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.

Background/Purpose: Previous studies have suggested that environmental factors, such as weather, atmospheric temperature, humidity and seasonal change, may affect the disease activity of rheumatoid arthritis (RA). In the present study, we aimed to determine whether RA disease activity, including patient’s global assessment (PtGA), is influenced by seasonal variation, using a nationwide Japanese cohort database, NinJa (National Database of Rheumatic Diseases by iR-net in Japan). Methods: RA patients, who were registered in NinJa, are evaluated at any point during the indicated year. We analyzed data from RA patients (n=8,726), whose PtGA, pain visual analog scale (VAS) and physician’s global assessment (PhGA) data were available in NinJa 2012. In the present study, spring was defined as from March to May, summer as from June to November, Fall as from September to November and winter as from December to February. Age, sex, disease duration, number of tender joints, swollen joints, pain VAS, PtGA, PhGA, ESR, CRP, stage, class and mHAQ were also included as explanatory variables. Results: Univariable analysis using NinJa 2012 database revealed that PtGA, pain VAS and disease activity score (DAS)-28 were lowest during the fall months with statistical significance, which was reproducible in NinJa 2011 database analysis. On the other hand, multivariate analysis revealed that pain VAS, mHAQ and the number of swollen joints were the main determinants of PtGA, and seasonal variation was not identified as a statistically significant factor. Conclusion: We have clearly demonstrated that PtGA was lowest in fall. Seasonal changes can thus affect RA, although to a lesser degree than pain and activity of daily living, which should be taken into account when examining RA patients to better understand their symptoms.

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.