International Journal of Clinical Pharmacy最新文献

{"title":"Effects of antidepressant administration on physical performance and perceived exertion in athletes: systematic review and meta-analysis.","authors":"Jeongha Yun, Sohyeon Park, Kalynn Park, Chaeyoon Kim, Margo Mountjoy, Mark Stuart, Sandy Jeong Rhie","doi":"10.1007/s11096-026-02206-z","DOIUrl":"https://doi.org/10.1007/s11096-026-02206-z","url":null,"abstract":"<p><strong>Introduction: </strong>Antidepressants are commonly prescribed in athletes with depressive disorders, yet their potential effects on physical performance and perceived exertion remain unclear, and existing evidence is limited and inconsistent.</p><p><strong>Aim: </strong>This systematic review and meta-analysis aimed to evaluate the effects of antidepressant use on objective physical performance and perceived exertion in athletes.</p><p><strong>Method: </strong>A systematic literature search was conducted in PubMed, the Cochrane Library, Web of Science, and SPORTDiscus through March 2025. Eligible studies were randomised controlled trials (RCTs) published in English that enrolled elite, competitive, or recreational athletes; compared antidepressant administration with placebo or no treatment; and reported at least one objective or subjective performance-related outcome. Meta-analyses were performed using random-effects models, and pooled mean differences with 95% confidence intervals (CI) were calculated. This systematic review and meta-analysis was registered in PROSPERO (CRD420251123740).</p><p><strong>Results: </strong>Ten crossover RCTs involving 99 male athletes were included. Interventions included a norepinephrine reuptake inhibitor (reboxetine), a norepinephrine-dopamine reuptake inhibitor (bupropion), and selective serotonin reuptake inhibitors (fluoxetine or paroxetine). Acute antidepressant administration was associated with a small increase in rating of perceived exertion (RPE; mean difference 0.52 points on the Borg 6-20 scale, 95% CI 0.01-1.04; p < 0.05). No significant overall effects were observed for time-trial performance, mean power output, heart rate or blood lactate. However, subgroup analyses showed that reboxetine significantly impaired time-trial performance (mean difference 3.62 min, 95% CI 0.18-7.06; p < 0.05) and reduced mean power output (mean difference - 19.97 W, 95% CI - 36.87 to - 3.06; p < 0.05).</p><p><strong>Conclusion: </strong>Short-term antidepressant administration in athletes was associated with a small increase in perceived exertion, without consistent impairment in objective physical performance. As the current evidence derives exclusively from male athletes and acute exposure, further research should clarify its relevance to female athletes and to longer-term antidepressant treatment in athletes with depressive disorders.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148678322","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":"Developing pharmacist practice through a pilot family practice preceptorship programme: a prospective quantitative pre-post evaluation.","authors":"Tamara M Cairney, Heather Harrison, Mairi-Anne McLean, Tania Ramos, David Kernaghan, Chris F Johnson","doi":"10.1007/s11096-026-02198-w","DOIUrl":"https://doi.org/10.1007/s11096-026-02198-w","url":null,"abstract":"<p><strong>Introduction: </strong>Primary care health services face workforce pressures internationally. Greater multidisciplinary working is seen as a solution. In Scotland, pharmacists are embedded within primary care teams. General Practice Clinical Pharmacists (GPCPs) deliver medicines-related services, including independent prescribing, medicines optimisation and medication review. However, GPCPs' clinical experience and training vary considerably. A structured preceptorship programme was developed to support role development.</p><p><strong>Aim: </strong>To evaluate the impact of a preceptorship programme for GPCPs on self-assessed training needs, competence and confidence within routine primary care practice.</p><p><strong>Method: </strong>A prospective repeated-measures survey and medication review activity analysis were conducted with GPCPs in one health board between January 2024 and March 2025. Reported using the Checklist for Reporting of Survey Studies (CROSS). Preceptees, identified using eligibility criteria, completed a 32-item Hennessy-Hicks Training Needs Analysis questionnaire pre- and post a 12-week preceptorship programme, rating tasks for importance, self-perceived performance and confidence. Matched pre-post questionnaire responses were analysed using the Wilcoxon signed-rank test. Routinely recorded medication review activity was extracted from electronic clinical systems for six months pre- and post-programme and summarised descriptively.