Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial

获得阿片类解毒剂纳洛酮是解决阿片类药物流行病的关键组成部分。纳洛酮是一种 人口一级的预防干预与过量死亡率的大幅降低有关。 此外，新出现的数据表明，联合处方纳洛酮的人在过量的风险，从慢性 阿片类药物治疗可通过避免非致命性过量而在风险范围内更早地减少负面健康结果。 通过药房扩大社区纳洛酮的可及性可能是延长 这种救命药的范围几乎每个社区都有药店， 健康专业人员在咨询病人关于药物安全培训;许多国家还允许药房 在柜台上卖注射器来注射毒品药房在配药和销售方面的关键作用 注射器使他们处于阿片类药物获取和纳洛酮供应等风险缓解方法的十字路口。 测试优化基于药房的纳洛酮（PBN）供应的方法将是关键，因为该国扩大了 通过医疗系统实施纳洛酮。我们建议对一家药店进行一项大规模的实际研究- 重点干预，以增加PBN分配和提高阿片类药物的安全性。干预措施包括 两个成功的示范研究项目（RESPOND，PI：Hartung; MOON Study，PI：绿色，均为R18）， 其中包括在线和一对一的教育推广（即学术细节），以提供 药剂师的知识和培训，以识别和有效地与可能处于高风险的患者接触 因为阿片类药物过量这项研究的总体目标是减少阿片类药物过量死亡的人数， 美国通过更多地获得和使用纳洛酮，更安全地使用阿片类药物。独特的是，这项研究将 利用与两家大型零售连锁药店CVS Pharmacy和Fred Meyer（ 克罗格公司），谁将提供一个“真实世界”的样本，以支持可复制性和外部有效性。具体 目标1：将MOON和RESPOND工具包材料整合到一个有凝聚力的教育计划中 (MOON+），并简化材料，以加强对纳洛酮政策，沟通和 目的2：使用阶梯楔形，随机分组试验设计，评价 MOON+在160家社区药房的应用：a）PBN分发率，纳洛酮相关患者 参与，以及药剂师的态度，知识，感知行为控制和自我效能感， 纳洛酮;和B）药房注射器销售，以及药剂师的态度，知识，感知行为控制 和对阿片类药物使用障碍的丁丙诺啡分配的自我效能（次要结局）。目标3： 采用混合方法，确定促进因素和障碍（例如，州和商店政策、区域 （三）实施和效果。研究结果将创建一个可推广的，以证据为基础的 在40多个州为治疗使用处方或非法阿片类药物患者的药剂师提供培训和工具包 采用或扩大药学纳洛酮。

Access to the opioid antidote naloxone is a critical component of addressing the opioid epidemic. Naloxone is a population-level prevention intervention associated with substantial reductions in overdose mortality. Furthermore, emerging data suggest that co-prescription of naloxone to people at risk of overdose from chronic opioid therapies may reduce negative health outcomes earlier in the risk horizon by avoiding nonfatal overdose. Expanding access to naloxone in the community through the pharmacy can be a critical mechanism for extending this lifesaving medication’s reach. Pharmacies exist in nearly every community and are staffed by knowledgeable health professionals trained in counseling patients about medication safety; many states also permit pharmacies to sell syringes over the counter for drug injection. Pharmacies’ pivotal role in dispensing medications and selling syringes places them at the crossroads of opioid access and risk mitigation methods like naloxone provision. Testing ways to optimize pharmacy based naloxone (PBN) provision will be key as the country expands the implementation of naloxone through the medical system. We propose a large, practical study of a pharmacy- focused intervention to increase PBN dispensing and improve opioid safety. The intervention is comprised of two successful demonstration research projects (RESPOND, PI: Hartung; MOON Study, PI: Green, both R18), which include online and one-on-one educational outreach (i.e. academic detailing) demonstrated to provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high-risk for an opioid overdose. The overarching goal of this study is to reduce the number of opioid overdose deaths in the United States through greater access and use of naloxone, and safer opioid use. Uniquely, the study will draw from partnerships with two large retail pharmacy chains, CVS Pharmacy and Fred Meyer (a division of Kroger Corporation), who will provide a “real-world” sample to support replicability and external validity. Specific aims are to: Aim 1: Integrate the MOON and RESPOND toolkit materials into one cohesive educational program (MOON+), and streamline the materials to enhance the focus on naloxone policy, communication, and administration; Aim 2: Using a stepped wedge, clustered randomized trial design, evaluate the effectiveness of MOON+ in 160 community pharmacies in increasing: a) PBN distribution rates, naloxone-related patient engagement, and pharmacists’ attitudes, knowledge, perceived behavioral control and self-efficacy toward naloxone; and b) pharmacy syringe sales, and pharmacists’ attitudes, knowledge, perceived behavioral control and self-efficacy toward dispensing buprenorphine for opioid use disorder (secondary outcomes). Aim 3: Applying a mixed methods approach, identify facilitators and barriers (e.g. state and store policies, regional characteristics) to implementation and effectiveness. Study findings will create a generalizable, evidence-based training and toolkit for pharmacists caring for patients who use prescribed or illicit opioids, in the over 40 states adopting or expanding pharmacy naloxone.