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

增加纳洛酮在社区药房的参与和分配的干预措施：四州随机试验

• 批准号: 10249360
• 负责人: TRACI C GREEN
• 金额: $ 58.75万
• 依托单位: BRANDEIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249360
• 关键词: Academic Detailing; Address; Adopted; Adverse event; Advocate; Agreement; American; Antidotes; Attitude; Behavior Control; Buprenorphine; Characteristics; Chronic; Cluster randomized trial; Communication; Communities; Community Pharmacy; Counseling; Country; Data; Data Analyses; Educational Intervention; Effectiveness; Effectiveness of Interventions; Epidemic; Feeling; Funding; Goals; Health; Health Personnel; Health Professional; Heroin; Hybrids; Individual; Injections; Intervention; Judgment; Knowledge; Laws; Literature; Massachusetts; Medical; Methods; Naloxone; Nature; New Hampshire; Non-Prescription Drugs; Opioid; Opioid Antagonist; Oregon; Outcome; Overdose; Patient Care; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Poisoning; Policies; Population; Public Health; Research; Research Project Grants; Resources; Rhode Island; Risk; Role; Safety; Sales; Sampling; Self Efficacy; Site; Statutes and Laws; Surveys; Syringes; System; Testing; Training; Training Programs; Treatment Efficacy; United States; Washington; authority; base; cohesion; effectiveness evaluation; efficacy testing; evidence base; experience; follow-up; health care availability; high risk; illicit opioid; implementation intervention; improved; medication safety; mortality; nonmedical use; online course; online delivery; online resource; opioid epidemic; opioid mortality; opioid overdose; opioid therapy; opioid use; opioid use disorder; outreach; overdose risk; patient engagement; posters; prescription monitoring program; prescription opioid; prevent; preventive intervention; programs; randomized trial; risk mitigation; secondary outcome; tool; trial design

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.

获得阿片类药物解毒剂纳洛酮是解决阿片类药物流行病的一个重要组成部分。 人口层面的预防干预与大幅降低药物过量死亡率相关。 此外，新出现的数据表明，向有慢性慢性病服药过量风险的人同时开具纳洛酮处方 阿片类药物疗法可以通过避免非致命性过量服用来减少风险范围早期的负面健康后果。 通过药房扩大社区对纳洛酮的获取可能是延长纳洛酮使用范围的关键机制。 这种救命药物几乎遍布每个社区，并且配备了知识渊博的工作人员。 接受过向患者提供药物安全咨询培训的卫生专业人员也允许药店开业； 在柜台销售用于注射药物的注射器。药房在配药和销售方面发挥着关键作用。 注射器将他们置于阿片类药物获取和纳洛酮等风险缓解方法的十字路口。 随着国家扩大纳洛酮（PBN）的供应，测试优化纳洛酮（PBN）供应的方法将是关键 我们建议对药房进行一项大规模的实践研究。 旨在增加 PBN 配药并提高阿片类药物安全性的重点干预措施包括： 两个成功的示范研究项目（RESPOND，PI：Hartung；MOON Study，PI：Green，均为 R18）， 其中包括在线和一对一的教育外展（即学术细节），经证明可以提供 药剂师的知识和培训，以识别和有效地接触可能处于高风险的患者 这项研究的首要目标是减少阿片类药物过量死亡的人数。 这项研究将通过更广泛地获取和使用纳洛酮以及更安全地使用阿片类药物来改善美国。 得益于与两家大型零售药房连锁店 CVS Pharmacy 和 Fred Meyer（ 克罗格公司），他们将提供“真实世界”样本来支持可复制性和外部有效性。 目标是： 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 目标 2：使用阶梯楔形、聚类随机试验设计，评估治疗的有效性 MOON+ 在 160 家社区药房中不断增加：a) PBN 分发率、纳洛酮相关患者 参与度，以及药剂师的态度、知识、感知行为控制和自我效能 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 以及针对阿片类药物使用障碍配发丁丙诺啡的自我效能（次要目标 3）： 应用混合方法，确定促进因素和障碍（例如州和商店政策、区域政策） 特征）到实施和有效性，研究结果将创建一个可推广的、基于证据的。 为 40 多个州照顾使用处方或非法阿片类药物的患者的药剂师提供培训和工具包 采用或扩大药房纳洛酮。

项目成果

The Cost of Safe Injection: Insights on Nonprescription Syringe Price Variability From Systematic Secret Shopping.

安全注射的成本：从系统性秘密购物中洞察非处方注射器价格波动。

• 发表时间: 2024-04
• 作者: Blough, Malcolm J;Rocha, Amanda;Bratberg, Jeffrey;Silcox, Joseph;Bolivar, Derek;Floyd, Anthony S;Gray, Mary;Green, Traci C
• 通讯作者: Green, Traci C

"Like it was just everyday business": A qualitative study of pharmacy-based naloxone and syringe customer experience.

“就像这只是日常事务”：基于药房的纳洛酮和注射器客户体验的定性研究。

• 发表时间: 2023
• 作者: Gray, Mary;Shin, Sarah S;Silcox, Joseph;Flores, Diana;Bolivar, Derek;Irwin, Adriane N;Floyd, Anthony S;Bratberg, Jeffrey;Boggis, Jesse S;Hartung, Daniel M;Green, Traci C
• 通讯作者: Green, Traci C

"I go out of my way to give them an extra smile now:" A study of pharmacists who participated in Respond to Prevent, a community pharmacy intervention to accelerate provision of harm reduction materials.

“我现在不遗余力地给他们一个额外的微笑：”一项针对参与响应预防项目的药剂师的研究，这是一项社区药房干预措施，旨在加速提供减少危害的材料。

• 发表时间: 2024-05
• 作者: Irwin, Adriane N;Gray, Mary;Ventricelli, Daniel;Boggis, Jesse S;Bratberg, Jeffrey;Floyd, Anthony S;Silcox, Joseph;Hartung, Daniel M;Green, Traci C
• 通讯作者: Green, Traci C

Readiness of community pharmacies to implement an opioid safety intervention.

社区药房准备实施阿片类药物安全干预。

• 发表时间: 2023
• 作者: Floyd, Anthony S;Silcox, Joseph;Cousin, Emma;Irwin, Adriane N;Gray, Mary;Bolivar, Derek;Bratberg, Jeffrey;Arnold, Jenny;Al;Hansen, Ryan N;Hartung, Daniel M;Green, Traci C
• 通讯作者: Green, Traci C

Pharmacy staff-reported adaptations to naloxone provision and over-the-counter (OTC) syringe sales during the COVID-19 pandemic: Experiences across multiple states and 2 pharmacy chains.

药房工作人员报告了 COVID-19 大流行期间对纳洛酮供应和非处方 (OTC) 注射器销售的调整：多个州和 2 个药房连锁店的经验。

• 发表时间: 2024
• 作者: Green, Traci C;Silcox, Joseph;Bolivar, Derek;Gray, Mary;Floyd, Anthony S;Irwin, Adriane N;Hansen, Ryan N;Hartung, Daniel M;Bratberg, Jeffrey
• 通讯作者: Bratberg, Jeffrey