製薬企業の行うPMSとその方法論

Abstract

Post-marketing surveillance (PMS) of ethical drugs has been institutionalized in Japan. The framework of the PMS consists of : 1) collection of information related to the drug, 2) evaluation and analysis of that information, and determining the correspondence, 3) reporting the information and filing of applications of Reexamination/Reevaluation to the Ministry of Health and Welfare (the Koseisho), and finally 4) dissemination of information to medical and pharmaceutical professionals. Although a sphere of strict regulations is imposed for conducting these tasks, pharmaceutical companies comply with these regulations and execute post-marketing surveillance with an aim toward the true objective of the PMS, which is to “secure the proper use of ethical drugs”. In order to accomplish this objective, nothing is more important than for medical representatives (MR) to collect as much accurate information as possible, and for post-marketing surveillance management to conduct a precise evaluation and analysis of the collected information and then to feed back the pertinent information to medical and pharmaceutical professionals. With this in mind, pharmaceutical companies can be considered as conducting post-marketing surveillance systematically.