State-level opioid policies and policies that regulate substance use duringpregnancy: a mixed methods exploration of their effects on maternal and infantoutcomes

The opioid and overdose crisis in the United States (US) disproportionately affects women of childbearing age (15–44 years), particularly pregnant women and their newborns: 20% of pregnant women are prescribed opioids during pregnancy.1,2 States have enacted both general opioid policies (e.g., access to medication for opioid use disorder (MOUD)) and policies specific to substance use during pregnancy, but the effects of these policies on pregnant women’s opioid use and newborn outcomes remain poorly defined. States’ policy responses to prenatal opioid use vary widely, resulting in inconsistent approaches to pregnant women’s opioid use. In this mixed- methods project, we will apply a convergent parallel design to examine the separate and combined impacts and consequences of state opioid policies on pregnant women and their newborns using Medicaid and commercial insurance databases (MarketScan). We aim to: 1. Examine the separate effects of general and prenatal state opioid policies on pregnant/postpartum women and newborns. We will: 1a) systematically map all 50 states’ prenatal opioid policies (2011–2020) to categorize policy variations and build a publicly available time-varying dataset; 1b) use this prenatal policy dataset and existing data on general opioid policies to explore the individual- level impact of general and prenatal opioid policies on opioid use disorder (OUD), MOUD access, and neonatal opioid withdrawal syndrome (NOWS) for pregnant women and their newborns; and 1c) test for effect modification by maternal race/ethnicity and age. 2. Investigate the combined effects of general and prenatal state opioid policies on pregnant/postpartum women and their newborns (2011-2020). To move beyond the impact of single policies in isolation, we will: 2a) use a modified Delphi approach to create a time-varying taxonomy of each state’s overall opioid policy climate relevant to pregnant women, ranging from penalizing to health- promoting, based on states’ combination of prenatal and general opioid policies; and 2b) explore the individual- level impact of states’ overall policy climates on pregnant/postpartum women and newborns using the same outcomes and effect modification as Aim 1. 3. Explore how prenatal policy implementation affects daily life for pregnant women and their newborns. We will: 3a) apply the Consolidated Framework for Implementation Research (CFIR) to interviews with 60 key stakeholders across states that vary by their overall policy climate to explore multilevel drivers of prenatal opioid policy implementation and how variations in implementation affect maternal and newborn health; and 3b) create an ethnographic cohort of 40 pregnant women who use opioids across states with four different prenatal policy climates (punitive, prosocial, mixed, inaction) and conduct three interviews with each over one year. We will explore how variations in prenatal opioid policy implementation affect how women navigate pre- and postnatal care, MOUD use, and state services. Findings will have concrete real- world impacts by describing the effects of state opioid policies on pregnant/postpartum women and their newborns and by identifying intervention points and policy changes that promote maternal and infant wellbeing.