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.

PURPOSE: To examine the effects of conservative and surgical treatments for nocturnal leg cramps in patients with lumbar spinal stenosis (LSS). Nocturnal leg cramps is frequently observed in patients with peripheral neuropathy. However, there have been few reports on the relationship between nocturnal leg cramps and LSS, and it remains unknown whether conservative or surgical intervention has an impact on leg cramps in patients with LSS. MATERIALS AND METHODS: The subjects were 130 LSS patients with low back and leg pain. Conservative treatment such as exercise, medication, and epidural block was used in 66 patients and surgical treatment such as decompression or decompression and fusion was performed in 64 patients. Pain scores and frequency of nocturnal leg cramps were evaluated based on self-reported questionnaires completed before and 3 months after treatment. RESULTS: The severity of low back and leg pain was higher and the incidence of nocturnal leg cramps was significantly higher before treatment in the surgically treated group compared with the conservatively treated group. Pain scores improved in both groups after the intervention. The incidence of nocturnal leg cramps was significantly improved by surgical treatment (p=0.027), but not by conservative treatment (p=0.122). CONCLUSION: The findings of this prospective study indicate that the prevalence of nocturnal leg cramps is associated with LSS and severity of symptoms. Pain symptoms were improved by conservative or surgical treatment, but only surgery improved nocturnal leg cramps in patients with LSS. Thus, these results indicate that the prevalence of nocturnal leg cramps is associated with spinal nerve compression by LSS.
Adult ; Aged ; Aged, 80 and over ; Decompression, Surgical ; Female ; Humans ; Leg/*pathology ; Low Back Pain/epidemiology/etiology ; Male ; Middle Aged ; Pain/*epidemiology/*etiology ; Prospective Studies ; Questionnaires ; Spinal Stenosis/*complications/*physiopathology/surgery

We report a case of ulcerative colitis (UC) after mitral valve replacement (MVR) surgery due to infective endocarditis (IE). A 59-year-old woman underwent MVR for mitral regurgitation due to IE. Six days after the surgery, melena was observed suddenly, and she received a blood transfusion. Ulcer and erosion were observed in the rectum 5 to 10 cm from the anal ring by endoscopy. We changed her antibiotic treatment and stopped warfarin potassium. Heparin sodium was started 2 days after melena. We diagnosed ulcerative colitis from the finding of the rectal lesion and biopsy. We gave mesalazine and betamethasone as treatment for UC. The patient's condition improved and her general condition stabilized. She was discharged 36 days after surgery.

A 51-year-old man with osteogenesis imperfecta and who had aortic regurgitation was admitted to our hospital for aortic valve replacement. His height was 146cm and his weight was 49kg. The patient had suffered from bone fractures several times since childhood. Bone deformity, blue sclera and his status were clinically indicative of osteogenesis imperfecta. Aortic valve replacement with a 25mm SJM^® prosthetic valve was successfully performed for aortic valve insufficiency and slight annulo-aortic ectasia. Soft tissues and the sternum were fragile. Pathological examination (Elastica-Masson stain) of the aortic valve and left ventricular wall revealed a loss of fibrous tissues and remarkable thickening due to elastic fibers. The patient was discharged 31 days after surgery. Osteogenesis imperfecta is one of the collagen diseases caused by gene abnormality, in which fragile bones are easily fractured. Cardiovascular disease is rarely associated with it and the surgery-related mortality rate is reported to be approximately 30%, due to bleeding.

The first trial of common achievement test-computer-based testing was held from January through August 2002. The number of examinees was 5, 693, of whom 5, 676 were analyzed. Single-best-answer, five-choice questions were used. The highest score was 92 points, the lowest score was 19 points, and the average score was 55.9±10.2 points (standard deviation). Scores were distributed normally. The test sets did not differ significantly in difficulty, although test-set items differed for each student. The percentage of correct answers, the ∅-coefficient, and the point-biserial correlation coefficient were calculated for each category of the model core curriculum. The percentage of correct answers was highest in category A of the model core curriculum, and percentages of correct answers were similar in categories B, C, D, E, and F. The ∅-coefficient and the correlation coefficient were low in categories A and F and were highest in category C. Although the percentage of correct answers in this trial was lower than expected, many test items had discriminatory power. The Test Items Evaluation Subcommittee is now evaluating test items, determining pool items, and revising new test items for the second trial and expect to compile a useful item bank.

