International Journal of Clinical Pharmacy最新文献

筛选
英文 中文
Peripheral neuropathy associated with immunomodulatory drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database. 与免疫调节药物相关的周围神经病变:基于FDA不良事件报告系统数据库的药物警戒分析。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-05-20 DOI: 10.1007/s11096-025-01925-z
Chunhong Liang, Xueyan Zhang, Lijuan Zhou, Weiquan Zhang, Leifeng Liang, Di Xiao, Pingzhi Peng
{"title":"Peripheral neuropathy associated with immunomodulatory drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.","authors":"Chunhong Liang, Xueyan Zhang, Lijuan Zhou, Weiquan Zhang, Leifeng Liang, Di Xiao, Pingzhi Peng","doi":"10.1007/s11096-025-01925-z","DOIUrl":"10.1007/s11096-025-01925-z","url":null,"abstract":"<p><strong>Background: </strong>Peripheral neuropathy requires early detection and intervention.</p><p><strong>Aim: </strong>This study aimed to examine the association between immunomodulatory medications (IMiDs; thalidomide, lenalidomide, and pomalidomide) and peripheral neuropathy.</p><p><strong>Method: </strong>OpenVigil 2.1 was used to retrieve data associated with IMiDs and peripheral neuropathy from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using the reporting odds ratio (ROR) and information components (IC) with a 95% credibility interval. Peripheral neuropathy signals were further prioritized using a rating scale.</p><p><strong>Results: </strong>We found 645 cases of peripheral neuropathy in 19,622 adverse event reports for thalidomide, 4849 cases in 197,866 adverse event reports for lenalidomide, and 933 cases in 40,582 adverse event reports for pomalidomide. Based on the clinical priority assessment, peripheral neuropathy was identified as having moderate clinical priority for the three immunomodulatory drugs (priority score = 6). In plasma cell myelomas, more peripheral neuropathy was reported for thalidomide [4.24% vs. 2.51%; ROR = 1.72 (1.42, 2.08); IC = 0.23 (0.05, 0.41)] and lenalidomide [2.71% vs. 1.06%, ROR = 2.59 (2.29, 2.91); IC = 0.14 (0.08, 0.20)] than in non-plasma cell myelomas. Peripheral neuropathy signals were detected in age groups 51-74, 63-74, and 51-62 for lenalidomide, thalidomide, and pomalidomide, respectively. No disproportionate gender differences were detected.</p><p><strong>Conclusion: </strong>Our study indicated that the risk of peripheral neuropathy varied among patients with different indications and age subgroups for the same IMiD. Further investigation is required to verify these risk signals.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1324-1332"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept. 真实世界数据和孟德尔随机化分析评估利洛那接受不良反应。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-02 DOI: 10.1007/s11096-025-01932-0
Lihong Liu, Zhenfei Chi, Zhe Zhang
{"title":"Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept.","authors":"Lihong Liu, Zhenfei Chi, Zhe Zhang","doi":"10.1007/s11096-025-01932-0","DOIUrl":"10.1007/s11096-025-01932-0","url":null,"abstract":"<p><strong>Background: </strong>Rilonacept, an interleukin-1 (IL-1) \"trap,\" is FDA-approved for recurrent pericarditis, but research on its adverse reactions is limited due to its recent introduction.</p><p><strong>Aim: </strong>This study aimed to identify potential adverse reactions associated with rilonacept using the FDA Adverse Event Reporting System (FAERS) and to evaluate long-term effects through Mendelian randomization (MR) analysis.</p><p><strong>Method: </strong>We analyzed all adverse event reports related to rilonacept from the FAERS database between January 2021 and June 2024. Positive signals for adverse reactions were extracted using reporting odds ratios (ROR) and information components (IC). MR analysis was conducted using genetic variants as instrumental variables to explore causal relationships between rilonacept and identified adverse reactions, with sensitivity analyses performed for robustness.