International Journal of Clinical Pharmacy最新文献

{"title":"Real-world safety of maribavir: a retrospective study based on signal detection in the FDA adverse event reporting system.","authors":"Qineng Gong, Linlin Zhang, Hui Wu, Yang Miao, Lei Huang, Cunlin Yin, Ye Hu","doi":"10.1007/s11096-025-01869-4","DOIUrl":"10.1007/s11096-025-01869-4","url":null,"abstract":"<p><strong>Background: </strong>Maribavir is a novel antiviral agent targeting cytomegalovirus through inhibition of the UL97 protein kinase, exhibiting a distinct mechanism of action. However, limited data are available on its safety profile post-marketing.</p><p><strong>Aim: </strong>This study aimed to evaluate the adverse events (AEs) associated with maribavir using the Food and Drug Administration's Adverse Event Reporting System (FAERS), providing insights to inform clinical practice.</p><p><strong>Method: </strong>We conducted a retrospective analysis of maribavir-related adverse event reports from the FAERS database, spanning the fourth quarter of 2021 to the second quarter of 2024. Signal detection was performed using four statistical methods: the proportional reporting ratio, reporting odds ratio, Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker.</p><p><strong>Results: </strong>A total of 1372 reports associated with maribavir were identified. Seven significant signals emerged at the system organ class level. At the preferred term level, 76 adverse events (AEs) demonstrated positive signals, including novel events such as pleural effusion, hypersomnia, and anosmia, alongside signals related to ear disorders. The majority of AEs were reported within the first month of maribavir use.</p><p><strong>Conclusion: </strong>This study identified several new adverse event signals for maribavir, offering healthcare professionals a deeper understanding of its safety profile, which may guide safer clinical usage.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"767-774"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143004519","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}

{"title":"Response to comment on 'Perioperative esketamine combined with butorphanol versus butorphanol alone for pain management following video-assisted lobectomy: a randomized controlled trial'.","authors":"Hongjian Wang, Zicheng Wang, Junbao Zhang, Xin Wang, Bingqian Fan, Wensheng He, Xianwen Hu","doi":"10.1007/s11096-025-01898-z","DOIUrl":"10.1007/s11096-025-01898-z","url":null,"abstract":"","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"915-916"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143692005","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}

{"title":"A clinical decision support tool for improving venous thromboembolism risk assessment and thromboprophylaxis prescribing compliance within an electronic medication management system: a retrospective observational study.","authors":"Samantha Loh, Kimberly Wijaya, Michelle Rogers, Mohammad Asghari-Jafarabadi, Robert Wojnar","doi":"10.1007/s11096-024-01857-0","DOIUrl":"10.1007/s11096-024-01857-0","url":null,"abstract":"<p><strong>Background: </strong>Despite various interventions to improve best-practice venous thromboembolism (VTE) prevention measures within hospitals, compliance remains poor. For health services utilising electronic medication management systems (eMMS), implementation of clinical decision support (CDS) tools could address this gap.</p><p><strong>Aim: </strong>To evaluate whether local implementation of an integrated electronic alert system linked with a computerised physician order entry (CPOE)-based order set for VTE risk assessment within an eMMS improves the rates of timely VTE risk assessment and guideline-compliant VTE prophylaxis prescribing among hospitalised patients.</p><p><strong>Method: </strong>A retrospective observational study conducted among hospitalised patients pre- and post-implementation of an electronic alert system combined with a CPOE-based order set to prompt VTE risk assessment documentation and VTE prophylaxis prescribing within a single tertiary hospital. Admissions were consecutively screened over 7-day periods before and after implementation for inclusion and assessed for compliance with a local VTE prevention protocol.</p><p><strong>Results: </strong>Eight hundred and fifty patients (458 pre-intervention, 392 post-intervention) were included for evaluation. Rates of VTE risk assessment documentation within 24 h of admission increased by 29.9% (p < 0.001). Guideline-compliant VTE prophylaxis improved by 10.4% (p < 0.001). Patients with completed VTE risk assessments were significantly more likely to receive guideline-compliant VTE prophylaxis, compared to patients without documented VTE risk assessments (19.3% difference, p < 0.001). After adjusting for demographic differences, the odds of achieving positive outcomes significantly increased across all measures, with adjusted odds ratios ranging from 1.95 to 4.89 (p < 0.001).</p><p><strong>Conclusion: </strong>Local implementation of CDS featuring CPOE within the eMMS improved rates of VTE risk assessment documentation and guideline-compliant VTE prophylaxis prescribing.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"699-707"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142948476","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}

