Journal of Pharmaceutical Health Care and Sciences最新文献

Background: The global crisis of antimicrobial resistance (AMR) necessitates robust antimicrobial stewardship. The World Health Organization's (WHO) Access, Watch, Reserve (AWaRe) classification is a key tool for guiding antibiotic prescribing to combat AMR. The WHO's global target was to have at least 60% of antibiotic consumption fall into the Access category by 2023. This study evaluated the effectiveness of localized interventions toward this goal.

Methods: This retrospective, longitudinal study analyzed oral outpatient antibiotic prescriptions at Kochi Medical School Hospital from April 2022 to June 2025. Data included defined daily doses (DDDs), days of therapy (DOTs), and AWaRe classifications. Based on a preceding analysis, the antimicrobial stewardship team (AST) implemented targeted, department-specific educational interventions starting in April 2024. The impact was evaluated using seasonally adjusted time-series analysis and regression models. The study also included a survey of Escherichia coli susceptibility to levofloxacin, ciprofloxacin, and sulfamethoxazole/trimethoprim from outpatient urinary isolates.

Results: The AST intervention led to a statistically significant increase in the usage proportion and DDDs of Access antibiotics (+ 2.92%, p = 0.005 and + 376.5 DDDs, p = 0.001, respectively), with a corresponding decrease in Watch antibiotics (-3.00%, p = 0.003). However, DOTs did not significantly change, indicating the intervention primarily impacted drug choice, not treatment duration. Top prescribed agents were clarithromycin (24.2%), sulfamethoxazole/trimethoprim (20.7%), and rifaximin (10.7%). E. coli susceptibility to levofloxacin and ciprofloxacin was low (< 80% overall), particularly in extended-spectrum β-lactamase (ESBL)-producing strains (~ 10%). Sulfamethoxazole/trimethoprim susceptibility remained high overall (≥ 80%) but was low (< 80%) for ESBL-producing strains.

Conclusions: AST interventions successfully shifted outpatient prescribing from Watch to Access antibiotics, demonstrating that targeted interventions can modify prescribing behavior. However, challenges remain, such as addressing treatment duration and achieving broader goals. The observed resistance patterns highlight the critical need for prescribers to consult local antibiograms. Future strategies require a more comprehensive approach, including real-time alerts and improved diagnostics, to further optimize antibiotic use and combat AMR.

Background: Japanese traditional (Kampo) medicines are commonly prescribed in clinical practice, with increasing evidence supporting their use during pregnancy. The efficacy and safety of Kampo medicines during pregnancy have increasingly been studied; however, evidence in support of these medicines is inadequate. Thus, we conducted a temporal trend analysis of Kampo medicine prescriptions to determine the Kampo medicines for which further safety evidence is required.

Methods: Administrative data from pregnant Japanese women who visited acute-care diagnosis procedure combination hospitals between January 1, 2014, and December 31, 2023, were used in this study. Therapeutic categories related to the Kyoto Encyclopedia of Genes and Genomes D numbers 5100 and 5200 were defined as target Kampo medicines. Annual prescription trends were calculated as proportions. Temporal trends in the proportion of prescriptions for each Kampo medicine were assessed using the Cochran-Armitage trend test. Statistical significance was set at p < 0.05.

Results: Between 2014 and 2023, the proportion of Kampo medicine prescriptions increased significantly from 12.0% to 13.6% (p < 0.001). As of 2023, tokishakuyakusan (2.9%) was the most prescribed medication, followed by kakkonto (2.4%) and daikenchuto (2.0%). From 2014 to 2023, the proportions of tokishakuyakusan (3.3% to 2.9%) and kakkonto (2.4% to 2.4%) prescriptions showed no significant temporal changes (p = 0.07 and 0.36, respectively). In contrast, the proportion of daikenchuto prescriptions increased significantly from 0.8% to 2.0% (p < 0.001).

Conclusion: The primary prescribed Kampo medicines were those with established safety evidence for use in pregnant women. The proportion of Kampo medicine prescriptions for pregnant women in Japan has increased over time, with tokishakuyakusan being the most prescribed during the study period.

Background: Nano-liposomal irinotecan (nal-IRI) combined with 5-fluorouracil (5-FU) and levofolinate has been reported to extend the survival of patients with pancreatic cancer and represents an effective second-line treatment. Nal-IRI encapsulates IRI in liposomes modified with polyethylene glycol (PEGylation), which can lead to infusion reactions. Hypersensitivity reactions (HSR) to chemotherapeutic agents include both allergic and infusion reactions, which are difficult to distinguish. Severe HSR can be fatal; however, discontinuation of the suspected drug directly affects the treatment strategy. We report a case of severe HSR during the first nal-IRI administration, in which treatment was successfully continued with supportive management.

