Comparative Risk of Oral Complications Associated with Medications for Opioid Use Disorder: A Mixed-Methods Approach

项目摘要/摘要 抗击阿片类药物流行是联邦政府的优先事项。而阿片类药物的使用 障碍(Moud)显著降低死亡率，由于以下原因，治疗接受率仍然较低 多重障碍，包括社会耻辱以及患者和提供者的安全 担忧。2022年1月，美国食品和药物管理局(FDA)发布了一份 药物安全沟通警告：经粘膜丁丙诺啡用于阿片类药物 紊乱(OUD)和疼痛可能与牙齿问题有关。此通信 是基于病例报告和不良事件报告。在缺乏严谨的 证据，几个成瘾药物组织联合写信给FDA 由于压倒性的好处，建议撤回通信 丁丙诺啡和“有缺陷的因果关系分析”。因此，FDA 如果没有严格的数据，通信可能会成为Moud启动的障碍 展示了Moud对口腔并发症的因果作用。对牙科的评价 Moud的安全性迫切需要为临床实践提供信息并支持或驳斥 关于病例系列的发现、不良事件报告和人们的经历 患有阿片使用障碍(PWOUD)。对穆德的影响缺乏了解 关于口腔并发症的信息是一个关键的信息缺口，因为患者和提供者需要 严格的证据，以作出知情的治疗选择，并采取措施降低风险 牙齿健康状况不佳。我们将使用国家数据库进行观察性研究， 包括超过120,000个Medicaid的相关牙科和医疗索赔数据-或 商业保险的Moud的新用户来治疗Moud。接下来，我们将使用定性的 方法从口腔科疾病对口腔健康影响的角度进行调查。 FDA的沟通，以及获得口腔保健的障碍。最后，我们将 使用以人为中心的设计活动开发教育辅助工具，以告知 讨论与口腔和口腔并发症相关的风险和好处。 这项大型研究将产生证据，以解决有关 Moud对不良口腔健康结局的影响和以人为本的杠杆作用 设计为患者创建一种教育辅助工具。我们的结果将使PWOUD能够 寻求有效的牙科治疗，并围绕以下方面促进高质量的风险-收益讨论 这消除了接受他们救命治疗的障碍。

Project Summary/Abstract Combating the opioid epidemic is a federal priority. While medications for opioid use disorder (MOUD) substantially reduce mortality, treatment uptake remains low due to multiple barriers, including societal stigma as well as patient and provider safety concerns. In January 2022, the US Food and Drug Administration (FDA) released a Drug Safety Communication warning that transmucosal buprenorphine for opioid use disorder (OUD) and pain may be associated with dental problems. This Communication was based on case reports and adverse events reporting. In the absence of rigorous evidence, several addiction medicine organizations jointly wrote to the FDA recommending retraction of the Communication due to overwhelming benefit of buprenorphine and “flawed analysis regarding causation.” As a result, the FDA Communication may contribute to barriers for MOUD initiation without rigorous data that demonstrates a causal effect of MOUD on oral complications. Evaluation of the dental safety of MOUD is urgently needed to inform clinical practice and support or refute concerning findings from case series, adverse event reports, and experience of people with opioid use disorder (PWOUD). The lack of understanding of the effects of MOUD on oral complications is a critical information gap, as patients and providers need rigorous evidence to make informed treatment choices and take steps to mitigate risk of poor dental health. We will conduct an observational study using national databases, including linked dental and medical claims data for more than 120,000 Medicaid- or commercially-insured new users of MOUD to treat OUD. Next, we will use qualitative methods to examine the perspectives of PWOUD on the oral health impact of MOUD, the FDA Communication, and barriers to obtaining oral health care. Lastly, we will develop an educational aid using human-centered design activities to inform discussions of the risks and benefits associated with MOUD and oral complications. This large study will generate evidence to address critical gaps in knowledge about the impact of MOUD on adverse oral health outcomes and leverage human-centered design to create an educational aid for patients. Our results will empower PWOUD to seek effective dental treatment and foster high-quality, risk-benefit discussions around MOUD that removes barriers to receiving their life-saving treatment.