A survey intends to get a clear picture of women’s experiences of medicating while pregnant or breast-feeding
Video: Caroline Swain was five weeks pregnant when she was diagnosed with breast cancer. Her health providers didn't initially know what treatments she could take. © The Pregnancy and Medicines Initiative
Evidence suggests that up to 95% of the five million women who get pregnant in the EU every year will reach for a prescription drug at some point. And yet, only about 5% of the medication they take comes with pregnancy and breast-feeding-related safety information. That’s because there’s a lack of data: pregnant and breast-feeding women are excluded, for obvious reasons, from the early phase clinical trials that take place before marketing the drugs.
The ConcePTION project
With no single reliable source of information, expectant and nursing mothers and their doctors end up making decisions on their own. What data does exist is not presented in any kind of consistent way. Worse still, it can contradict information from other sources. The IMI project ConcePTION wants to fill the data gap. They will establish new and better ways to collect digital data and samples; create a Europe-wide breast milk biobank for research; develop tools to predict transferability of
drugs medicines into breastmilk; and build a web-based drug info bank, presented in a way that women have a reliable single source and don’t need a medical degree to understand.
The problem seems to be growing, thanks to the rise of women with chronic conditions getting pregnant. This is perhaps due to women waiting longer to have kids. Some statistics from Denmark throw this into sharp relief: figures suggest as many as 20% of pregnant women have comorbid conditions, a jump from just 5% in 1990. This can be a huge source of stress for expectant mothers who find themselves in need of medication during the 40 or so weeks of gestation, and if breastfeeding, beyond.
Where will the data come from?
The idea of the project is to go beyond traditional clinical research, whereby volunteers sign up to be monitored for a specified period. Rather, the data collected during routine care will be used. The (anonymised) data will come from sources such as prescription data, primary care data, maternity data, hospital discharge data, medical birth registries etc. as well as disease registries and birth cohorts collected for research and surveillance.
You can help by sharing your experience
The first step is to get as much information as possible about how these women are currently making choices about medication. In September, ConcePTION launched a survey to collect information on their needs and preferences. So if you are a woman with kids, if you’re ever been pregnant, or you think that one day you might be, you can help out by sharing your needs, likes and dislikes regarding medicine safety information.
You can help by filling in the survey before 1 November 2019.