Tiantian Gao, Shuai Huang, Liyan Shen, Jia Yin, Qiang Sun
{"title":"Effects of County Medical Community Central Pharmacy on antibiotic use in primary care: a multicenter quasi-experiment.","authors":"Tiantian Gao, Shuai Huang, Liyan Shen, Jia Yin, Qiang Sun","doi":"10.1007/s11096-025-02014-x","DOIUrl":"https://doi.org/10.1007/s11096-025-02014-x","url":null,"abstract":"<p><strong>Introduction: </strong>Antimicrobial resistance poses a growing global health threat and is largely driven by the inappropriate use of antibiotics. Primary healthcare institutions, particularly in low-resource settings, often face challenges, such as limited oversight and irrational prescribing practices. While progress has been made in improving antibiotic stewardship in higher-level hospitals, efforts to optimize prescription in primary healthcare institutions remain insufficient. The County Medical Community Central Pharmacy (CMCP) program was introduced as an integrated intervention to enhance pharmacy services and promote rational antibiotic use through centralized oversight, training, and pharmacist collaboration.</p><p><strong>Aim: </strong>This multicenter quasi-experimental study aimed to evaluate the effectiveness of the CMCP program in reducing antibiotic misuse and improving prescribing rationality in primary healthcare institutions in Shandong Province, China.</p><p><strong>Method: </strong>This multicenter quasi-experimental study was conducted between July and December 2023 in six geographically and economically diverse rural regions of Shandong Province. A total of 37 primary healthcare institutions were included, with 25 voluntarily implementing the CMCP program (intervention group) and 12 continuing routine practices (control group). Data were collected at two time points via structured questionnaires and reviews of 100 randomly selected outpatient prescriptions from each primary healthcare institution. A difference-in-differences (DID) regression model was applied to estimate the impact of the intervention on antibiotic usage and irrational prescribing, controlling for institutional and staffing characteristics.</p><p><strong>Results: </strong>Antibiotic usage rates increased in both groups, but to a lesser extent in the intervention group (from 15.726 to 18.732%; P = 0.006) than in the control group (from 17.682 to 26.582%; P < 0.001). DID analysis showed a mitigating effect on antibiotic use (DID coefficient = - 0.061; P = 0.054). Irrational antibiotic use in the intervention group decreased from 50.660 to 27.655% (P < 0.001), whereas it remained largely unchanged in the control group (36.893% vs. 35.238%).</p><p><strong>Conclusion: </strong>The CMCP program was effective in curbing unnecessary antibiotic prescriptions and enhancing prescription quality in primary healthcare institutions. These findings support the continued implementation and scale-up of CMCP as a strategy to strengthen antibiotic stewardship at the primary care level in resource-limited settings.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274578","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}
Ziad G Nasr, Hanin M Said, Kaoutar R Barakat, Raghad M Elwan, Aya Maklad, Zachariah J Nazar
{"title":"An evaluation of pre-post antimicrobial stewardship healthcare educational intervention studies utilizing the Kirkpatrick model: a scoping review.","authors":"Ziad G Nasr, Hanin M Said, Kaoutar R Barakat, Raghad M Elwan, Aya Maklad, Zachariah J Nazar","doi":"10.1007/s11096-025-02007-w","DOIUrl":"https://doi.org/10.1007/s11096-025-02007-w","url":null,"abstract":"<p><strong>Introduction: </strong>Antimicrobial stewardship (AMS) education plays a vital role in addressing antimicrobial resistance (AMR), yet its long-term impact on behavior and clinical outcomes remains underexplored. Educational interventions are often assessed through knowledge-based outcomes, with limited evaluation of sustained practice changes or patient-level results, and standardized higher-level outcome measures across diverse healthcare settings.</p><p><strong>Aim: </strong>This scoping review aimed to map pre-post AMS healthcare educational interventions using the Kirkpatrick Model, evaluating their effectiveness across its four levels: reaction, learning, behavior, and results. The goal was to identify trends, highlight gaps, and provide insight into reported outcomes, delivery methods, and evaluation tools, supporting future research and strengthening the evidence base for AMS education.</p><p><strong>Method: </strong>This review followed the Joanna Briggs Institute framework. A literature search of nine databases identified studies from 2010 to 2024. Eligible studies included pre-post AMS educational interventions targeting undergraduate students and healthcare professionals (HCPs) and reporting outcomes which were subsequently mapped by the reviewers to the Kirkpatrick Model. Data were categorized by target population, delivery format, and evaluation tools. Narrative synthesis was used to describe trends and relationships.