December 18, 2018
Research Specific to Pregnant Women and Lactating Women Task Force Recommendations Finalized
By: Sharon Muza, BS, LCCE, FACCE, CD/BDT(DONA), CLE | 0 Comments
A year ago, I shared with Science & Sensibility readers that a special task force had been created by the National Institutes of Health to solve the problem of a lack of best practice and lots of insufficient information when it comes to treating pregnant people with appropriate and safe medications. "What Medications are Safe for Pregnant and Nursing People?" introduced the PRGLAC (Research Specific to Pregnant Women and Lactating Women) task force to readers. The task force was charged with improving the development of safe and effective therapies for pregnant and nursing people, as well as guidance on how to best collaborate and coordinate these activities at the federal level. Pregnant and lactating people (and their health care providers) should be able to access information about the safety and efficacy of medications as it pertains to their situation in gestating or breast/chestfeeding a child.
Longtime childbirth educator, Susan Givens, RNC-OB, MPH, LCCE, served on this task force to help them reach their goals of better information for pregnant and nursing parents as well as the healthcare providers who serve them. The final report was issued in September and has been forward to Congress and the Secretary of Health and Human Services for approval. You can access the report: Task Force on Research Specific to Pregnant Women and Lactating Women on the government website.
NPR just recently covered this topic "Research Gaps Leave Doctors Guessing About Treatments For Pregnant Women" that you can read or listen to learn more about the issues and the task force's final report.
The 388-page report included 15 recommendations from the Task Force that include:
- Include and integrate pregnant women and lactating women in the clinical research agenda.
- Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women.
- Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics.
- Remove regulatory barriers to research in pregnant women.
- Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women.
- Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women.
- Develop separate programs to study therapeutic products used off-patent in pregnant women and lactating women using the National Institute of Health (NIH) Best Pharmaceuticals for Children Act (BPCA) as a model.
- Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women.
- Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research.
- Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women.
- Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women.
- Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women.
- Optimize registries for pregnancy and lactation.
- The Department of Health and Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019.
- Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research.
It is imperative that clinicians and the families they serve have access to current, solid research results of the best medications available to pregnant and lactating people. Treatment for common diseases such as gestational hypertension, for example, should not include providers taking best guesses on what medications might work and what might be safe for the parent and the fetus/baby. These recommendations encourage the inclusion of this unique population when exploring treatment options so that proper treatments can be initiated.
On behalf of myself and Lamaze International, I want to thank Susan Givens for volunteering her time and expertise to serving on this Task Force, compiling this report and working for improving outcomes for pregnant and lactating people.
TagsPregnancy Research Maternal Infant Care PRGLAC Susan Givens Sharon Muza Breast/Chestfeeding Medications