultant Clinical Geneticist and former Head of the UK Teratology Information Service, described the current situation for pregnancy pharmacovigilance, whereby medicine exposures data are collected by a variety of systems. These systems use different methods of data collection and analysis methodologies. This makes it difficult to compare safety results from different sources. She explained that ConcePTION aims to improve the current situation by optimising and standardising the way we collect and analyse pregnancy medicine exposure data. ConcePTION is therefore building an ecosystem that allows us to make the best use of the data that’s available and provide recommendations to optimise future data collections.
During the meeting, stakeholders reported that they experienced uncertainties about which pregnancy information sources they can trust. Eugène van Puijenbroek, Head of Science and Research at the Netherlands Pharmacovigilance Centre, Lareb, presented how the ConcePTION project is developing methods and tools, one of which is the PregDoc tool, to assist with assessing the quality of data reports as they are received. The ConcePTION project is also developing a knowledge bank that will provide written summaries of the evidence for individual medicines and which will explain the quality of pregnancy safety data in a way that both clinicians and women can understand.
A current challenge is knowing where pregnancy safety data might be available. To make current data sources more ‘findable’, a ConcePTION data source catalogue is being developed. Amalia Alexe, Policy and Liaison Lead at Novartis, shared the results of the work so far. During her presentation of the tool, 90 % of meeting participants stated that having this tool to search primary sources of data about medicines taken during pregnancy publicly available to search would be useful to them personally.
However, interpreting data from different sources is difficult when data are not well defined and have different meanings between sources. Guillaume Favre, Obstetrics and Gynaecology resident and PhD candidate, Materno-fetal and Obstetrics Research Unit at Lausanne University Hospital introduced the concept of ‘core data elements’- a set of clearly defined data items which should be collected in every report about exposure to a medicine during pregnancy. This approach will be tested in a demonstration study that will apply these core data elements to Real World Data (information collected from women with Multiple Sclerosis who needed medications during their pregnancies
Most systems used for monitoring medicine safety during pregnancy are focused on problems that occur during the pregnancy or soon after birth, like structural birth defects in the baby, miscarriage and preterm birth. In her presentation, Rebecca Bromley, Clinical Psychologist in Neuropsychology at the University of Manchester, explained the importance of enabling long-term follow-up of children to determine potential effects of exposure in the womb to medicines on a child’s health and neurodevelopment beyond the first few months of their life. The LifeTIME study extends existing data collections and asks parents to complete a series of validated questionnaires about their child’s development. This represents a cost-effective surveillance system that will help to flag medications that may affect development as early as possible so that more detailed assessments can be carried out. Stakeholders expressed strong support for the study and more routine consideration of neurodevelopmental outcomes.
Before we can attribute a malformation to drug exposure during pregnancy (gestational drug exposure), it is important to rule out genetic causes and examine the interplay between genetics and medications. Laura Yates shared how ConcePTION is joining forces with the Decipher consortium, to utilise and adapt their existing platform for rare diseases to include information about exposure to medicines during pregnancy. The platform will also allow for an establishment of global collaboration between clinicians to better identify and understand developmental and birth defect syndromes caused by medications, and to create an important source of information for the future, where personalised medicine will become increasingly important.
Increasing the volume and quality of information available about medicine use in pregnancy and breastfeeding is important. Parents and health care professionals can all contribute to the data. ConcePTION is developing an app that will collect information from parents and health care professionals while providing them with evidence-based information. The app is based on an existing pharmacovigilance app which was co-developed by the UK Medicine and Healthcare products Regulatory Agency, academic partners and industry, and later adopted by the Uppsala Monitoring Centre of the World Health Organisation for use in multiple countries around the world The first version of the ConcePTION app will be launched in the UK, in English, sometime during the spring of 2022 before expanding to other countries, in other languages.
The ConcePTION project extends its thanks to all speakers and participants for providing valuable input, to Dipak Kalra for chairing the workshop, and to Maximiliane Rauch and Anna Holm for facilitating.