{"title":"Pharmacovigilance analysis of drug-induced hypofibrinogenemia using the FDA Adverse Event Reporting System.","authors":"Xiao Wen, Le Cai, Ao Gao, An Fu, Daihong Guo, Man Zhu","doi":"10.1007/s11096-025-01867-6","DOIUrl":"10.1007/s11096-025-01867-6","url":null,"abstract":"<p><strong>Background: </strong>Drug-induced hypofibrinogenemia has received increasing scrutiny; however, the specific drugs involved remain poorly characterized. Hypofibrinogenemia can have significant clinical implications, including increased bleeding risks.</p><p><strong>Aim: </strong>This study aimed to utilize the FDA Adverse Event Reporting System (FAERS) to identify and analyze drugs frequently implicated in drug-induced hypofibrinogenemia.</p><p><strong>Method: </strong>A disproportionality analysis was conducted using FAERS data from January 2004 to March 2024. Various statistical tools were used, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio, Medicines and Healthcare Products Regulatory Agency metrics, and Bayesian confidence propagation neural network.</p><p><strong>Results: </strong>The analysis included 17,627,340 cases involving 52,373,206 adverse events, with 1,661 cases identified as hypofibrinogenemia. The top five drugs associated with hypofibrinogenemia by case number were methotrexate (124 cases), tigecycline (119 cases), tocilizumab (100 cases), pegaspargase (83 cases), and alteplase (57 cases). The drugs ranked by signal strength based on ROR included eravacycline (ROR 2173.84, 95% CI 1208.80-3909.30), tigecycline (ROR 747.34, 95% CI 619.03-902.24), crotalidae polyvalent immune Fab (ROR 407.67, 95% CI 291.07-570.99), pegaspargase (ROR 216.06, 95% CI 173.15-269.61), and asparaginase (ROR 184.93, 95% CI 132.18-258.72).</p><p><strong>Conclusion: </strong>This analysis of FAERS data identified 52 drugs associated with hypofibrinogenemia, most (88.5%) of which do not mention this risk in their prescribing information. These findings demonstrate the need for the monitoring of blood fibrinogen and may serve as a reference for the explore of the characteristics and underlying mechanism of drug-induced hypofibrinogenemia in the real world.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"755-766"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065366","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}

{"title":"Patient and hospital staff perspectives on introducing pharmacist-led medication reviews at an orthopedic ward: a mixed methods pilot study.","authors":"Joo Hanne Poulsen Revell, Maja Schlünsen, Abisha Kandasamy, Annette Meijers, Jens Eggers, Lene Juel Kjeldsen","doi":"10.1007/s11096-025-01874-7","DOIUrl":"10.1007/s11096-025-01874-7","url":null,"abstract":"<p><strong>Background: </strong>Multi-morbidity is associated with multiple medication use, which potentially increases the risk of adverse drug events. Pharmacist-led medication reviews have been introduced to meet these challenges.</p><p><strong>Aim: </strong>To evaluate the implementation of pharmacist-led medication reviews for older patients admitted to an orthopedic ward in terms of quality and safety from the perspectives of patients, hospital-based physicians, nurses, and healthcare assistants.</p><p><strong>Method: </strong>Patients (n=11) were interviewed, with the interviews having a reflexive thematic analysis using the hermeneutic approach, while healthcare-professionals' (HCPs) (n=26) perspectives on pharmacist-led medication reviews were assessed using questionnaires.</p><p><strong>Results: </strong>The qualitative patient interviews revealed four themes: (1) Positive perception of pharmacists' medication communication, (2) Mixed perceptions of a medication review, (3) Satisfaction with the general outcome of the medication review, and (4) Safety perception with medication treatment. Twenty-six HCPs completed the questionnaire (response rate 48%) with a distribution of 10 hospital-based physicians (38%), eight nurses (31%), and eight healthcare assistants (31%). Almost 85% of the HCPs (n = 22) were familiar with the pharmacist conducting medication reviews. More than 70% of the HCPs reported that pharmacist-led medication reviews contributed to increased quality of admitted patients' medication use.</p><p><strong>Conclusion: </strong>High levels of satisfaction with the outcomes of the medication reviews-particularly regarding quality, patient safety, and their overall positive impact on the ward-indicate that both patients and HCPs perceived the service as highly valuable in supporting patient care throughout the medication process.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"794-802"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457809","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}

