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Benralizumab, a monoclonal antibody targeting IL-5 receptors, reduces exacerbations and oral corticosteroid requirements for severe, uncontrolled eosinophilic asthma. In Japan, geographic disparities in asthma outcomes suggest differential prescribing and access. This study aimed to quantify regional prescribing variations for benralizumab nationwide. Using Japan's National Database (NDB) of insurance claims (2009-2019), benralizumab standardized claim ratios (SCRs) were calculated for 47 prefectures. Correlations between SCRs and other biologics' SCRs, economic variables like average income, and physician densities were evaluated through univariate analysis and multivariate regressions. Income-related barriers to optimal prescribing were examined. Wide variation emerged in benralizumab SCRs, from 40.1 to 184.2 across prefectures. SCRs strongly correlated with omalizumab (r = 0.61, p < 0.00001) and mepolizumab (r = 0.43, p = 0.0024). Average monthly income also positively correlated with benralizumab SCRs (r = 0.45, p = 0.0016), whereas lifestyle factors were insignificant. Respiratory specialist density modestly correlated with SCRs (r = 0.29, p = 0.047). In multivariate regressions, average income remained the most robust predictor (B = 0.74, p = 0.022). Benralizumab SCRs strongly associate with income metrics more than healthcare infrastructure/population factors. Many regions show low SCRs, constituting apparent prescribing gaps. Access barriers for advanced asthma therapies remain inequitable among Japan's income strata. Addressing affordability alongside specialist allocation can achieve better prescribing quality and asthma outcomes., (© 2024. The Author(s).)

The 14th Japan Bioanalysis Forum Symposium was held at Tower Hall Funabori, Japan from 1-3 March 2023. The conference theme, 'Bringing Together - the Expertise of Bioanalysis', aimed to enable people from various fields to gather, learn and collaborate together for the common goal of delivering medicines to patients faster. Approximately 360 participants from various fields, including pharmaceutical industries, contractors, academia and regulatory authorities, gathered at an in-person symposium which had an online participation option, for the first time in 4 years. The symposium offered a wide range of topics including ICH M10, new modalities, biomarkers, immunogenicity, electronization and patient-centric sampling. The latest research results were provided from domestic and overseas scientists. This report summarizes the major topics.

Nucleic acid (NA) biomarkers play critical roles in drug development. However, the global regulatory guidelines for assessing quantification methods specific to NA biomarkers are limited. The validation of analytical methods is crucial for the use of biomarkers in clinical and post-marketing evaluations of drug efficacy and adverse reactions. Given that quantitative polymerase chain reaction (qPCR) and reverse transcription qPCR (RT-qPCR) methods are the gold standards for the quantification of NA biomarkers, the Biomarker Analytical Method Validation Study Group in Japan has discussed considerations and made recommendations for the development and validation of qPCR- and RT-qPCR-based analytical methods for endogenous NA biomarkers as drug development tools. This white paper aims to contribute to the global harmonization of NA biomarker assay validation.

Studies show that the burden of caregiving tends to fall on individuals of low socioeconomic status (SES); however, the association between SES and the likelihood of caregiving has not yet been established. We studied the relationship between SES and the likelihood of adults providing long-term care for their parents in Japan, where compulsory public long-term insurance has been implemented. We used the following six comprehensive measures of SES for the analysis: income, financial assets, expenditure, living conditions, housing conditions, and education. We found that for some SES measures the probability of care provision for parents was greater in higher SES categories than in the lowest category, although the results were not systematically related to the order of SES categories or consistent across SES measures. The results did not change even after the difference in the probability of parents' survival according to SES was considered. Overall, we did not find evidence that individuals with lower SES were more likely to provide care to parents than higher-SES individuals. Although a negative association between SES and care burden has been repeatedly reported in terms of care intensity, the caregiving decision could be different in relation to SES. Further research is necessary to generalize the results., Competing Interests: The authors have declared that no competing interests exist.

