Ministry Of Health, Labour And Welfare Research Articles

Guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance in Japan: A tiered approach for the assessment of clinically meaningful driving impairment.

In December 2022, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued and implemented the guideline for evaluating the effects of psychotropic drugs on motor vehicle driving performance. This guideline recommends the use of a tiered approach to assess clinically meaningful driving impairment. It is noted that adverse events cannot be solely explained by pharmacokinetics, as the onset and duration of these events vary. Among these adverse events, those affecting alertness, such as drowsiness caused by psychotropic drugs on driving performance, are more frequently observed during initial treatment stages and dose escalation. Hence, when evaluating the effects of psychotropic drugs on driving performance, it becomes crucial to assess the persistence of clinically meaningful impairment. Therefore, the MHLW guideline, developed by the authors, emphasizes the need to assess the temporal profile of adverse events affecting driving in all clinical trials. Additionally, the guideline states that when conducting driving studies, the timing of multiple dosing should consider not only the pharmacokinetics of the investigational drug but also its tolerance.

Postmarket safety communications on drugs approved in Japan: A 25-year analysis.

Drug safety communications (DSCs) are essential tools for communicating important postmarket serious drug safety information to healthcare professionals and patients. Previous studies characterized DSCs issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA); however, knowledge about the activities of the Pharmaceuticals and Medical Devices Agency (PMDA)/the Ministry of Health, Labor and Welfare (MHLW) is limited. This study characterized DSCs by the PMDA/MHLW in comparison with previously reported DSCs by the FDA and the EMA. We retrospectively analyzed 37 DSCs of 41 adverse drug reactions (ADRs) for 33 drugs in Japan from 1997 to 2022. Most DSCs were related to non-oncology drugs (30/37, 81.1%), and the median (interquartile range) time from approval to DSC issuance was 19 (10-51) months. Notably, the regulatory review reports and the latest labels before DSC issuance did not describe 16/28 (57.1%) and 12/37 (32.4%) of the ADRs related to DSCs, respectively. Most DSCs resulted in label revisions (36/37, 97.3%) and seven drugs were eventually withdrawn. Some DSC characteristics are similar among the PMDA/MHLW, the FDA, and the EMA; however, the number, contents, and range of new safety issues addressed by DSCs differ among the three jurisdictions. Our study emphasized the importance of continuous efforts to gather postmarket drug safety information because substantial ADRs that led to DSCs were recognized after approval and were associated with critical label revisions and withdrawals. Future studies are required to address global challenges for regulatory harmonization of safety-related regulatory actions.

Fragility Fracture Network-Japan: The challenge of establishment of a national hip fracture database and successful achievement of nationwide health system change for hip fracture care in Japan

BackgroundIn April 2022, a new reimbursement scheme for hip fracture was implemented by the Japanese health ministry. Japan is one of the world's most aged societies, facing a significant, rapidly growing burden of osteoporosis and fragility fractures. The incidence of hip fractures is projected to increase from 240,000 in 2020 to 320,000 by 2040. In 2015, Fragility Fracture Network-Japan (FFN-Japan) was formally established as a nonprofit organization in order to create the optimal fragility fracture care system in Japan. MethodsFFN-Japan launched the Japan National Hip Fracture Database (JNHFD) in 2017, initially with only eight participating hospitals across Japan. The number of patients enrolled from May 2017 to the end of 2020 in the JNHFD from the 16 hospitals registered the patients during this period with amounting to 4271 patients in total. FFN-Japan invited officials from the Ministry of Health, Labor and Welfare (MHLW) to participate in round table meetings to discuss the data collected in the JNHFD and to consider opportunities for nationwide improvement in hip fracture care. ResultsThe proportion of patients who underwent surgery within 36 h of arrival at hospital was 48.1% in 2018, 58.6% in 2019, and 44.9% in 2020 indicating the delay of surgery. Regarding secondary fracture prevention, initiation of osteoporosis treatment during the in-patients was 60.2% in 2018, 54.0% in 2019, and 64.5% in 2020 indicating the inadequate post fracture care. In April 2022, the Central Social Insurance Medical Council of the Japanese MHLW announced a new reimbursement scheme for hip fracture care including two key components: Early surgery (within 48 h from injury) and Secondary fracture prevention immediately after fracture. DiscussionThe new reimbursement scheme of hip fracture care in Japan will catalyze and underpin major improvements on acute multidisciplinary care and post-fracture care with secondary fracture prevention. FFN-Japan played a key role on these policy changes to the health system by means the close collaboration and ongoing communication with the government. ConclusionWithin five years of establishment of the JNHFD, FFN-Japan in collaboration with visionary leaders from the Japanese government have successfully achieved a major reform of the Japanese health system's reimbursement of hip fracture care. This reform has laid the foundation for transformation of management of this debilitating and life-threatening injury that currently afflicts almost a quarter of a million older Japanese citizens each year.

