Pharmacovigilance for vaccines has different considerations from other drugs. In this article, contributions of databases for vaccines pharmacovigilance are discussed, such as spontaneous case reporting databases and medical information databases (claims databases and electronic health record databases). Regarding spontaneous case reporting databases, some databases such as in-house databases and Japanese Adverse Drug Event Report database (JADER) have been already established, and can be utilized for detection of a vaccination failure, a vaccine quality defect-related issue and a statistical safety signal. In the future, a pharmacovigilance activity for vaccines with spontaneous case reporting databases will be expected to become more robust by integrating data which pharmaceutical companies and regulators respectively accumulate and by compiling data from current regulatory programs. Regarding medical information databases, while there is a critical limitation that vaccination information cannot be captured, some points can be utilized, for example, to understand background incidence/trend of events or infections. Also there is a possibility that an assessment by using medical information databases can be alternative means of current regulatory programs. In the future, a paradigm shift will be expected through establishment of further medical information databases, for example, by standardization of vaccine code on the electronic medical record and by linkage of vaccine data to the medical information databases.

This article describes findings about effective utilization of electronic medical databases from a viewpoint of a pharmaceutical company, with a progress of MIHARI Project in mind. Purposes of this article are (1) to understand merits to perform a database study and a drug use result survey as an additional pharmacovigilance activity for each risk in a risk management plan, and (2) to find points to be considered when their activities are to be selected. A database study has advantages as follows: a comparison group can be set easily; a power is high as a database has many cases; and no need to consider some points such as reporting bias and recall bias. On the other hand, some issues of a technical point (e.g. understanding characteristics of each database) and a regulatory system (e.g. clarifying association to the drug reexamination system) should be considered. A drug use result survey has advantages as follows: data can be collected, even the data that databases do not have; and a drug use result survey in a specific condition can be useful. As a usual design of drug use result surveys however is hard to answer a research question on each risk, more various designs should be considered. Each pharmacovigilance activity has different points to be considered. Therefore, we have to clearly understand the purpose to perform an additional activity and select the most appropriate activity to maximize the benefit of medication users.

To examine the personal space perception, measurements were conducted on both arms in 227 young men and women. Each subject, with his eyes closed, was instructed to stop the horizontal swing motion of his arm at the point he considered to be the middle of the range of possible motion on the horizontal plane, and this was repeated ten times.
Mean values of bisected angles were deviated from the middle points in the direction of the horizontal adduction, although there were large differences between the individuals. The deviation was larger in the right arms than that in the left, and it increased with the increasing range of motion of the horizontal abduction.
It was suggested that the gain of the personal space perception is higher in front of the body than in the side on the horizontal plane of the human shoulder.

We report a case of chronic DeBakey type I dissecting aneurysm with an aberrant right subclavian artery, in which replacement of the ascending aorta and the transverse aortic arch was performed under selective cerebral perfusion, resulting in complete obliteration of the false channel in the descending thoracic aorta. A 57-year-old female was admitted to our service complaining of chest and back pain. An aberrant right subclavian artery that originated from the descending thoracic aorta was identified. During operation, the dissected aortic wall of the aortic arch and the proximal descending thoracic aorta that involved more than half of its circumference was resected, the dissected intima was reapproximated at the distal stump, and the beveled distal end of the tubular ascending aortic prosthesis was secured to the cut edge. The postoperative course was uneventful, and she is leading a normal life now four years after surgery. It is rare to reconstruct the aortic arch for aortic dissection that occurred in a patient with aberrant right subclavian artery, and the technical details were reported.

In order to examine the personal space perception, measurements were conducted on both elbows in 14 men and 46 women. Each subject, with his (or her) eyes closed and with his upper arm fixed horizontally, was instructed to stop the vertical and horizontal swing motion of his lower arm at the point he considered to be the middle of the range of possible motion on the front and side of plane at his shoulder, and this was repeated ten times. In various conditions, similar measurements were also done to study factors affecting the personal space perception in 14 men.
Mean values of bisected angles in percentage against range of motion were deviated from the middle points in the direction of the elbow extension, although there were large differences between the individuals. The deviation was smallest in the vertical. side of plane, and was larger in the horizontal plane than that in the vertical plane. The deviation was not so much affected by the various conditions.
It was suggested that the gain of the personal space perception is higher in the elbow extension than in the elbow flexion and its difference is larger in the horizontal plane than in vertical plane of the human elbow joint.