</p><p><strong>Results: </strong>A total of 419 adverse event reports were analyzed, documenting 1847 AEs. Common events included COVID-19, injection site rash, pain, and injection site reaction, categorized into 27 System Organ Classes (SOCs). Notable frequencies were found in Infections and Infestations, Nervous System Disorders, and Skin and Subcutaneous Tissue Disorders. Disproportionality analysis identified positive signals primarily in Skin and Subcutaneous Tissue Disorders, Cardiac Disorders, and Immune System Disorders, with 11 AEs showing positive signals in both Preferred Terms (PTs) and SOCs. MR analysis revealed significant associations between IL-1RN (rilonacept) and allergic urticaria (OR: 1.56), rash (OR: 0.64), and myocarditis (OR: 2.26).</p><p><strong>Conclusion: </strong>Rilonacept is effective for certain inflammatory conditions, but careful monitoring for adverse reactions, particularly involving the immune system, skin, and cardiac issues, is essential.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1365-1374"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540130","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-effectiveness of benmelstobart-anlotinib-chemotherapy in extensive-stage small-cell lung cancer: A comparative analysis across United States and Chinese healthcare systems. benmelstobbart -anlotinib化疗治疗大分期小细胞肺癌的成本-效果:美国和中国医疗保健系统的比较分析
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-24 DOI: 10.1007/s11096-025-01968-2
Junjie Wan, Yizhou Xu, Bin Wan, Haixia Ding
{"title":"Cost-effectiveness of benmelstobart-anlotinib-chemotherapy in extensive-stage small-cell lung cancer: A comparative analysis across United States and Chinese healthcare systems.","authors":"Junjie Wan, Yizhou Xu, Bin Wan, Haixia Ding","doi":"10.1007/s11096-025-01968-2","DOIUrl":"10.1007/s11096-025-01968-2","url":null,"abstract":"<p><strong>Introduction: </strong>Benmelstobart and anlotinib plus etoposide-carboplatin (EC) group has demonstrated substantial clinical efficacy in improving survival outcomes for patients with extensive-stage small-cell lung cancer (ES-SCLC). However, the high treatment cost raises concerns regarding its affordability and cost-effectiveness across healthcare systems with heterogeneous pricing and reimbursement mechanisms.</p><p><strong>Aim: </strong>This study aimed to evaluate the cost-effectiveness of benmelstobart and anlotinib plus EC group compared to EC alone group and anlotinib plus EC group from both US and Chinese payer perspectives. The findings are intended to inform value-based pricing strategies and evidence-based reimbursement decision-making.</p><p><strong>Method: </strong>A partitioned survival model (PSM) with a lifetime horizon and 21-day cycles was constructed using clinical data from the ETER701 trial. Direct medical costs and health utility inputs were obtained from national databases, local hospitals, and published literature. The primary outcome was the incremental cost-effectiveness ratio (ICER), calculated by comparing costs and quality-adjusted life years (QALYs) between treatment strategies. Scenario analyses, including drug price simulations and deterministic and probabilistic sensitivity analyses, were conducted to evaluate model robustness. Willingness-to-pay (WTP) thresholds were set at $100,000/QALY and $150,000/QALY (US) and $40,011/QALY (China).</p><p><strong>Results: </strong>In the US, the benmelstobart and anlotinib plus EC group yielded ICER of $121,560.40/QALY versus EC alone group and $127,579.09/QALY versus anlotinib plus EC group, both below the $150,000/QALY threshold. However, at the $100,000/QALY threshold, cost-effectiveness would require reducing benmelstobart's price to $1316.12/600 mg. In China, the ICER of $117,667.17/QALY exceeded the local threshold. Price simulations suggested that cost-effectiveness could be achieved if prices were reduced below $2230.60/600 mg (US) and $328.47/600 mg (China). Sensitivity analyses identified progression-free survival (PFS) utility and benmelstobart pricing as major cost drivers. Probabilistic analysis indicated a 75.1% probability of cost-effectiveness at $150,000/QALY in the US. However, the probability of cost-effectiveness is 0% at WTP thresholds of $100,000/QALY in the US and $40,011/QALY in China.</p><p><strong>Conclusion: </strong>Benmelstobart plus anlotinib and EC group is likely to be cost-effective in the US at a WTP threshold of $150,000/QALY, but not in China at current prices. An 80% price reduction in China would be necessary to align with its WTP threshold, emphasizing the need for policy interventions in drug pricing and reimbursement to improve patient access.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1493-1509"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Drivers of engagement in virtual communities of practice: a qualitative study of Australian pharmacists' perceptions and experiences. 参与实践的虚拟社区的驱动因素:澳大利亚药剂师的看法和经验的定性研究。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-04-28 DOI: 10.1007/s11096-025-01913-3
