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用药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%的孕妇服用处方阿片类药物 在怀孕期间，1，2个国家颁布了两项一般阿片类药物政策(例如，获得阿片类药物的使用 精神障碍(Moud))和特定于怀孕期间使用药物的政策，但这些政策对 孕妇使用阿片类药物和新生儿结局的定义仍然不明确。国家对产前的政策反应 阿片类药物的使用差异很大，导致孕妇使用阿片类药物的方法不一致。在这个混杂的- 方法项目，我们将应用收敛的并行设计来检查单独和组合的影响和 国家阿片类药物政策对使用医疗补助和商业广告的孕妇及其新生儿的影响 保险数据库(MarketScan)。我们的目标是：1.检验一般状态和产前状态的不同影响 针对孕妇/产后妇女和新生儿的阿片类药物政策。我们将：1)系统地绘制所有50个州的地图 产前阿片类药物政策(2011-2020)，对政策差异进行分类，并建立可公开获得的时变数据 数据集；1b)使用这一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人-- 一般和产前阿片类药物政策对阿片类药物使用障碍(OUD)、Moud通路和新生儿的水平影响 孕妇及其新生儿的阿片类药物戒断综合征(NOWS)；以及1c)效果修正试验 按产妇种族/族裔和年龄分列。2.研究全身阿片类药物和产前状态阿片类药物的联合作用 关于孕妇/产后妇女及其新生儿的政策(2011-2020年)。超越…的影响 在孤立的单个策略中，我们将：2A)使用改进的Delphi方法创建随时间变化的分类 每个州的总体阿片类药物政策氛围与孕妇有关，从惩罚到健康- 基于各国产前和一般阿片类药物政策的结合，促进；以及2b)探索个人-- 各州总体政策气候对使用相同药物的孕妇/产后妇女和新生儿的水平影响 以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 孕妇和她们的新生儿。我们将：3A)实施综合框架 研究(CFIR)对各州60个主要利益攸关方的采访，这些州因其总体政策环境而有所不同 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中的差异如何影响 孕产妇和新生儿健康；以及3b)建立40名使用阿片类药物的孕妇的人种学队列 在具有四种不同产前政策气候(惩罚性、亲社会性、混合性、不作为)的州之间进行三次 与每个人的面谈都超过一年。我们将探索产前阿片类药物政策实施的差异如何影响 妇女如何适应产前和产后护理、母婴使用和国家服务。调查结果将有具体的、真实的- 通过描述国家阿片类药物政策对怀孕/产后妇女的影响及其对世界的影响 通过确定可促进母婴福祉的干预点和政策变化，为新生婴儿的健康作出贡献。

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.