Chapter 24 : Risk Assessment and Its Use in Approval, Licensing, and Prudent Use Guidelines

Abstract:

The purpose of risk assessment is to help a manager better understand the risks (and opportunities) being faced and to evaluate the options available for their control. The chapter describes some antimicrobial resistance risk assessments that have been completed. The Food and Drug Administration (FDA) wanted to produce a model that was based on reliable data. The FDA deemed that the risk assessment had quantitatively demonstrated that the resistance in question presented a risk to human health, and subsequently moved to withdraw use of the antimicrobial. The major strengths of the model were its mathematical simplicity, its reliance on mostly federally collected data, its very limited set of assumptions, and the ease with which it could be updated as new data became available. The data problems underlined the difficulties of evaluating even relatively simple model parameters for antimicrobial risk assessments. The FDA’s quantitative risk analysis model was successful in that it provided robust information from which the FDA was able to make an important decision. A key to the successful involvement of risk assessment in decision making is the neutrality of the risk assessor. There is, unfortunately, a growing trend in published antimicrobial resistance risk assessments that are clearly selective about their sources or manipulate a risk assessment model to produce the desired answer. The FDA guidance takes an essentially qualitative approach to evaluating drugs for approval and continued use.