</p><p><strong>Results: </strong>Studies targeted HCPs such as physicians, pharmacists, nurses, and dental professionals, and undergraduate students in pharmacy, medicine, nursing, and dentistry. Sixty-three studies were included. Outcomes were distributed across Level 1 (Reaction) (n = 46, 24%), Level 2 (Learning) (n = 51, 27%), Level 3 (Behavior) (n = 50, 26%), and Level 4 (Results) (n = 45, 23%). While n = 24 (38%) assessed all four levels, another n = 24 (38%) reported mixed or partial levels. Face-to-face or online-only formats achieved Levels 1 and 2. Whereas blended or workplace-integrated interventions more often demonstrated behavior change and clinical outcomes (Levels 3 and 4). Longitudinal follow-up and mixed evaluation tools (e.g., surveys, chart reviews, interviews) supported higher-level impacts. Pharmacy-led, interdisciplinary, and contextually tailored interventions mapped to all levels.</p><p><strong>Conclusion: </strong>AMS education often leads to short-term learning gains, but fewer interventions achieve sustained behavior change or measurable clinical outcomes. Blended and practice-integrated formats, paired with long-term evaluation, are key to realizing the full potential of AMS education. Embedding such approaches in undergraduate and professional programs can better prepare the future HCPs to address AMR effectively.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250938","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":"Prevalence and factors associated with anticholinergic medication use in community-dwelling older adults: a systematic review.","authors":"Keren Pelen, Willy-Brad Hagenimana, Marie-Laure Baroud, Yohann Moanahere Chiu, Hassiba Chebbihi, Karina Lebel, Patrick Boissy, Benoit Cossette","doi":"10.1007/s11096-025-02012-z","DOIUrl":"https://doi.org/10.1007/s11096-025-02012-z","url":null,"abstract":"<p><strong>Introduction: </strong>Medications with anticholinergic effects are widely used despite the mounting evidence of physical and cognitive impairment associated with their use among older adults.</p><p><strong>Aim: </strong>A systematic review was conducted to describe the prevalence of anticholinergic medication use in community-dwelling older adults, document the factors associated with their use and describe the most frequently used medication classes.</p><p><strong>Method: </strong>MEDLINE, Embase and CINAHL were searched from inception to May 2024. All study designs except case reports and case studies were eligible if they included community-dwelling older adults aged 65 and older and assessed the factors associated with anticholinergic medication use. An open-source artificial intelligence screening tool was used to optimise title and abstract screening. The subsequent review of the full texts of potentially eligible studies and data extraction were conducted in the Covidence systematic review tool using standardised data collection forms. Study quality was assessed with the Newcastle-Ottawa scale. The study selection, data extraction and quality assessment were conducted independently by two reviewers.</p><p><strong>Results: </strong>From 4139 records of interest, the seven selected studies included five cross-sectional and two retrospective studies, published between 2014 and 2021. The risk of bias was assessed to be low in five studies and high in two studies. Greater anticholinergic burden was associated with female sex, lower socioeconomic status, higher co-morbidity score, higher frailty probability, specific diseases, polypharmacy and greater use of healthcare, while increasing age was associated with both increased and decreased anticholinergic burden. Anticholinergic exposure, varied from a low of 6.2% of medical visits in the United States between 2006 and 2015, assessed with the 2015 Beers Criteria and the Anticholinergic Risk Scale, to a high of 72.8% of medication claims (dispensed medications) in South Korea, over the year 2012, assessed with the 2015 Beers Criteria and the Anticholinergic Burden Scale. The use of six different anticholinergic scales and different evaluation periods did not allow a meaningful comparison of the prevalence of anticholinergic exposure across studies. Antidepressants, antihistamines and antimuscarinics were the most common medication classes in the two studies using this classification.</p><p><strong>Conclusion: </strong>This systematic review documented key socioeconomic and health status factors to be targeted by interventions aimed at limiting the use of anticholinergic medications in community-dwelling older adults.