</p><p><strong>Results: </strong>Fifty-three GPCPs enrolled; 51 (96%) completed (median age 34 [range 24-57] years; 43 (84%) female. Median years qualified were 11 (range 1-33) and 3 years (0-10) primary care experience. Pre- to post-response rate was 76% (39/51). At baseline, the top five scoring self-reported priority training needs items (task importance minus perceived performance score) of the 32 items were: mental health and chronic pain reviews, conflict management, biopsychosocial assessment, and assessing patient decision-making capacity. At 12 weeks all scores had reduced, with larger reductions observed in the top five items (p < 0.001 for each item). Self-reported competence and confidence across all superordinate categories appeared to increase. Recorded medication review activity was summarised descriptively. Median monthly reviews increased from 2 (IQR 0-4) before preceptorship to 4 (IQR 1-10) during preceptorship, before returning to 2 (IQR 0-7) after programme completion.</p><p><strong>Conclusion: </strong>Structured preceptorship was associated with improved self-reported competence and confidence and a short-term increase in recorded medication review activity. Further evaluation is required to determine whether these changes translate into sustained clinical activity for improved patient outcomes.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148678405","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":"AI-generated patient information leaflets for oral anticoagulants: quality, usability, readability, and reproducibility compared with FDA-referenced materials.","authors":"Mohammed Amer Khan, Mohammed Maazuddin, Ammar Al Abdullah, Ihtisham Sultan, Hakam Abdallah Alzaeem, Mohammed Qintar, Krishana Kumar Sharma, Biplab Pal","doi":"10.1007/s11096-026-02203-2","DOIUrl":"https://doi.org/10.1007/s11096-026-02203-2","url":null,"abstract":"<p><strong>Introduction: </strong>Oral anticoagulants are frequently associated with preventable hospital admissions, and patient education is essential to their safe and effective use. Patients increasingly use large language models (LLMs) for medication information, yet few studies have compared AI-generated outputs with regulatory materials or examined oral anticoagulants, a class in which misunderstanding can cause bleeding or thrombosis.</p><p><strong>Aim: </strong>To assess the informational quality, usability, readability, and output reproducibility of AI-generated patient information leaflets (PILs) for oral anticoagulants compared with FDA-referenced patient materials.</p><p><strong>Method: </strong>PILs for five oral anticoagulants (warfarin, apixaban, dabigatran, rivaroxaban, and edoxaban) were generated by ChatGPT, Gemini, and DeepSeek using a standardised zero-shot prompt based on FDA labelling templates; FDA-approved leaflets served as the comparator. Materials were anonymised and brand-blinded. Three clinical pharmacists independently evaluated each PIL using the Patient Education Materials Assessment Tool for Print Materials (PEMAT-P) and a modified DISCERN (mDISCERN), which assess informational quality, understandability, and actionability, but not pharmacological accuracy or clinical safety. Readability was assessed using seven validated indices. Output reproducibility was examined within the same day and at Day 1, 14, and 28.</p><p><strong>Results: </strong>ChatGPT produced PILs of informational quality similar to FDA-referenced materials, both achieving a median mDISCERN score of (41/65); DeepSeek (34/65) and Gemini (33/65) scored significantly lower than ChatGPT; Gemini also scored significantly lower than the FDA-referenced materials. Understandability was acceptable for all sources, whereas actionability was limited, including in FDA materials, with no leaflet providing a patient summary or decision-support tool. All materials exceeded the recommended sixth- to eighth-grade range on most indices, with FDA leaflets the most complex. Output was stable across generations, with no significant within-model differences and the largest mean difference of 0.23 points.</p><p><strong>Conclusion: </strong>Among the evaluated models, ChatGPT most closely matched FDA-referenced materials in the assessed informational domains and demonstrated stable output over 28 days. Shared deficiencies across AI-generated and FDA leaflets suggest broader limitations in written health information. This comparability was limited to the assessed informational domains and does not establish equivalence in pharmacological accuracy, clinical correctness, or patient safety. AI-generated PILs may serve as clinician-reviewed supplementary materials and should not be used as standalone tools without independent professional review and verification of clinical content.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148678412","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":"How direct healthcare professional communications are operationalised by general practitioners and community pharmacists in Ireland: a national cross sectional study.","authors":"Paul E Ryan, Ann Sinéad Doherty, Darren L Dahly, Stephen Byrne, Sinead Curran, Darren Scully, Ruchika Sharma, Emma Wallace","doi":"10.1007/s11096-026-02105-3","DOIUrl":"10.1007/s11096-026-02105-3","url":null,"abstract":"<p><strong>Introduction: </strong>Direct Healthcare Professional Communications (DHPCs) alert healthcare professionals of important safety information relating to medication(s) and of the need to adapt practices with respect to these. International evidence suggests that their implementation varies in clinical practice. To date, few studies have examined implementation of DHPCs in primary care.