CERSI Collaborators: Christine Ladd-Acosta, PhD; Irina Burd, MD, PhD; Heather Volk, PhD, MPH; Susan Hutfless, PhD, SM; Xiaobin Wang, ScD; Daniele Fallin, PhD.

FDA Collaborators: Tamara Johnson, MD, MS; Kira Leishear, PhD, MS; Qi Liu, PhD; Bridget Nugent, PhD

Project Start Date: June 1, 2020

Regulatory Science Challenge

Many people need to take drugs to treat medical conditions during pregnancy and lactation. Most drug dosing schedules (the amount, frequency, and duration of drug use) are determined using data from individuals who are not pregnant or lactating. During pregnancy, the body undergoes dramatic biologic changes which can impact how drugs are absorbed, distributed, metabolized and excreted. Due to these biologic changes, drug dosing schedules may need to be adjusted for pregnant and lactating people to achieve the same level of safety and efficacy as in non-pregnant individuals. In order to maintain optimal drug dosing schedules for pregnant and lactating people, it is important to understand and monitor what drugs are commonly used during pregnancy and lactation, in which combinations, and during which trimesters of pregnancy. Having a better understanding of this information will help scientists prioritize which drugs to study and, in which combinations, to best address the complex health care needs of this subgroup of people. In addition, it is important to understand whether use of drugs, while pregnant or lactating, has changed over time and whether any changes correlate with major shifts in public health initiatives, public health challenges, or regulatory changes.

Project Description and Goals

The goal of this project is to describe what drugs pregnant and lactating people commonly use in the United States and whether their use has changed over time. The results will inform work to optimize dosing schedules during pregnancy and lactation by helping researchers prioritize which drugs to study and in which combinations. In addition, the results may provide knowledge about whether changes in use patterns are correlated with any major regulatory or policy changes in public health. To achieve this goal, we will determine: (1) how many and what type of drugs pregnant and lactating people use to treat medical conditions, (2) what types of drugs are often used at the same time, (3) whether drug use differs in pregnant and lactating people based on certain characteristics such as their age, race, or weight, and (4) patterns of drug use over time and their potential correlation with major public health initiatives or challenges and regulatory changes. We will use existing data collected over the past twenty years, from a variety of U.S. population-based sources, to answer these questions.