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145250955","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":"Pharmacists' views on barriers and enablers to the implementation of advanced pharmacist prescribing in Scotland: a qualitative study using normalisation process theory.","authors":"Mairi-Anne McLean, Paul Forsyth, Anne C Boyter","doi":"10.1007/s11096-025-02021-y","DOIUrl":"https://doi.org/10.1007/s11096-025-02021-y","url":null,"abstract":"<p><strong>Introduction: </strong>Healthcare systems need more professionals able to deliver autonomous holistic advanced care. Exploring pharmacists' views on the implementation of advanced pharmacist prescribing (i.e. prescribing autonomously in complex, uncertain, or higher-risk situations) will allow stakeholders to reflect on possible changes that may embed and sustain this work.</p><p><strong>Aim: </strong>To explore pharmacists' views on barriers and enablers to the implementation of advanced pharmacist prescribing in Scotland.</p><p><strong>Method: </strong>Semi-structured one-to-one interviews were conducted with National Health Service employed pharmacists from across Scotland, recruited via professional networks using purposive sampling to ensure a range of professional backgrounds, geography and prescribing activity. Interviews were developed and analysed using Normalisation Process Theory (NPT), a sociological framework for understanding how new practices become embedded in routine healthcare and analysed using a hybrid deductive/inductive thematic framework analysis approach.</p><p><strong>Results: </strong>Thirteen pharmacists from across Scotland participated in the study. Barriers and enablers to advanced pharmacist prescribing were identified in all NPT constructs (Coherence, Cognitive Participation, Collective Action, and Reflexive Monitoring). In responses relating to the Coherence construct, enablers included individual understanding of how advanced pharmacist prescribing differs from other advanced pharmacist tasks, as well as the role of an advanced pharmacist prescriber. Lack of shared understanding emerged as a barrier. Cognitive Participation identified barriers including lack of appropriate roles and training as well as a lack of infrastructure to support advanced pharmacist prescribing. In Collective Action, barriers included lack of confidence in consistent delivery of advanced pharmacist prescribing and resource constraints. Reflexive Monitoring revealed strong individual belief in advanced pharmacist prescribing, but barriers included a lack of multidisciplinary evaluation and a need for service reconfiguration.</p><p><strong>Conclusion: </strong>While individual pharmacists were found to be committed to advanced pharmacist prescribing, widespread implementation is hindered by a lack of shared understanding, inconsistent role structures, and limited strategic alignment. These findings offer valuable insight for those with an interest in embedding and sustaining advanced pharmacist prescribing.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232422","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}
D Patterson, C McGuinness, S Dunne, C Ibechukwu Kane, L R Wogu, J Hayden, J Strawbridge
{"title":"Disparities associated with race and ethnicity in pain management: a scoping review.","authors":"D Patterson, C McGuinness, S Dunne, C Ibechukwu Kane, L R Wogu, J Hayden, J Strawbridge","doi":"10.1007/s11096-025-02008-9","DOIUrl":"https://doi.org/10.1007/s11096-025-02008-9","url":null,"abstract":"<p><strong>Introduction: </strong>Health inequalities can occur where there are differences in how people are treated with respect to their race and ethnicity. Disparities and systemic inequities in healthcare have led to negative outcomes. Pain management is an area where there are perceived health inequalities. Medicines optimisation is a framework for healthcare provider interventions under four principles to ensure that medicines are used safely and effectively, producing the best possible outcomes for patients. Using this framework allows a systematic and theory-informed identification of areas of care at risk of disparities.</p><p><strong>Aim: </strong>The aim was to assess disparities associated with race and ethnicity in pain management, mapped to the medicines optimisation framework.</p><p><strong>Method: </strong>Electronic databases CINAHL, Ovid and Medline were searched from 2012 to 2025. Studies involving pain management, medicine optimisation, ethnicity, ethnic minorities and race were included. Two reviewers independently screened titles, abstracts and full texts. Data were extracted on evidence relating to the application of the four principles of medicines optimisation, and for the presence or absence of disparities in pain management overall.