</p><p><strong>Aim: </strong>To examine how general practitioners (GPs) and community pharmacists implement DHPCs in Ireland and their preferences for receiving medication safety updates.</p><p><strong>Method: </strong>A national cross-sectional survey of GPs and pharmacists in collaboration with the Irish Health Products Regulatory Authority (HPRA), was conducted in June 2024. GPs and CPs were invited to participate via national gatekeepers (Irish College of GPs, Pharmaceutical Society of Ireland). Following piloting, the questionnaire were administered via email using Qualtrics. Data was analysed using R and R Studio.</p><p><strong>Results: </strong>A total of 277 GPs and 219 pharmacists completed the questionnaire, a response rate of 6% and 8% respectively. Most GPs (n = 227, 82%) and pharmacists (n = 196, 89%) reported DHPCs as their preferred source of medication safety updates. Practice protocols for sharing DPHCs once received differed across the two professional groups. For example, DHPCs were more likely to be disseminated and discussed at a pharmacy practice meeting (n = 64 pharmacists, 29%) compared with GP practice meetings (n = 24 GPs, 9%). More than one-third of GPs (n = 98, 35%) identified time constraints as the most important barrier to DHPC implementation, followed by absence of prescribing notifications on patient electronic health records (EHRs), n = 36 GPs (13%), n = 39 CPs (18%). A total of 257 GPs (93%) and 198 CPs (90%) identified patient EHR prescribing alerts, aligned with DHPC recommendations, integrated at the point of patient care as a preferred way to support implementation.</p><p><strong>Conclusion: </strong>Surveyed GPs and pharmacists use DHPCs as their primary information source for new medication safety alerts and most reported these communications as very useful. Repeated DHPC communications across different modalities were valued. Barriers to implementation included time constraints and lack of point of care alerts for both GPs and pharmacists. Remote clinical support is acceptable to GPs and pharmacists and may support the implementation of DHPC recommendations to optimise medication safety in primary care.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1303-1314"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13369712/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147432813","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}

{"title":"A novel predictive model for evaluating thrombus regression in postpartum venous thromboembolism patients.","authors":"Meixiang Yu, Congcong Jia, Zhenyu Zhou, Qingshan Chen, Xuemei Di, Ning Zhang, Xiaoqing Zhang, Zhendong Xu, Hai Zhang","doi":"10.1007/s11096-026-02125-z","DOIUrl":"10.1007/s11096-026-02125-z","url":null,"abstract":"<p><strong>Introduction: </strong>Antithrombotic evaluation of postpartum venous thromboembolism (VTE) after anticoagulant therapy is challenging because of the lack of high-quality clinical evidence.</p><p><strong>Aim: </strong>To identify and validate a machine learning model to predict thrombus regression in postpartum VTE patients.</p><p><strong>Method: </strong>This study constructed three cohorts of postpartum VTE patients receiving low-molecular-weight heparin (LMWH): retrospective (n = 200), prospective (n = 50), and external (n = 29) cohorts. The main endpoint was imaging-based thrombus regression. Based on clinical guidelines and literature, we screened 16 potential predictors. The retrospective dataset was analyzed using eight machine learning models to predict thrombus regression after anticoagulant therapy. The performance of the model was evaluated by the area under the receiver operating characteristic curve (AUC-ROC), residual analysis, accuracy, sensitivity and specificity. The optimal model was selected based on its comprehensive performance and further validated on the prospective and external cohorts. Model interpretability was analyzed using variable importance and partial dependence plots.</p><p><strong>Results: </strong>Thrombus regression was significantly associated with anti-Xa activity (p = 0.009), antithrombin III levels (p = 0.028), and D-dimer levels (p = 0.024). Of the eight models, the random forest (RF) model demonstrated the best predictive performance, with the AUC-ROC value of 0.831(95%CI 0.696-0.967), accuracy of 0.77, sensitivity of 0.45, specificity of 0.89, and the highest accuracy in predicting thrombus regression events in the prospective (94.29%) and external (90.00%) postpartum VTE datasets. The key predictive variables were anti-Xa activity, antithrombin III levels, D-dimer levels, and body mass index (BMI).</p><p><strong>Conclusion: </strong>Based on data from the three cohorts of patients with postpartum VTE, the RF model was identified as the optimal model for predicting thrombus regression events, with anti-Xa activity, antithrombin III levels, D-dimer levels, and BMI serving as key predictors. This study may help assess changes in the thrombotic state of postpartum VTE patients and guide clinical precision medication.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1476-1488"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13369046/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147627638","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}

