Measures for ensuring drug safety and post-marketing surveillance

Abstract

In considering the status of post-marketing surveillance (PMS) in Japan, it is important to disseminate the collection, assessment, and transmission of drug and safety information to gain an understanding of proper-use information on drugs and the mechanism of transmitting such information for seeking cooperation in drug safety measures. It is especially important to ensure that physicians, pharmacists, nurses and other health care professionals are well-informed about adverse events.It is also essential for patients to have an appropriate understanding of adverse events. It is thus hoped that explaining PMS will help pharmaceutical companies and those engaged in medical care take rational measures against adverse events. Internationally shared information on appropriate drug use is necessary for taking full mutual advantage of drug information to benefit patients worldwide, especially for promoting drug safety given the globe's growing borderlessness. An agreement must thus be reached on globally applicable information exchange and standardization of electronic transmission abreast of the times. Accordingly, such are also discussed. To detect and announce new adverse events is crucial for the physician or patient to have valid suspicion about the use of drugs and changes in symptoms caused by drugs.