Abdella Birhan Yabeyu, Jo Cavanagh, Rachel Lawson, Kathy Le, Lili Schmah, Kenneth Lee, Deborah Hawthorne, Amy T Page
{"title":"Drivers of engagement in virtual communities of practice: a qualitative study of Australian pharmacists' perceptions and experiences.","authors":"Abdella Birhan Yabeyu, Jo Cavanagh, Rachel Lawson, Kathy Le, Lili Schmah, Kenneth Lee, Deborah Hawthorne, Amy T Page","doi":"10.1007/s11096-025-01913-3","DOIUrl":"10.1007/s11096-025-01913-3","url":null,"abstract":"<p><strong>Background: </strong>In today's digital age, virtual Communities of Practice allow pharmacists to connect and collaborate across geographical and professional boundaries. These platforms create opportunities for shared learning and knowledge exchange, fostering innovation and helping pharmacists stay informed about evolving practices.</p><p><strong>Aim: </strong>This study aimed to explore the factors that drive engagement in virtual Communities of Practice among Australian pharmacists.</p><p><strong>Method: </strong>A qualitative study was conducted with 24 Australian pharmacists recruited via social media, professional networks, and conferences. Five online focus groups (each with 3-4 participants) were conducted, lasting 45-60 min. Discussions were transcribed verbatim, and data were analysed thematically using the Framework Method. Rigor was ensured through convenience sampling, maintenance of an audit trail, and the use of independent coding and thematic analysis to enhance credibility and confirmability.</p><p><strong>Results: </strong>Four major themes emerged from the analysis: 'access to information', 'sense of community', 'active facilitation', and 'platform usability'. Participants appreciated peer-shared knowledge and staying informed about current practices. A strong sense of community was cultivated as participants supported by others within the virtual community of practice. Active facilitation, such as moderators filtering content and engaging participants, was essential for maintaining a constructive environment. Additionally, platform usability, characterised by user-friendly features, the ability to keep personal and professional boundaries, and flexibility in accessing activities, significantly enhanced participant engagement.</p><p><strong>Conclusion: </strong>The study identified four key drivers of engagement in virtual Communities of Practice including accessible information, community support, active facilitation, and platform usability. These findings inform the design of virtual Communities of Practice to enhance professional collaboration and practice. Addressing these factors can enhance virtual Communities of Practice effectiveness in supporting professional collaboration, reducing isolation, and fostering continuous learning, particularly in evolving pharmacy roles.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1286-1295"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12431881/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Triggers for identifying anticoagulation-associated adverse drug events in hospitalized patients: a systematic review and meta-analysis. 识别住院患者抗凝相关药物不良事件的触发因素:系统回顾和荟萃分析
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-05-21 DOI: 10.1007/s11096-025-01916-0
Uyen Thi Nguyen, Khanh N C Duong, Phuong Thi Lan Nguyen, Ha Ngan Tran, Hoa Mai Nguyen, Huyen Thi Thu Cao, Hoa Dinh Vu, Hoang Anh Nguyen
