Background: Previous surveys have demonstrated that a significant proportion of inpatients did not receive adequate pain management at an acute care hospital in Japan. Aim: The aim of this study was to evaluate the usefulness of a hospital-wide audit for assessing pain management with opioids according to the electronic medical records (EMRs) Methods: The subjects of this audit were inpatients receiving strong opioids who had not been consulted by the pallia. tive care team (PCT). The PCT held a weekly pharmacist-led conference to evaluate the adequacy and appropriateness of analgesics, including opioids, as well as drugs administered for adverse effects according to information collected by the PCT pharmacists. The PCT subsequently recorded the advisory comments in the EMRs. Each week, the PCT monitored whether the suggestions had been accepted by primary physicians and whether the pain and/or adverse effects had improved. Results: Among a total of 4,978 cases evaluated during the 3-year survey period, 888 (17.8％) had inadequate pain and/or adverse effect management. Symptoms improved in 82.3％ of cases for which PCT proposals were accepted. Conclusion: The results suggest that this hospital-wide audit may be useful for improving pain management with opioids at an acute care hospital.

We report three closely watched cases of intractable Meniere's disease in the elderly that were successfully treated with Kampo medicine. Case 1 is a 75-year-old female. At the time of the 4th Meniere's attack, we gave her western medicines such as isosorbide, but she had a significant hearing loss. Then, we administered hachimijiogan extract granules, and her hearing level improved and she had been free of Meniere's attack for 23 months. Case 2 is a 78-year-old male. We diagnosed as bilateral Meniere's disease and treated him with western medicines such as isosorbide. In September of year X, his hearing level in the left ear worsened despite the treatment, so we prescribed hachimijiogan extract granules. After the treatment, we found the patient's hearing improved and nystagmus decreased gradually. He has also been free of Meniere's attack for 9 months. Case 3 is a 70-year-old male. He had repeated episodes of vertigo in spite of the administration of western medicines. After we prescribed shimbuto extract granules, vertigo attack and nystagmus disappeared. He has been relieved from Meniere's attack for 8 months. These cases indicate that Kampo therapy is one of the useful therapeutic options for intractable Meniere's disease in the elderly.

We collected and analyzed the case reports of minor incidents in the preparation of Kampo products in Japanese pharmacies in order to manage the medical safety control in Japanese traditional Kampo medicine. We extracted 2,166 reports that are related to Kampo products from the database of minor incidents in pharmacies supplied from The Japan Council for Quality Health Care from 2009 to 2019. Among the reports, we found the cases that pharmacists could find the mistakes about the name, dosage and administration of Kampo products or could prevent the appearance of adverse reaction when pharmacists check the prescription and ask prescription question for doctors. It is suggested that the system of separation of dispensing and prescribing functions would be well working in medical safety control. At the same time, we also found many cases that pharmacists have actually made mistakes by confusing the name of Kampo products and dosage. In this report, we summarized the cases of these minor incidents and frequently appearing confusions about the names of Kampo products.

The Medical Safety Committee analyzed the case reports of minor incidents from the pharmacies last time as part of an activity to promote patient safety in Japanese traditional Kampo medicine. This time, we analyzed the case reports of medical accidents and minor incidents from the medical institutions. We extracted 626 reports related to Kampo products from the public database, which the Japan Council for Quality Health Care has established based on the collected information related to the medical accidents and minor incidents. The medical accident information includes case reports related to drug-induced liver injury. The minor incident reports include prescribing error due to misinterpretation related to the quantity of one sachet of Kampo extract product, dispensing error due to similarity of product appearance, number or name, and administration error due to judging the medicine only by Kanji characters or product company names without checking the Kampo formula name. Additionally, the minor incidents were often discovered by people belonging to different professions or patients themselves. In order to promote patient safety, knowledge about these incidents should be shared among the people involved in the same or different professions.

The Medical Safety Committee has conducted various activities for patient safety in Japanese traditional Kampo medicines. In this study, we conducted a questionnaire survey to promote the prevention of medical accidents and their recurrence. We received responses from 15 of 19 facilities specializing in Kampo medicine and collected a total of 247 incident and accident cases in the field of Kampo medicine. Cases of side effects included interstitial pneumonia caused by Kampo prescriptions containing Scutellariae Radix, aconite poisoning, and licorice-induced pseudoaldosteronism. Furthermore, we also collected decoction-specific cases, which are unique to facilities specializing in Kampo medicine, for the first time. From the results, we included the following seven points for risk management in the field of Kampo medicine : 1) insufficient recognition to the side effects of Kampo medicines, 2) misunderstanding of the dosages of Kampo products, 3) errors due to similarities in Kampo formulas and crude drug names, 4) preconception of frequently used Kampo prescriptions, 5) contamination in the decoctions, 6) errors related to crude drug items and their dosages that are frequently added or subtracted, 7) errors in hospital wards.

The Japan society of oriental medicine created a committee of medical safety in 2017. The first activity was to summarize the representative side effects of Kampo medicine and to enlighten members of our society about them. In this report, we documented the knowledge to keep in mind at present on pseudoaldosteronism, drug-induced liver injury, and drug-induced lung injury. Since these three major side effects may cause clinically severe conditions, it is very important to detect them early and take appropriate measures. Therefore, proper examinations at the right time are necessary while taking Kampo medicine.

We are planning a study focused on the gathering of clinical data for the purpose of formalizing diagnostic logic at 6 institutions specialized in Kampo-based medical examinations. However, during the planning stage, it has been recognized that there are a large number of Kampo formulas to be studied, and differences among faculties and individuals exist regarding how to identify each Kampo formula, methods of gathering findings, and the evaluation of efficacy. Here we report the solution proposal reached after building consensus among all participating faculties on these issues. After raising the issues, conferences were held for each of them, until a unanimous consensus was obtained. As a result, the following conclusions were reached. Thirty-three Kampo formulas were selected as targets for the formalization of diagnostic logic. In addition, the range of dosage forms, crude drug ingredients, and permissible dosages for each Kampo formula were determined. Regarding clinical findings for these Kampo medicines, the items to be collected and evaluation criteria were also established. The criteria for evaluating the validity and safety of each Kampo medicine were decided, together with the grading and timing of evaluation. We hope that our solution proposal reached after building consensus becomes the basis for Kampo research in the future.