Background: Ipilimumab, a monoclonal antibody that targets cytotoxic T-lymphocyte antigen-4 (CTLA-4), is effective against malignant tumors, including non-small-cell lung cancer. In Japan, ipilimumab was launched in 2015 with only a 50-mg formulation, followed by a 20-mg formulation in November 2021. However, its effects on clinical practice remain unclear. This study evaluated changes in ipilimumab prescription patterns and drug costs following the introduction of the 20-mg formulation. Methods: Clinical data were analyzed using the MDV analyzer^® (Medical Data Vision Co., Ltd.). The study population included patients who received ipilimumab between November 2020 and October 2023. The investigated parameters included the number of patients, number of prescriptions, prescribed dose (potency), drug costs, and prescribed formulations. Results: Data from 245 medical institutions included 4,366 patients and 13,805 prescriptions. The prescription rate of the 20-mg formulation increased over 12 months after introduction and stabilized at approximately 40% in the following year. The average prescribed dose per prescription decreased from the 80-mg range before the introduction to the 70-mg range 12 months after the introduction. The average drug cost per prescription decreased from the 800,000-yen range to the 600,000-yen range. Conclusion: The addition of the 20-mg formulation increased its usage and reduced the prescribed dose and drug costs. This reduction was likely due to decreased drug waste. These findings suggest that the introduction of low-dose formulations can contribute to cost savings in clinical practice.

The Japanese Ministry of Health, Labor, and Welfare has established guideline values for indoor air concentrations of eight volatile organic compounds (VOCs) and five semi-volatile organic compounds (SVOCs). In 2019, the Ministry updated the guidelines for three chemicals, including two phthalates, to reduce allowable concentrations. The Manual for the Measuring of Chemicals in Indoor Air proposes methods for analyzing these compounds; however, those for SVOCs, such as phthalates, are tentative. Therefore, in this study, inter-laboratory validation was performed in six facilities to propose a highly sensitive standard test method for the new guideline values of phthalate. The additional amount in this assessment was 5 ng, estimated based on the lowest concentration of the latest guideline values for phthalates (di-n-butyl phthalate: 17 µg/m³). The results showed that the average accuracy of each compound at each facility ranged from 73.7 to 150%, with bis(2-ethylhexyl) phthalate exceeding the validation criteria in the two facilities. However, the average accuracy across all facilities ranged from 96.5 to 119%, and repeatability and reproducibility varied from 1.4 to 17% and 10 to 17%, respectively. Therefore, the findings are largely consistent with the criteria for interlaboratory validation studies. This analytical method was proposed and published in the Manual for the Measuring of Chemicals in Indoor Air (Integrated Edition) as a standard test method for phthalates with guideline values established.

Xerostomia is a condition characterized by the primary complaint of dry mouth, which can lead not only to oral issues but also to systemic diseases and a decline in quality of life (QOL). While drug adverse reactions are among its causes, the underlying mechanisms and risks associated with each medication remain unclear. Therefore, this study aimed to clarify aspects of drug-induced xerostomia using the Japanese Adverse Drug Event Report Database. Five Preferred Terms defined by the Japanese version of the Medical Dictionary for Regulatory Activities, including Thirst, Dry mouth, Dry throat, Lip dry, and Salivary hyposecretion, were classified as representing adverse reactions related to xerostomia and were extracted. An analysis of approximately 20 years of data revealed 781 cases were reported as xerostomia. Signals were detected for 27 drugs, classified into 10 categories according to the Anatomical Therapeutic Chemical classification. Of these, 20 drugs had xerostomia descriptions in their package inserts, and 12 drugs were assigned scores on the Anticholinergic Risk Scale. Signals were also detected for drugs not widely known to be associated with xerostomia, such as ANTINEOPLASTIC AGENTS and VACCINES, suggesting the influence of patients’ underlying diseases and concomitant medications. Both the newly identified seven drugs and those that do not exhibit anticholinergic effects should be evaluated in conjunction with further clinical data. Future investigations considering patients’ underlying conditions and concomitant medications are important. Furthermore, since xerostomia may impact QOL and systemic health, pharmacists are expected to play an active role in its prevention and early detection.

Goreisan has long been prescribed for weather- and barometric pressure-related headache. However, its efficacy when initiated during the premonitory phase of migraine has not been systematically evaluated. We retrospectively reviewed 81 patients diagnosed with migraine (mean age: 41.7 ± 11.5 years; 14.8% male). Subtypes included migraine with aura (MA, n = 1), without aura (MO, n = 72), and combined type (MA + MO, n = 8). Patients who received Goreisan monotherapy during the premonitory phase were categorized as consistent responders (CRs) or inconsistent responders (IRs). Clinical characteristics and treatment responses were compared between the two groups. The overall response rate to Goreisan was 61.7% (n = 50). Headache profiles and the efficacy of triptans did not differ significantly between CRs and IRs. However, psychiatric comorbidities were more frequent in IRs than in CRs (p = 0.011). Initiating Goreisan during the premonitory phase appears to be an effective therapeutic approach for migraine patients with weather- and barometric pressure-related headache. Clinical background, including psychiatric history, may influence treatment outcomes and should be considered when selecting patients for this strategy.