Effectiveness of catch-up and routine program of the 9-valent vaccine on cervical cancer risk reduction in Japan.

In 2013, the national human papillomavirus (HPV) immunization program began. However, in June 2013, Japan's Ministry of Health, Labor and Welfare (MHLW) announced a "temporary" suspension of its recommendation for the human papillomavirus vaccine. Finally, in November 2021, the MHLW ended its suspension of the recommendation of the HPV vaccine. To address the 9-year gap in HPV vaccinations the suspension had caused, the MHLW conducted a program of catch-up vaccinations from April 2022 to March 2025. Finally, in April 2023, the 9-valent HPV vaccine was approved for both the routine and catch-up vaccination programs in Japan. In this study, we investigated the potential effects of the introduction of the 9-valent vaccine on the increased risk of cervical cancer in females born after fiscal year (FY) 2000. We estimated the lifetime relative risk of cervical cancer incidence and death using the improved routine and catch-up vaccination rates after the recent resumption of the governmental recommendation for women and girls to have the HPV vaccination. These relative risks were calculated using a lifetime risk of 1.000 for cervical cancer incidence and death for females born in FY 1993. We predicted that even if a 90% vaccination rate were to be achieved by FY 2024 with the 9-valent vaccine among women born between FY 2000 and FY 2005, the risk would remain higher than for the vaccination generation. Therefore, for women born between FY 2000 and FY 2005, it will be necessary to significantly improve the cervical cancer screening rate to compensate for this increased risk.

Review of a Series of Surveys on Adverse Reactions to the COVID-19 mRNA-1273 Vaccine at Okayama University.

This paper presents the results of a series of surveys conducted from July 2021 to March 2023 to investigate the post-vaccination adverse reactions to the mRNA-1273 (Moderna) vaccine among faculty, staff, and students at Okayama University. These studies complement the official surveys conducted by the Ministry of Health, Labour and Welfare (MHLW) and provide a more representative picture of adverse reactions in the general population including large numbers of healthy young people. Pain, swelling, redness at the injection site, fever, headache, and malaise were the main adverse reactions reported. The proportion of adverse reactions was generally higher after the second vaccination and decreased with each additional vaccination. No statistically significant differences in the adverse reactions were found for males and females and those with/without a history of allergy, but a lower proportion of fever was observed in older participants and those with underlying medical conditions. We also evaluated the association between adverse reactions and antibody titers after the third vaccination and found no significant differences in antibody levels one month after vaccination. This series of studies highlights the importance of conducting surveys in diverse populations to provide a more representative picture of post-vaccination adverse reactions during a pandemic.

Causes of Countermeasures Against Serious Accidents Caused by Health Hazards of Chemical Substances, Based on Cases of Occupational Accidents in Japan

