In the Basic Principles for the Preparation of the Japanese Pharmacopoeia (JP), 18th edition, the JP is referred to as an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan and as a public property that should be widely used by all parties concerned, such as pharmaceutical administrations, companies, and those involved in research, education, and medical practice. In addition, it states that the JP should play an appropriate role of providing information and proper understanding of drug quality to the public and should promote and maintain advances, consistency, and harmonization of technical requirements in the international community. These show that the JP not only contributes as a written standard but also as a provider of information on test methods and international understanding for drug quality control. JP articles refer to a wide range of drugs at various phases of the product life cycle, as it should cover all drugs in terms of importance from the healthcare viewpoint. When the JP is viewed from a panoramic perspective, these are the reasons why its contents are extremely profound and complex. This report discusses the JP's role and expected future as a scientific document from the author's viewpoint as a JP Expert Committee member for more than 30 years.

The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan. To ensure the efficacy and safety of pharmaceutical products, it is essential to establish standards that ensure their quality. For this purpose, the JP aims to include all drugs that are important from the viewpoint of healthcare and medical treatment, and description of each monograph of medicine is maintained and improved so that those standards can be generally practiced. In addition, to play a key role as the official document in the field of pharmaceutical product quality, JP contents are enhanced by proactively introducing the latest scientific knowledge and technologies. As the international manufacturing of pharmaceutical products and their raw materials that are distributed in Japan is increasing, the JP has recently begun to promote the international harmonisation of pharmaceutical excipients and general tests through the Pharmacopoeial Discussion Group (PDG) and to swiftly implement the harmonised items in the JP. In addition, the JP will implement internationally harmonised concepts and specifications for pharmaceutical products, e.g., the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to define the latest concepts of quality control for pharmaceutical products in the official document. We introduce the implementation of the latest scientific knowledge, technologies, and activities for international harmonisation of the JP.

The Japanese Pharmacopoeia (JP) has played a major role in ensuring the quality of drugs used in Japan as the ultimate source of information on pharmaceuticals. Physicians and pharmacists can reliably use drugs in the clinical setting because they trust the quality when medical treatment progresses smoothly. When there is a problem or challenge, they can refer to the JP. For pharmacists, both the quality of the drug and information on its efficacy and safety are indispensable. Twelve years have passed since the introduction of a 6-year course in pharmacy education, but the weight placed upon the JP has not increased in the educational curriculum. A specific behavioral objective of describing the significance and structure of the JP is included in the revised model core curriculum for pharmacy education. However, fewer than 60% of pharmacy schools have courses specifically focusing on the JP. Professors of physical chemistry, analytical chemistry, pharmaceutics, and pharmacognosy often teach the relevant sections of the JP in their lectures. The foundations of the Japanese manufacturing industry have been questioned because data falsification and inspection fraud have been disclosed in numerous fields. Therefore, ethical education for those who use the JP is a prerequisite for ensuring the reliability of pharmaceuticals.

The rapid increase in the use of ethical generic pharmaceutical formulations in Japan emphasizes the importance of measures to ensure the quality of pharmaceutical distribution. This short review discusses the contributions of the Japanese Pharmacopoeia (JP) to pharmaceutical quality control. Numerous monographs have defined specifications and tests for multiple active pharmaceutical ingredients and excipients. Standardized methods of performing general tests and reference standards allow efficient, reliable evaluation of pharmaceutical quality during development processes and commercial manufacturing. Some new methods of characterizing the structure and performance of nonbiological complex drugs have been included in recent editions. An introduction to general tests and general information regarding the control of impurities in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines should significantly reduce the safety risks of pharmaceuticals.