Background: Though mass evacuation may increase the need for long-term care (LTC) services, how the need for LTC services increases and how the public LTC system affects it is not well understood. We evaluated changes in public LTC benefits for the people living in the mandatory evacuation areas established after the 2011 Fukushima nuclear disaster and examined the roles of the universal LTC insurance system in Japan., Methods: In order to evaluate the effect of the mandatory evacuation on LTC benefits, we examined the trends of LTC benefits in the Fukushima evacuation group and the nationwide non-evacuation group. We first decomposed per-elderly-individual benefits at the municipality level into the LTC certification rate and per-certified-individual benefits, and then implemented difference-in-differences analysis using these variables as outcomes., Results: Per-elderly-individual benefits significantly increased from 2012 onward in the evacuation group, and this was explained by an increase in the certification rate rather than in per-certified-individual benefits. Increases in per-elderly-individual benefits and the certification rate in the post-disaster period were observed in all but the highest care level, and the corresponding outcomes for the highest care level decreased immediately after the disaster. We also found that the increase in the certification rate had been mostly realized by an increase in the number of certified individuals., Conclusions: The increase in LTC benefits can be associated with the impact of the increase in the number of people newly certified to receive LTC benefits after the mandatory evacuation. In order to cope with the increase in utilization of long-term care and associated costs after disasters in aging societies, both formal long-term care services and social support for informal care for evacuees should be considered important., Competing Interests: The authors have declared that no competing interests exist.

Using a newly developed rapid test, an outbreak of human metapneumovirus (HMPV) infection in a long-term care facility was detected within only 2 days after the onset of symptoms in a putative index case. The outbreak was almost under control within 8 days mainly by zoning patients, with the exception of two cases of HMPV that were diagnosed 16 and 17 days after the onset of the outbreak. According to an immunological diagnosis as well as the rapid test, it was eventually proven that 18 patients had HMPV infections. We suspected that even asymptomatic residents, who had not been completely separated from the facility population, were a source of infection. That suggested that all asymptomatic residents should be tested and that the separation of the infected patients should be absolute, if an outbreak of HMPV infection is suspected in such a facility.

To determine the "home pharmacy" activities including preventive medicine in community pharmacies and their regional differences, we conducted two questionnaire surveys of pharmacies belonging to the pharmacists' association in four areas, two metropolitan areas (Kita-tama area and Minato-ku in Tokyo) and two rural areas (Ueda-shi in Nagano and Aira-gun in Kagoshima) in 1998 and 2007. The questionnaire consisted of 42 questions including the scale and characteristics of the pharmacy, the offering of information to patients and information collection from patients, and activities related to home care medicine, environmental sanitation, and healthcare. Based on 14 factors in the questionnaire, an index of "Community Medicine Contributed by Home Pharmacies" was evaluated to represent the extent of activity including preventive medicine in pharmacy. The median of the indexes in the four areas rose in 2007, and was the highest in Ueda-shi. However, the increase in the index was found to result from increases in activity related to clinical medicine such as the use of "Medication Notebooks" and the circulation of "Pharmaceutical Instructions" and did not result from increased activity related to preventive medicine. Factors to promote preventive medicine activity are discussed based on the data from Aira-gun where the greatest home care medicine activity occurred and from Ueda-shi where the greatest environmental sanitation and healthcare activities occurred.

A homicidal case by an air gun involving a 73-year-old woman who was found dead in her home is described. At autopsy, two gunshot wounds were observed on the left anterior chest and the right back. There was neither exit wound nor powder burns. The fatal pellet, 0.9 g and 5.5mm diameter, penetrated the left anterior chest and the heart to cause cardiac tamponade (200 ml) before lodging in the left subclavian artery. Death was due to cardiac tamponade. This case has exhibited two rare phenomena: homicide by an air gun and pellet embolisation. This is the first homicide case by use of air gun in Japan and demonstrates that although it may be rare, air guns can be used as potential homicidal weapons. This experience will alert our society and others on the potential hazards of air guns we have tended to regard as toys.

In Japan, the use of amantadine for treatment of influenza A virus infection was not accepted until November 1998, although it was widely used for treatment of Parkinsonism. Since then, we have monitored the emergence of amantadine-resistant viruses and isolated two viruses from patients on long-term treatment with amantadine.

An epidemic of aseptic meningitis caused by human echovirus 9 (E-9) occurred in the summer of 1997 in northern Kyushu, Japan. Sequences of genome position 2504-3358, which encoded a part of VP1, of the nine isolated viruses were determined. An RGD motif and B-C loop were found in all. They were almost identical and closely related to the virulent strain Barty.

The nucleotide sequences of the genome RNA encoding the RNA polymerase and the 3' non-coding region (NCR) of bovine enterovirus (BEV) serotype I Japanese isolate, MZ468, were determined. The genetic distance between the two BEV serotype I strains, MZ468 and VG-5-27, was calculated by pairwise comparison of nucleotide sequences. The synonymous substitution rate was high (1.40 x 10(-2)/site/year), and of the same order as those of influenza virus HA, HIV-1 gag and env, and enterovirus 70 VP1 genes.