{"title":"Barriers and enablers to medicine-taking behaviours in chronic obstructive pulmonary disease: a qualitative interview study.","authors":"Torbjørn Nygård, David Wright, Reidun L S Kjome, Hamde Nazar, Bernt Aarli, Aase Raddum","doi":"10.1007/s11096-025-01872-9","DOIUrl":"10.1007/s11096-025-01872-9","url":null,"abstract":"<p><strong>Background: </strong>Chronic Obstructive Pulmonary Disease (COPD) is associated with low health-related quality of life and high costs to healthcare systems, particularly due to hospital admissions and exacerbations. Medicines, inhalers especially, reduce the risk of hospitalisations and exacerbations, but factors influencing medicine-taking behaviours are not fully understood.</p><p><strong>Aim: </strong>To explore experiences of people with COPD related to medicines, and followingly identify and characterise any barriers and enablers related to medicine-taking behaviours using the Theoretical Domains Framework (TDF).</p><p><strong>Method: </strong>Semi-structured qualitative interviews were conducted and included ten people with COPD who had previously been admitted to hospital. Systematic text condensation was used inductively in the primary analysis of the interviews. In the secondary analysis, meaning units from the primary analysis were mapped to the TDF and summarised as barriers and enablers.</p><p><strong>Results: </strong>Five major themes were developed in the primary analysis: (1) health literacy and information needs, (2) patient autonomy, (3) lack of access to medicines, (4) lack of effect from medicines, and (5) experiences of medicines-related issues. In the secondary analysis, thirteen barriers and nine enablers were mapped to nine out of the fourteen domains of the TDF.</p><p><strong>Conclusion: </strong>People with COPD experience challenges related to medicines which need to be addressed by researchers and healthcare providers. The identified barriers and enablers mapped to the TDF can guide and inform future design of interventions and health care services.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"775-783"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189250","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}

{"title":"Cost-effectiveness analysis of PD-L1 testing associated with pembrolizumab for first-line treatment of advanced non-small cell lung cancer in China.","authors":"Yao Wu, Libo Tao, Chang Liu, Fangxu Wang, Shuang Sun","doi":"10.1007/s11096-025-01865-8","DOIUrl":"10.1007/s11096-025-01865-8","url":null,"abstract":"<p><strong>Background: </strong>Lung cancer is the leading cause of cancer-related deaths in China, and pembrolizumab shows differential efficacy in advanced non-small cell lung cancer (NSCLC) with different PD-L1 expression levels.</p><p><strong>Aim: </strong>To assess the cost-effectiveness of PD-L1 testing associated with pembrolizumab for first-line treatment of NSCLC from the perspective of Chinese healthcare system.</p><p><strong>Method: </strong>Over a lifetime horizon, a three-state partitioned survival model was developed to assess the cost-effectiveness of PD-L1 testing and no PD-L1 testing. In the PD-L1 testing group, patients were stratified by PD-L1 tumor proportion score ≥ 50%, 1-49%, or < 1% and received pembrolizumab monotherapy, pembrolizumab plus chemotherapy, or chemotherapy alone, respectively. In the non-PD-L1 testing group, all patients received pembrolizumab plus chemotherapy. Model inputs were obtained from published literature and a healthcare price database, and clinical outcomes from two randomized clinical trials were used. The net monetary benefit (NMB) was estimated for the PD-L1 testing group versus the non-PD-L1 testing group. Deterministic and probabilistic sensitivity analyses, and scenario analyses were conducted to assess robustness of results.</p><p><strong>Results: </strong>Using PD-L1 testing to guide treatment led to cost savings of $49,392.7 and a reduction in quality-adjusted life years (QALYs) of 0.234, resulting in a positive NMB of $46,421.7 at a willingness-to-pay (WTP) threshold of $12,680.8/QALY (GDP per capita in China, 2023). Findings were robust across sensitivity and scenario analyses.</p><p><strong>Conclusion: </strong>Using PD-L1 testing to guide first-line pembrolizumab treatment in patients with advanced NSCLC is a cost-effective strategy at a WTP threshold of $12,680.8/QALY for China.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"737-746"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142970766","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}