{"title":"Post-marketing safety surveillance of EGFR-targeted agents and disseminated intravascular coagulation risk: a disproportionality analysis based on the FDA Adverse Event Reporting System.","authors":"Hai-Yu Liu, Mei-Yu Qu, Shu-Yun Wang, Jun-Jin Liu, Si-Yang Wang, Rui-Gang Hou","doi":"10.1007/s11096-026-02153-9","DOIUrl":"10.1007/s11096-026-02153-9","url":null,"abstract":"<p><strong>Introduction: </strong>The epidermal growth factor receptor (EGFR) serves as a principal therapeutic target in oncology, with EGFR inhibitors representing essential agents in cancer treatment. Although thrombotic complications related to EGFR inhibitors have been reported in the literature, the evidence remains insufficient. Notably, EGFR inhibitor-associated disseminated intravascular coagulation (DIC) constitutes a potentially fatal condition that currently lacks comprehensive systematic investigation.</p><p><strong>Aim: </strong>To systematically assess the signal and clinical characteristics of DIC potentially associated with EGFR inhibitors using pharmacovigilance data.</p><p><strong>Method: </strong>Individual case safety reports (ICSRs) from the FDA Adverse Event Reporting System (FAERS) were extracted, with the 11 currently approved EGFR inhibitors designated as the primary suspect agents. Each drug's data was extracted from the initial approval date (or January 1, 2004, if approved prior to 2004) to December 31, 2024. After deduplication, disproportionality analyses were performed using four algorithms: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Positive and negative controls were used to evaluate potential reporting bias.</p><p><strong>Results: </strong>In FAERS, 104 ICSRs of DIC potentially associated with EGFR inhibitors were identified, of which 64 (61.54%) were fatal. Healthcare professionals accounted for the predominant proportion (82.69%) of ICSR submissions. All seven drugs with reports-cetuximab, panitumumab, gefitinib, erlotinib, afatinib, osimertinib and lapatinib-generated significant disproportionality signals. Cetuximab and gefitinib displayed the strongest disproportionality signals. ICSRs were predominantly reported from Asia, with Japan accounting for 43 ICSRs (41.35%). The median patient age was 68 years, with a balanced gender distribution. Non-small cell lung cancer (NSCLC) was the primary indication (24.04%).</p><p><strong>Conclusion: </strong> DIC may represent a pharmacovigilance signal associated with EGFR inhibitors, and may exhibit a potential class effect. Further clinical validation is required to establish causality. Proactive monitoring for DIC in patients receiving EGFR inhibitors is recommended.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1703-1713"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13368855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147770802","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}

{"title":"Perspectives on shared decision making related to medications from patients with multiple long-term conditions transitioning from hospital to home: a qualitative study.","authors":"Mikas Glatkauskas, Malin Olsen Syversen, Liv Mathiesen, Michael Scott, Karin Svensberg, Berit Gallefoss Denstad, Marianne Lea","doi":"10.1007/s11096-026-02143-x","DOIUrl":"10.1007/s11096-026-02143-x","url":null,"abstract":"<p><strong>Introduction: </strong>Shared decision making is particularly important for patients with multiple long-term conditions due to the nature of long-term treatments and frequent changes in medication regimens. However, the complexity of the medication regimens could exclude these vulnerable patients from shared decision making. There is little knowledge about how patients with multiple long-term conditions experience and perceive shared decision making.</p><p><strong>Aim: </strong>The aim was to explore the perspectives and experiences of patients with multiple long-term conditions regarding shared decision making related to medications before, during and after a hospital stay.</p><p><strong>Method: </strong>Semi-structured interviews with 21 patients and three next of kin were conducted. Patients ≥ 18 years, usually living at home, on at least four medications for at least two separate conditions were included. These patients were purposively sampled from two geriatric wards and one internal medicine ward at a university hospital in Norway and interviewed approximately 14 days post hospital discharge. The inclusion and interviews lasted from December 2022 to February 2024. A semi-structured interview guide was used, and the qualitative data were analyzed using directed content analysis guided by the three-talk model developed by Elwyn et al. from 2017.