{"title":"Triggers for identifying anticoagulation-associated adverse drug events in hospitalized patients: a systematic review and meta-analysis.","authors":"Uyen Thi Nguyen, Khanh N C Duong, Phuong Thi Lan Nguyen, Ha Ngan Tran, Hoa Mai Nguyen, Huyen Thi Thu Cao, Hoa Dinh Vu, Hoang Anh Nguyen","doi":"10.1007/s11096-025-01916-0","DOIUrl":"10.1007/s11096-025-01916-0","url":null,"abstract":"<p><strong>Background: </strong>Anticoagulation therapy presents a high risk of adverse drug events (ADEs) in hospitalized patients, highlighting the need for effective detection strategies in clinical practice.</p><p><strong>Aim: </strong>The review aimed to identify triggers for detecting anticoagulation-associated ADEs in hospitalized patients and describe the performance of these triggers.</p><p><strong>Method: </strong>PubMed, Cochrane, and Embase were queried until April 19, 2024. We included studies on trigger tools for detecting anticoagulation-related ADEs in hospitalized patients. The study quality was assessed using the Quality Assessment Trigger framework based on the QUADAS-2 tool for diagnostic accuracy. We performed random-effects meta-analyses to pool positive predictive values (PPV), with heterogeneity assessed via I<sup>2</sup> statistic and Cochran's Q test.</p><p><strong>Results: </strong>Twenty-three studies were included. Seventeen triggers were reported and categorized into three modules: abnormal laboratory values (11 triggers), medications or antidotes (three triggers), and care (three triggers). Elevated international normalized ratio (INR) was the most prevalent trigger (16 studies) with a PPV of 0.539 (95% Confidence Interval [CI] 0.310-0.768). Other triggers exhibited lower pooled PPVs than elevated INR, including vitamin K administration (15 studies, PPV 0.222, 95% CI 0.153-0.290), abrupt medication cessation (14 studies, PPV 0.418, 95% CI 0.169-0.667), and activated partial thromboplastin time > 100 s (11 studies, PPV 0.336, 95% CI 0.173-0.498). Importantly, in-hospital stroke (three studies) had the highest pooled PPV of 0.964 (95% CI 0.803-1.000).</p><p><strong>Conclusion: </strong>This review demonstrated the variability in PPVs of triggers for anticoagulation-associated ADEs, emphasizing the necessity for a specialized trigger tool for hospitalized patients on anticoagulants.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1132-1149"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparative effectiveness of the Beers Criteria (2023) versus the STOPP (v3) in detecting potentially inappropriate medications in older adults with heart failure: a retrospective cross-sectional study. Beers标准(2023)与STOPP (v3)在检测老年心力衰竭患者可能不适当的药物方面的比较有效性:一项回顾性横断面研究。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-07-18 DOI: 10.1007/s11096-025-01964-6
Suyan Zhu, Xiaomeng Zheng, Miao Fan, Yiyi Jin, Chunyan Chen, Mengjing Cheng
{"title":"Comparative effectiveness of the Beers Criteria (2023) versus the STOPP (v3) in detecting potentially inappropriate medications in older adults with heart failure: a retrospective cross-sectional study.","authors":"Suyan Zhu, Xiaomeng Zheng, Miao Fan, Yiyi Jin, Chunyan Chen, Mengjing Cheng","doi":"10.1007/s11096-025-01964-6","DOIUrl":"10.1007/s11096-025-01964-6","url":null,"abstract":"<p><strong>Introduction: </strong>The American Geriatrics Society (AGS) Beers Criteria and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP)/Screening Tool to Alert to Right Treatment (START) criteria are extensively utilized in identifying potentially inappropriate medications (PIMs) among older adults. Older adults with heart failure (HF) confront the dual challenge of polypharmacy and inadequate adherence to evidence-based medications, which further complicates their medication management and clinical outcomes.</p><p><strong>Aim: </strong>To assess the effectiveness of the AGS Beers (2023) Criteria and the STOPP (v3) criteria in identifying PIMs among older adults with HF and to analyze patterns of polypharmacy and evidence-based medications.</p><p><strong>Method: </strong>This retrospective study was conducted at a tertiary academic medical center in China and involved 1578 outpatients aged ≥ 65 years with HF who received at least one outpatient prescription between January 1 and December 31, 2023. Data on demographics, comorbidities, and prescribed medications were extracted from the hospital's electronic medical record (EMR) system. PIMs were identified with the AGS Beers (2023) Criteria and the STOPP (v3) criteria. The data were analyzed using descriptive statistics in Microsoft Excel.