Biologics listed in the Japanese Pharmacopoeia (JP) include drugs in which the active pharmaceutical ingredient is a peptide, protein, or polysaccharide. Biologics were previously manufactured by purification from biological sources, however, most recently developed products are manufactured using biotechnology such as genetic recombination and cell culture technologies. The JP provides useful information to ensure the quality of such products in the form of monographs, general test, and general information. A recent topic related to biologics is the adoption of general test 〈6.17〉 “Insoluble Particulate Matter Test for Protein Injections”. Test 〈6.17〉 enables the determination of insoluble particulate matter using the light obscuration method with smaller sample volumes and indicates points to consider in handling protein samples. In addition, the draft general information “Basic Concept of Quality Assurance of Biotechnology Products (Biopharmaceuticals)” has been released for public consultation and will be listed in the 18th edition of the JP. In this review, the contents of JP monographs, general chapters, and general information on biologics are introduced, and future perspectives on the role of the JP for ensuring the quality of biologics are discussed.

The latest edition of the Japanese Pharmacopoeia (JP) is the second supplement to the 17th edition containing 324 herbal medicines, of which 176 are crude drugs and 35 are Kampo extracts. Although 148 prescription Kampo extracts are covered by national health insurance, only 35 are listed in the latest JP. However, the sales volume of these 35 Kampo extracts accounts for more than 70% of the total sales volume of Kampo products, as Kampo formulas with higher sales volumes are preferentially listed in the JP. The JP officially defines the origin and description of the listed crude drugs and Kampo extracts and elaborates on their limited values and testing methods. As crude drugs and Kampo extracts are derived from natural products and have the characteristics of traditional medicines, some degree of variation has been experienced during their long-term use, which is one of the crucial differences from chemical drugs. The Japanese Pharmacopoeia Committee on Crude Drugs promotes standardization of the JP by reflecting the actual Japanese market situation. This review explains the characteristics of natural and traditional medicines in crude drug-related items, the JP drafting process and points to be noted, and the significance of listing in the JP.

Dry powder inhalers (DPI) are frequently used by asthmatic patients, and the usage rate increases every year. The pharmacists at our hospital provided initial inhalation instructions on how the inhaler must be used but did not elaborate on the cleaning of the device. Therefore, the cleaning status of the inhaler is unknown, and there is a possibility of bacterial growth. This study investigated the cleaning status and hygiene of steroid drug inhalers used by elderly asthma patients. We administered a questionnaire to investigate the inhaler cleaning status after inhalation, and conducted a cross-sectional survey on hygiene using ATP measurement and bacterial culture examination. Considering the responses by 53 patients, it became clear that the ATP values of patients who answered “never cleaned” after inhalation were significantly higher than those who answered “cleaned every time”. Moreover, some bacteria were detected in 62% of inhalers; 4 patients' inhalers contained bacteria other than normal oral microbial flora. In conclusion, because the inhalers used by elderly patients are in poor hygienic conditions, we must give cleaning instructions accordingly. We believe that it is necessary to give proper medical instructions along with instructions on the cleaning method with dry cloth.

Pharmacy practice experience (PPE) is essential in the six-year course of pharmaceutical education in Japan. We previously found that PPE reinforced students' self-efficacy for curriculums (SECs), leading robust acquisition and reconstruction of pharmaceutical expertise. In this study, we aimed to clarify whether students' SECs affect successful experiences as enactive attainments in PPE. We distributed survey questionnaires to the fifth-year students in Keio University in 2016-2017 before and after PPE. The students made a self-assessment of their psychological state “expect to do well” on a seven-point Likert scale for each curriculum (C1 to C18), and their successful experiences were also collected from free description type questionnaire. We could follow up 139 students. The SEC scores increased from pre-PPE to post I (p<0.001) and II terms (p<0.01). The increase in SEC scores during PPE was associated with the rate of students' successful experiences in the first-term PPE (p=0.04). The path analysis revealed the following as significant predictive factors of SECs for successful experiences: basic sciences (C1, C2, C3, C4, C5, and C6) with stand-ardizing coefficient 0.35, health and environmental sciences (C11 and C12) with 0.39, and pharmaceutical sciences (C7, C8, C9, C10, C13, and C14) with −0.51. Students in the first-term PPE tended to experience successful performance in medical professions by using their pharmaceutical expertise that they had learned. In this study, for the first time, we demonstrated that Japanese students' SECs for pharmaceutical expertise affected successful experiences, leading better outcomes of PPE.

