We analyzed dispensing receipt data in the medical treatment in October 2019 using the Receipt Information/Specific Medical Examination Information National Database (NDB), extracted the cases of multiple combinations of Kampo prescriptions, and analyzed their frequencies. Of the 536,524 receipts, 44,731 (8.3%) included Kampo and non-Kampo crude drug preparations. Of the receipts that included Kampo and non-Kampo crude drug preparations, 38,032 receipts (7.1%) included single Kampo or non-Kampo crude drug preparation. There were 6,699 receipts (1.2%) that included multiple Kampo and non-Kampo crude drug preparations. There were 187 receipts for the decoctions containing multiple rude drugs without Kampo preparations, and the ratio was 0.035% of all receipts and 0.42% of the receipts containing Kampo and non-Kampo crude drug preparations. There was one receipt containing eight Kampo preparations, three receipts containing seven Kampo preparations, and a total of 84 receipts containing five or more Kampo preparations. Although it is unclear how many multiple Kampo preparations were prescribed at the same time, this investigation indicates the actual duplication of multiple Kampo preparations.

The usage of Kampo medicine has been expanding in hospitals and pharmacies, and the systematic education on Kampo medicines and their components is urgently needed. Although the efficacies of Kampo formulations are approved at the national level, those of the composing crude drugs are not approved individually except for some cases. Consequently, the efficacy description of individual crude drug in textbooks differs much depending on the authors. To clarify this situation, we suggested the standardized description of the efficacy of crude drugs used in ethical Kampo formulation using terms of modern Western medicine in the previous study. In this study, we reviewed the descriptions of efficacies using the terms of Kampo medicine in the books published in Japan from the 17 century to the present to explore the possibility of standardizing the crude drug efficacies using the terms of Kampo medicine. The proposal for standardized description of the efficacy of crude drugs was based on the high frequency of appearance of the terms in successive books.

Japanese valerian root (kanokoso, the dried root of Valeriana fauriei) has been known as a substitute for European valerian root (the dried root of V. officinalis). However, the usage of Japanese valerian root and the change of its crude drug name from ancient times in Japan have not been clear. We investigated ancient literatures, and revealed that Japanese valerian root might be used as folk medicine with the name of Japanese nard (wakansho) in the mid Edo period. Similar to the usage of European valerian root, Japanese valerian root had been used in the treatment for hysteria specifically in the late Edo period. It is considered that Japanese valerian root began to be used as women’s home medicines since hysteria had come to be assorted in women’s medical disorders in the early Showa era. Japanese valerian root had been originally named as kesso. However, kesso had been recognized as European valerian root since the plant name of V. officinalis was translated into Japanese as kanokoso in the late Edo period. In the early Showa era, the name of Japanese valerian root was changed into kissokon, and the Japanese nomenclatures for both Japanese and European valerian roots became recognized separately. After World War II, the description of kanokoso changed from kanji into katakana characters in Japanese.

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.

Following the Chinese-led global standardization of Chinese medicine, the 9 th edition of the European Pharmacopoeia, published in 2016, listed 66 kinds of crude drugs that are used in traditional Chinese medicine. By the spread of dietary supplements in the United States, the number of herbal medicines listed in United States Pharmacopoeia is tended to be increasing. In this article, we compare the names and origins of crude drugs listed in the European and American Pharmacopoeias and used in ethical Kampo extract formulation with those described in the pharmacopoeias of Japan, China, Taiwan, and South Korea. There were 4 crude drugs that had the same origins and names in the pharmacopoeia of these 6 countries, but only Coix Seed had the same English name. The pharmacopoeia of the 5 countries except the United States had 19 crude drugs with the same origin, but only Platycodon Root and Eucommia Bark had the same English and Latin names. For other crude drugs, the names and origins in the pharmacopoeia of each country were different. When scientists in each country disseminate the information about crude drugs used in their own countries to the world, it is necessary for them to describe the original plant scientific names and their medicinal parts that are unified by International Code of Nomenclature for plants instead of English or Latin names of crude drugs.

Although the descriptions of shigyakukachotanto in “Waitaimiyaofang” and tsumyakushigyakukachotanjuto in “Songban Shanghanlun” are quite similar to each other, the specifications of the dosages of crude drugs and the water volume in the books were considerably different. Focused on the specified water volume to decoct these formulas, each reasonable decocting period was estimated, then the decoctions were prepared using hard water that was common in mainland China. The dosages of aconite root were 2­-fold different between these two formulas, but the contents of aconitine-­type diester alkaloids (ADA) in both decoctions were found in the range of 1.2—1.4­-fold. It was suggested that in order to control the efficacy and the safety of aconite, the decocting period was well regulated by the specification of water volume for decocting at this ancient era. Moreover, the dosages of aconite root and glycyrrhiza in bukuryoshigyakuto (BSGT) formula of “Songban Shanghanlun” are equal to those of shigyakuto (SGT) but the specified water volume to begin decocting is as about twice as that of SGT. When prepared using hard water, BSGT resulted to make the contents of ADA lower and those of non-­ester alkaloids higher compared with those of SGT decoction. It was suggested the spe­cific water volume for each formula prescribed in classical Chinese medicine had considerable significance to determine the dosages of chemical ingredients in the decoctions especially in the circumstances using hard water to prepare them.

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.

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.

Kampo physicians in the Showa era, such as ARAKI Seiji and OTSUKA Keisetsu, had called raw ginger as the herbal medicament “ginger”, and processed or unprocessed dried ginger as the medicament “processed gin­ger”. However, many Kampo physicians in the present Japan call unprocessed dried ginger as the medicament “ginger”, and processed dried ginger as the medicament “processed ginger”. The aim of this study is to investi­gate the background of the process of this change from the Showa era to the present. We searched the defini­tions of the medicaments “ginger” and “processed ginger” in successive Japanese Pharmacopoeia editions and other related books describing these definitions. In Japanese Kampo medicine before the Showa era, the herbal medicament “ginger” had referred to raw ginger, and the medicament “processed ginger” had referred to proc­essed or unprocessed dried ginger. However, after the Heisei era, the medicaments “ginger” and “processed ginger” have referred to unprocessed dried ginger and processed dried ginger, respectively. And the raw ginger has been called as “preserved ginger”.

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.