</p><p><strong>Results: </strong>Polypharmacy and hyperpolypharmacy were prevalent among the patients, affecting 65.3% and 15.7% of the cohort, respectively. PIMs were identified in 75.5% of patients (1192/1578), with a total of 2128 PIM cases observed according to the Beers Criteria, with the most common PIM being rivaroxaban (32.3%). The STOPP (v3) criteria identified PIMs in 28.9% of patients (n = 471), with the most frequent PIMs being statin use in frail patients aged ≥ 85 years (26.8%) and prolonged use of proton-pump inhibitors (16.6%). Among all patients in our study, 61.6% received either an angiotensin-converting enzyme inhibitor, angiotensin-II receptor blocker, or angiotensin receptor-neprilysin inhibitor (ACEI/ARB/ARNI); 57.0% were prescribed β-blockers; and 32.6% used a sodium-glucose cotransporter 2 inhibitor.</p><p><strong>Conclusion: </strong>While the Beers Criteria identified a greater number of PIMs in this study, both tools have differing strengths in detecting medication-related risks. Their combined use may provide a more holistic assessment of prescribing appropriateness. The widespread use of PIMs in older adults with HF, coupled with the frequent underuse of beneficial therapies, calls for systematic interventions. Pharmacist-led interventions and electronic decision-support systems that integrate evidence-based prescribing, deprescribing, and regular medication reviews are crucial for optimizing therapeutic outcomes in older adults with HF.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1485-1492"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pharmacovigilance analysis of metabolic and nutritional adverse reactions associated with entecavir and tenofovir using the FDA adverse event reporting system database. 利用FDA不良事件报告系统数据库对恩替卡韦和替诺福韦相关的代谢和营养不良反应进行药物警戒分析。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-08-19 DOI: 10.1007/s11096-025-01969-1
Haomin Zhu, Baolong Ding, Zhuying Jing, Hongting Yao, Yue Li, Lihong Gao, Yulu Zhu, Xin Li
{"title":"Pharmacovigilance analysis of metabolic and nutritional adverse reactions associated with entecavir and tenofovir using the FDA adverse event reporting system database.","authors":"Haomin Zhu, Baolong Ding, Zhuying Jing, Hongting Yao, Yue Li, Lihong Gao, Yulu Zhu, Xin Li","doi":"10.1007/s11096-025-01969-1","DOIUrl":"10.1007/s11096-025-01969-1","url":null,"abstract":"<p><strong>Introduction: </strong>Entecavir and tenofovir are the first-line therapies for chronic hepatitis B. Although effective, long-term use may cause adverse drug reactions (ADRs), affecting the metabolic and nutritional systems. However, many such risks are not comprehensively reflected in the current drug labels.</p><p><strong>Aim: </strong>This study aimed to systematically detect and validate metabolic and nutritional ADR signals associated with entecavir and tenofovir using the US FDA Adverse Event Reporting System (FAERS) database.</p><p><strong>Method: </strong>The FAERS reports from Q1 2004 to Q3 2024 were extracted. Reports that listed entecavir (4820 cases) or tenofovir (76,452 cases) as the primary suspect drugs were screened for metabolic and nutritional ADRs coded by the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis (reporting odds ratio [ROR], proportional reporting ratio [PRR]) and the Bayesian Confidence Propagation Neural Network (BCPNN) were applied. Positive signals were defined as fulfilling three criteria: ROR 95% CI lower bound > 1, PRR ≥ 2 with χ<sup>2</sup> ≥ 4, and IC025 > 0.</p><p><strong>Results: </strong>Eight positive ADR signals were detected for entecavir, and the top five in descending order of the number of reports are: lactic acidosis [46 reports; ROR(95%CI) = 10.06(7.53-13.44)], metabolic acidosis [11 reports;ROR(95%CI) = 2.36(1.3-4.26)], hypophosphatemia [9 reports;ROR(95%CI) = 8.3(4.32-15.97)], cell death [5 reports;ROR(95%CI) = 16.58(6.89-39.9)], and hyperlactacidaemia [5 reports;ROR (95%CI) = 13.63(5.67-32.8)]. For tenofovir, 16 positive signals were identified, with vitamin D deficiency[1,149 reports;ROR(95%CI) = 27.7(26.03-29.48)], hypophosphatemia [270 reports;ROR(95%CI) = 7.88(6.98-8.9)], dyslipidaemia [72 reports; ROR(95%CI) = 2.85(2.26-3.6)], mitochondrial toxicity [66 reports; ROR(95%CI) = 17.68(13.73-22.76))],and fat redistribution [30 reports; ROR(95%CI) = 28.81(19.59-42.37)] being the most prominent. Most signals were not addressed in the existing labels.