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

项目总结/摘要 打击阿片类药物流行是联邦的优先事项。虽然阿片类药物的使用 疾病（MOUD）大大降低了死亡率，治疗吸收仍然很低， 多重障碍，包括社会耻辱以及患者和提供者的安全 性问题2022年1月，美国食品和药物管理局（FDA）发布了一份 药物安全性通信警告，经粘膜丁丙诺啡用于阿片类药物 OUD和疼痛可能与牙齿问题有关。该通信 基于病例报告和不良事件报告。在缺乏严格的 几个成瘾医学组织联合写信给FDA， 建议撤回来文，因为 丁丙诺啡和“关于因果关系的错误分析”。因此，FDA 如果没有严格的数据，沟通可能会导致MOUD启动的障碍， 表明MOUD对口腔并发症的因果关系。牙科评估 迫切需要MOUD的安全性来告知临床实践，并支持或反驳 关于病例系列、不良事件报告和患者经验的结果 阿片类药物使用障碍（PWOUD）对MOUD的影响缺乏了解 口腔并发症是一个关键的信息差距，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，以减轻风险 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份医疗补助的相关牙科和医疗索赔数据-或 商业保险的MOUD新用户治疗OUD。接下来，我们将使用定性 方法来检查PWOUD对MOUD口腔健康影响的观点， FDA通信，以及获得口腔保健的障碍。最后，我们将 使用以人为本的设计活动开发教育辅助工具， 与MOUD和口腔并发症相关的风险和益处的讨论。 这项大型研究将提供证据，以解决有关 MOUD对不良口腔健康结果影响和以人为本的杠杆作用 为患者提供教育帮助。我们的研究结果将使PWOUD能够 寻求有效的牙科治疗，并促进高质量的，风险效益的讨论， MOUD消除了接受挽救生命治疗的障碍。

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.