In 2002, Japanese medical students began computer-based testing (CBT) to assess their basic and clinical medical knowledge, based on the model core-curriculum, before starting clinical clerkships. Of 9, 919 multiple choice questions submitted by 80 medical schools, 2, 791 were used for CBT and 7, 128 were rejected. To improve the quality of future CBT, we analyzed why questions were rejected. The most commons reasons were difficulty, length, and inappropriate choice of answers. A training course may be needed to improve the ability of medical school staff to devise questions.

Japan's food self-sufficiency rate has fallen off to around 40%. A questionnaire survey of residents of Toride-city reveals that 60% of the citizens are concerned about this low self-support rate. Even junior and senior high school students are anxious about this situation.
It is feared that world food production will not increase in proportion the rise in demand from now on by the influence of global warming. There is a possibility that foods supply could be temporarily cut off by the interruption of shipping lanes considering the unstable political conditions around Japan.
Although the decline in the self-sufficiency rate should be discussed as a fundamental subject of the country, the mass media of Japan do not take it up seriously. The mass media would not show how to deal with the food crisis, but only blame it as a result of the unreasonable agricultural policy.
Since 1993, Japan has approved minimum access of rice import, because the GATT and WTO put pressure on the Japanese government to approve the liberalization of the rice market. In 1999, rice tariffication was put into effect. The mass media and the government are afraid of the import restriction by foreign nation of industrial products from Japan as a result of the opposition to rice import in the name of food security.
The opening of the rice market will increase the imports of rice and the rice growers of Japan will sustain serious damage. Countries other than the U. S. and the Cairns Group will understand the Japanese assertion of food self-sufficiency as Japan is an island country. After reaching an agreement with the developing countries and NGO on this matter, Japan should revise the WTO agreement.
Although a farm village should retain some original scenery of Japan, housing styles and colors of a farm village in Japan are in total disarray. We want to propose to build 10-20 “model farm villages” in the country. If the model farm village retains Japanese original scenery, many city residents visit it and the image of an old farm village will give them a good impression, opening up the possibility of green tourism. If the model farm village gets a good reputation, the number of farm villages which hope to retain Japanese original scenery will increase and regain the rural beauty.
It is also important for a farm village to return to its original recycling life style. In Europe, it is a prevailing practice to recycle the garbage discharged from a farm village, including excretions of livestock, straw and so forth. And the technology, that changes biomass into methane or ethanol has been developed and become commercialized in Europe. It is important for a farm village to introduce such a technology and aim at a circulation style society more promptly than a city.
The Japanese Association of Rural Medicine should conduct a long-term prospective epidemiological survey to clarify whether the decrease in carbohydrate intake including rice and the increase in the ingestion of animal food have some relations with the recent rapid increase of diabetes. It will not be impossible to do so if collaboraion from medical examination centers across the country is obtained. If it becomes clear that the present eating habits are not good for our health, the rice-based diet revives and the demand for rice grows. And Japan's food self-sufficiency rate will go up in the long run.

A 45-year-old woman who was a Jehovah's Witness was admitted to our hospital with a complaint of palpitation and sort on-effort. A ruptured aneurysm of the sinus of Valsalva (RASV) associated with stenosis of the right ventricular outflow was diagnosed. Operative findings revealed a RASV with a double chambered right ventricle (DCRV) and a ventricular septal defect (VSD). RASV, DCRV and VSD were successfully repaired with extracorporeal circulation without use of homologous blood. We reported this case because congenital combination of RASV, DCRV and VSD is very rare.

A 69-year-old man complained of abdominal pain with inflammatory reaction. Abdominal aortic aneurysm (AAA) with a left main trunk lesion was diagnosed and he successfully underwent Y-graft replacement of the abdominal aorta and coronary artery bypass grafting. Finally AAA was classified as “inflammatory” by histopathological findings. We present this case of “inflammatory AAA” associated with coronary artery disease, and discuss it with a review of literatures.