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

项目摘要 阿片类药物过量在美国已达到流行病的程度。我们的研究团队，沿着 其他团体，已经确定了阿片类药物过量风险的关键人群，包括艾滋病毒感染者， 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， 服药过量传统上由医务人员使用，纳洛酮用于带回家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以降低过量的风险 服用阿片类药物止痛的患者死亡。我们的研究将检查扩大的安全性和影响， 在两个大型和多样化的卫生系统中为处方阿片类药物的患者提供纳洛酮。这些健康 系统药房为许多主要的过量风险群体提供服务。而纳洛酮通过卫生系统提供 药房有可能防止过量死亡，我们的发展研究已经确定了关键的障碍， 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 患者可能无法获得足够的知识来有效地使用药物和教育 潜在的旁观者此外，提供者还担心与下列因素相关的不良健康结果： 合并症患者中纳洛酮的使用。拟议的研究将解决这些关键证据 差距。我们将进行一项随机分组的实用性试验，将纳洛酮与阿片类药物共同分配， 科罗拉多通过了新的议事规则。本试验将在综合安全网中进行 社区卫生中心和医院网络以及大型管理式医疗机构。我们的成果 将包括阿片类药物风险行为，过量和纳洛酮知识，以及过量率。随后将 通过定性调查过量和纳洛酮使用的人分发纳洛酮，以阐明 知识差距、流程失败和意外的不良后果。最后，我们将进行一个后- 纳洛酮的实施安全性评估，以检查使用新的 自控分析技术。总之，这些目标将提供一个全面的评估 纳洛酮扩大使用对HIV和其他初级保健中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.