</p><p><strong>Conclusion: </strong>Entecavir and tenofovir exhibit under-recognized risks of mitochondrial toxicity, electrolyte imbalance, and bone metabolism disorders. Routine monitoring of the serum phosphorus, vitamin D, and lactate levels is recommended. Drug labeling should be updated to include newly identified risks such as hypokalemic alkalosis and fat redistribution. Further research on mitochondrial mechanisms and gender-based differences is needed to optimize individualized therapy for chronic hepatitis B patients.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1510-1519"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144873078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Developing a pharmacist preceptorship programme to support UK advanced level practice: a consensus study. 开发一个药剂师学徒计划,以支持英国先进水平的实践:一项共识研究。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-04-16 DOI: 10.1007/s11096-025-01909-z
Mairi-Anne McLean, Paul Forsyth, Emma Dunlop, Anne C Boyter
{"title":"Developing a pharmacist preceptorship programme to support UK advanced level practice: a consensus study.","authors":"Mairi-Anne McLean, Paul Forsyth, Emma Dunlop, Anne C Boyter","doi":"10.1007/s11096-025-01909-z","DOIUrl":"10.1007/s11096-025-01909-z","url":null,"abstract":"<p><strong>Background: </strong>Globally, health professionals are advancing roles to meet growing healthcare demands. Pharmacists are increasingly required to deliver autonomous, holistic, highly complex advanced care. Preceptorship could be used more widely to support delivery of advanced pharmaceutical care.</p><p><strong>Aim: </strong>The aim of this study was to formulate statements describing features of preceptorship programmes, and to measure consensus in the Scottish pharmacy workforce on the applicability of these statements to an advanced pharmacist preceptorship programme.</p><p><strong>Method: </strong>Phase 1-formulation of statements relating to key features of healthcare preceptorship programmes through literature review and author expertise. Phase 2-modified nominal group technique (m-NGT) to add expert ideas to phase 1 statements and to reach consensus on statement wording. Phase 3-a two round modified Delphi (m-Delphi) survey to measure consensus in the Scottish pharmacy workforce on whether the features presented should be part of a Scottish advanced pharmacist preceptorship programme. Consensus agreement was set at 75% for m-NGT and m-Delphi.</p><p><strong>Results: </strong>Fifty-one statements were generated from literature. Seven statements were generated by authors. Three statements were generated by experts during m-NGT stage: 61 statements progressed to m-Delphi. After two rounds (n = 194 and 144 participants in round one and two respectively) of m-Delphi, consensus was reached on 48 of the 61 statements across categories including programme design, preceptor training requirements and programme assessment.</p><p><strong>Conclusion: </strong>This study provides a strong basis for research into the impact of preceptorship programmes for pharmacists working towards the advanced career stage.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1248-1260"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12432034/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144004816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A multi-site evaluation of clinical pharmacist time, motion, interventions and interruptions. 临床药师时间、动作、干预和中断的多地点评价。
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-04-21 DOI: 10.1007/s11096-025-01910-6
Martin L Canning, Andrew Munns, Jaryth Twine, Elizabeth McCourt, Russol Hussain, Timothy Dunn, Liz Hayward, Erin Dunn