</p><p><strong>Results: </strong>One hundred and eighteen studies were identified that met the inclusion criteria. Eighty-nine (75%) identified pain management disparities in respect to race and ethnicity, with the majority of disparities related to medicine optimisation principle 2 (evidenced based medicine). Disparities identified were discrepancies in the reporting of pain scores, time to pain and pain assessment and discrepancies in the receipt of opioids across all races. Other disparities were, inconsistencies with prescriptions issued at discharge or outpatients, patients' dissatisfaction with pain management. There were less disparities observed in studies that involved children, when managing surgical pain and pain in palliative care and when protocols were used in the management of pain.</p><p><strong>Conclusion: </strong>Disparities in pain management associated with patient race and ethnicity are prevalent have decreased over the past decade. Healthcare professionals should seek to understand the patient experience and incorporate protocols/guidelines into their care to promote evidence-based medicine. Further research in wider geographies is required, particularly in medication safety and incorporating medicines optimisation into routine care.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232427","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}
Jurjen S Kingma, Cindy Loh, Ingo A Eland, Marcel P H van den Broek, Wouter J M Derksen, Catherijne A J Knibbe, Fatma Karapinar-Çarkit, Patricia M L A van den Bemt, Desirée M T Burgers
{"title":"The prevalence of medication-related hospital readmissions after bariatric surgery: a retrospective observational study.","authors":"Jurjen S Kingma, Cindy Loh, Ingo A Eland, Marcel P H van den Broek, Wouter J M Derksen, Catherijne A J Knibbe, Fatma Karapinar-Çarkit, Patricia M L A van den Bemt, Desirée M T Burgers","doi":"10.1007/s11096-025-02017-8","DOIUrl":"https://doi.org/10.1007/s11096-025-02017-8","url":null,"abstract":"<p><strong>Introduction: </strong>Bariatric surgery may induce changes in the effects of oral medication, which may result in medication related problems. Therefore, tailored pharmacotherapy is necessary for individual patients following surgery. In case pharmacotherapy is not adjusted, adverse drug events and even unplanned hospital readmissions may occur. The prevalence of these medication-related readmissions is not known.</p><p><strong>Aim: </strong>The primary objective of this study was to determine the prevalence of medication-related readmissions within two years after bariatric surgery. Secondary objectives were to determine the percentage of potentially preventable medication-related readmissions. The reasons for readmission, the associated medication, and medication errors involved in the potentially preventable readmissions were also determined.</p><p><strong>Method: </strong>A retrospective, observational study in a large Dutch teaching hospital was performed. Unplanned readmissions of patients who underwent primary bariatric surgery between January 1, 2018 and August 31, 2020 were included with a follow-up of two years. Records were screened to identify potential medication-related reasons for readmissions. Identified records were independently assessed using adjusted versions of the algorithms of Kramer, Schumock & Thornton for causality and preventability by a doctor and pharmacist. All readmissions assessed as possibly (Kamer scores 0 through 3) or probably (Kramer score 4) related to medication were included. In addition, reasons for readmission, associated medication and medication errors were recorded. Descriptive statistics were used to analyze the data.</p><p><strong>Results: </strong>In total, 606 unplanned readmissions of 356 individual patients were included. Eighty-three of 606 (13.7%, 95% CI 11.1-16.7%) readmissions were identified as medication-related with a median time between index hospitalization and readmission of 152 days (IQR 16-438). Of these readmissions 36 (43.3%) from 32 unique patients were potentially preventable. The most frequently occurring reasons for readmissions were abdominal pain and infections. Medication most frequently associated with readmissions were Proton Pump Inhibitors, opioids and antibiotics. Medication errors involved in the preventable readmissions were most often prescribing errors followed by non-adherence.</p><p><strong>Conclusion: </strong>Medication-related readmissions frequently occur after bariatric surgery. More attention is needed for correct pharmacotherapy and patient education in this population.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145232497","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}
Zhenzhen Zhou, Weili Li, Yanfeng Liu, Fujian Si, Dongmei Wang, Xu Sun, Nan Song, Wenjing Chen, Huilan Du
