Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement

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Accessibility and availability of evidence based medications for addiction treatment (MAT) such as methadone, buprenorphine/naloxone (BNX), and naltrexone (NTX) are critical components of addressing the current opioid epidemic. Yet treatment need vastly exceeds treatment availability, including BNX office-based opioid therapy (OBOT) approaches. New models of MAT provision are being implemented and trialed. One such groundbreaking approach is the Rhode Island (RI) Centers of Excellence in MAT (COE). Designed as bidirectional hubs of MAT induction and (re)stabilization, COEs are intended to complement both traditional opioid treatment programs (OTPs) and jump-start BNX OBOT expansion. In addition to funding 9 COEs to date, uniquely, RI invested in the maintenance and initiation of inmates with OUD onto MAT with a transfer post-release to COEs. However, both approaches necessitate even greater community MAT availability. The new STR grant funds introduce nurse-based supports to BNX prescribers in community healthcare settings, but other health professionals could also help expand MAT reach, namely pharmacists. The goal of this study is to examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based MAT for maintenance. This study aims to develop (R21 phase) then test (R33 phase) a model of MAT maintenance and coordinated care in the pharmacy. To do so, the study will work closely with thought leaders, stakeholders and state leadership to design a pharmacy collaborative practice agreement for the management of OUD using BNX and NTX (P-MAT) that fulfills the Board of Pharmacy’s requirements of the CPA, is agreeable to our study partners Genoa Pharmacy and CODAC, Inc. OTP, safe for patients, and potentially scaleable for further study. R21 phase aims are: Aim 1: Develop the P-MAT for the management of OUD, including establishing training components, documentation, management protocols, relapse assessment and management, specifications for conducting urine analysis, patient education, and identifying physical space specifications for patient confidentiality. Aim 2: For patient inmates on MAT, assess the feasibility and timing of randomization and transfer to a P-MAT pharmacy post-release. This targeted assessment will inform the R33 design. Aim 3: Pilot test P-MAT with up to 10 patients, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of P-MAT. Provided that milestones have been met and stakeholders and leadership endorse advancement to the R33 phase, aims are: Aim 4: Expand P-MAT to all six study pharmacies, and assess pharmacist readiness to provide PMAT. Aim 5: Conduct a randomized controlled trial of 250 medication-stabilized (with BNX or NTX) patients with OUD receiving care at a COE or in OBOT, comparing engagement and clinical outcomes for patients followed up in OBOT/COE to those maintained and followed up in P-MAT. Findings may have clinical and policy implications if a P-MAT model effectively engages pharmacists as part of the patient care team for OUD.