Feasibility of Electronic Screening to Identify Risk of Opioid Misuse and Overdose

Program Summary/Abstract From 1999–2020, more than 564,000 people died from an overdose involving any opioid, including prescription and illicit opioids. Despite the decades-long nationwide effort to address opioid overdose in the United States, we continue to see annual increases in opioid-related deaths. Prescription opioids are an entry point for over 75% of illicit drug users. Therefore, primary prevention is one of the four critical components of the U.S. Department of Health & Human Services Overdose Prevention Strategy. The Food and Drug Administration (FDA) has Risk Evaluation and Mitigation Strategy (REMS) for all opioids, although the current program has not demonstrated significant benefits due to multiple factors including inconsistent delivery. ONE (Opioid and Naloxone Education) is our innovative approach to screening and educating patients who receive prescribed opioid medications. The program has been implemented in community pharmacies in three states and has demonstrated positive outcomes including naloxone dispensing for high risk opioid prescriptions that is six times the national average. Currently, the ONE program’s screening tool is paper-based, with the collected data retrospectively entered into pharmacy computers. This proposal intends to integrate the tools and process developed by the ONE Program into a digital platform on tablet PCs to improve the ability to consistently deliver screening for opioid risk and provide targeted opioid safety interventions based on individual risk factors. Oprems and North Dakota State University researchers will provide tablets with the digital platform to select community pharmacy locations currently using the paper-based ONE screening tool. The tablet will collect additional information on patient interaction with the digital screening tools, including the hesitation answering certain questions, changed answers, and other variables which can be used to assess the functionality and validity of the screening tools. These data will undergo statistical analysis to determine whether the digital platforms aid in predicting potential opioid misuse and overdose and serve as another input to a robust screening process. Concurrently, other predictive indicators for opioid misuse will be identified, including factors not currently available, to support their assessment and to generate a longer-term target analytical model. The artificial intelligence (AI) incorporated into the digital platform will be utilized to characterize patient actions and identify patient behavioral characteristics that may indicate uncertainty, deceptive intent, or concern. Characteristics associated with opioid misuse, overdose or overdose-related deaths will be used to identify the screening elements with the most impact. Qualitative data gathered by surveys of pharmacy staff will be used to determine how the digital platform fits into clinical workflow. Lastly, the digital platform will be compared to existing paper- based ONE Program results to establish if there are significant differences in predictive efficacy. The research will result in a consistent product suited for incorporation into FDA opioid REMS programs.