Methods: This study enrolled 273 patients who underwent an initial BKP. To treat osteoporosis, parathyroid hormone (PTH) administration was started 1–2 weeks before BKP and continued for at least 6 months postoperatively. Corsets were applied for 3 months after the procedure. Rehabilitative interventions, including hip range-of-motion training, muscle strengthening exercises, and motion/posture instruction, were started from the preoperative assessment time point and resumed 3 hours postoperatively. Corsets were used in all patients. Therefore, no grouping based on corset use was performed. PTH was used in 180 patients, and they were divided into the following two groups: PTH user group and PTH nonuser group. Rehabilitative interventions were provided to all patients for a median duration of 17 days. Patients who underwent rehabilitative intervention for <17 and ≥17 days were included in the short-term and long-term intervention groups, respectively. The incidences of SVBFs for these four groups were compared. Results: SVBF occurred in 29 patients (10.6%). The SVBF incidence among patients who were prescribed all three prophylactic measures was 6.2%. The PTH user group had a significantly lower incidence of distant vertebral body fractures as compared to the PTH nonuser group. The long-term rehabilitation group had a significantly lower incidence of SVBFs and adjacent vertebral body fractures within 50 postoperative days than the short-term group. Conclusions A 17-day or longer rehabilitative intervention may lower the risk of early adjacent vertebral body fractures, and the use of PTH may reduce the risk of distant vertebral body fractures.

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: We evaluated patients’ degree of understanding of the effects and adverse drug reactions of SGLT2 inhibitors.Methods: We targeted 26 patients who were administered SGLT2 inhibitors during hospitalizations between April 2017 and March 2018. The survey was conducted by interviewing the patients using a questionnaire.Results: In total, 14 patients (53. 8%) were able to explain the term “efficacy.” Although 6 patients (23. 1%) understood “dehydration,” there was little understanding of “urinary tract infection” (7.7%) and “rash/erythema” (2 and 0 patients, respectively). In addition, we confirmed the details of the descriptions of adverse reactions caused by SGLT2 inhibitors with pharmacists, and found that 13 patients (50.0%) clearly received an explanation of “dehydration,” only 3 patients received an explanation of “urinary tract infection” (11.5%), and none of them comprehended “rash/erythema.” Overall, the patients’ awareness of the adverse drug reactions of SGLT2 inhibitors was low.Conclusion: Unlike common drugs for diabetes, SGLT2 inhibitors have been attracting attention as protective agents of the heart and kidneys. Therefore, it is expected that prescriptions for SGLT2 will increase in the future. Pharmacists need to explain the effects and adverse drug reactions of SGLT2 inhibitors to the patients as well as make the patients understand the pharmacological mechanisms of action of SGLT2 inhibitors.