Infectious diseases, which are shaped by clinical practice, pathogen evolution, shifts in healthcare systems, and societal behavior, require multifaceted responses. In recent years, real-world data (RWD) findings have been used to inform decision-making in the field of infectious diseases. The infrastructure for using diverse RWD relevant to infectious disease research is being established in Japan. Promoting the use of RWD enables approaches to answer questions that have been difficult to address with conventional clinical research and can generate reliable evidence for antimicrobial stewardship, safety evaluation, antimicrobial resistance control, and public health intervention assessment. Simultaneously, because the RWD are not collected for research, caution is warranted when interpreting the results. The volume and granularity of information, data coverage, and longitudinal follow-up differ by data source. Without understanding these properties, the use of RWD can lead to erroneous conclusions. To ensure the quality of RWD studies, the structure and limitations of each dataset must be understood, and appropriate study designs and statistical methods to address various biases must be adopted. This review outlines the characteristics of RWD available in Japan, concrete examples of their use, and key considerations when employing RWD in research, with a focus on infectious diseases.
Inhalation therapy plays a central role in the pharmacological treatment of both chronic obstructive pulmonary disease (COPD) and asthma. Appropriate selection of inhaler devices and accurate mastery of inhalation techniques are essential for maximizing therapeutic efficacy. Advanced age is considered a major risk factor for difficulties in learning inhalation techniques, and patients with COPD commonly exhibit higher-order cognitive dysfunction. In Japan, the number of older individuals with dementia is increasing owing to population aging, making the provision of effective inhalation instructions for older adults an urgent issue. This retrospective study investigated the relationship between cognitive function and the degree of mastery of inhalation techniques in older patients, as assessed using the Mini-Mental State Examination (MMSE) and Frontal Assessment Battery (FAB). Overall, FAB scores were more strongly associated with inhalation technique mastery than MMSE scores; indeed, patients with FAB scores of ≤12 had difficulty acquiring proper inhalation techniques. Dry powder inhalers that require manual capsule loading are difficult to master because of their operational complexity. The results of this study will help design effective strategies to improve inhalation technique and maximize therapeutic efficacy in older patients with COPD and asthma.
Generative artificial intelligence (AI) has rapidly advanced and is expected to enhance the efficiency and quality of clinical practice. In pharmacy practice, determining perioperative medication discontinuation is a critical task that is directly related to patient safety. However, standardized guidance remains limited, particularly for over-the-counter (OTC) drugs and dietary supplements, and decisions often rely on the individual expertise of pharmacists. In this study, the accuracy of nine generative AI models available in April 2025 (GPT-4o, GPT-4o mini, OpenAI o3, Gemini 2.5 Pro Exp, Gemini 2.0 Flash, Claude 3.7 Sonnet, Grok 3, Llama 4 Scout, and DeepSeek R1) for perioperative medication discontinuation decisions was evaluated using 15 mock prescription sets comprising 105 items. Each model received a standardized Japanese prompt, and outputs were independently assessed by five hospital pharmacists (≥5 years of clinical experience) based on three criteria: accurate drug identification, appropriateness of discontinuation and resumption timing, and the validity of the pharmacological rationale. A response was considered correct when at least four of the pharmacists agreed. OpenAI o3 demonstrated the highest accuracy (87.6%), followed by Gemini 2.5 Pro Exp (84.8%) and GPT-4o (83.8%). Lightweight models demonstrated lower accuracy, particularly for OTC products, dietary supplements, and fixed-dose combination drugs. High-performance models with advanced reasoning capabilities exhibited high accuracy and may serve as useful decision-support tools. However, incorrect responses occurred in approximately 10 – 20% of cases, even among the top-performing models. Therefore, safe clinical implementation requires careful model selection, integration with institutional knowledge resources, and final verification by pharmacists.
The increasing sophistication of medical care demands a reduction in the workload of physicians and an expansion of the roles of pharmacists in ward-based duties. However, advanced pharmacotherapy often relies on pharmacists’ individual knowledge and experience, posing challenges for standardizing operations and ensuring quality. To address these issues, a ward-duty support system was developed using Microsoft Excel VBA and Google Apps Script, incorporating practical audit items based on major clinical pathways in cardiology and urology. The developed system features prescription audit support and medication guidance record functions. A questionnaire survey revealed high utility, particularly in “homogenizing the quality of medication-guidance records.” This suggests that the system’s built-in audit items and record-creation functions can standardize the quality of work, regardless of a pharmacist’s years of experience. This system is expected to reduce the reliance on individual pharmacists’ knowledge and experience, thereby supporting consistent and high-quality prescription audits.
Inhaled medications are crucial in the pharmacological treatment of bronchial asthma and COPD, and proper inhalation instruction and adherence are essential in improving treatment outcomes. However, inhalation therapy in patients with permanent tracheostomy is technically challenging due to the upper airway’s anatomical bypassing. In this report, we describe a case in which inhalation therapy using the AeroChamber Plus® and guidance from a pharmacist was successful in a patient with a permanent tracheostomy, resulting in improved asthma control. The patient is a male in his 70s who underwent total laryngectomy for laryngeal cancer, resulting in permanent tracheostomy. Asthma developed, and the patient was prescribed Flutiform®. Because oral inhalation was not possible, the pharmacist provided inhalation instruction. The inhalation instruction used an AeroChamber Plus® with a mask positioned upside down to prevent air leakage, making inhalation through the permanent tracheostomy feasible. Because oral inhalation was not possible, gargling was unnecessary, and wiping the surrounding area of the tracheostomy was recommended as a measure for side effects. The patient showed improvement in respiratory distress, and asthma symptoms remained stable after discharge. The regular follow-up visits were continued. This case suggests that inhaled medications can be used effectively even in patients with a permanent tracheostomy, allowing for long-term asthma management with adjustments to inhalation techniques. Proper use of inhaled medications helps prevent exacerbation of asthma and maintains the patient’s quality of life.