Background: There is a shortage of general practitioners in Japan. With the revision of educational guidelines, general practice (GP) education has improved. However, the amount of education on GP in medical schools remains inconsistent. This study examined the relationship between medical students’ amount of GP-related education and their subsequent choice of GP majors. Methods: A retrospective cohort study was conducted in a teaching hospital in Japan. Participants were residents in the hospital. The exposure comprised compulsory lectures and training time for community-based medicine in medical schools. The outcome included participants choosing GP majors after their initial 2-year junior residency. Results: Fifty-one participants were included in the final analysis. Of these, 14 majored in GP and 37 in non-GP after their initial 2-year junior residency. Of the participants who took GP lectures for 18 hours or more, 11 chose GP majors, and 18 chose non-GP majors (risk ratio, 2.78; 95% confidence interval [CI], 0.88–8.79). Of the participants who underwent training for 12 days or more, 10 chose GP majors, and 16 chose non-GP majors (risk ratio, 2.40; 95% CI, 0.87–6.68). Conclusion The results do not support the association between the amount of compulsory undergraduate education for community-based medicine and the subsequent increase in the number of residents choosing GP majors in Japan. Educators would do well to explore different approaches, such as improving the quality of education to increase the number of GP residents. Further research is needed to reach more definitive conclusions.

Good Post-Marketing Study Practice (GPSP) changed in April 2018, allows pharmaceutical companies to use a real-world data for pharmacovigilance activity. On the other hand, it is known that there are 3 major dimensions of pharmacovigilance： “Monitoring, vigilance, and science：building the best evidence” ,“Regulation, industry, and legal system：ensuring public health” and “Medicine, medicines, and uncertainty : doing good to patients” . Therefore, in this article, we consider how the change of GPSP reflects on the 3 features of pharmacovigilance.In general, it is thought that the change of GPSP contributes pharmacovigilance, considering the 3 features of pharmacovigilance. On the other hand, there are some points to improve pharmacovigilance system：1) how a safety question for pharmacovigilance should be addressed, 2) how information of routine pharmacovigilance should contribute to a safety question to be addressed, 3) how a feasibility assessment (assessment of data source before conducting a formal comparative activity) should be conducted, and 4) a necessity of a variety of methodology and data sources such as descriptive studies and disease registry. These improvements will contribute to global standardization and give us global competence.Overall, it is very difficult to consider the best safety question, data source and methodology from many options. However, it is thought that keep considering them in order to accumulate experiences is important for our ultimate goal, which is to help our patients. We expect more discussions among all the stakeholders together.

Autoimmune enteropathy (AIE) is a rare disease, characterized by intractable diarrhea, villous atrophy of the small intestine, and the presence of circulating anti-enterocyte autoantibodies. Immune dysregulation, polyendocrinopathy, enteropathy, X-linked (IPEX) syndrome, and mutations in FOXP3, which is a master gene of regulatory T cells (Tregs), are major causes of AIE. Recent studies have demonstrated that mutations in other Treg-associated genes, such as CD25 and CTLA4, show an IPEX-like phenotype. We present the case of a 13-year-old girl with CTLA4 haploinsufficiency, suffering from recurrent immune thrombocytopenic purpura and intractable diarrhea. We detected an autoantibody to the AIE-related 75 kDa antigen (AIE-75), a hallmark of the IPEX syndrome, in her serum. She responded well to a medium dose of prednisolone and a controlled dose of 6-mercaptopurine (6-MP), even after the cessation of prednisolone administration. Serum levels of the soluble interleukin-2 receptor and immunoglobulin G (IgG) were useful in monitoring disease activity during 6-MP therapy. In conclusion, autoimmune-mediated mechanisms, similar to the IPEX syndrome, may be involved in the development of enteropathy in CTLA4 haploinsufficiency. Treatment with 6-MP and monitoring of disease activity using serum levels of soluble interleukin-2 receptor and IgG is suggested for such cases.

Following the revision of the structure and content of the Model Core Curriculum for Medical Education to be more outcome-based and the legal status of the medical practice performed by medical students in the clinical clerkship, we have revised the Guideline for Participatory Clinical Clerkship. The following items were revised or newly described : significance of enhancing the participatory clinical clerkship, scope of medical practice, confidentiality, patient consent, patient consultation and support service, objectives of the clinical clerkship, simulation education, departments where the clinical clerkship is conducted, assessment in the clinical practice setting, CC-EPOC, and entrustable professional activities. A foundation has been established to promote seamless undergraduate and postgraduate medical education. However, future work is needed to examine the specific level of performance expected at the end of the clinical clerkship and department-specific clinical practice goals and educational strategies.