A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2．How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3．How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4．How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5．Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6．Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.

Objective : Parkinson’s disease (PD) is a disease treated by polytherapy. This time, the authors report the role of pharmacists in one of the few Parkinson’s disease facilities in Japan (https://sunwels.jp/pdhouse/; abbreviated as PD House), which was born from the voices of PD patients. Methods : The backgrounds of 52 patients admitted to the PD House and prescriptions for them were analyzed to mainly clarify: the percentages of patients aged 75 or over and those using 7 or more prescribed drugs; and frequently used drugs to be carefully administered to the elderly. The approaches provided by pharmacists through interprofessional collaboration were also analyzed. Results : The percentages of patients aged 75 or over and those receiving benefits for individuals requiring care were 71.2 and 92.3%, respectively. Those using 7 or more prescribed drugs accounted for 75.0%. In multidisciplinary collaboration, pharmacists were involved in not only pharmacotherapy but also nutritional evaluation of patients with severe nutritional disorders, proposal of appropriate nutritional therapy, understanding of swallowing function, and appropriate medication teaching. Conclusion : The actual situation of PD patients, where they used multiple drugs, and their backgrounds suggest that interprofessional collaboration is indispensable for PD treatment, and the roles of pharmacists were shown to be important.