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Abstract
The number of opioid-related adverse drug events (ADEs) reported for deaths in the United States spiked in 2018 (29,000). There was a slow rise in opioid-related ADEs from 2013 to 2015, with the number of ADEs more than doubling from 2011 to 2017. To address the challenges associated with deaths and adverse events, a study was conducted focusing on a correlation using data from illegal opioid products to help inform prevention and treatment strategies. The objectives of this study were to determine if there is a positive correlation between the U.S. Food and Drug Administration’s (FDA) opioid testing data and the National Vital Statistics System’s (NVSS) data on opioid overdose deaths. The five opioid drugs researched in the FDA’s analytical database (oxycodone, fentanyl, hydromorphone, methadone, oxymorphone) were associated with over 50% of all deaths, hospitalizations, and life-threatening events in the adverse events database. The study design employed a retrospective data analysis of the NVSS and the FDA’s Online Reporting Analysis and Decision Surveillance System (ORADSS) databases between 2010 and 2020. Correlation coefficient was used to examine statistical relationships between the number of opioid samples analyzed and the number of opioid-related overdose deaths. Major findings from the study show that the opioid data from the FDA’s ORADSS database positively correlated with the outcome of death from the NVSS’s database. Over time, there was an increase in the number of fentanyl samples analyzed by the FDA, which aligned with the third wave of the opioid crisis. The Office of Criminal Investigations (OCI) needs additional resources (collaborations, joint task forces, partnerships, etc.) to enhance the knowledge sharing when illicit drugs are detected in various communities/states. These partnerships can provide advance notification to public health entities to assist in addressing the challenges associated with the rise in illegal opioid products that are crossing the borders into the United States. Policy recommendations of an integrated database between the FDA’s OCI and state law enforcement agencies/crime labs with the intent to monitor patterns of illegal activity regarding opioid abuse and misuse can act as a harm reduction strategy and to inform policy development.