Objective: The changes in plasma drug concentrations must be estimated for safely and effectively using medications. Physiologically based pharmacokinetic (PBPK) modeling requires simultaneously solving differential equations, which hinders the practical application of PBPK modeling in clinical settings. In this study, we developed a PBPK model that incorporates the first-pass effect to quantitatively predict pharmacokinetics in clinical applications. The model was used with data obtained from the literature data to estimate the effects of co-administering various enzyme inducers and renal impairment on plasma concentration profiles.

Methods: Plasma drug concentrations were quantified using a data extraction tool based on the literature on concomitant use of drugs with smoking cigarettes or consuming St. John's Wort (SJW). PBPK models were constructed for intrinsic hepatic and renal clearance to evaluate the impact of smoking, SJW consumption, and renal impairment on the plasma concentrations of various drugs. In addition, the pharmacokinetics and plasma concentration profiles of multiple doses were examined.

Results: The area under the curve (AUC) of the PBPK model was 47% lower than the reference range for erlotinib in smokers. For other drugs, the predicted AUC differences were within 80－125% of the values in the literature under enzyme induction or renal impairment. The AUC for theophylline differed with repeated dosing: a smoking-induced reduction in the elimination half-life (t_1/2) decreased the trough concentration. Moreover, alprazolam did not reach a steady state in the SJW. Renal impairment increased the AUC and prolonged the t_1/2 of alogliptin and bepotastine.

Discussion: PBPK modeling effectively quantified the effects of enzyme induction and renal impairment. Repeated dosing strongly affected the enzyme induction and renal impairment of the administered drugs. The developed model is a valuable tool for clinical applications that use drug information.

Objective: Currently, information regarding regimens and adverse events related to outpatient cancer chemotherapy is exchanged with community pharmacies via paper-based methods. In recent years, electronic patient diaries have been increasingly utilized in Japan to enhance patient self-care. Accordingly, we developed a comprehensive support system (CINVePRO-PMS) that integrates an electronic patient diary (CINVePRO), designed to optimize chemotherapy-induced nausea and vomiting (CINV) management, with a Pharmaceutical Management System (PMS) capable of generating records of pharmaceutical interventions. Following confirmation of its usability in hospitalized patients, this clinical study was conducted to evaluate the usability and utility of CINVePRO-PMS for outpatients undergoing cancer chemotherapy, hospital pharmacists, and community pharmacists, as a preparatory step for practical implementation.

Methods: Outpatients receiving cancer chemotherapy at Chiba-Nishi General Hospital, hospital pharmacists, and the patients' community pharmacists used CINVePRO-PMS for 21 days. Twelve cancer patients were included in this study. Following this period, a structured questionnaire was conducted to assess usability, and data entered into CINVePRO-PMS were analyzed.

Results: After 21 days, patient questionnaire responses indicated that each CINVePRO screen was rated highly for being "easy to see," "easy to understand," and "easy to remember," with a patient usage continuation rate of 73% ± 36.4%. Moreover, data captured in the PMS demonstrated significant inter-individual variability in nausea and vomiting, enabling pharmacists to provide tailored interventions and effectively utilize the system to manage these symptoms. In the pharmacist questionnaire, CINVePRO-PMS was perceived as enhancing collaboration between hospitals and community pharmacies. A notable limitation was the lack of integration with electronic medical records or existing systems.

Conclusions: CINVePRO-PMS is feasible for practical implementation in outpatient settings.

Objective: Handling and guidelines regarding physical characteristics, including, hardness, viscosity, and cohesiveness are stipulated for foods intended for dysphagic individuals in Approval Standards I, II, and III. However, the physical characteristics of the medical oral jelly formulation (JP XVIII) developed for patients experiencing difficulty swallowing tablets are not clearly defined, resulting in inconsistencies with food standards. In this study, we measured the physical properties of oral jelly formulations listed in the National Health Insurance Drug Price List, referencing the approved food standards for dysphagic individuals. Further, we assessed the documentation status of pharmaceutical characteristics for the target formulations using an Interview Form (IF), followed by an evaluation.

Methods: A total of 18 items from 10 pharmaceutical oral jelly formulations were selected as test formulations. Texture profile analyses were conducted using a creep meter and the results were compared with food standards (I, II, and III) for dysphagic individuals. Additionally, the descriptions of physical properties and pharmaceutical characteristics of test formulations in the IFs were examined within the "Development Background" section.

Results: Of the 18 items across 10 formulations, 6, 5, and 3 met Approval Standards I, II, and III, respectively. Further, four items, including the two originator drugs, did not meet the applicable approval criteria. Notably, originator and generic drug formulations with differing applicable criteria were identified. Consideration for administration to dysphagic patients was included in three (seven items) test formulation IFs, albeit without the description of physical properties.

Conclusion: The IF formulation of the oral jelly preparation evaluated in this study did not include information on its physical properties. Our results suggest that existing food approval standards are sufficient for evaluating oral jelly preparations. Further, the information obtained will support pharmacists in selecting appropriate medications for dysphagic patients. Therefore, the inclusion of physical characteristics and approval criteria in IFs is desirable.

Objective: Message-based medication follow-up applications are increasingly used in community pharmacies, but age-stratified differences in use and alert characteristics remain insufficiently examined. We compared the use of a follow-up application between non-elderly and elderly patients and clarified the characteristics of alerts and app-triggered tracing reports (TRs).

Design: Retrospective observational study at a single community pharmacy.

Methods: Patients who used the Pocket Musubi^® application at a community pharmacy in Japan from April to October 2025 were included. Patient-level outcomes (recipients, responders, alert patients, pharmacist actions) and message-level outcomes (questions, responses, alerts, pharmacist actions) were compared between non-elderly (< 65 years) and elderly (≥ 65 years) patients. Alerts categorized into five types were compared. App-triggered TRs were reviewed for alert content, medications, and physician interventions.

Results: Among pharmacy visitors during the study period, questions were sent to 206 non-elderly and 155 elderly patients registered to the application. In patient-level analyses, the elderly group showed a higher response proportion (59.2% vs. 69.0%; p = 0.07) and a significantly higher alert proportion (50.0% vs. 64.5%; p = 0.04). In message-level analyses, 2,135 and 2,316 question messages were sent to non-elderly and elderly patients, respectively, and the elderly group showed a higher response proportion (38.5% vs. 43.1%; p < 0.01) and a higher alert proportion (19.1% vs. 23.9%; p = 0.02). "Adverse effects" was the most common alert in both groups; however, "appropriate use" was more frequent in non-elderly patients, whereas "lifestyle guidance" was more frequent in elderly patients (p < 0.01). Six app-triggered TRs were identified, mainly involving issues that patients are less aware of (e.g., inhalation errors, minor health changes, blood pressure variation). Four TRs resulted in physician interventions.

Conclusion: The follow-up application was used effectively across age groups. Pharmacist follow-up using the app supported early detection of clinical changes and timely communication with physicians.