The Safety and Impact of Expanded Access to Naloxone in Health Systems

项目总结 阿片类药物过量在美国已经达到流行的程度。我们的研究团队，以及 其他群体，已经确定了阿片类药物过量的关键人群，包括艾滋病毒携带者，物质 使用障碍和精神健康状况。纳洛酮是一种有效的阿片类解毒剂，可逆转阿片类药物 服药过量。传统上由医务人员使用的纳洛酮，作为带回家的使用正在获得更广泛的接受 防止吸毒者死亡。然而，带回家的纳洛酮也可能降低过量服药的风险。 患者中的死亡患者开了阿片类止痛药。我们的研究将检查扩展的安全性和影响 在两个大型和多样化的卫生系统中，患者获得纳洛酮处方的阿片类药物。这些健康 系统药店为许多关键的过量用药风险群体提供服务。纳洛酮通过医疗系统给药 药房可能会防止过量死亡，我们的发展研究已经确定了关键障碍 广泛采用这种做法。其中包括医疗提供者担心纳洛酮会增加风险。 患者可能得不到足够的知识来有效地使用药物并进行教育 潜在的旁观者。此外，提供者还担心与以下方面有关的不良健康后果 纳洛酮在合并疾病患者中的应用。拟议的研究将解决这些关键证据 差距。我们将在以下情况下进行纳洛酮与阿片类药物联合分配的随机分组务实试验 科罗拉多州通过了新的会议常规立法。这项试验将在一个综合安全网中进行 社区卫生中心和医院的网络以及大型管理型医疗组织。我们的结果 将包括阿片类药物危险行为、过量服药和纳洛酮知识以及过量服药率。这将是遵循的 通过对纳洛酮配药者服药过量和纳洛酮使用情况的定性调查，阐明纳洛酮配伍情况。 知识差距、流程失败和意想不到的不良后果。最后，我们将进行一次后- 纳洛酮的实施安全性评估，以检查不良健康后果的风险 自我控制的分析技术。综合起来，这些目标将对 扩大使用纳洛酮对艾滋病毒和其他初级保健中处方阿片类药物患者的影响和安全性 设置。

PROJECT SUMMARY Opioid overdoses have reached epidemic proportions in the United States. Our research team, along with other groups, has identified key populations at risk for opioid overdose, including people with HIV, substance use disorders, and mental health conditions. Naloxone is an effective opioid antidote which reverses opioid overdose. Traditionally used by medical personnel, naloxone for take-home use is gaining wider acceptance to prevent death among people who use drugs. Yet, take-home naloxone may also reduce the risk of overdose death among patients prescribed opioids for pain. Our study will examine the safety and impact of expanded access to naloxone for patients prescribed opioids in two large and diverse health systems. These health system pharmacies serve many key risk groups for overdose. While naloxone delivered through health system pharmacies is likely to prevent overdose fatalities, our developmental research has identified critical barriers to wide scale adoption of this practice. These include medical provider concerns that naloxone will increase risk behavior and that patients may not acquire adequate knowledge to effectively use the medication and educate potential bystanders. In addition, providers had concerns about adverse health outcomes associated with naloxone use among patients with co-morbidities. The proposed research will address these key evidence gaps. We will conduct a clustered randomized pragmatic trial of co-dispensing naloxone with opioids under new standing order legislation passed in Colorado. This trial will be conducted in an integrated safety net network of community health centers and hospital and in a large managed care organization. Our outcomes will include opioid risk behavior, overdose and naloxone knowledge, and overdose rates. This will be followed by a qualitative investigation into overdose and naloxone use among people dispensed naloxone to elucidate knowledge gaps, process failures, and unanticipated adverse outcomes. Finally, we will conduct a post- implementation safety assessment of naloxone to examine the risk of adverse health outcomes using novel self-controlled analytic techniques. Together, these aims will provide a comprehensive assessment of the impact and safety of expanded access naloxone for patients prescribed opioids in HIV and other primary care settings.