Objective: Prolonged use of Kampo medicines containing Gardenia fruit can cause mesenteric phlebosclerosis. A cumulative dose exceeding 5,000 g of Gardenia fruit may trigger this condition. However, the Japanese Pharmacopoeia 18th edition only specifies the minimum geniposide content in Gardenia fruits, making it difficult to assess the risk based solely on the cumulative Gardenia fruit dose. Hence, we evaluated mesenteric phlebosclerosis risk concerning cumulative geniposide intake in the current study. Quantitative analyses were conducted on ethical Kampo extract formulations containing Gardenia fruit.
Methods: Ethical Kampo extract formulations containing Gardenia fruit were separately extracted using an H₂O/methanol (1:1) solution and the resulting extracts underwent filtration. Each filtrate underwent quantitative, high-performance liquid chromatography analysis.
Results: Significant variation was observed in the geniposide quantities among various ethical Kampo extract formulations containing identical amounts of Gardenia fruit in each daily dose. Additionally, the extracts of orengedokuto, kamishoyosan, and bofutsushosan obtained from various companies exhibited maximum differences in geniposide quantities ranging from 1.5- to 2.7-fold.
Conclusion: This study highlights the challenges in accurately assessing geniposide levels in ethical Kampo extract formulations containing Gardenia fruit solely based on the daily dose of Gardenia fruit. The potential development of mesenteric phlebosclerosis should be considered based on the cumulative intake of geniposide rather than the cumulative dose of Gardenia fruit. Additionally, the study offers recommendations regarding the optimal geniposide quantities in ethical Kampo extract formulations containing Gardenia fruits.

Objective: The collection and utilization of adverse drug reaction (ADR) reports are essential in pharmacovigilance activities. Healthcare professionals, especially pharmacists, are required to report ADRs to the regulatory authorities in Japan. The ability of pharmacists to identify ADRs, assess causality and severity, and submit ADR reports is of utmost importance. This study aimed to investigate the current status and challenges of education regarding ADR reporting in pharmacy schools in Japan.
Design: A cross-sectional survey.
Methods: A self-reported questionnaire was conducted among faculty members of 77 pharmacy schools in Japan to assess the implementation of ADR reporting system education. A separate survey was conducted among hospital and community pharmacists to understand ADR reporting-related training provided during practical training. The questionnaire included items on implementing ADR-related lectures and practical training, characteristics and innovations in such education, and opinions on ADR reporting education.
Results: Responses were obtained from 48 pharmacy schools (response rate: 62%). The implementation rates for lectures on the ADR reporting system and ADR causality assessment were 94 and 83%, respectively, typically conducted in the 3rd or 4th year. However, the implementation rate for training on completing ADR reporting forms was only 38%, with 61% of these schools providing practical exercises. The survey of hospital and community pharmacists (n=22) revealed that 82% provided training on completing ADR reporting forms, often using case studies or simulated scenarios.
Conclusion: The survey found that pharmacy schools offer lectures on ADR reporting, but there isa need for practical training to improve pharmacists’ ability to report ADRs. To enhance pharmacists’ skills in this area, there should be more collaboration between schools and training sites, and comprehensive educational programs and lifelong learning opportunities should be developed.

Objective: Self-medication is promoted to extend healthy life expectancy. Accordingly, it is important for general consumers to properly use over-the-counter drugs. We investigated whether graphical symbols to visually aid the understanding of drug information (i.e., precautions and instructions to consult with a medical professional) provided in over-the-counter drug package inserts are easily understood in light of the International Organization for Standardization (ISO) criterion of 66％ comprehension.
Methods: First, two questionnaire surveys were conducted with pharmacy students to calculate their comprehension level of the illustrations. The first round was for modifying illustrations that did not meet the ISO standard, and the second round was for seeing if comprehension had improved. Then, a questionnaire survey targeting general consumers was conducted to see if these illustrations functioned as graphical symbols.
Results: When the referent of “Do not take this medicine if your experience falls under the following conditions” was placed in the upper left corner of the symbol, some students answered that this meant, “If you do not take this medicine, you will be under the following conditions,” but when it was placed in the lower right corner, many students accurately understood the intended information. In the student surveys, one illustration each for “cannot be taken/under treatment/heart,” “cannot be taken/under treatment/stomach,” “cannot be taken/under treatment/liver,” and “cannot be taken/under treatment/kidney” all exceeded 66％. Since none of the illustrations exceeded the 66％ comprehension in the survey of general consumers, it was found to be difficult for general consumers to understand drug information from the present illustrations. However, there were several illustrations that improved in comprehension compared to the previous study, which makes the continuation of this study significant.
Conclusion: Although there were no illustrations exceeded 66％ comprehension of general consumers, the study shows that continued improvement may result in establishing pictograms for general consumers.

