Risk assessment using paired comparison expert judgment for ranking of compounding outsourcing facilities

Government regulators, like other managers and decision makers, are often faced with the challenge of completing a task or project with scarce resources. In such cases, decision makers must optimitize allocation of their insufficient resources to achieve the best outcome. For regulators like the Internal Revenue Service (IRS) and the U.S. Food and Drug Administration (FDA), optimitization of scarce audit resources is accomplished through ranking of individuals or institutions based on risks and other deciding factors. In this paper, we will discuss a novel application of the paired comparison expert judgment technique to develop a risk-ranking model that can allow FDA regulators to efficiently allocate their resources and focus on pharmacy compounding firms that could pose the greatest public health risk. Empirical research on the factors that can assess compounding risks is explored to understand their influences. Sensitivity analysis of these risk factors identified the top factors that had the most significant effect on the outcome of the quantitative risk assessment model. The resulting model from this research is inclusive as it was developed with inputs from experts from the federal and state governments, and also members of the pharmacy compounding industry. As such, it can be beneficial to stakeholders from both the private and public pharmacy compounding sectors.