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arXiv · 2312.05678

Measuring sampling plan utility in post-marketing surveillance of medical products

Eugene Wickett·Matthew Plumlee·Karen Smilowitz·Souly Phanouvong·Timothy Nwogu
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Abstract

Ensuring product quality is critical to combating the global challenge of substandard and falsified medical products. Post-marketing surveillance is a central quality-assurance activity in which products from consumer-facing locations are collected and tested. Regulators in low-resource settings use post-marketing surveillance to evaluate product quality across locations and determine corrective actions. Part of post-marketing surveillance is developing a sampling plan, which specifies where to test and the number of tests to conduct at a location. With limited resources, it is important to base decisions on the utility of the samples tested. We propose a Bayesian approach to generate a comprehensive utility metric for sampling plans. This sampling plan utility integrates regulatory risk assessments with prior testing data, available supply-chain information, and valuations of regulatory objectives. We develop an efficient method for calculating sampling plan utility. We illustrate the value of the utility metric with a case study based on de-identified post-marketing surveillance data from a low-resource setting.

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Eugene Wickett, Matthew Plumlee, Karen Smilowitz, Souly Phanouvong, Timothy Nwogu. 2023-12-09. Measuring sampling plan utility in post-marketing surveillance of medical products. https://arxiv.org/abs/2312.05678

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