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  1. Advancing Regulatory Science

The Assessment of Commercially Available In-Home Drug Disposal Products

CERSI Collaborators: Stephen W. Hoag, PhD (PI); Chad Johnson, PhD (Co-PI); Ahmed Ibrahim, PhD (Co-I); Monifia Vaughn-Cooke, PhD (Co-I); Andrew Coop, PhD; Steven Deck, DM, MBA

FDA Collaborators: Bic Nguyen, PharmD, MPH; Xiaoming Xu, PhD; Julia Pinto, PhD; Irene Z. Chan, PharmD; Jana McAninch, MD, MPH, MS

CERSI Subcontractors: Monifia Vaughn-Cooke, PhD, Associate Professor at the Virginia Tech Carilion School of Medicine (VTCSOM) (Co-I)

Project Start Date: June 18, 2024

Regulatory Science Framework

Charge III "Invigorate public health preparedness and response of FDA, Patients & Consumers" and Focus Area "D. Substance Use and Misuse"

Regulatory Science Challenge

In-home storage of unused opioid medicines presents a risk of opioid misuse, diversion, and young children accidentally accessing the medicine. Hence, it is critical to remove unused opioid medicines from the home. In-home disposal systems have been developed to provide a disposal option for unused opioids. These systems may function by binding the opioid to activated carbon, by sequestering the opioid, or by using chemical reactions (e.g., oxidation) to deactivate the opioids. It is important to study how these systems work and determine how well they are designed for users to understand and follow the instructions and use them as they were intended. This information helps us to better understand the safety of these systems and how well they work.

The broad regulatory science issue being addressed by this project is how in-home disposal systems may contribute to FDA’s goal of reducing the risks associated with opioid medications. The key questions that we will answer are the following: (1) are these systems safe, (2) can they be used correctly by intended users, (3) what is their capability to bind, sequester, or deactivate the active pharmaceutical ingredient (API), regardless of the pharmaceutical formulation type, (4) and what is their potential for leaching API over time. Additionally, researchers will evaluate what happens if the consumer does not follow instructions and uses the systems incorrectly, and then see if these systems still bind, sequester, or deactivate the API.

Project Description and Goals

The overall goal of the project is to gain an understanding of the mechanisms of action, ingredients, safety, usability, and capability of commercially available in-home drug disposal systems. Researchers will collect the data using (1) standard pharmaceutical laboratory techniques applied to the in-home systems, (2) various analyses, and (3) participant surveys and interviews.

Research Outcomes/Results

An outcome for the FDA will be an interim report and a final scientific report fully describing the methods and results of the investigations. Researchers will also publish results in peer-reviewed journals and present the findings at scientific meetings. Finally, researchers will create materials for the general public on the proper use of these in home disposal systems.

 

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