SUMMARY The primary goal of this project is to integrate and assess the practicality of a closed-loop medication management system dispensed through a hospital-based pharmacy with a focus on opioid pain management for ambulatory patients with extremity fractures being discharged from the emergency department. The Addinex system involves packaging medication in low-cost mechanical dispensers where each medication dose requires a unique password provided by a smartphone app. The dispenser restricts medication access by limiting each individual dose only as prescribed through unique one-time passcodes. Proper passcode entry via dial-turning and the pull of a lever dispenses the next dose to the patient. Once patients retrieve a dose, they are unable to access their next dose until the prescribed interval has passed, at which point they can request the next passcode. The system was designed to work with our partner pharmacy to deliver medication ahead of time for pre- scheduled surgeries. However, to accommodate same-day treatment, Addinex must partner with a hospital’s pharmacy. In addition, onboarding has heretofore been handled by a research associate. Non-study patients must be able to on-board themselves for the Addinex platform to be an effective commercial product. This project will adapt and enhance the system to meet these two requirements by establishing new protocols, aligning patient management processes with emergency room workflows, streamlining onboarding procedures for both patients and staff, and executing essential commercial steps required for successful implementation, including the development of specific patient monitoring policies. Collaboration with medical institutions is a crucial aspect to get the most out of the Addinex system by creating monitoring policies tailored to various types of patients and procedures. These custom policies encompass patient questions, notifications, alerts, and corresponding actions based on their responses. These will be collaboratively designed in conjunction with clinical experts from Brown Emergency Department. Once the logistical aspects of the revised system are in place, we will conduct a clinical trial involving 100 patients with extremity fractures treated by the emergency department. Half the patients (25 adults and 25 minors) will utilize the Addinex system, while the other half will have their opioids dispensed in a standard pill bottle as the control group. Addinex’s system promotes the return of medication using a pre-paid disposal mailer once patients have completed their course of treatment. The clinical study's main goals involve evaluating the system's effectiveness with patients obtaining same day treatment. This evaluation will encompass an analysis of medication consumption, disposal rates, pain levels, the impact of monitoring policies, and ensuring that the established commercial protocols function seamlessly. Ultimately, the project aims to demonstrate that the Addinex system can successfully operate within the broader hospital environment (same day and scheduled procedures), controlling and monitoring opioid usage, promoting patient well-being, and lowering costs.

NARRATIVE The opioid epidemic continues to suffer from overprescribing, overuse, and lack of disposal. Based on successful results in a pilot study with post-surgical cancer patients, Addinex now proposes to adapt our medication control, monitoring, and disposal system for commercialization in a hospital setting by partnering with a hospital pharmacy and running a study of ambulatory patients being discharged after treatment for bone fractures. This intervention is designed to reduce misuse and diversion of post-surgical opioids by controlling access, providing clinician-derived automated feedback, and promoting disposal of unused pills without compromising pain control.