There can be no doubt that the current lack of evidence-based decision making concerning medication use and pregnancy is a major problem in public health
Lode Dewulf MD
VP, Chief Patient Affairs Officer,
UCB, Brussels, Belgium
Women all across Europe continue to have fewer children and to have them later in life. And yet, when they do get pregnant, they find themselves being routinely left without medical care options that include or may require a medication. The main reason is that most medicines are indeed contraindicated for use in pregnancy, usually because of insufficient data. This fact is in sharp contrast with another fact: most (>90%)(1) women do take medicines (on average three to four) during their pregnancy.
There are two fundamental reasons why pregnant women take medicines: the pregnant get sick (from pregnancy- or life-related medical hazards) and the sick increasingly get pregnant. Today, already one in four women enters pregnancy while living with a chronic condition, and this number will only go up in the years to come. Advancing age at conception, already around 30 years for the first pregnancy in many European countries, is perhaps the main explanation for this continued increase because the likelihood of developing a chronic condition generally increases with age. Data from 2012 in the US found that 30% of women received the diagnosis of either diabetes (9%), hypertension (>8%) or depression (13%), and this number accounts only for these three chronic conditions.(2)
Another important driver of the increasing frequency of chronic patients entering pregnancy is the better disease control achieved in certain chronic conditions (for example, Crohn’s disease, lupus) which now allows many of these patients to feel well enough to start relationships and a family. Finally, the increased survival of childhood diseases that used to have an almost universally fatal outcome (for example, blood and bone cancers; various metabolic diseases such as diabetes type 1; cystic fibrosis) further adds to the increasing frequency.
Faced with contraindications in the product labels, and often also lacking evidence-based literature and professional guidelines, individual clinicians will often base their therapeutic approach on the avoidance of any medical and liability risks. The resulting issue for the women concerned, however, is that they find themselves unsupported while having to make important decisions that may impact their own health as well as that of their baby. The significant inconsistency in medical practice within and between medical specialties, driven by the high variability in medical and liability concerns, further increases their fears. And these fears are not compensated by the richness of the readily accessible information on the internet because that often contains conflicting and alarming information as well.
This important and growing public health issue has been present for decades, partly because it is spread across all area of medicine. It is now time to address it, and hospital can make a very important contribution to the much-needed improvement in the care for the pregnant.
A unique information platform for the public and for patients
Many women will go to the hospital during their pregnancy, if only for a routine pregnancy monitoring visit. Those who are already living with a chronic disease will often have regular visits to their treating specialist, also in the time before pregnancy. These multiple contact points with pregnant women and with women of childbearing age living with a chronic condition offer unique opportunities for increasing awareness. This is especially relevant for adolescents, who may have no other contact points in the healthcare system. The impact of health education on the topic of medication and pregnancy can be further increased by also targeting families and friends who visit or come along with hospital patients. This puts hospitals in a unique position to spread, via brochures or other means, some general health education messages (see Table 1) which are of particular relevance in countries with high rates of unplanned or teenage pregnancies.
Table 1. General awareness messages about medicines and pregnancy
- If you are or could be pregnant, talk to your doctor before taking a medicine
- Planning your pregnancy is the best thing you can do for your own health and that of your baby
- Having a chronic disease generally does not prevent you from having a successful pregnancy
- If you are living with a chronic disease, then pre-conception disease control is the best way to have a successful pregnancy, so talk early to your specialist
- Make sure that your disease specialist, your gynaecologist, your primary care doctor and you communicate and collaborate
- If you are not comfortable with the advice or support from your doctor, seek a second opinion
- Always seek to understand both benefits and risks before making a decision
Hospitals can create integrated care for the pregnant
The current care for the pregnant woman who is living with a chronic disease is often very fragmented. She needs to make separate visits to her disease specialist and to the physician following her pregnancy. Recent research shows that these different physicians do not communicate well, and even less consult or align before making recommendation regarding the use of medication during pregnancy.(3)
In recent years, very successful integrated clinics have been developed around specific patient issues that demand input from multiple specialties to achieve the best possible health outcomes. Perhaps the best example is diabetes clinics where endocrinologists, dieticians, physiotherapists, cardiologists, ophthalmologists, psychologists and other specialists provide collaborative and truly patient-centred and integrated care. It is important to underscore the unique role and contribution of nurses in these settings. Other examples include pain clinics and movement clinics. Even though it may not be easy to set up a similarly integrated multi-specialty clinic for the pregnant, isolated initiatives across Europe are already showing that better coordination between specialties can bring about important improvements in the quality of care provided to pregnant women.(4)
Generating more insights and filling current knowledge gaps
One main reason why we still know so little about the pregnancy-related effects of medication is that pregnant women are systematically excluded and dropped-out from clinical studies. This has been the research standard ever since the thalidomide tragedy, now half a century ago. Thus, observations remain the primary source of information and can take the form of single case reports, case-control studies or prospective registries. All of these have limitations, however, of which the common and most important are low patient numbers, a limited observation window, the lack of controls and reporting bias.
Many hospitals have implemented electronic health records years ago, and larger institutions reportedly have thousands of such records in their databases. Many of the patients in these databases will have had a pregnancy, and medical data prior to and following the pregnancy may also have been recorded. This offers a unique opportunity for hospitals, academic and non-academic ones, to engage in informative analyses that overcome the limitations of classical research methods listed above: numbers can be large, the observation window can be wide, controls can be matched and all recorded observations can be included. Connecting data analyses across institutions can yield even more powerful insights and advance our knowledge. Outcome metrics that can be compared across institutions and countries will also provide a strong impetus for best practice sharing and continuous improvement.
There can be no doubt that the current lack of evidence-based decision making concerning medication use and pregnancy is a huge and growing problem in public health. It spans across specialties and geographic borders and ultimately affects us all. It is time for collaborative action, and hospitals are in a unique leadership position to drive the necessary change that will improve outcomes for both the pregnant and their children.
- Centers for Disease Control and Prevention. Safe medication lists on the Internet. www.cdc.gov/media/dpk/2013/dpk-safe-meds.html (accessed 18 February 2014).
- Childbirth Connection. Listening to Mothers III. www.childbirthconnection.org;2013:5.
- Clowse MEB et al. Arthritis Rheum 2013; 65(Suppl 10):5815–6.
- Dewulf L. Medicines and pregnancy – Women and children first? Time for a coalition to address a substantial patient need. Ther Innov Res Sci 2013; 47:528.