Risk Minimization

Risk minimization is an essential component of the European Union Risk Management Plan and the United States Risk Evaluation and Mitigation Strategy. Appropriate planning to risk minimization/mitigation allows for medicines with considerable risk to be approved and maintained into the market. Routine risk minimization, for example product information, is sufficient for the majority of products. For some drugs, however, it may be necessary to implement additional measures, such as educational programs, targeted communication, or restrictive systems for drug dispensing/prescribing. Another key element of the risk minimization plan is the evaluation of the effects of the risk minimization measures to ensure that their objectives are fulfilled. Appropriate evaluation should consider measurement of the different elements of the risk minimization strategy. Safety outcomes, which correlate the implementation of the risk minimization with fewer occurrences or less severity of the adverse events, generally define the ultimate success of a risk minimization program