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

美国的阿片类药物和过量危机对育龄妇女的影响不成比例 （15-44岁），特别是孕妇及其新生儿：20%的孕妇被处方阿片类药物 1，2各国颁布了一般性阿片类药物政策（例如，获得阿片类药物使用的药物 疾病（MOUD））和具体的政策，在怀孕期间使用物质，但这些政策的影响， 孕妇的阿片类药物使用和新生儿结局仍然定义不清。国家对产前检查的政策反应 阿片类药物使用情况差异很大，导致对孕妇使用阿片类药物的做法不一致。在这个混合- 方法项目，我们将采用一个收敛的平行设计，以检查单独和合并的影响， 国家阿片类药物政策对使用医疗补助和商业药物的孕妇及其新生儿的影响 保险数据库（MarketScan）。我们的目标是：1.检查一般和产前状态的单独影响 关于孕妇/产后妇女和新生儿的阿片类药物政策。我们将：1a）系统地绘制所有50个州的地图， 产前阿片类药物政策（2011-2020年），对政策变化进行分类， 数据集; 1b）使用该产前政策数据集和关于一般阿片类药物政策的现有数据来探索个体- 一般和产前阿片类药物政策对阿片类药物使用障碍（OUD），MOUD访问和新生儿的影响 孕妇及其新生儿的阿片类戒断综合征（NOWS）;和1c）效应改变试验 母亲的种族/民族和年龄。2.研究一般和产前状态阿片类药物的联合作用 孕妇/产后妇女及其新生儿政策（2011-2020年）。为了超越 我们将：2a）使用修改后的德尔菲方法来创建一个随时间变化的分类， 每个州与孕妇相关的总体阿片类药物政策气候，从惩罚到健康， 在国家产前和一般阿片类药物政策相结合的基础上促进; 2b）探讨个人- 国家总体政策气候对孕妇/产后妇女和新生儿使用相同产品的影响 结果和效果修改为目标1。3.探讨产前政策实施如何影响日常生活 对孕妇和新生儿来说都很重要我们将：3a）适用《综合执行框架》 研究（CFIR）采访了各州60个主要利益相关者，这些利益相关者因其整体政策气候而异， 探索产前阿片类药物政策实施的多层次驱动因素，以及实施的变化如何影响 孕产妇和新生儿健康;以及3b）建立一个由40名使用阿片类药物的孕妇组成的人种学队列 在具有四种不同产前政策气候（惩罚性，亲社会，混合，不作为）和行为三 每一次采访都超过一年。我们将探讨产前阿片类药物政策实施的变化如何影响 妇女如何导航产前和产后护理，MOUD使用，和国家服务。调查结果会有具体的真实的- 通过描述国家阿片类药物政策对孕妇/产后妇女及其 新生儿，并确定促进孕产妇和婴儿福祉的干预点和政策变化。

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.