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PurposeThis study aimed to investigate the current status of end-of-life chemotherapy and targeted therapy and explore the aggressiveness of end-of-life care in Japan using the DeSC database, a large administrative claims database.Methods We identified fatal cases of at least one cancer-related diagnosis between April 2015 and November 2020. Patients prescribed at least one anticancer drug were analyzed, and chemotherapy regimens were categorized based on the combination of concomitant anticancer drugs prescribed.ResultsAmong 1,095,713 individuals enrolled in the National Health Insurance database, 7,300 deaths with cancer-related diagnosis were identified. Of these, 4,010 cases were identified in which at least one anticancer drug was prescribed, and 11.6% of 7,300 death had been prescribed anticancer drugs in their last 30 days of life. The most commonly used regimen was S-1 (tegafur, gimeracil, and oteracil potassium combination) monotherapy, followed by nivolumab monotherapy and nab-paclitaxel plus gemcitabine. Immune checkpoint inhibitor monotherapy was more likely prescribed to patients whose last chemotherapy dose was in the last 30 days of life (p = 0.0066, chi-squared test).ConclusionsThis study provides insights into the current status of end-of-life chemotherapy and targeted therapy in Japan, using a large administrative claims database. The results of this study will inform future research on end-of-life chemotherapy and targeted therapy, and help develop strategies to improve the quality of life of patients with advanced cancer.

The association between capecitabine efficacy and proton pump inhibitors (PPIs) is controversial. Here, we determined whether co-administration of PPIs affects the real-world effectiveness of capecitabine. This retrospective observational study included consecutive patients with stage II–III colorectal cancer (CRC) who received adjuvant capecitabine monotherapy or CapeOX (capecitabine and oxaliplatin) between January 2009 and December 2014 at nine participating institutions. The primary endpoint was the difference in relapse-free survival (RFS) between patients who received PPIs and those who did not and was estimated using the Kaplan–Meier method. Overall survival (OS) was the secondary endpoint. Multivariable analysis of RFS and OS was performed using a Cox proportional hazards model, propensity score adjustment, and inverse probability of treatment weighting (IPTW) analyses. Data from 606 patients were evaluated, 54 of whom had received a PPI. PPI-treated patients tended to have poorer RFS and OS than patients treated without PPIs. The hazard ratio for RFS with capecitabine monotherapy was 2.48 (95% confidence interval: 1.22–5.07). These results were consistent with sensitivity analyses performed using propensity score adjustment and IPTW methods. Co-administration of PPIs may reduce the effectiveness of capecitabine and negatively impact patients with stage II–III CRC.

Background The quality of adverse drug reaction reports can have a strong influence on the causality assessment or the detection of safety signals. Various methods have been used to evaluate the quality of adverse drug reaction reports. Objective We used the vigiGrade completeness score to evaluate the quality of the Japanese adverse drug event report database (JADER). Methods Among all reports in the JADER (cases received by regulatory authorities from April 2004 to November 2018), 427,797 cases that did not meet the exclusion criteria were analyzed using vigiGrade. An report was considered a ‘well-documented’ report if the completeness score > 0.8. For each dimension, the proportion of incomplete information was calculated. Main outcome measure Proportion of ‘well-documented’ reports. Results A total of 211,774 (49.5%) cases were classified as ‘well-documented’ reports. When classified by sender, 6240 out of 8257 cases (75.6%) from medical institutions were ‘well-documented’, while 205,534 out of 419,540 cases (49.0%) from pharmaceutical companies were categorized as such. ‘Time-to-onset’ could not be calculated in 173,027 (41.2%) cases from the pharmaceutical companies and in 1228 (14.9%) cases from medical institutions. Conclusion In the JADER, the proportion of ‘well-documented’ adverse drug reaction reports from medical institutions was higher than that from pharmaceutical companies, and reports from medical institutions could help to clarify generated safety signals. We also found that more than 40% of the reports from pharmaceutical companies did not include information that is considered essential for the evaluation of any causal relationship between suspected drugs and adverse drug reactions, which could pose challenges to the detection of safety signals.