{"title":"A multi-site evaluation of clinical pharmacist time, motion, interventions and interruptions.","authors":"Martin L Canning, Andrew Munns, Jaryth Twine, Elizabeth McCourt, Russol Hussain, Timothy Dunn, Liz Hayward, Erin Dunn","doi":"10.1007/s11096-025-01910-6","DOIUrl":"10.1007/s11096-025-01910-6","url":null,"abstract":"<p><strong>Background: </strong>Patient centred clinical pharmacy activities have demonstrated improvements in patient outcomes. There are limited published data on workflow practices of pharmacists to assist with clinical pharmacy service delivery improvement.</p><p><strong>Aim: </strong>To determine the amount of time clinical pharmacists spend each day performing their work tasks, interventions and interruptions. To determine the proportion of time performing clinical tasks and tasks face-to-face with patients.</p><p><strong>Method: </strong>Trained pharmacy students observed clinical pharmacists and recorded clinical activities using the timer app Clockify™ on a smart device (phone or tablet) at four hospitals over 9 days between 29th July and 8th August 2024. Pharmacy students recorded the number and types of patients seen, interventions and interruption patterns.</p><p><strong>Results: </strong>A total of 678.3 h of pharmacist activity were recorded. The mean time spent per day per patient type was 25.9 min (discharge patient), 23.5 min (new patient) and 10.3 min (review patient). Pharmacists spent the largest proportion of time (21.9%) on discharge patients followed by review patients (21.6%). Over 80% of pharmacist time was spent performing clinical activities, of which almost 12% was spent face-to-face with patients. Pharmacists were interrupted 34 times per day and performed 67 interventions per 100 patients.</p><p><strong>Conclusion: </strong>Pharmacists spend over 80% of their work time performing clinical activities for patients, of which almost 12% is spent face-to-face with patients. The largest proportion of time is spent with discharge patients followed by review patients.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1261-1269"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144018888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cost-effectiveness analysis of glofitamab versus rituximab for relapsed or refractory diffuse large B-cell lymphoma patients in China. 格非他单抗与利妥昔单抗治疗复发或难治性弥漫性大b细胞淋巴瘤的成本-效果分析
IF 3.2 4区 医学
International Journal of Clinical Pharmacy Pub Date : 2025-10-01 Epub Date: 2025-04-28 DOI: 10.1007/s11096-025-01912-4
Hanrui Zheng, Linke Zou, Ming Hu
{"title":"Cost-effectiveness analysis of glofitamab versus rituximab for relapsed or refractory diffuse large B-cell lymphoma patients in China.","authors":"Hanrui Zheng, Linke Zou, Ming Hu","doi":"10.1007/s11096-025-01912-4","DOIUrl":"10.1007/s11096-025-01912-4","url":null,"abstract":"<p><strong>Background: </strong>The CD20 × CD3 bispecific antibody glofitamab combined with gemcitabine and oxaliplatin (Glofit-GemOx) has demonstrated clinical efficacy in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL).</p><p><strong>Aim: </strong>The aim of this study was to evaluate the cost-effectiveness of Glofit-GemOx versus R-GemOx for relapsed or refractory DLBCL patients following one or more previous lines of therapy from the perspective of healthcare in China.</p><p><strong>Method: </strong>A three-state partitioned survival model was constructed based on the STARGLO study to assess the cost-effectiveness of Glofit-GemOx versus rituximab-GemOx (R-GemOx). Quality-adjusted life years (QALYs) were used as health outcomes, and the incremental cost-effectiveness ratio (ICER) was calculated. One-way deterministic sensitivity analyses and probabilistic sensitivity analyses were performed on key parameters to assess the robustness of the base analysis results.</p><p><strong>Results: </strong>The costs in Glofit-GemOx regimen were $266,518.83, whereas the costs of R-GemOx regimen were $43,227.09. Compared with the R-GemOx regimen, the Glofit-GemOx regimen resulted in an increase of 0.85 QALYs, yielding an ICER of $262,696.16 per QALY. The ICER significantly exceeded the willingness-to-pay (WTP) threshold of $38,188/QALY and sensitivity analysis revealed the cost of glofitamab had a substantial effect on results.</p><p><strong>Conclusion: </strong>Compared with R-GemOx, Glofit-GemOx is not cost-effective compared for relapsed or refractory DLBCL patients in China at current price. A negotiated price reduction for glofitamab could substantially improve its cost-effectiveness profile.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1278-1285"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信