Lode Dewulf has studied and practiced medicine and worked in the pharmaceutical industry for more than 25 years. Outspoken on the rights of pregnant women to receive information and treatment, Dr. Dewulf took part in the recent European Gender Medicine Network (EUGenMed) Sex and Gender conference at the at the European Economic and Social Commission, giving a talk entitled “Safe Use of Medicines during Pregnancy and Lactation.” Here, he guides us through his key concerns.
Even within the medical community, often, pregnancy and medication is still not on the radar. It is vital that this changes. Every year, around five million babies are born in the EU and up to 90% of these children will have been exposed to medication before their birth. We need to know what medicines women are taking, how this differs according to country, and what the picture is across the EU.
Because a growing number of women have babies later in life, the prevalence of chronic disease during pregnancy is increasing. Every year in Europe, around 1.5 million women with depression, diabetes or hypertension become pregnant. Heart disease should also be a priority as it is the leading cause of death during pregnancy. Pregnant women with a pre-existing heart condition are 100 times more likely to die during pregnancy.
Despite this, pregnant women in Europe are often not receiving the data they need to make informed decisions. Research shows that only 40% of pregnant women are given consistent information on medication from their different health care providers.
So what needs to be done?
My first recommendation is that we change the language around the use of medication during pregnancy. Safety for both the mother and baby should be a goal but not an excuse for inaction.
We accept that there is some risk when we go out onto the street, but our lives would not function if we didn’t leave the house and children would not get to school. Therefore, we make things as safe as possible by creating traffic rules, installing clear signage, setting out safety zones, educating children and drivers, and fostering a culture of respect and helpfulness.
The same must happen with medicine use in pregnancy. We need general rules, clear information, education of both women and health care providers, safe centers, and again, a culture of respect and willingness to help.
Change needs to come from politicians and regulators. At present, the Internet is the prime information source about medication and pregnancy and many good sites exist, but they’re often hard to find. An EU-wide dedicated site or quality label for medical information would help direct women and physicians to the right information.
I recommend that we also improve the sources of new information and increase access to the information that already exists. In general, we need to also know about the successful pregnancies, not only those in which adverse reactions take place. If women become pregnant while taking part in a medical trial, they should be allowed to remain in the study.
We can learn a lot more via the Internet. Thousands of pregnant women are entering information about their pregnancies into mobile apps and we’re not tapping into this data. We should be partnering with providers and offering a simple informed consent and opt-out approach for app users.
Last but not least, we need better protection for the providers and prescribers of medication. When healthcare providers prescribe a medication to a pregnant woman, which is often off-label, they create a legal record. This “off-label act” means prescribers can be held liable if something goes wrong, making doctors and pharmacists reluctant to report when they give medications to pregnant women. A better legal framework could change this.
Much remains to be done if we want to ensure women and doctors have the right information around pregnancy and medication. Introducing a quality label for information and creating a standard for reporting pregnancy and medication use should be the next steps.