Monitoring and Evaluating the Effect of Regulatory Action: Some Recent Case Studies

Large electronic health care databases can be used to evaluate the effectiveness of regulatory action. Designing and interpreting such studies can be challenging. We demonstrate using case studies on modafinil, benzodiazepines, dosulepin, and piroxicam that measuring the impact of regulatory action is possible and can be beneficial, particularly in determining the need for further action or communication. For each case study, we discuss difficulties that may arise when measuring the effectiveness of regulatory action, which include but are not limited to: the choice of denominator, changes in the patient population, the availability and selection of comparators, and the fact that the regulatory voice may be but one voice among many. The evaluation of regulatory action is possible, but not without its challenges, and a routine, one-size-fits all approach is unlikely to be possible.