</p><p><strong>Results: </strong>Patients reported not being invited to be part of the shared decision-making process and perceived their limited medical knowledge as a barrier to being invited to participate. They reflected on themselves being primarily focused on single details regarding one medication option they had received. Furthermore, they were not encouraged by the healthcare professionals to discuss and compare different medication options. Both patients and next of kin described an expectation that decisions being made by healthcare professionals would be accepted although the patient did not necessarily understand the treatment plan adequately. Several patients reported that healthcare professional led decisions left little to no room for further discussion and that medication decisions and patient health goals were almost solely in the hands of the healthcare professional. Although most patients trusted the healthcare professional to act in their best interests, this reliance resulted in further disengagement from their own treatment.</p><p><strong>Conclusion: </strong>Patients with multiple long-term conditions were in general unfamiliar with and uninvolved in shared decision making related to medications. Additionally, the patients reflected on a lack of invitation to team talk which resulted in limited patient involvement both in option and decision talk.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1636-1645"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13368897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147770765","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}

{"title":"Comparison of treatment efficacy of targeted therapies approved in China for non-small cell lung cancer before and after the introduction of accelerated drug marketing registration procedures.","authors":"Chenning Liu, Liyang Lyu, Yufan Zhang, Yingyi Tian, Jing Yuan, Chihua Li, Yuanjia Hu","doi":"10.1007/s11096-026-02119-x","DOIUrl":"10.1007/s11096-026-02119-x","url":null,"abstract":"<p><strong>Introduction: </strong>The introduction of Accelerated Drug Marketing Registration Procedures (ADMRPs) in China has improved patient access to innovative therapies, but concerns remain about the robustness and consistency of efficacy evidence.</p><p><strong>Aim: </strong>This study aimed to compare the treatment efficacy of approved targeted therapies for non-small cell lung cancer (NSCLC) before and after the implementation of ADMRPs.</p><p><strong>Method: </strong>In this retrospective study, we analyzed targeted therapies for NSCLC approved in China as of December 31, 2024. Approvals were categorized as pre-policy or post-policy groups based on the July 1, 2020 implementation of ADMRPs. Descriptive statistics were used to examine approved indications and pivotal trial designs. Meta-analysis and meta-regression compared pre-approval efficacy outcomes, including overall survival (OS), progression-free survival (PFS), disease-free survival, and objective response rate (ORR), between groups. Sensitivity analyses evaluated post-marketing OS data and the robustness of results.</p><p><strong>Results: </strong>A total of 59 indications supported by 72 trials were approved. Post-policy approvals increased markedly (41 vs 18), with rises in domestic drugs (16.7% pre-policy vs 61.0% post-policy) and uncommon targets (5.6% pre-policy vs 43.9% post-policy) (both P < 0.05). Pivotal trials shifted from primarily Phase III-IV randomized controlled trials (RCTs) (76.0%) pre-policy to Phase I-II single-arm designs (68.1%) post-policy, mainly supporting drugs for uncommon or resistance mutations, whereas approvals for classical targets remained predominantly based on RCTs (90.0% pre-policy vs 93.8% post-policy; P = 0.416). Meta-analyses found no significant differences in pre-approval efficacy between groups for PFS (HR: 0.52 [0.45-0.61] vs 0.44 [0.36-0.54]; P = 0.206) or ORR (0.63 [0.55-0.70] vs 0.65 [0.59-0.70]; P = 0.705). However, OS meta-analysis was only feasible in the pre-policy group, whereas OS data in the post-policy group remained immature, with a median follow-up of 17 months (IQR 8-34) after approval.</p><p><strong>Conclusion: </strong>After the introduction of ADMRPs, approvals of targeted therapies for NSCLC increased substantially, without significant loss of pre-approval treatment efficacy. However, due to the limited follow-up, definitive survival benefits for the post-policy group cannot yet be established. The increased reliance on single-arm trials underscores the necessity of rigorous confirmatory post-marketing studies.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1412-1423"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13369530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147473579","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}

