Analysis of the Vioxx Case

The hazards, system safety requirements and constraints, and documentation of the safety control structure for pharmaceutical safety were shown in chapter 7 Using these, Couturier performed several types of analysis. 

He first traced the system requirements to the responsibilities assigned to each of the components in the safety control structure, that is, he performed a gap analysis as described above for the NASA ITA risk analysis. The goal was to check that at least one controller was responsible for enforcing each of the safety requirements, to identify when multiple controllers had the same responsibility, and to study each 

Controllers must also have the resources and information necessary to enforce the safety constraints they have been assigned. Physicians need information about drug safety and efficacy that is independent from the pharmaceutical company representatives in order to adequately protect their patients. One of the first steps in performing an analysis of the drug safety control structure is to identify the contextual factors that can influence whether each component s responsibilities are carried out and the information required to create an accurate process model to support informed decision making in exercising the controls they have available to carry out their responsibilities. 

System dynamics modeling was used to show the relationship among the contextual factors and unsafe control actions and the reasons why the safety control structure migrated toward ineffectiveness over time. Most modeling techniques provide 

Overview of reinforcing pressures preventing the recall of drugs. 

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