We developed a program to generate scenarios of pathological changes for problem-based learning (PBL) in a physical assessment workshop using the patient simulator, "Physiko^®”. With these programs, PBL-style case experiencing also became possible by actually performing physical assessment on “Physiko^®” using a stethoscope while presenting information such as the patient background. The results of a survey conducted during the physical assessment workshop showed that participants were significantly interested in simulation-based education. However, the results also revealed a lack of understanding of technical terms used in physical assessment, suggesting the need to urgently facilitate not only the acquisition of basic skills to monitor vital signs but also that of symptomatology knowledge in order to understand technical terms and pathological characteristics.

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.

The number of patients with osteoporosis is an estimated 12,800,000 in Japan. Osteoporosis represents a risk factor for becoming bedridden, and also for increased mortality. It would thus be important to take measures to prevent non-examination and treatment interruption as their rate is high. We recruited participants at a health-supporting event for local residents at our pharmacy on April 14, 2019 and obtained consent from 40 individuals to participate in this study. At this event held by a pharmacy, we conducted bone density measurement and osteoporosis-related preventive education by pharmacists, considering the influence the event had on health-related awareness and behavior in the local residents. Knowledge of osteoporosis was higher after than before the events. Participant health and lifestyle awareness was not observed between before the event and one month after the event. However, one month after the event, several changes could be observed in the behavior of 79.4% (27/34) of the participants. Based on these results, bone density measurement and osteoporosis-related preventive education by pharmacists are suggested to increase osteoporosis-related knowledge among local residents and to promote behavior change related to healthcare and osteoporosis.

Mid-ventricular obstructive hypertrophic cardiomyopathy (MVOHCM) is a rare type of cardiomyopathy, associated with apical aneurysm formation in some cases. We report a patient presenting with ventricular fibrillation, an ECG with an above normal ST segment, and elevated levels of cardiac enzymes but normal coronary arteries. Left ventriculography revealed a left ventricular obstruction without apical aneurysm. There was a significant pressure gradient between the apical and basal sites of the left ventricle. Cine magnetic resonance imaging (MRI), performed on the 10th hospital day, showed asymmetric septal hypertrophy, mid-ventricular obstruction, and an apical aneurysm with a thrombus. The first evaluation by contrast-enhanced imaging showed a subendocardial perfusion defect and delayed enhancement. It was speculated that the intraventricular pressure gradient, due to mid- ventricular obstruction, triggered myocardial infarction, which subsequently resulted in apical aneurysm formation.
Cardiomyopathy, Hypertrophic/complications/*diagnosis ; Coronary Angiography ; Echocardiography, Doppler ; Heart Aneurysm/*diagnosis/etiology ; Humans ; Hypertrophy, Left Ventricular/complications/*diagnosis ; Magnetic Resonance Imaging, Cine ; Male ; Middle Aged ; Myocardial Ischemia/complications/diagnosis

Methods: A total of 14 patients with unilateral radicular symptoms and five healthy subjects were subjected to simultaneous apparent T2 mapping and neurography with nerve-sheath signal increased with inked rest-tissue rapid acquisition of relaxation enhancement signaling (SHINKEI-Quant) using a 3-Tesla magnetic resonance imaging. The Visual Analog Scale (VAS) score for neck pain and upper arm pain was used to evaluate clinical symptoms. T2 relaxation times of the cervical dorsal root ganglia of the brachial plexus were measured bilaterally from C4 to C8 in patients with radicular symptoms and from C5 to C8 in healthy controls. The T2 ratio was calculated as the affected side to unaffected side. Results: When comparing nerve roots bilaterally at each spinal level, no significant differences in T2 relaxation times were found between patients and healthy subjects. However, T2 relaxation times of nerve roots in the patients with unilateral radicular symptoms were significantly prolonged on the involved side compared with the uninvolved side (p<0.05). The VAS score for upper arm pain was not significantly correlated with the T2 relaxation times, but was positively correlated with the T2 ratio. Conclusions In patients with cervical radiculopathy, the SHINKEI-Quant technique can be used to quantitatively evaluate the compressed cervical nerve roots. The VAS score for upper arm pain was positively correlated with the T2 ratio. This suggests that the SHINKEI-Quant is a potential tool for the diagnosis of cervical nerve entrapment.

BACKGROUNDAlthough various studies have been conducted on the effects of radiation therapy for prostate cancer, rectal toxicity after radiation therapy for prostate cancer, which is an important late adverse event associated with radiation therapy, has not been sufficiently examined. This study aimed to assess the associations of late rectal disorder (LRD) with dosimetric, anatomic, and clinical factors in patients with prostate cancer who underwent three-dimensional conformal radiation therapy (3D-CRT).

METHODSWe retrospectively analyzed 104 patients undergoing 3D-CRT between January 2009 and October 2011. Thirty patients were administered anticoagulation/antiplatelet (AC/AP) agents. The standard dose was 74 Gy. Uni- and multi-variate analyses were performed to identify factors predictive of LRD after 3D-CRT.

RESULTSThe median follow-up period was 66 (range: 14-87) months. LRD occurred in 10.6% (11/104) of patients. The median time from RT to LRD was 15 months (range: 7-41 months). Sixty-four percent of those with LRD (7/11 patients) had been given AC/AP agents. Fifty-five (6/11) patients had severe internal iliac artery calcification. By univariate analysis, significant predictors of LRD were internal iliac artery calcification, administration of AC/AP agents, and age. Being very elderly was the significant predictor identified by multivariate analysis (P = 0.0276). For patients receiving AC/AP agents and those with severe internal iliac artery calcification, the LRD incidences were 23.3% (7/30 patients) and 23.1% (6/26 patients), respectively, and being 75 years of age or older was a significant predictor in these subsets.

CONCLUSIONSOur results suggest advanced age, administration of AC/AP agents, and severe internal iliac artery calcification to be risk factors for LRD in patients undergoing standard RT. Therefore, it is necessary to administer radiation with particular caution in the very elderly, especially those receiving AC/AP agents and/or with severe internal iliac artery calcification.