Objectives : Pharmaceutical companies in Japan can attach pharmacoeconomic (PE) data to their application for new drug prices covered by the National Health Insurance (NHI) system since 1992. To examine the present state of PE studies in Japan by investigating the situation of PE data attachments and their details and also to identify problems concerning how to reflect the PE information in new drug pricing, a questionnaire-based survey of pharmaceutical companies was conducted.
Method : The survey covered 115 drugs filed by the members of the Japanese Pharmaceutical Manufacturers Association (JPMA), which are among the 137 drugs listed between June 20, 1997, when the NHI drug price formula was published, and November 17, 2000. Questionnaires were returned on 114 of the 115 drugs studied and the response rate was 99%.
Results : PE data was attached to 37 of the 114 drugs (32%) at the time of application. The ratio of applications accompanied by PE data tended to be decreased from 1998. No significant relation was observed between a premium for a drug and the attachment of PE data. The most common method used in the attached PE data was cost-effective analysis (14 of 37 drugs ; 38%), followed by cost-benefit analysis (7 drugs) and cost-minimization analysis (6 drugs). Cost-utility analysis was not applied to any of the 37 drugs.
Discussion : Compared with overseas PE studies, Japanese studies were found to be less comparable with one another due to the lack of a uniform system of research and reporting results. Other problems observed included insufficient epidemiological data for analysis and difficulty in the cost data collection. The questionnaire-based survey revealed that Japan needs to set guidelines for PE studies and to establish epidemiological and cost databases for these research activities. It also suggested the necessity of reviewing the present method of clinical tests so that economic parameters for PE analysis and QOL may be obtained from these tests.

We experienced 4 cases of graft-enteric fistulas in which 2 cases were died due to intestinal hemorrhage and the other 2 cases are survived by the surgical treatment of infected graft excision with extra-anatomical bypass or anatomical bypass grafting with omental wrap. The most important thing is to prevent this late complications at the first operation by wrapping of graft with the surrounding tissues or omentum.

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 Standardized Structured Medical record Information eXchange (SS-MIX) was started in 2006 as the project supported by the Ministry of Health, Labour and Welfare (MHLW) for promoting the exchange of the standardized medical information. Free soft wares developed in the project allow the storage of medical information to receive HL7 messages for prescription, laboratory test results, diagnoses and patient demographics in the hospital information system (HIS). We encourage the use of the SS-MIX standardized storage for postmarketing surveys and clinical studies. The recommendations consist of the following 7 parts. [1] In surveys and clinical studies, the information of drugs and laboratory test results in the SS-MIX standardized storage can be directly transferred to the electronic questionnaire and the investigators may obtain the information with high accuracy and granularity. [2] The SS-MIX standardized storage works as the backup system for the HIS because it can provide the minimum information essential in patient care even under the disastrous condition like earthquake or unexpected network failure. [3] The SS-MIX standardized storage may be useful to conduct a good pharmacoepidemiology study not only because it provides the information in the storage efficiently but also it can be used to identify “new users” who started the drug after some period of non-use.The “new user” design is often essential to have the unbiased results. [4] When the drug company conducts postmarketing surveys according to the current regulation, the use of the SS-MIX standardized storage will facilitate the fast and efficient collection of data to develop the timely measure to minimize the drug-related risk. With the SS-MIX standardized storage, it is also expected that many types of study design can be employed and the quality of data is improved in the survey. [5] The SS-MIX standardized storage maybe also useful to evaluate the risk minimization action plan by comparing the prescription pattern or incidence of the targeted adverse event between two periods before and after the implementation of the action plan. [6] In planning clinical trials, the SS-MIX standardized storage may be used to estimate the size of eligible patients. The storage may also allow conducting cross-sectional studies to know characteristics of diseases or drug treatment. In addition, cohorts of those who had coronary artery angiography, new users of a drug and those with a rare disease may be readily identified. Using such cohorts, investigators can initiate a case-control study nested within the cohort, pharmacogenomic studies and comparative effectiveness researches. [7] The SS-MIX standardized storage may be used as the formal data source in clinical trials in the future when some conditions are satisfied. For instance, the formal agreement should be reached between industry, government and academia on the use of standards of data structure in Clinical Data Interchange Standards Consortium (CDISC) and on the operation of computerized system validation (CSV) in the clinical trials.

