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.

Simultaneous creation of an enterostomy for enteral nutrition during esophagectomy has been useful in our experience, but bowel obstruction associated with intestinal fistula remains a problem. Therefore, in this study, we retrospectively reviewed 18 patients with esophageal cancer who underwent transdiaphragmatic transgastric tube enteral feeding catheter placement during gastric tube reconstruction via the mediastinal route after esophagectomy from November 2012 to March 2014. The catheter was guided from the gastric tube into the gastrointestinal tract, with the tip placed in the jejunum distal to the ligament of Treitz. From the gastric tube, the catheter was guided along the diaphragm to the anterior abdominal wall through the extraperitoneal route. No bowel obstruction associated with catheter placement has been observed in any of the patients from the time of surgery to this writing. Also, the procedure enabled jejunostomy use for more than 5 years, similar to conventional jejunostomy. We experienced 1 case of catheter deviation into the mediastinum. Overall, transgastric tube enteral feeding catheter placement for reconstruction of the posterior mediastinal gastric tube was useful for avoiding intestinal obstruction associated with jejunostomy. However, there may be a risk of catheter displacement into the mediastinum.

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.

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.

We report here 2 cases of traumatic diaphragmatic hernia. Case 1 was a 76-year-old man who was injured in a road traffic accident (RTA). Chest X-ray and computed tomography (CT) revealed prolapse of the stomach into the left thoracic cavity. We performed laparotomy with a diagnosis of traumatic left diaphragmatic hernia. A 12-cm hole was seen in the central tendon of the left diaphragm and this was repaired by suturing. Case 2 was a 75-year-old man who was also injured in an RTA. Chest X-ray and CT revealed prolapse of the stomach and transverse colon into the left thoracic cavity. We performed laparotomy with a diagnosis of traumatic left diaphragmatic hernia. A 15-cm hole was seen in the central tendon of the left diaphragm and this was repaired by suturing. Traumatic diaphragmatic hernia is a relatively rare condition and one that requires surgical repair. It is important to make prompt diagnosis with appropriate radiological investigations. Additionally, patients with diaphragm hernia caused by blunt trauma often have injuries to other organs. Care should be taken so as not to miss associated injuries.

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 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.