Standard analytical methods for the detection of dieldrin and 4,6-dichloro-7-(2,4,5-trichlorophenoxy)-2-trifluoromethylbenzimidazole (DTTB) in textiles, which are regulated by Japanese law (“Act on the Control of Household Products Containing Harmful Substances”), have been in place for more than 30 years. In this study, we developed an improved analytical method, based on GC-MS, that uses safe reagents and can simultaneously detect dieldrin and DTTB analytes. In the standard (existing) analytical method, dimethyl sulfate, which is a potential carcinogen, is used to derivatize DTTB. In the developed method, phenyltrimethylammonium hydroxide, as an alternative reagent, was used to derivatize DTTB in good results. Dieldrin and the derivatized DTTBs gave highly linear calibration curves when analyzed by GC-MS. Moreover, we found that both analytes are adequately extracted from textiles by refluxing in hydrochloric acid and methanol. Furthermore, we established a purification method using the Bond Elut PRS column that effectively removed interfering substances in woolen products. Finally, we developed an improved analysis method by combining the above-mentioned techniques; the developed method exhibited a recovery rate of 94-104% and a relative standard deviation of less than 7% for both analytes. In addition, the limits of quantitation (dieldrin: 1.3 μg/g, DTTB: 0.72 μg/g) were sufficiently lower than the Japanese regulatory value of 30 μg/g.

The quality of chest compression affects survival after sudden cardiac arrest, particularly when it occurs out of hospital. Pharmacy students should acquire basic life support skills as part of the model core curriculum of pharmacy education. Here, we trained first-year students at the Faculty of Pharmacy to deliver cardiopulmonary resuscitation and used a manikin with a real-time feedback device that quantified chest compression skills. Students were classified into shallow compressions (SC; <50 mm) and deep compressions (DC; ≥50 mm) groups based on the depth of chest compressions measured prior to training. After training, the mean compression depth (mm) was significantly shallower for the SC, than the DC group and many students in the SC group did not reach a depth of 50 mm. Similarly, students were classified into slow compression rate (SR; ≤120/min) and rapid compression rate (RR; >120/min) groups based on the results of training in the rate of chest compressions. Significant differences in mean compression rates were not found between the groups. However, correct compression rate (%), the percentage of maintaining 100-120 compression/min was significantly higher in the SR, than in the RR group. Chest compression rates correlated with compression depth, and chest compression tended to be too shallow in group that was too fast. The quality of chest compression might be improved by delivering chest compressions at a constant rate within the recommended range.

Japan passed a law that eliminated discrimination against persons with disabilities in 2016. Health care providers must comply with this law and are required to deepen their understanding of disabilities and take action to eliminate discrimination based on a higher level of awareness. Pharmacists need to better understand hearing disabilities to effectively communicate and provide medication education to deaf and hard of hearing (HH). This study examined the understanding about deaf and HH communities and the effects of learning through a lecture and hearing loss simulation experiences on 151 students in Daiichi University of Pharmacy to improve their understanding deaf and HH communities and ability to communicate effectively with deaf and HH patients in providing medication education in April 2018. Before the learning, 125 students indicated a lack of confidence in their ability to communicate medication education due to a lack of understanding. However, 26 students responded that they could communicate with deaf and HH patients despite their misunderstandings about deaf and HH communities and the features of such communication. After the learning 132 students indicated they had the confidence to interact with deaf and HH patients in communication for medication education. This study suggests that students need to learn about deaf and HH communities and develop communication skills to interact with them for medication education. Taking these steps may contribute to creating an educational program to facilitate communication and improve medication education for deaf and HH through effective communication by pharmacists.