EAGER: ISN: Unraveling Illicit Supply Chains for Falsified Pharmaceuticals with a Citizen Science Approach

University Of Notre Dame, Notre Dame IN

Investigators

Abstract

This EArly-concept Grant for Exploratory Research (EAGER) will advance the national health, welfare, and prosperity by studying ways to detect and disrupt the supply networks for falsified pharmaceuticals and illicit drugs. Falsified pharmaceuticals harm hundreds of thousands of patients in the developing world, as well as injuring Americans when they penetrate the U.S. pharmaceutical supply. Illicit drugs, such as opioids, are the cause of more deaths in the U.S. than automobile accidents or gun violence. Analyzing pharmaceuticals using traditional methods is time-consuming and expensive, so producers and distributors often escape discovery. This research will utilize an inexpensive paper analytic device (PAD) in the form of a test card that can be deployed by community health workers and ordinary citizens, that is capable of detecting active ingredients and fillers in a pill or powder within 5 minutes. By swiftly identifying of the types of fillers used, counterfeit pharmaceuticals or illicit drugs in several different locations can be linked, and researchers can begin to reverse engineer the supply chain to identify the source of the product and its distribution channels. Effective deployment strategies for test cards will be developed, and data visualization tools can then be provided to enable local regulatory agencies to act quickly to trace and disrupt suppliers of falsified medicines or illicit drugs. The project will involve both graduate students, focused on detection of fake medicines and supply chain vulnerabilities in low resource settings, and undergraduates, focused on detection of supply chains for illicit opioid drugs. The research will lead to models that describe the movement of products through the supply chain, suggesting pinch points or critical pathways that could be used to shut down distribution of the illicit products. Through the partnership between an analytical chemist and an operations researcher, this project will allow for timely collection and analysis of post-market pharmaceutical samples to detect a wide range of illegal practices and harmful medicines or drugs drugs. The PAD gives fast but imperfect data via the cell phone network; from an operations engineering perspective, the system offers new opportunities to dynamically retarget sample collection, optimize logistics of confirmatory analysis and interactions with regulatory authorities, and model how illicit products enter the pharmaceutical supply chain. The project will test these strategies in real-world settings. Samples of essential medicines will be collected by covert shoppers in Kenya, Malawi, and Bangladesh, and tested with PADs. Integrating methods from operations engineering, the project will test approaches for detecting active ingredients and fillers, determine the incremental value of different types of samples for understanding the supply chains of falsified medications, and examine innovative sampling methods that respond dynamically to early reports of bad quality products. The research will lead to models that describe the movement of the products through the supply chain. Students involved in this project will test samples of street drugs in a police drug lab and classify them into batches according to active ingredient and filler content, with the goal of deducing how many producers are active in the supply chains for these illegal products. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.