Patient Safety in the Context of Disease Outcome and Effectiveness of Therapy.

Safety is more than pharmacovigilance. Safety is also optimization of disease outcome with acceptable side effects. Safety is in this context related to effectiveness. Risk management in treatment is levering the risks an benefits. The process is characterized by five steps, risk definition, risk assessment, risk control, risk communication and risk review. In risk definition terms as safety, efficacy and effectiveness will be explained and related to the treatment. The risks of therapeutic measurements are characterized by the five classes of the common terminology criteria. The benefits of a treatment by among others efficacy, quality of life and effectiveness. In order to assess the risks literature review, analysis of scientific results, evaluation of risks related to prognostic factors for disease outcome are to be considered. In risk control, risk reduction or minimization and acceptance of certain risks will need to be considered. The role of therapeutic measurements as well as the disease stage and timing of therapy will be addressed in the context of in risk control. In risk communication explanation of this balance and the various forementioned parameters is important to offer most optimal prediction of beneficial disease outcome and effectiveness of a treatment. We will introduce the concepts described hereabove and address that limited side effects may actually be very unsafe in the context of effectiveness of therapy.