Benjamin Cocchiaro

The current mechanisms in the United States to research and develop novel reversal agents for substances that can lead to overdose are restricted by regulations placed on the pharmaceutical industry. While there are many forms of harm reduction critical to saving lives that require increased investment and research, it is proven that reversal agents, such as naloxone, help prevent overdose morbidity and mortality. In the setting of an evolving crisis of illicit substance use and related overdose with new, increasingly potent substances appearing in communities nationwide, it is essential to implement a structured approach to rapidly develop and deploy efficacious harm reduction tools to save lives. In this article, we review the history of US scheduled drug regulation which aims to mitigate substance use but also paradoxically hinders research into treatments for drug overdose. We also discuss the regulation of drug reversal agents in the context of changing patterns in illicit substance use as well as barriers to the rapid development of medical devices associated with drug reversal agents that address immense public health needs. The overdose epidemic is a national crisis that requires technological solutions in addition to sociopolitical reform. Even if a reversal agent or medication is approved for an emerging substance, the existing regulatory landscape for drug delivery devices discourages the development, access, and widespread adoption of potentially lifesaving treatments. A systematic approach to monitoring the evolution of illicit drugs and a more streamlined regulatory pathway is urgently needed to facilitate the development and deployment of effective harm reduction tools.

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: For over a decade, drug overdose has been the leading cause of injury and accidental death in the United States. Most fatal overdoses involve opioids and occur during solitary drug use events when no one is available to initiate lifesaving responses (e.g., naloxone).​ While there is a growing interest in devices providing early overdose detection and automated response, little research has engaged end users in a device design process.​ Objective: To describe user experience, perceived harms and benefits, and the acceptability of a shoulder-mounted wearable sensor among people who inject drugs who wore a device prototype for seven days, and to explore real-time responses that could be incorporated into a next generation sensor. Methods: Individuals ≥18 years reporting past week injection drug use were recruited from a walk-in substance use disorder clinic in Camden, NJ, USA. Participants completed a brief survey assessing socio-demographics and recent drug use and were assigned a sensor prototype that they were asked to wear near-continuously for seven days. At endline, they completed semi-structured interviews exploring acceptability, usability, and form and function preferences for next-generation devices with integrated automated response options. Structured field notes and transcripts were analyzed to identify key themes and design considerations. Results: Participants (n=23) had a median age of 41 years. Most were primarily non-Hispanic White (65%) males (61%), experiencing homelessness (57%) who reported daily injection drug use (74%) within 3-months and receipt of opioid use disorder medication within a month (74%). Sixteen completed an exit interview. They found the concept of a shoulder-mounted overdose detection device acceptable and unanimously endorsed the need for long-lasting discreet devices. They emphasized the importance of having multiple response options that wearers could tailor to their individual circumstances and preferences, noting some might prefer an automatic call to emergency services, while others might prefer to alert a peer. Participants expressed a preference for solutions that alert first responders over automated biomedical solutions, such as naloxone injection, because of concerns about device error (e.g., false positives) leading to precipitated withdrawal. Conclusions: After wearing a shoulder-mounted protype, this small group of participants found the idea acceptable and provided feedback to improve usability and design. Data suggest that a variety of devices with differing functions, size, and capacity will be needed to meet user needs and increase the likelihood of adoption once devices come to market.