Pharmacists and Regulatory Science.

ABSTRACT

For providing appropriate pharmacotherapy, "Doing the right things, and doing things right" are necessary. Additionally, vigilance is required for the appropriate use of pharmaceuticals. Evidence-based medicine has been a common approach to healthcare, and many guidelines have been published. In addition, risk management plans (RMPs) are developed upon the approval of new drugs. Therefore an environment to provide the best healthcare based on scientific evidence has been developed. When putting RMPs into practice, it is necessary to understand and utilize regulatory science (RS). If pharmaceuticals are not used, no adverse drug reactions will occur; at the same time, diseases will not be cured or symptoms controlled. We should exploit RS to use drugs appropriately. RS is not meant to limit the use of drugs in pharmacotherapy but to indicate the rules for their appropriate use. Pharmacists should ensure that patients receive maximum benefit from prescribed drugs in every case and should determine the best ways to minimize risk.