{"title":"Development and evaluation of an e-learning program on drug-related problems for community pharmacists.","authors":"Cathrin J Vogt, Alesia Reuther, Viktoria S Wurmbach, Marina Weißenborn, Janina A Bittmann, Katharina Wien, Anette Lampert, Emilia Maria Boček Eknes, Patrick Schäfer, Hanna M Seidling","doi":"10.1007/s11096-026-02111-5","DOIUrl":"10.1007/s11096-026-02111-5","url":null,"abstract":"<p><strong>Introduction: </strong>Community pharmacists (CPs) are pivotal in the management of drug-related problems (DRPs), yet a need for additional training has been recognized.</p><p><strong>Aim: </strong>The aim was to develop and evaluate an e-learning program to enhance pharmacists' ability to detect and manage DRPs.</p><p><strong>Method: </strong>The e-learning program provided a self-paced learning experience with 10 modules, each focusing on a DRP. The DRPs were chosen as part of a previous Delphi consensus study. The development team, consisting of researchers, clinical pharmacists, and CPs, considered DRPs applicable if they occurred frequently and could be solved in a pharmacy. Moreover, a predefined checklist was established to guide the development of new modules and specify quality standards. Each module was structured into an educational phase (tutorials, pre- and post-knowledge quizzes, in-depth exercises), and a practical phase (documentation of anonymized patient encounters). After completing all modules, participants took a final comprehensive quiz with 2 questions per module (in total 20 questions). The program was evaluated on multiple levels: pharmacists' knowledge change, how they implemented this knowledge in practice, and their feedback. Data were analyzed descriptively. Comparison between the quizzes were calculated using the Wilcoxon test.</p><p><strong>Results: </strong>A total of 203 pharmacists registered to participate in the study, with participation declining across modules (184 participants completed Module 1 pre-knowledge quiz vs. 119 in Module 10). Across all modules, a significant knowledge increase was observed when comparing pre- and post-knowledge-quizzes (p < 0.001). Knowledge levels remained high in the final quiz (on average 1.63 ± 0.61 correct answers). Participants documented 13,778 patient encounters, thereof 5073 encounters with at least one DRP. According to the participants, most of the DRPs (90.1%, n = 4550) could be resolved. A total of 1137 feedbacks were received. Overall, feedback was positive, with participants highlighting improved abilities to engage with patients (85.2%, n = 969) and to identify DRPs (82.0%, n = 629).</p><p><strong>Conclusion: </strong>By bridging the gap between theoretical learning and practical application, this e-learning program improves pharmacists' skills in DRP management.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1349-1358"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13369537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147511806","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}

{"title":"Cost-effectiveness of toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma in China and the United States healthcare systems.","authors":"Junhao Yang, Haixia Ding","doi":"10.1007/s11096-026-02133-z","DOIUrl":"10.1007/s11096-026-02133-z","url":null,"abstract":"<p><strong>Introduction: </strong>Toripalimab combined with bevacizumab has demonstrated significant clinical efficacy and survival benefits in patients with advanced hepatocellular carcinoma (HCC). However, the high cost of this combination therapy raises concerns regarding its cost-effectiveness in healthcare systems in China and the U.S.</p><p><strong>Aim: </strong>This study evaluated the cost-effectiveness of toripalimab plus bevacizumab compared with sorafenib from the perspectives of the Chinese and U.S. healthcare systems. The findings are intended to inform value-based pricing strategies, reimbursement decisions, and clinical resource allocation.</p><p><strong>Method: </strong>A partitioned survival model (PSM) was developed to estimate incremental cost-effectiveness ratios (ICERs) from the healthcare system perspective. Willingness-to-pay (WTP) thresholds were set at $40,011 per quality-adjusted life year (QALY) in China and $100,000-$150,000 per QALY in the U.S. Deterministic and probabilistic sensitivity analyses were conducted to evaluate the robustness of the model outcomes.</p><p><strong>Results: </strong>In China, toripalimab plus bevacizumab produced an ICER of $55,764.00/QALY compared with sorafenib, exceeding the local WTP threshold of $40,011/QALY. In the U.S., the ICER was $460,054.17/QALY, which also exceeded the commonly accepted WTP thresholds. Sensitivity analyses indicated that the discount rate and the proportion of patients receiving subsequent anti-cancer therapies were the primary cost drivers in China and the United States, respectively. Probabilistic sensitivity analysis showed a 0.7% and 1.5% probability of cost-effectiveness at WTP thresholds of $100,000/QALY and $150,000/QALY in the U.S., respectively. In China, the probability of cost-effectiveness was 3.2% at a WTP threshold of $40,011/QALY.</p><p><strong>Conclusion: </strong>At current pricing levels, toripalimab plus bevacizumab is unlikely to be cost-effective compared with sorafenib in either China or the U.S. These findings highlight the need for value-based pricing strategies and more efficient allocation of healthcare resources.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"1533-1547"},"PeriodicalIF":3.2,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13369023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147689898","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}