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.

进入Ooid解毒剂纳洛酮是解决Ooid流行病的关键组成部分。纳洛酮是一个 人口级预防干预与过量死亡率的大量降低有关。 此外，新兴的数据表明，纳洛酮的共同处方为慢性药物过量的人 阿片类药物疗法可以通过避免非致命性过量来降低风险范围内的负面健康结果。 通过药学扩大社区中纳洛酮的访问可能是扩展的关键机制 这种救生药物的影响力。药房几乎存在于每个社区，并具有知识渊博 卫生专业人员培训了有关药物安全的咨询；许多州还允许药房 在柜台上出售注射器进行药物注射。药房在分配药物和销售中的关键作用 注射器将它们置于阿片类药物通道的十字路口，并使用纳洛酮的危险方法进行降低风险。 随着该国扩展，测试优化基于药房的纳洛酮（PBN）条款的方法将是关键 通过医疗系统实施纳洛酮。我们建议对药房进行大型实用研究 - 集中干预以增加PBN分配并改善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（响应，PI：Hartung； Moon研究，PI：Green，R18）， 其中包括在线和一对一的教育外展（即学术细节）提供 为药剂师的知识和培训，以识别并有效与可能处于高风险的患者 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数量 美国通过更多的访问和使用纳洛酮以及更安全的阿片类药物使用。独特的研究将 从与两个大型零售药房连锁店，CVS Pharmacy和Fred Meyer（部门 克罗格公司（Kroger Corporation），他将提供“现实世界”样本，以支持可复制性和外部有效性。具体的 目的是：目标1：将月球和响应工具包材料整合到一个凝聚力的教育计划中 （月亮+），并简化材料以增强对纳洛酮政策，交流和 行政;目标2：使用阶梯楔形，聚类的随机试验设计，评估的有效性 月球+在160个社区药房增加：a）PBN分布率，纳洛酮相关患者 参与和药剂师的参与者知道，感知的行为控制和自我效能 纳洛酮； b）药房注射器销售，药剂师的参加，知道，感知的行为控制 和为阿片类药物使用障碍分配丁丙诺啡的自我效能感（次要结果）。目标3： 采用混合方法方法，确定促进者和障碍（例如，州和商店政策，地区 特征）实施和有效性。研究结果将创建一个可概括的可循证的 在40多个州 采用或扩大药房纳洛酮。

项目成果

Study protocol for the Respond to Prevent Study: a multi-state randomized controlled trial to improve provision of naloxone, buprenorphine and nonprescription syringes in community pharmacies.

• DOI: 10.1080/08897077.2021.2010162
• 发表时间: 2022
• 期刊: SUBSTANCE ABUSE
• 影响因子: 3.5
• 作者: Green, Traci C.;Bratberg, Jeffrey;Irwin, Adriane N.;Boggis, Jesse;Gray, Mary;Leichtling, Gillian;Bolivar, Derek;Floyd, Anthony;Al-Jammali, Zain;Arnold, Jenny;Hansen, Ryan;Hartung, Daniel
• 通讯作者: Hartung, Daniel

"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。

• DOI: 10.1016/j.japh.2023.01.013
• 发表时间: 2023
• 期刊: Journal of the American Pharmacists Association : JAPhA
• 作者: Gray,Mary;Shin,SarahS;Silcox,Joseph;Flores,Diana;Bolivar,Derek;Irwin,AdrianeN;Floyd,AnthonyS;Bratberg,Jeffrey;Boggis,JesseS;Hartung,DanielM;Green,TraciC
• 通讯作者: Green,TraciC

Examining the effects of COVID-19 on pharmacy dispensing of naloxone and syringes sales across Massachusetts and New Hampshire.

• DOI: 10.1016/j.japh.2022.10.012
• 发表时间: 2023-01
• 期刊: Journal of the American Pharmacists Association : JAPhA
• 作者: Bolivar D;Hartung D;Silcox J;Bratberg J;Boggis J;Rabin M;Green TC
• 通讯作者: Green TC