Case presentation: A woman in her early 80s with metastatic pancreatic cancer received nal-IRI + 5-FU + levofolinate as second-line treatment. Five minutes after the initiation of the first nal-IRI infusion, the patient developed a tightening sensation in the head, respiratory distress, convulsions, and loss of consciousness, with percutaneous oxygen saturation dropping to the 80% range. The nal-IRI infusion was immediately discontinued, and emergency management was initiated with intravenous infusion of hydrocortisone, famotidine, d-chlorpheniramine maleate, and oxygen administration, resulting in symptom improvement. Given the limited treatment options for metastatic pancreatic cancer and the patient's strong desire to continue therapy, we decided to re-administer the regimen with intensified management, increasing dexamethasone to 19.8 mg and adding famotidine 20 mg and d-chlorpheniramine maleate 5 mg. Furthermore, we adopted a three-step dose-escalation method. The infusion was started at one-third of the standard rate, increased to two-thirds after 30 min, and finally adjusted to the full rate after another 30 min, after confirming the absence of HSR symptoms. Consequently, the patient did not exhibit any signs of HSR, and the same administration method was continued for 11 cycles until disease progression.

Conclusions: The novelty of this report lies in presenting, for the first time, the detailed course and process by which treatment was successfully continued in a patient experiencing severe HSR upon initial nal-IRI administration, through enhanced supportive care tailored to the characteristics of the drug and stepwise dose adjustment.

Background: The implementation of local formularies in Japan began in November 2018 in the Sakata area of Yamagata Prefecture. A local formulary is a regional list of recommended pharmaceuticals selected based on comprehensive criteria, including efficacy, safety, and economic considerations. However, the economic impact of these formulations has not yet been clearly demonstrated. This retrospective observational study aimed to verify their effectiveness by analyzing real-world data.

Methods: Prescription and outpatient data from the National Database were extracted for October 2018, 2019, and 2020, covering both the Sakata area and the rest of Yamagata Prefecture. The number of prescriptions and cost per prescription were calculated for four therapeutic classes: proton pump inhibitors/potassium-competitive acid blockers, angiotensin receptor blockers, α-glucosidase inhibitors, and statins.

Results: In 2020, the formulary adherence rate in Sakata exceeded that in the rest of Yamagata Prefecture across all therapeutic classes. Although the cost per prescription annually decreased in Sakata, some therapeutic classes showed increased costs in the remainder of the prefecture from 2019 to 2020. In contrast, formulary adherence to outpatient medical prescriptions was lower in Sakata, and no clear impact of the local formulary was observed. Applying the rate of cost reduction observed in Sakata to the rest of the prefecture, the estimated monthly savings reached approximately 35 million JPY after 1 year and 15 million JPY after 2 years. Furthermore, although no prior measures existed to control the use of originator drugs without generics, Sakata showed a trend of reduced usage compared with the rest of the prefecture, suggesting the influence of the local formulary.

Conclusions: Local formularies can contribute to the sustainability of Japan's healthcare financing systems.

Background: In 2021, the Education and Training Committee of the Japanese Society for Pharmaceutical Palliative Care and Sciences established an educational training program for pharmacists in palliative care, named Palliative care-Situational Motivating Interactive Learning and Education (pSMILE), based on web-based and face-to-face workshops. The program aims to enhance pharmacists' knowledge of palliative care and develop communication and cooperation skills.

Methods: We constructed a web-based pSMILE training program, which was later adapted for face-to-face workshops. This program consisted of two sessions, with the first half at a hospital and the second half at a clinic or community pharmacy. The participants could choose from three learning scenarios. A post-survey (within 1 week of the workshop) assessed usefulness, difficulty, length, and satisfaction. Participants also completed a web-based survey on behavioral changes related to daily palliative care following the workshop. Nine items on behavioral changes were assessed before and 1 month after the workshop, which was held from April 2021 to March 2024.

Results: Twelve pSMILE workshops were held during this period (10 web-based and two face-to-face). A total of 296 pharmacists participated, 152 (51.4%) of whom were Board Certified Pharmacist in Palliative Pharmacy, and 292 (98.6%) responded to the before/after workshop survey. Usefulness ratings were 4.39 for Session I and 4.20 for Session II. Satisfaction ratings were high (≥ 4.5), with no significant differences based on affiliation, training format, or certification. All confidence scores of nine daily palliative care behaviors (symptom assessment; multidisciplinary information sharing; proposing pharmacotherapy; polypharmacy intervention; palliative pharmacotherapy with awareness of pharmacokinetics; explanation of delirium; response in the discharge conference; information sharing between hospitals, clinics, and community pharmacies; and pharmacotherapy suggestions in view of the post-discharge) improved significantly post-workshop (p < 0.01), across both web-based and face-to-face workshops. Certified participants had higher confidence scores both before and after the workshop, and each group showed a significant improvement.

Conclusions: These results suggest that either web-based or face-to-face pSMILE workshops improve the quality of pharmacists' contribution in daily palliative care. This is the first report on the effectiveness of an academically approved web-based educational program for palliative care pharmacists, comparable to face-to-face workshops.