Immunization Health Damage Relief Program is a system created with the aim of providing “quick and wide-ranging” relief for health damage caused by routine vaccinations. In this study, we investigated the current status of payments awarded for side effects of the human papilloma virus (HPV) vaccine over the 10-year period from 2013 to 2023. We obtained the data for this study from reports of the subcommittees of the Vaccination Health Damage Relief System, such as the results of deliberations by the Infectious Diseases and Immunization Review Subcommittee. The certification rate under this system was approximately 50%, which is the same as the certification rate of the Adverse Drug Reaction Relief System. The types of diseases and disorders reported in the system were diverse and had multiple symptoms. The number of applications increased in the final year of the study because of the recommendation for reopening the system for applications in 2022.

Two sizes of acetaminophen injection, 500 and 1,000 mg, have been approved for use in the USA and Europe, while only 1,000 mg has been approved in Japan. In Japan, overdosage of intravenous acetaminophen has been reported in pediatric patients. It is necessary align with international practices and introduce a 500 mg dosage, as in the USA and Europe. Therefore, we conducted a 6-month survey at Kyoto Chubu Medical Center from October 2020, focusing on single dose intravenous acetaminophen. Out of 400 cases, 333 (83.3%) received a single dose of 1,000 mg, 49 cases (12.3%) received 500 mg. Among children (< 15 years), all 17 cases (100%) received a single dose of 500 mg or less; in adults (≥ 15 years), out of 383 cases, 45 cases (11.7%) received 500 mg or less. The most commonly used single dose of intravenous acetaminophen was 1,000 mg, followed by 500 mg. These findings suggest that 1,000 mg is less necessary in children if 500 mg is available, and that, in adults, 1,000 mg may not always be required. In Japan, to avoid overdose in children and optimize dosage in adults, early introduction of 500 mg intravenous acetaminophen is crucial.

Objective: Pharmacists deliver medicines that require refrigeration directly to patients’ homes for home medical care or due to supply shortages. However, there are no investigations into the delivery of medicines under appropriate temperature control. Therefore, we conducted a questionnaire survey regarding the delivery of cold-stored pharmaceuticals and considered packaging methods for medicines that would enable appropriate temperature control based on the results.
Methods: A questionnaire survey was conducted at 86 pharmacies between January 25 and March 31, 2019. Subsequently, we measured the surface temperature of the medicine (InnoLet^® 30R Injection) using a cold bag and ice pack.
Results: We received responses from 79 pharmacies. The questionnaire survey revealed that 44% (35 pharmacies) delivered medicines needing refrigeration directly to patients’ homes, and of those, 43% (15 pharmacies) expressing concerns about temperature control during delivery. Additionally, based on a reproduction experiment using the packaging method confirmed in the questionnaire survey (using a cold bag, 0 to 4 ice packs, and an outside temperature of 28℃), the lowest storage temperature (mean±SD) of InnoLet^® was 18.8±0.3℃ for zero ice packs, 18.0±0.3℃ for one ice pack, 12.7±0.1℃ for two ice packs, and −0.2±0.3℃ for four ice packs. Thus, the storage temperature of InnoLet^® was outside the range of 2-8℃. Therefore, we improved the packaging method to maintain the proper storage temperature by using bubble wrap and paper wiper (Kim Towels^®) in 10-45℃ weather conditions.
Conclusion: In this study, we discovered the packaging method of medicines to maintain the proper storage temperature (2-8℃) in 10-45℃ weather conditions. Applying the temperature-based packaging method studied in this paper to actual pharmacy operations will ensure the quality of pharmaceuticals that require refrigeration, contribute to ensuring their efficacy and safety, and help ensure delivery. This is expected to alleviate pharmacists’ concerns regarding temperature control of medicines.