Objective: The coronavirus disease 2019 (COVID-19) vaccine was a specially approved pharmaceutical in Japan in February 2021. However, several people were concerned about its safety. Therefore, we conducted a survey on our hospital staff with suspected adverse effects related to COVID-19 vaccines and promptly published the results on our website. Methods: The current study included hospital staff who received the COVID-19 vaccine. A questionnaire survey on suspected adverse effects was conducted after each vaccination from the first to the fifth dose. Data on the survey results were promptly posted on the hospital’s website. The number of hits and time spent on the site were also evaluated. Then, we examined. the media (newspapers and television) that reported our findings and the content of their coverage. Results: There were no new findings regarding suspected adverse effects of the COVID-19 vaccines. An article published on our website on June 18, 2021, received more than 9,000 page views with an average time spent of > 3 min. Four media outlets reported on our hospital’s articles from June to July 2021, when public interest in the first and second doses of the vaccine was high. Conclusion: The early release of the survey results has provided a source of information for people who want to obtain safety information regarding the adverse effects of the COVID-19 vaccine.

Home-based and in hospital pharmacists at our hospital pharmacy participated in this study. A survey of the home-based pharmacists’ work contents was tabulated from November 2019 to May 2021. Furthermore, a questionnaire survey was administered within the pharmacy in May 2020. 90% of the hospital pharmacists would consider some drug information management to be able to work from home. Moreover, evaluation of the questionnaires revealed that more than 90% of the in-hospital pharmacists were “satisfied” or “somewhat satisfied” with deliverables of home-based pharmacists. The in-hospital pharmacists found communication tools (e.g., social networking services, telephone, and web-conferencing systems) to be useful for facilitating collaboration with the home-based pharmacist. Therefore, it is necessary to improve the internet environment to work from home. Moreover, it is important to create an environment where pharmacists can work from home according to their desire and needs in cases such as childcare, nursing care, during treatment, and during a pandemic. This study indicates that hospital pharmacists can carry out their responsibilities and demonstrate their work abilities not only in the hospital pharmacy setting but also in a remote working environment.

A 17-year-old male was admitted to our hospital because of strong abdominal pain. His symptoms gradually worsened even after hospitalization, and contrast computed tomography (CT) revealed hemorrhage in the abdominal cavity. Interventional radiology (IVR) was performed to identify the bleeding site. No obvious source of bleeding was identifiable on IVR, so we opted to perform laparoscopic examination and hemostasis. The intraperitoneal finding was hematoma in the omentum, and omentectomy was performed for idiopathic omental hemorrhage because there was no history of trauma. The postoperative course was good and the patient was discharged after postoperative day 4. Performing laparoscopic surgery for omental hemorrhage facilitated minimally invasive treatment with a short hospital stay.

In our hospital, we typically perform laparoscopic partial gastrectomy as surgical treatment for extragastric growth type of submucosal tumor (SMT), and laparoscopic intragastric surgery for intragastric growth type. In 2008, laparoscopic and endoscopic cooperative surgery (LECS) was reported for the first time by Hiki et al. Against the background of LECS as laparoscopic local gastric resection with endoscopic resection, we started LECS for gastric SMT from 2015. 　　We performed laparoscopic (LAP) surgery for 15 gastric SMT cases from 2009, and compared 5 cases for which LECS was performed and 10 cases for which LAP was performed. Tumor diameter was 15–21 mm (mean 19.2 mm) in the LECS group, and 20–53 mm (mean 35.5 mm) in the LAP group; the LECS group had a significantly smaller tumor diameter. Operative time was 299 ± 45 min in LECS and 222 ± 25 min in LAP. The volume of blood loss was 24 ± 13 mL in LECS and 33 ± 13 mL in LAP. Hospitalization days was 14.0 ± 3.0 days in LECS and 12.9 ±0.8 days in LAP. There was no significant difference between them.

A 70-year-old man with continuous diarrhea for over 1 month consulted a primary care doctor. He was treated with oral antibiotics and probiotics but his condition worsened. He developed generalized edema and was referred to our hospital. Abdominal ultrasound and computed tomography (CT) scan findings were suggestive of colon cancer with accompanying liver metastasis. Total colonoscopy and endoscopy for pathological diagnosis led to a diagnosis of cancer of the sigmoid colon accompanied with liver metastasis or liver abscess. We planned to perform sigmoidectomy with simultaneous resection of the liver lesion. However, we considered that he was not particularly fit to undergo two concurrent surgeries. Therefore, based on his physical condition, we planned to first do a sigmoidectomy. Before surgery, the fever persisted and a repeat CT scan showed deterioration of the liver lesion. We diagnosed the liver lesion as abscess and performed percutaneous transhepatic abscess drainage (PTAD). Three days after PTAD, we then performed sigmoidectomy. Subsequently, the liver abscess resolved and gradually disappeared. At 5 years after surgery, there has been no recurrence of the cancer or abscess.