| In 2012, improperly compounded sterile products caused an outbreak of fungal meningitis and other fungal infections to become the largest outbreak of healthcare-associated infections in the United States. This outbreak, along with other adverse events associated with larger compounders demonstrated a significant public health risk and highlighted the need for more-rigorous regulatory oversight of pharmacy compounding. In response, the U.S. Congress passed the Drug Quality and Security Act in November 2013, giving the Food and Drug Administration (FDA) authority to oversee compounding outsourcing facilities. However, even with the new authority, the regulators are faced with the challenge of safeguarding the public against improperly compounded products despite limited data and resources. This dissertation will discuss a novel application of the paired comparison expert elicitation technique to develop a risk-ranking model that can allow regulators to efficiently allocate their resources and focus on compounding firms that could pose the greatest 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 FDA, the States Board of Pharmacy, and members of the compounding industry. As such, it can be beneficial to stakeholders from both the private and public pharmacy compounding sectors. Prior to conducting the paired comparison expert elicitation, a gap analysis is performed to gain a better understanding of the pharmacy compounding regulations among the states and to identify the gaps in the state regulation and oversight of the compounding industry. |