{"title":"The second victim experience and support tool: a cross-cultural adaptation, validation and psychometric evaluation of the Serbian version for pharmacy professionals (SR-SVEST-R).","authors":"Ivana Zimonjić, Valentina Marinković, José Joaquín Mira, Bojana Knežević, Borivoje-Boris Djokic, Nataša Bogavac-Stanojević, Marina Odalović","doi":"10.1007/s11096-025-01875-6","DOIUrl":"10.1007/s11096-025-01875-6","url":null,"abstract":"<p><strong>Background: </strong>The second victim phenomenon, involving emotional and psychological distress after adverse events, is underexplored among pharmacy professionals. The validated Second Victim Experience and Support Tool measures these experiences and support options, with the improved version also assessing resilience.</p><p><strong>Aim: </strong>This study aimed to validate the Second Victim Experience and Support Tool-Revised, measure the second victim phenomenon, and present results among pharmacy professionals in Serbia.</p><p><strong>Method: </strong>This cross-sectional study included 350 pharmacy professionals (MPharm and technicians). The questionnaire, with 9 factors and 35 statements, was translated and adapted following guidelines, and the content was validated by five experts. A pre-test with 30 participants ensured clarity, followed by Confirmatory Factor Analysis for construct validity and Cronbach's Alpha for reliability.</p><p><strong>Results: </strong>Content validity was confirmed with item scores from 0.8 to 1 and a mean scale score of 0.83. Factor analysis identified 9 factors and 30 items (Chi-square = 545.6, degrees of freedom = 366, p < 0.001). The model fit was supported by a Root Mean Square Error of Approximation of 0.037, a Comparative Fit Index of 0.958, a Tucker-Lewis Index of 0.950, and a Standardised Root Mean Square Residual of 0.040. Reliability analysis showed a Cronbach's alpha of 0.88, with factor values from 0.60 to 0.90. Among participants, 49.5% feared future events, 47.4% felt exhausted, 22.6% considered quitting, 72.6% valued peer support, and 28.9% improved work quality.</p><p><strong>Conclusion: </strong>The Serbian resilience measuring tool is valid and reliable, effectively evaluating second victim experiences and support, with half of pharmacy professionals affected.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"803-814"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143407497","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}

{"title":"European Society of Clinical Pharmacy: 'From interprofessional education to interprofessional practice'.","authors":"Pierrick Bedouch, Monika Lutters, Jean-Didier Bardet","doi":"10.1007/s11096-025-01929-9","DOIUrl":"10.1007/s11096-025-01929-9","url":null,"abstract":"","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"593-594"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985007","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}

{"title":"Relative effectiveness and gastrointestinal safety of NSAIDs being prescribed for upper respiratory tract infections: an explorative cohort study in primary care.","authors":"Francesco Lapi, Ettore Marconi, Alberto Magni, Pierangelo Lora Aprile, Erik Lagolio, Ignazio Grattagliano, Diego Fornasari, Alessandro Rossi, Claudio Cricelli","doi":"10.1007/s11096-025-01878-3","DOIUrl":"10.1007/s11096-025-01878-3","url":null,"abstract":"<p><strong>Background: </strong>Non-steroidal anti-inflammatory drugs (NSAIDs) are prescribed to control pain, inflammation, and fever in upper respiratory tract infections (URTIs).</p><p><strong>Aim: </strong>To explore the relative effectiveness and gastrointestinal (GI)-related safety of individual NSAIDs to control symptoms of URTIs.</p><p><strong>Method: </strong>Using an Italian primary care data source, we identified patients aged ≥ 15 years who were newly prescribed NSAIDs for URTIs between 2013 and 2022. Switching to another NSAID for the same indication within the 30-day follow-up was a proxy for drug effectiveness. The study outcome for GI safety analysis was upper gastrointestinal bleeding (UGIB).</p><p><strong>Results: </strong>In a cohort of 57,971 patients, the most prevalent subgroups were those treated with ketoprofen (39.5%) and dexibuprofen/ibuprofen (22.4%). Ketoprofen showed the lowest rate of switching to another NSAID [Hazard Ratio (HR) 0.40 (95% CI 0.20-0.83)] against acetylsalicylic acid/coxibs/diclofenac. Dexibuprofen/ibuprofen showed similar results [HR 0.50 (95% CI 0.22-1.10)], with no significant association. Ketoprofen and dexibuprofen/ibuprofen were prescribed as lysine and arginine salts in 85 and 6% of URTIs sufferers, respectively. Across NSAIDs, we did not find any significant difference in the risk of UGIB.</p><p><strong>Conclusion: </strong>Our findings indicated that various NSAIDs may exhibit differing levels of effectiveness in treating URTIs, particularly those formulated for quick onset of action. No NSAIDs-UGIBs association was found. Further prospective, larger studies are needed to confirm these findings.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"873-877"},"PeriodicalIF":2.6,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390819","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}