The purpose of this study was to summarize the typical and specific causes and risk reduction measures of serious accidents in Japan caused by chemical substances in terms of the 10 types of human health hazards in the UN GHS (Globally Harmonized System of Classification and Labelling of Chemicals) classification. The list of "Cases of Major Accidents Caused by Chemical Substances" published on the "Safety in the Workplace Website" of the Ministry of Health, Labor and Welfare (MHLW) was linked to the "Results of GHS Classification by the Government" of the National Institute of Technology and Evaluation (NITE). Analysis was conducted by health hazards in order to obtain reference examples of measures taken against health hazards in response to the revision of the law on autonomous chemical substance management in 2022. Using the text mining tool KH Coder ver. Three using cluster analysis, we grouped causes and measures among serious disasters by health hazard, illustrated co-occurrence networks, and extracted typical examples of each in a co-occurrence network. Representative causes of and measures against occupational accidents caused by health hazardous properties were summarized from the extracted typical cases. Although few occupational accidents were caused by the health hazards of chemicals, when all health hazards were classified into acute toxicity, acute health hazard, and chronic health hazard, contact was a clear cause for many of the acute toxicity and acute health hazards, such as corrosiveness and sensitization. However, many occupational accidents were caused by the physical hazardous aspects of the chemical substances or by the safety aspects of the workplace. Causes of occupational accidents due to health hazards included unsafe behavior and unsafe conditions, or lack of understanding of the physicochemical properties of a substance and specific reactions such as mixing or hydrolysis of the substance. Typical risk reduction measures for health hazards included equipment to prevent human contact with health hazardous substances, systems to control unsafe behavior, promoting understanding of chemical reactions, and providing information about chemicals to all persons involved in testing, research, and subcontract work. The data of occupational accident cases of "death or more than 4 days lost from work" were used. Most of the cases were related to acute health hazards, but relatively few to chronic health hazards, and few occupational accidents were caused by health hazards. Most of the occupational accidents were caused by health hazards due to the physical hazards of chemical substances and inadequate workplace safety. In light of the above, it is necessary in autonomous chemical substance management to first take risk reduction measures for workplace safety and chemical physical hazards, then to prevent contact with acute toxicity and acute health hazards such as corrosiveness and sensitization, and, lastly, to take risk reduction measures for chronic health hazards, using allowable concentrations and controlled concentrations as indices.

A questionnaire survey on the prevention of HPV infection among females and males who came of age in Japan under various scenarios of HPV vaccine recommendation

ABSTRACT The Japanese Ministry of Health, Labor and Welfare (MHLW) temporarily suspended recommendation for HPV vaccinations for girls in June 2013. It resumed its recommendation in November 2021. To compensate for eight years of lost overage, a ‘catch-up HPV vaccination’ program began in April 2022. To determine intervention needs in regards to HPV vaccine hesitancy, from October 13 2021 to April 31 2022, we surveyed 12–28 year-old vaccine-eligible males and females (281 males, 583 females). We investigated the gender and ‘vaccine generational’ differences in attitudes, perceptions, and future intentions regarding HPV vaccination. Two generations were defined by the vaccine recommendation environment they grew up in. The ‘vaccine generation’ was born in FY 1994–1999; the ‘vaccine-suspension generation’ born in FY 2000–2009. Knowledge regarding the HPV vaccine correlated significantly with being female, of the vaccination generation, a medical student, and having received the COVID-19 vaccine. There was a significant ‘generational’ difference in terms of approval of the MHLW’s recommendation resumption. The attitudes, perceptions, and future intentions of Japan’s two generation groups are unique and should be dealt with accordingly. HPV vaccination promotion should consider the strong gender differences we identified. As an extension of the anti-cervical cancer program, HPV vaccinations for boys should begin immediately. Our study of their unique outlooks will contribute to the discussion surrounding that implementation.

Influenza vaccine viruses and the development of seasonal vaccines: A Japanese perspective

In Japan, the Ministry of Health, Labour and Welfare (MHLW) designates one specific virus strain for each component of the quadrivalent seasonal influenza vaccine, and four domestic manufacturers produce egg-based influenza vaccines with the same formulation (inactivated, split-virus) using uniform vaccine strains. Thus, discussions of the development of effective seasonal influenza vaccines so far has focused solely on the antigenic match between the vaccine strains and epidemic viruses. However, in 2017, the Japanese selection system of vaccine viruses demonstrated that even a candidate vaccine virus that is antigenically similar to the predicted circulating viruses is not necessarily suitable for vaccine production, given lower productivity of the vaccine. Taking this experience into account, the MHLW reformed the scheme of vaccine strain selection in 2018, and instructed the Vaccine Epidemiology Research Group created by the MHLW to probe how the virus strains for the seasonal influenza vaccine should be selected in Japan. In this context, a symposium, entitled “Issues of the Present Seasonal Influenza Vaccines and Future Prospects”, was held as part of the 22nd Annual Meeting of the Japanese Society for Vaccinology in 2018, and subjects related to the influenza vaccine viruses were discussed among relevant administrators, manufacturers, and researchers. This report summarizes the presentations given at that symposium in order to convey the present scheme of vaccine virus selection, the evaluation of the resulting vaccines, and the efforts at new vaccine formulation in Japan. Notably, from March 2022, the MHLW has launched a discussion of the merits of the seasonal influenza vaccines produced by foreign manufacturers.