Tablets and capsules are widely used forms of oral medication, but some patients experience difficulty handling them, which can reduce medication adherence and affect health outcomes. This study aimed to identify factors contributing to perceived handling difficulty, using data from harmo ® , a nationwide electronic medication notebook system. A questionnaire was distributed to adult users who had been prescribed oral medications, and the responses were linked with personal health records to analyze medication characteristics and patient backgrounds. Among the 1,230 respondents, 24% reported difficulty with small tablets or capsules. A size threshold was identified: a combined long and short diameter of 13.3 mm or less was most associated with handling problems (ROC-AUC = 0.834). Binomial logistic regression analysis revealed that difficulty in applying force with the hands (OR = 2.64), prescription of small tablets or capsules (OR = 2.52), and medical histories of hypertension (OR = 1.69) and osteoporosis (OR = 4.99) were significantly associated with reported difficulty. These results suggest that both the physical characteristics of formulations and individual patient factors influence medication usability. Our results provide evidence to inform more patient-centered approaches to oral formulation design and prescribing practices, ultimately supporting better adherence and medication safety.

In this retrospective observational study, we aimed to investigate the potential of natural language processing (NLP) for drug repositioning by analyzing the preventive effects of cardioprotective drugs against anthracycline-induced cardiotoxicity (AIC) using electronic medical records. We evaluated the effects of angiotensin II receptor blockers/angiotensin-converting enzyme inhibitors (ARB/ACEIs), beta-blockers (BBs), statins, and calcium channel blockers (CCBs) on AIC using signals extracted from clinical texts via NLP. The study included 2935 patients prescribed anthracyclines at a single hospital, with concomitant prescriptions of ARB/ACEIs, BBs, statins, and CCBs. Upon propensity score matching, groups with and without these medications were compared, and expressions suggestive of cardiotoxicity, extracted via NLP, were considered as the outcome. The hazard ratios for ARB/ACEIs, BBs, statins, and CCBs were 0.58 [95% CI: 0.38–0.88], 0.71 [95% CI: 0.35–1.44], 0.60 [95% CI 0.38–0.95], and 0.63 [95% CI: 0.45–0.88], respectively. ARB/ACEIs, statins, and CCBs significantly suppressed AIC, whereas BBs did not demonstrate statistical significance, possibly due to limited statistical power. NLP-extracted signals from clinical texts reflected the known effects of these medications, demonstrating the feasibility of NLP-based drug repositioning. Further investigation is needed to determine if similar results can be replicated using electronic medical records from other institutions.

Purpose Urothelial carcinoma (UC) is a common malignant tumor of the urinary tract, with bladder cancer as the most frequent type. Radical cystectomy (RC) is the standard treatment for muscle-invasive bladder cancer (MIBC), and perioperative chemotherapy is recommended in addition to RC in guidelines. However, no established evidence defines the optimal regimen and number of cycles, and treatment varies by institution. Therefore, this study aimed to clarify perioperative treatment patterns for MIBC using a hospital-based claims database. Methods Patients with claims records for bladder cancer recorded during the case-identification window (2012–2020) were identified using the Medical Data Vision Co., Ltd. database. The database spans April 2008 to July 2021, enabling longitudinal assessment. Patient characteristics and prescribed perioperative chemotherapy regimens were analyzed. Factors associated with neoadjuvant chemotherapy (NAC) were examined using univariable analysis and an exploratory multivariable logistic regression model. Results Among 6,723 patients, 78.5% were men, with a median diagnosis age of 71 years. The treatment groups included 2,324 patients who received NAC, 598 who received adjuvant chemotherapy (AC), 364 who received NAC and AC, and 3,437 who underwent RC-only. NAC utilization rate increased over time ( P for trend < 0.0001). Gemcitabine plus cisplatin was the most frequently administered regimen. Univariable analysis revealed an association between clinical stage 3 or higher and the NAC administration. In contrast, older age and comorbidities were associated with non-administration of NAC. Furthermore, the hospital size and cancer hospital designation influenced NAC administration. Conclusion Perioperative chemotherapy utilization for MIBC has increased annually. Patient characteristics and treatment facility factors influence NAC administration.

Patient-reported symptoms provide valuable insights into patient experiences and can enhance healthcare quality; however, effectively capturing them remains challenging. Although natural language processing (NLP) models have been developed to extract adverse events and symptoms from medical records written by healthcare professionals, limited studies have focused on models designed for patient-generated narratives. This study developed an NLP model to extract patient-reported symptoms from pharmaceutical care records and validated its effectiveness in analyzing diverse patient-generated narratives. The target dataset comprised “Subjective” sections of pharmaceutical care records created by community pharmacists for patients prescribed anticancer drugs. Two annotation guidelines were applied to develop robust ground-truth data, which was used to develop and evaluate a new transformer-based named entity recognition model. Model performance was compared with that of an existing tool for Japanese clinical texts and tested on external patient-generated blog data to evaluate generalizability. The newly developed BERT-CRF model significantly outperformed the existing model, achieving an F1 score > 0.8 on pharmaceutical care records and extracting > 98% of physical symptom entries from patient blogs, with a 20% improvement over the existing tool. These findings highlight the importance of fine-tuning models using patient-specific narrative data to capture nuanced and colloquial symptom expressions.

