This blog post was originally published by the Coalition to Advance Maternal Therapeutics.
Despite there being more than 3.5 million births in the United States each year, pregnant and lactating populations have been underrepresented in research, leading to limited data in the pregnancy section of drugs approved by the U.S. Food and Drug Administration (FDA) and to women, their families, and health care providers often needing to make health care decisions with incomplete data.
However, with support from maternal-metal medicine specialists (MFMs) and resources from federal agencies, independent organizations, and pharmaceutical companies, health care providers can be well-equipped to help support women who are pregnant, planning to become pregnant, or lactating in establishing a medication regimen as well as for future generations of women in their pregnancy journeys.
In April 2024 the Coalition to Advance Maternal Therapeutics (CAMT) hosted the Perinatal Patient Engagement Forum, which convened representatives from medical specialty organizations to discuss and propose recommendations on how physicians, nurses, and other health care providers might engage in conversations and in shared decision-making with women about medication use and reproductive health before and during pregnancy and when lactating.
Approaching conversations about medication regimens can be sensitive, Forum participants stressed, given safety concerns, lack of clear guidance, possible risks, and fear of judgment. Further, while MFMs are vital resources—with an understanding of medications and drug-drug interactions (including how to prevent them), where there is data available versus where there is not, and what the known risks of a given drug are—patients and providers alike may not always have access to an MFM. Therefore, knowing which resources are available and how to best approach these conversations with patients (and what those conversations should entail) could be valuable.
To assist health care providers in this work, the CAMT released “Perinatal Medication Use: Considerations for Health Care Providers,” which outlines steps that providers can take when considering a medication regimen for patients who are planning to become pregnant, pregnant, or lactating. Informed by the Forum, the document includes sections on Perinatal Counseling, which outlines ways to reduce risk to mother and baby throughout a pregnancy and beyond and Perinatal Pharmacology Resources, which shares tools providers can consult when they don’t have access to someone with expertise in maternal-fetal medicine. The document also includes links to federal agencies’ resources on medication use for pregnant and lactating populations, guidance documents, and population-based surveillance and national registries.
In addition to these pieces, there is also a section on Engaging Patients to Improve the Research Base. Beyond assisting women who are planning to become pregnant, pregnant, or lactating, providers also have a role to play in supporting future generations of pregnant and lactating populations by sharing information about ongoing studies that are enrolling these populations. If the culture surrounding the inclusion of these populations in clinical research does not change, patients and health care providers will be forced to continue making health care decisions with limited information. This could lead to either “unsafe use of medical products or refusal or reluctance to prescribe or accept necessary treatment,” as described in a 2022 American Journal of Obstetric Gynecology article.
Efforts like the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) are making efforts to change the culture surrounding the inclusion of pregnant and lactating populations in clinical trials and to build awareness about the importance of pregnancy research. The role of health care providers in bridging the gap between these populations and study enrollment is critical to these efforts.
View the document “Perinatal Medication Use: Considerations for Health Care Providers” here.