Increased number of live births by migrant mothers shows areal inequality in Japan: A descriptive study

Japan has not implemented policy of accepting many migrants, and the proportion of migrants in the total population is much smaller than that in other economically developed countries. Therefore, issues regarding the health status of migrants, especially migrant mothers and their children, have not been discussed enthusiastically in Japan. In the present study, we aimed to describe the epidemiology (time trend of the number, areal distribution, and frequency of maternal nationality of newborn births) of live births by migrant mothers in Japan, which contributes to the administration of medical policies on the perinatal care of migrant mothers. This study used data from the vital statistics reported by the Ministry of Health, Labour and Welfare (MHLW) of Japan and from foreign resident statistics reported by Immigration Services Agency (ISA) of Japan. To show areal inequality in the number of live births by migrant mothers, we applied the Gini coefficient. This study demonstrated that the number of live births by migrant mothers increased from 16,154 (1.31% of the total) in 1990 to 26,517 (3.08%) in 2020. It also showed stronger areal inequality at prefecture level by Japanese mothers (Gini coefficient; 0.64 vs 0.46 in 2020), and this areal inequality has increased during the last decade. This study also illustrated that the frequency of maternal nationality of newborns from migrant mothers has been altered in the last decade, especially in the composition of Asian countries. In conclusion, the number of live births by migrant mothers in Japan has been progressively increasing; however, this trend is excessively concentrated in specific areas in Japan. These tendencies are expected to become more prominent in the future, and their possible impacts on medical institutions and administrative agencies in specific areas that treat migrant mothers should be investigated and discussed.

Evaluation ofMinistry ofHealth, Labour andWelfare diagnostic criteria forantineutrophil cytoplasmic antibody-associated vasculitis compared to ACR/EULAR 2022 classification criteria.

This study aimed to evaluate the Ministry of Health, Labour and Welfare (MHLW) diagnostic criteria for antineutrophil cytoplasmic antibody-associated vasculitis compared to the new American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria. Two nationwide cohort studies were used, and participants were categorised as having eosinophilic granulomatosis with polyangiitis, granulomatosis with polyangiitis (GPA), or microscopic polyangiitis (MPA) according to the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 and MHLW criteria. Of the entire patient population, only 10 (2.1%) were unclassifiable according to the MHLW probable criteria, while a significant number of patients (71.3%) met at least two criteria. The MHLW probable criteria for MPA had some challenges in differentiating between MPA and eosinophilic granulomatosis with polyangiitis, and the same was true for MHLW probable criteria for GPA in differentiating MPA from GPA. Nevertheless, improved classification results were obtained when the MHLW probable criteria were applied in the order of eosinophilic granulomatosis with polyangiitis, MPA, and GPA. The application of MHLW criteria could categorise a substantial number of patients with antineutrophil cytoplasmic antibody-associated vasculitis into one of the three antineutrophil cytoplasmic antibody-associated vasculitis diseases. The classification was in accordance with the American College of Rheumatology/European Alliance of Associations for Rheumatology 2022 criteria when considering the order of application.

Progress report of a cross-organ and biomarker-based platform study: BELIEVE trial NCCH1901.

TPS1611 Background: Cancer Genomic Medicine (CGM) has been developing and more patients have received the comprehensive genomic profiling (GCP) test under national healthcare system in Japan. However, the number of patients who could receive the genomically matched therapy based on the results of CGP tests was limited. To improve the drug accessibility, we initiated a cross-organ, biomarker-based clinical trial (NCCH1901, the BELIEVE trial). It was a platform trial and could be considered as the Japanese counterpart to the National Cancer Institute's Molecular Analysis for Therapy Choice (NCI-MATCH) study in the United States. Methods: It was a multi-institutional joint research nationwide led by NCCH with a master’s protocol. Several drug cohorts were pre-established, allowing patients to participate in molecularly targeted treatments recommended as a result of CGP test. All drugs were provided for free from the pharmaceutical companies. The objective of this trial was to administer off-label drugs for the respective genomic abnormalities and collect efficacy and safety data for patients of the drugs. The primary endpoint was the response rate based on the best overall response for up to 16 weeks. This trial has been conducted under both of the Japanese Clinical Trial Act and the patient-proposed healthcare services which enable patients to receive unapproved, off-label drugs partially covered by National Health Insurance. The protocol and the informed consent forms were approved by the National Cancer Center Hospital (NCCH) certified review board and the Ministry of Health, Labour and Welfare (MHLW). The trial was registered in the Japan Registry of Clinical Trials (jRCTs031190104). As of January 31, 2023, we have 20 drug cohorts and the planned number of enrollments for each cohort was 50 with the target lesions and 30 without the target lesions. There were more than 500 patients so far. The most common cancer was brain tumours, followed by carcinoma of endocrine organs and the colorectal cancer. BRAF mutation and ERBB2 amplification were the frequent genomic abnormalities registered in this trial. Five drug cohorts have already finished recruiting and 2 drug cohorts assessed their efficacies. We are still continuing to discuss several pharmaceutical companies to increase the drugs cohorts in this platform. This trial is now recruiting the patients and is contributing significantly to increase the treatment opportunity for the cancer patients. Clinical trial information: jRCTs031190104 .