{"title":"Efficacy and safety of Jingqianshu granules in patients with premenstrual syndrome: a multicenter, randomized, double-blind, placebo-controlled trial.","authors":"Zhenzhen Zhou, Weili Li, Yanfeng Liu, Fujian Si, Dongmei Wang, Xu Sun, Nan Song, Wenjing Chen, Huilan Du","doi":"10.1007/s11096-025-01949-5","DOIUrl":"10.1007/s11096-025-01949-5","url":null,"abstract":"<p><strong>Introduction: </strong>Premenstrual syndrome (PMS) is a common disorder characterized by recurring somatic, emotional, and behavioral symptoms during the luteal phase of the menstrual cycle. Core manifestations include irritability, anxiety, insomnia, mood swings, breast tenderness, and headache. In Traditional Chinese Medicine (TCM), PMS with liver and qi stagnation is considered a pattern resulting from internal organ imbalance. Jingqianshu granules (JQS), a Chinese patented medicine, are traditionally used to soothe the liver, relieve depression, regulate qi, and alleviate pain.</p><p><strong>Aim: </strong>This study aimed to evaluate the clinical efficacy and safety of JQS in women with PMS characterized by liver stagnation and qi stagnation.</p><p><strong>Method: </strong>A total of 156 eligible participants were randomly assigned in a 2:1 ratio to receive JQS (n = 104) or placebo (n = 52) over three menstrual cycles, followed by a three-cycle post-treatment follow-up. The primary outcome was the change in the Daily Record of Severity of Problems (DRSP) scores. Secondary outcomes included TCM syndrome scores and improvements in individual symptoms. Safety was assessed by adverse event reporting and laboratory monitoring.</p><p><strong>Results: </strong>The full analysis set (FAS) included 155 participants, and the per-protocol set (PPS) included 137. After three treatment cycles, DRSP scores were significantly reduced in the JQS group compared to placebo (FAS: - 14.3 ± 8.85 vs. - 10.1 ± 7.61; PPS: - 14.5 ± 8.61 vs. - 10.2 ± 7.13; both P < 0.001) with a moderate effect size (Cohen's d = 0.51), indicating clinical relevance. TCM syndrome scores also showed greater improvement in the JQS group (FAS: 7.7 ± 3.11 vs. 9.0 ± 4.13; PPS: 7.7 ± 3.19 vs. 9.4 ± 4.23; P < 0.05). The JQS group exhibited significant improvements in individual DRSP symptoms including anxiety, fatigue, emotional instability, concentration difficulty, and breast tenderness (P < 0.05). Adverse events were mild and comparable between the groups (4.81% in JQS vs. 3.92% in placebo; P > 0.05), with no serious events reported.</p><p><strong>Conclusion: </strong>Jingqianshu granules significantly alleviated PMS symptoms and demonstrated good tolerability, supporting their use as a safe and effective treatment option for women with liver and qi stagnation-type PMS.</p><p><strong>Trial registration: </strong>This trial was registered in the Chinese Clinical Trials Registry (ChiCTR2200058599).</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1427-1436"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144527842","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 real-world pharmacovigilance study of belzutifan in renal cell carcinoma and von Hippel-Lindau disease: insights from the FDA adverse event reporting system database.","authors":"Yang Ye, Bohan Fan, Xiaopeng Hu","doi":"10.1007/s11096-025-01953-9","DOIUrl":"10.1007/s11096-025-01953-9","url":null,"abstract":"<p><strong>Background: </strong>Belzutifan, a first-in-class HIF-2α inhibitor, has been approved for von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) and previously treated sporadic RCC. While its safety profile has been characterized in LITESPARK clinical trials, real-world pharmacovigilance data remain limited.</p><p><strong>Aim: </strong>This study evaluated the characteristics (including frequency, system-specific toxicities, and time-to-onset) of real-world belzutifan-associated adverse events (AEs), aiming to identify emerging safety signals, and assessing potential disease progression-related AEs using data from the FDA Adverse Event Reporting System (FAERS).</p><p><strong>Method: </strong>FAERS reports related to belzutifan were retrieved for the period Q1 2004 to Q4 2024. Duplicate reports and those flagged for deletion were excluded. Disproportionality analysis was conducted using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and the Medicines and Healthcare Products Regulatory Agency (MHRA) method to identify significant safety signals. Time-to-onset analysis was performed to assess adverse event (AE) occurrence patterns.</p><p><strong>Results: </strong>A total of 248 AE reports were identified, with an increasing trend following FDA approvals in 2021 and 2023. The most frequently reported AEs were anemia (ROR: 19.00, 95% CI 13.51-26.73) and hypoxia (ROR: 59.48, 95% CI 38.09-92.88), consistent with clinical trial data. Significant signals for neurological (brain fog), hepatic (liver injury), metabolic (hypocalcemia), and respiratory (pneumonia) AEs were also observed. Reports of disease progression-related AEs were also prominent. A majority (71.1%) of AEs occurred within the first 6 months of treatment initiation, suggesting the need for early monitoring.</p><p><strong>Conclusion: </strong>This study provided the first real-world pharmacovigilance assessment of belzutifan, confirming expected AEs while identifying emerging safety signals. Close monitoring of hematologic, respiratory, hepatic, and neurological toxicities is warranted. Further prospective studies are needed to optimize patient selection and improve AE management.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1447-1457"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301961","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}
