ABSTRACT
ICH-E2E guideline was published on November 18, 2004. In Japan, it has been notified on September 16, 2005 as “Pharmacovigilance Planning”. Then, in parallel with the system development of PMDA is advanced, Ministry of Health, Labour and Welfare revised the notification, it was announced the “Risk Management Plan Guideline” on April 2012. Based on this Guideline, Marketing Authorization Holder creates a whole plan of post-marketing safety measures. This plan is the Japanese RMP (J-RMP). “Risk Management Plan Guideline” are created by the reference to REMS in US and EU-RMP, and modified in consideration of the real situation in Japan. Then, GVP Ordinance and GPSP Ordinance were revised on March 11, 2013. As the result, since October 2014, implementation and creation of the RMP was mandated. At the end of November 2014, 65 RMPs has already been published on Website of PMDA. J-RMP has been positioned as an important system for strengthening of post-marketing safety measures. Published versions of J-RMPs are summarized in compact an overall picture of the post-marketing safety measuresfor respective new drugs. It is also including planned time-line of post-marketing surveillance or post-marketing clinical study. By all stakeholders get a better understanding, it is expected thatthe J-RMP is steadily perform.
ABSTRACT
<b>Objective: </b>We conducted a questionnaire survey to comprehend the situation regarding the collection, provision, and utilization of drug safety information at hospitals. In addition, we asked pharmaceutical companies how they select medical institutions to provide drug safety information. We also investigated the current situation of information provision to Tokyo Medial Center by pharmaceutical companies.<br><b>Method: </b>A questionnaire was mailed to all hospitals in Japan. The survey was conducted between January 13 and February 10, 2011. Moreover, we asked thirteen pharmaceutical companies by telephone and e-mail about the implementation status of the provision of information and performed a survey at Tokyo Medical Center on the current situation of information provision by pharmaceutical companies regarding revisions to precaution sections in package inserts.<br><b>Results: </b>The results of the questionnaire survey (response rate: 41.2%) showed that the major information sources for hospitals were medical representatives (77.8%), Drug Safety Update (50.3%) and direct mails (49.3%). Furthermore, in the case of drugs prescribed exclusively for extramural dispensing, fewer hospitals responded that medical representatives of the pharmaceutical companies provided drug safety information and more hospitals responded that they did not obtain any drug safety information at all, compared with drugs listed in the hospital formularies.<br><b>Conclusion: </b>To minimize the risks of drugs, healthcare professionals must collect a wide range of drug safety information and must utilize this information in their medical practice. Therefore, it is important that pharmaceutical companies and regulatory authorities make an effort to provide suitable information dissemination to medical institutions. Furthermore, medical institutions must also strengthen their systems for collecting drug safety information and providing such information to healthcare professionals.