This study aimed to examine the effects of concomitant use of proton-pump inhibitors (PPIs) on the survival outcomes in patients with endocrine-sensitive chemotherapy-naïve advanced breast cancer (BC) treated with palbociclib or abemaciclib. This multicenter, retrospective study was conducted at five hospitals in Japan. Data were collected from consecutive patients treated with palbociclib or abemaciclib in combination with endocrine therapy as first-line treatment for endocrine-sensitive chemotherapy-naïve advanced BC between December 2017 and August 2022. Associations between concomitant PPI use and survival outcomes were analyzed. Among 202 patients, 38 (19%) were concomitant PPI users. In the palbociclib population ( n  = 123), concomitant PPI use was associated with a trend toward decreased progression-free survival (PFS) and a significant reduction in overall survival (OS; crude hazard ratio [HR], 1.67; 95% confidence interval [CI], 0.86–3.00 and crude HR, 3.51; 95% CI, 1.53–7.64, respectively). In multivariable analyses, consistent results were obtained (adjusted HR, 1.29; 95% CI, 0.66–2.53 and adjusted HR, 3.23; 95% CI, 1.28–7.67, respectively). In contrast, concomitant PPI use did not significantly affect either PFS or OS in the abemaciclib group ( n  = 79). Concomitant PPI use decreased the efficacy of palbociclib regardless of the formulation, with no such impact observed with abemaciclib.

ObjectivesHospital pharmacists play vital roles in patient care, with career satisfaction influenced by work environment, career advancement opportunities and personal aspirations. Addressing these factors in Japan is essential to attract and retain hospital pharmacists. This study aimed to identify factors associated with hospital pharmacists’ satisfaction with their current careers in Japan.MethodsA nationwide cross-sectional questionnaire survey was distributed through the Japanese Society of Hospital Pharmacists website, journal and newsletter. Responses were collected from 14 June to 31 July 2024, using Google Forms. Ordinal logistic regression analysis was applied to evaluate the association between career satisfaction and individual-related factors, including background, work style and environment.ResultsOf the 712 respondents, 710 provided consent for analysis. Pharmacists in their 30s, 40s and 50s reported significantly higher career satisfaction than those in their 20s (OR: 2.311, 95% CI: 1.323 to 4.038; OR: 2.148, 95% CI: 1.128 to 4.092; and OR: 2.077, 95% CI: 1.048 to 4.116, respectively). Conversely, mid-level and senior managerial roles and certifications were associated with lower satisfaction (OR: 0.354, 95% CI: 0.200 to 0.627; OR: 0.258, 95% CI: 0.158 to 0.421; and OR: 0.668, 95% CI: 0.478 to 0.934, respectively).ConclusionsStructured mentorship programmes, financial support for advanced training and systems to reduce workload and improve flexibility could enhance career satisfaction among hospital pharmacists in Japan.

The purpose of this study was to assess the differences between consumer (patient) and healthcare professional submissions of adverse drug reaction (ADR) reports associated with certain antiviral treatments in children. We extracted ADR reports for children aged <20 years who received oseltamivir or similar drugs (zanamivir and amantadine) between April 2004 and May 2020 from the Japanese Adverse Drug Event Report database. Abnormal behavior after oseltamivir administration was reported frequently in the news in November 2005, and a Dear Healthcare Professional letter about abnormal behavior after oseltamivir use was issued on March 20, 2007. We compared the number of ADR reports by three periods: (1) before the news, (2) between the news and the letter, and (3) after the letter. These reports were tabulated and analyzed after stratification according to the reporter (healthcare professionals only, patients and healthcare professionals, patients only), patient age (<10 years, 10-19 years), and ADR (abnormal behavior, other ADRs). For the reports from healthcare professionals only, the number of reports per quarter associated with oseltamivir was largest during the period between the news about abnormal behavior after oseltamivir use and publication of the Dear Healthcare Professional letter. The reports from patients only about abnormal behavior after oseltamivir use were first reported after publication of the letter. The proportions of reports from patients only about abnormal behavior with oseltamivir were 81.0% and 92.2% for ages <10 and 10-19 years, respectively. A ripple effect of increasing reports was observed with zanamivir or amantadine. Reports from patients only might increase in response to the media more than reports from healthcare professionals only or patients and healthcare professionals do. The ADR reports from patients must be carefully assessed from the perspective of when they were reported.