Hui-Fang Jiang, Wei Hu, Ting-Ting Jin, Hai-Li Shan, Tao Zhu, Jun-Jun Xu, Yang-Min Hu, Hai-Bin Dai
{"title":"Genetic links between psychological distress, sleep disorders, and sepsis risk: a Mendelian randomization study.","authors":"Hui-Fang Jiang, Wei Hu, Ting-Ting Jin, Hai-Li Shan, Tao Zhu, Jun-Jun Xu, Yang-Min Hu, Hai-Bin Dai","doi":"10.1007/s11096-025-01931-1","DOIUrl":"10.1007/s11096-025-01931-1","url":null,"abstract":"<p><strong>Background: </strong>Psychological distress and sleep disorders have been associated with increased sepsis risk and mortality, but their causal genetic relationships remain unclear.</p><p><strong>Aim: </strong>This study aimed to evaluate the causal relationship between genetically predicted psychological distress, sleep disorders, and sepsis risk, using a two-sample Mendelian randomization approach.</p><p><strong>Method: </strong>Genetic instrumental variables were identified for anxiety disorders, depression, post-traumatic stress disorders (PTSD), insomnia, and sleep-wake schedule disorders. Genome-wide association study (GWAS) data were used as exposure datasets, and five sepsis severity levels were analyzed. The inverse-variance weighted (IVW) method was the primary analysis, supported by the MR-Egger and weighted median methods. Heterogeneity was assessed using Cochran's Q test and pleiotropy was evaluated using the MR-Egger intercept test. A Leave-one-out sensitivity analysis was conducted to ensure robustness.</p><p><strong>Results: </strong>MR analysis found that genetically predicted depression was significantly associated with increased sepsis risk in individuals under 75 years of age (OR 1.15, 95% CI 1.03-1.28; P = 0.016), while PTSD was associated with a higher likelihood of requiring critical care for sepsis (OR 1.11, 95% CI 1.04-1.18; P = 0.002). No significant associations were found between other psychological distress factors, sleep disorders, and the risk of sepsis. Sensitivity analyses confirmed the stability of these results.</p><p><strong>Conclusion: </strong>This study provides genetic evidence linking depression and PTSD to sepsis risk and severity, emphasizing the need for clinical awareness and targeted interventions in at-risk individuals.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1354-1364"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540129","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}
Anita E Weidmann, Cathal Cadogan, Daniela Fialová, Ankie Hazen, Martin C Henman, Betul Okuyan, Francesca Wirth, Abdikarim Abdi, Silvana A M Urru, Lotte Sig Nørgaard
{"title":"Behavioural theories, models and frameworks to underpin clinical pharmacy and pharmacy practice research: guidance from the European Society of Clinical Pharmacy.","authors":"Anita E Weidmann, Cathal Cadogan, Daniela Fialová, Ankie Hazen, Martin C Henman, Betul Okuyan, Francesca Wirth, Abdikarim Abdi, Silvana A M Urru, Lotte Sig Nørgaard","doi":"10.1007/s11096-025-01966-4","DOIUrl":"10.1007/s11096-025-01966-4","url":null,"abstract":"<p><p>The scope of clinical pharmacy practice and research has expanded to encompass behavioural, economic and humanistic dimensions alongside clinical responsibilities. The influence of behaviour on the efficacy of clinical services justifies the application of behaviour change theories to clinical pharmacy and practice research. This facilitates a deeper understanding of human behaviour in relation to health interventions and the provision of clinical pharmacy services. This commentary provides a summary of key concepts that researchers need to consider when using behavioural and/or social theories to underpin their research, outlining: (1) why this is important to support development of the pharmacist's role in patient care; (2) definitions of theories, models and frameworks; (3) a description of the UK Medical Research Council Framework; (4) an overview of the most commonly used behavioural theories, models and frameworks (supplemented by implementation, communication and other relevant humanistic and social theories); (5) lessons for clinical pharmacy and pharmacy practice researches. The comment aims to assist pharmacy practice and health research colleagues to improve the quality and rigour of theory underpinned research. The guidance in this paper is part of the commitment of the European Society of Clinical Pharmacy to stimulate innovative and high-quality research in all areas of clinical pharmacy.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1537-1543"},"PeriodicalIF":3.2,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144674704","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}