Addressing practical issues in the smooth implementation of revised guidelines for non-clinical studies of vaccines for infectious disease prevention

Herein, we investigated possible practical issues for the smooth implementation of the revised Japanese Guidelines for Non-clinical Studies of Vaccines for the Prevention of Infectious Diseases, which were raised in response to public comments on the proposed guideline revision and a gap analysis of the World Health Organization and European Medicines Agency guidelines. We identified main issues such as the non-clinical safety studies of adjuvants and evaluation of local cumulative tolerance in toxicity studies. The revised Japanese Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labour and Welfare (MHLW) guidelines require non-clinical safety studies for vaccines containing new adjuvants, but additional safety pharmacology studies or safety studies in two animal species may be required if non-clinical safety studies raise any concerns (i.e., systemic distribution). Adjuvant biodistribution studies may aid in understanding vaccine characteristics. The evaluation of local cumulative tolerance in non-clinical studies, which was the focus of the Japanese review, can be omitted by including a warning in the package insert to avoid injection to the same site. The study's findings will be reflected in a Q&A to be released by the Japanese MHLW. We hope that this study will contribute to the global and harmonized development of vaccines.

Conditional early approval for new drug applications in Japan: Current and emerging issues.

Conditional early approval for new drug applications in Japan: Current and emerging issues.

Current Status of the Disaster Health, Medical, and Welfare Coordination in Japan

Introduction:Non-coordinated support during disasters has negative effects on affected communities and people. From the 2004 Indian Ocean Tsunami, the United Nations introduced a cluster approach to avoid gaps and duplication of aid. Japan's disaster coordination of support for health and medical care was organized after the 2017 Kumamoto earthquake. The Ministry of Health, Labour and Welfare (MHLW) announced and issued the notice that the prefectures need to establish a system related to health and medical activities in the event of a large-scale disaster. In July 2022, welfare content was added. This study investigated the current status of health sector organizational coordination among health, medical, and welfare responders during 2022 the Large-Scale Earthquake National Exercise (LSENE).Method:The 2022 LSENE was conducted on October 1, 2022 with participation from the Disaster Medical Assistant Team (DMAT) and responders from each prefecture's health and welfare divisions and organizations. Each responder's exercise log sheet and the exercise controller's evaluation were reviewed.Results:Even though there was a notice from the MHLW, organized coordination was conducted only by several medical and health teams. DMAT is the only team with a system to dispatch teams from non-affected prefectures and coordinate well to allocate teams. Some other health and welfare organizations did not have a dispatching system. They had difficulty sending teams to affected areas, especially due to a lack of a systematic response system, training, coordination headquarters, and information sharing. It was suggested that information sharing and coordination among responders is necessary, although information gathering and request judgments related to dispatch coordination are different for each organization.Conclusion:In order to smoothly coordinate support teams for health, medical, and welfare in the event of a disaster, it is necessary not only to improve the coordination headquarters for health, medical, and welfare but also to verify its operation through training.

