MHLW released a guideline for Risk Management Plan (RMP) in April 2012, in order to manage the risk of pharmaceutical products from the development stage towards post marketing period. The guideline suggests to determine Safety Specification and to develop Pharmacovigilance Plan (PVP) and Risk Minimization Plan aligned to the ICH E2E guideline. However, in some of the RMPs, which had been published online (as of August 2014), conventional (Special) Drug Use Results Surveys are planned as a “universal” PVP regardless of the impact, severity and characteristics of the risks. Our JPMA taskforce (Data Science Expert Committee) summarized report and published in August 2014. In this report, we explained how to evaluate safety events based on evidence level for safety specification and how to develop PVP. Also, we would like to propose KAIZEN activities for RMP improvement as follows:
1. In order to clarify the research question, rationale and evidence for safety specification should be evaluated carefully.
2. It is essential to be considered in advance how to collect and analyze the safety data for detecting safety specification during clinical development.
3. Safety profiles should be discussed thoroughly on DSUR development among stakeholders in order to clarify safety specification at NDA. Research questions for each different risk and missing information should be established according to PECO, which will flow into appropriate PVP planning.
4. Continuous PDCA cycling is critical for RMP. The first survey or research will bring you next research question (s).
We expect all stakeholders, including clinical development specialists in industry, regulatory authorities, and academia, to have better understating of RMP principle and to manage and implement it more appropriately in a scientific manner.

Objective : In 2011, the Ishikawa Prefectural Joint Committee of Blood Transfusion Therapy was organized in Ishikawa Prefecture. Since 2012, pharmacists have promoted educational activities regarding the appropriate use of albumin products for different occupations based on a survey involving all medical institutions in Ishikawa Prefecture. We examined the effects of these activities with respect to the usage of albumin products. Methods : A questionnaire survey regarding blood transfusion therapy, including the total usage of albumin products, departments responsible for the management of albumin products, and health care professionals’ awareness of issues on the appropriate use of albumin products, was conducted from 2011 until 2014 involving all medical institutions where blood transfusion preparations were used in Ishikawa Prefecture. Results : The questionnaire collection rate was ≥70%. The results showed that, in middle- or small-scale medical institutions, departments/physicians other than the Department of Pharmacy were responsible for the management of albumin products. Furthermore, some health care professionals did not recognize/understand problems regarding the appropriate use of albumin products. Pharmacists newly increased educational activities by study meetings for various occupations or panel discussions involving participants. The participants’ occupations varied, and the number of institutions to which they belonged was 20 to 24. The total usage of albumin products in Ishikawa Prefecture decreased by approximately 20% between 2011, when these attempts were started, and 2014. Discussion : This study suggests that the educational activities by pharmacists and other health care professionals at the prefectural level reduced the total usage of albumin products.