Inferring sources of substandard and falsified products in pharmaceutical supply chains

Eugene Wickett, Matthew Plumlee, Karen Smilowitz, Souly Phanouvong and Victor Pribluda

IISE Transactions, 2024, vol. 56, issue 3, 241-256

Abstract: Substandard and falsified pharmaceuticals, prevalent in low- and middle-income countries, substantially increase levels of morbidity, mortality and drug resistance. Regulatory agencies combat this problem using post-market surveillance by collecting and testing samples where consumers purchase products. Existing analysis tools for post-market surveillance data focus attention on the locations of positive samples. This article looks to expand such analysis through underutilized supply-chain information to provide inference on sources of substandard and falsified products. We first establish the presence of unidentifiability issues when integrating this supply-chain information with surveillance data. We then develop a Bayesian methodology for evaluating substandard and falsified sources that extracts utility from supply-chain information and mitigates unidentifiability while accounting for multiple sources of uncertainty. Using de-identified surveillance data, we show the proposed methodology to be effective in providing valuable inference.

Date: 2024
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DOI: 10.1080/24725854.2023.2174277

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