Aiming for a Society Where No One is Left Behind in a Humanitarian Crisis: Examples of Cooperation Among Health, Medical Care, and Welfare

Introduction:Japan is geographically prone to natural disasters such as earthquakes, volcanoes, and tsunamis, economically advanced, and socially characterized as a super-aged society. The SDGs are a concrete strategy to achieve a society where no one is left behind. So what exactly can we do to protect the vulnerable populace? This presentation will introduce the system of cooperation and implementation of medical, health, and welfare disaster relief in Japan.Method:Government documents were received on developing national policies regarding the strategy for the unification of medical, health, and welfare. For implementation, the status of support teams specializing in disaster welfare and training status was reviewed.Results:National policy level achievements: The Ministry of Health, Labor and Welfare (MHLW) issued a "Notification on Enhancing and Strengthening the Medical System in Times of Disaster" in 2012 and conducted a critical review of the initial response to the Kumamoto earthquake in 2016 in the "Initial Response Verification Report." This process reaffirmed the need to support vulnerable populations such as the disabled, children, and the elderly. In 2021, the Disaster Welfare Assistance Team was added to the Basic Plan for Disaster Management and the MHLW Disaster Management Work Plan.Implementation level Achievement: As of 2022, 24 of the 47 prefectures have a DWAT in place. Gunma, Kyoto, and Miyazaki prefectures were the most advanced, with 1) ongoing meetings to strengthen cooperation with medical and health care teams, 2) participation in joint drills, and 3) DWAT awareness-raising activities through training for municipal administrative staff.Conclusion:While this review revealed that the national government had made progress in developing policies, the implementation revealed that some prefectures have not yet established DWATs.

The new guideline for evaluating effects of psychotropic drugs on the performance to drive a motor vehicle in Japan: Comparison with US FDA guideline.

In December 2022, the new guideline for evaluating the effect of psychotropic drugs on the performance to drive a motor vehicle was issued by the Ministry of Health, Labour and Welfare (MHLW) and implemented in Japan. Of the safety information, information on the influence of medications on driving performance is particularly important because it can be relevant to the social functioning of patients. In principle, the package inserts of medications are designed based on evidence and provide precautions regarding the operation of heavy machinery such as automobiles in Japan, the United States, and Europe. The effects of medications on driving performance are generally evaluated in a tiered approach involving nonclinical and clinical studies. Because of the wide variety of functional domains involved in automobile driving, the selection of evaluation methods for a given medication depends on their characteristics, which is a complicated method. Therefore, to evaluate the effects of psychotropic drugs on driving performance efficiently and appropriately, we developed the MHLW guideline that specifically defines the evaluation methods used in pharmacological studies, the neuropsychological tests used in pharmacodynamic studies, and the situations in which driving studies are necessary. Regarding the planning of appropriate drug development strategies, we review the background of the MHLW guideline and its differences from the US Food and Drug Administration (FDA) guideline.

Transversal Survey of Emergency Medicine Policy and Quality Metrics in Japan's Regional Health Care Plans.

It is essential to establish appropriate medical quality metrics and make improvements to safely and efficiently deliver optimum emergency medical services. The Ministry of Health, Labor and Welfare (MHLW) recommends prefectures to establish numerical quality metrics in their regional healthcare plans (RHCP). The 7th RHCP was issued by the MHLW in 2017 along with a notice of planning in covering the six-year period from 2018 to 2023. In this descriptive study, the emergency medicine policies in the 7th RHCP of each prefecture were analyzed from a quality improvement perspective. The authors examined the chapters on emergency medicine in the RHCPs of 47 prefectural governments for the overall structure, cost-benefits, and connection to community-based integrated care systems. The type and number of clinical measures listed as numerical metrics and their classification methods were emphasized. Regarding the overall plan structure, 40 prefectural governments began their description with an analysis of current surroundings. In total, 24 prefectural governments mentioned community-based integrated care systems but none mentioned cost-benefit analysis. Altogether, only 43 of 47 prefectural governments (91%) indicated numerical metrics. The maximum number of numerical targets for quality measures by prefecture was 19, the minimum was 0, and the median was 4 (IQR: 3-6.5); there were 220 metrics in total, with 82 structural, 96 process, and 42 outcome measures. Additionally, 13 prefectures (28%) classified quality measures according to the MHLW's guidance, 6 (13%) used their own classification manner, while the others did not classify their measures. There were significant differences in emergency medicine policies and quality metrics among the prefectural governments. Further research is needed to develop and establish more comprehensive and appropriate metrics based on a common methodology to improve the quality of emergency medicine.

Factors Related to Work Engagement in Occupational Health Nurses: From both Aspects of Work Environmental and Individual Factors

The Ministry of Health, Labour and Welfare (MHLW) states that it is an important issue to realize a work environment where people find their job worth doing, and the MHLW utilizes work engagement as the concept of a job worth doing. In this study, we aimed to clarify the factors related to work engagement in occupational health nurses from both aspects of work environmental and individual factors. An anonymous self-administered questionnaire was mailed to 2,172 occupational health nurses who belonged to the Japan Society for Occupational Health and were in charge of practical work. Among them, 720 responded and their responses were analyzed (valid response rate: 33.1%). The Japanese version of the Utrecht Work Engagement Scale (UWES-J) was used to measure their feelings on whether their job is worth doing. Question items at three levels, namely, work level, department level, and workplace level, were selected from the new brief job stress questionnaire as the work environmental factors. Three scales, namely, professional identity, self-management skills, and out-of-work resources, were used as the individual factors. Multiple linear regression analysis was performed to examine the factors related to work engagement. The mean total score of UWES-J was 57.0 points, and the mean item score was 3.4 points. Among attributes, age, having children, and the position of chief or above were positively correlated to the total score, but the number of occupational health nurses in the workplace was negatively correlated to the total score. Among work environmental factors, work-self balance (positive), which is a subscale at the workplace level, and suitable jobs and opportunities to grow up, which are the subscales at the work level, were positively correlated to the total score. Among individual factors, self-esteem as a professional and self-improvement to be professional, which are the subscales of the professional identity, and problem resolution, which is a subscale of self-management skills, were positively correlated to the total score. In order for occupational health nurses to find their job worth doing, it is desirable that they will have options to choose diverse and flexible work styles, and that their employers will establish a work-life balance for the entire organization. It is preferable that the occupational health nurses can self-improve, and that their employers will provide opportunities for them to develop professionally. The employers should also establish a personnel evaluation system that allows for promotion. Results also suggest that the occupational health nurses need to improve their self-management skills, and that the employers should assign them to positions suitable to their abilities.

Low billing rates for pediatric sedation fee on magnetic resonance imaging.

The 2018 revision of social insurance in Japan allows additional fees to be calculated for pediatric magnetic resonance imaging (MRI) that must be performed under sedation. The number and trend of actual claims since this revision was established is unknown. The aim of this study to investigate the use of the additional fees and any regional differences in the use. To analyze the claims of additional fees for pediatric sedated MRI after the fiscal year (FY) 2018, the actual claims in inpatient and outpatient practice was analyzed using publicly-available data from the Ministry of Health, Labour and Welfare (MHLW). We analyzed the calculation rate for all MRI scans. Annual changes in the actual number and calculation rate were analyzed. The ratio of the number of additional fees to the overall number of pediatric radiological procedures was used to examine the geographic disparity. The number of calculations from FY 2018 to FY 2020 was available. In FY 2020, only 1347 additional fees were calculated, corresponding to 0.35% of the total number of MRI scans. The number of fees showed a decreasing trend. Most cases were in the 0-4 year age group; however, there were a few cases in the 10-14 year age group without such a decrease. The relative number of calculations by prefecture showed an up to 14-fold disparity. The requirements for sedation for pediatric MRI are strict, but they are not fully utilized. Measures such as relaxing the requirements for the fee are needed to make MRI-related sedation safer.

An adolescent and young adult (AYA) cancer education initiative aimed at healthcare students in Japan.

The focus on cancer in adolescents and young adults (AYA) has increased in recent years. We participated in an event called AYA week 2021 as part of a research project of the Ministry of Health, Labour and Welfare (MHLW) and conducted a fact-finding survey to collect information for raising public awareness of AYA-generation cancers and to improve support for AYA-generation cancer patients. A 25-item questionnaire survey was conducted through requests sent to the deans of medical schools and presidents of related universities across Japan and by advertising on social networking sites and friendship networks. Furthermore, the effects of a lecture given by three cancer survivors on their cancer experience were examined. A total of 1288 healthcare students participated. The most common age group was between 20 and 24years, with the majority being medical students (83%). The AYA cancer-educated population had more knowledge about AYA-generation cancers than the overall group. At present, very few people are familiar with AYA-generation cancers (30.5%), which highlights the importance of school education. There were 163 participants who attended the lecture given by the cancer survivors, of whom 108 completed the questionnaire. The results showed high participant satisfaction related to the lecture given by cancer survivors, suggesting that such lectures could help educate and raise awareness about AYA-generation cancers. The knowledge survey and lecture given by cancer survivors had educational effects. Many healthcare students responded positively, suggesting the efficacy of these types of initiatives.