International Journal of Clinical Pharmacy最新文献

{"title":"Instruments for assessing healthcare professionals' knowledge, attitudes and practices regarding deprescribing: a scoping review.","authors":"Ana Carolina Figueiredo Modesto, Luis Phillipe Nagem Lopes, Mariana Del Grossi Moura, Alan Maicon de Oliveira, José Salvador Carrillo, Beatriz Birelli do Nascimento, Flávia Casale Abe, Luciane Cruz Lopes","doi":"10.1007/s11096-026-02215-y","DOIUrl":"https://doi.org/10.1007/s11096-026-02215-y","url":null,"abstract":"<p><strong>Introduction: </strong>Deprescribing is a multiprofessional process which aims to optimize medication use and improve patient safety, in which healthcare professionals' knowledge, attitudes, and practices (KAP) play a central role. The instruments used to assess KAP among nurses, pharmacists and physicians remain poorly characterised in terms of scope and measurement quality.</p><p><strong>Aim: </strong>To map and characterize the instruments used to assess healthcare professionals' knowledge, attitudes, and practices regarding deprescribing.</p><p><strong>Method: </strong>A scoping review was conducted following Joaassess healthcaree (JBI) methodology and reported according to the PRISMA Extension for Scoping Reviews (PRISMA-ScR). Primary studies were eligible if they involved nurses, pharmacists or physicians and applied any instrument assessing KAP related to deprescribing, individually or in combination, regardless of setting or country. Nine electronic databases were searched, including two grey literature sources were searched from inception to September 2024, without restrictions on language or publication date using terms related to nurses, pharmacists, physicians, deprescribing, surveys and questionnaires, and health knowledge, attitudes, and practice Study selection and data charting were performed independently by three pairs of reviewers using a standardised extraction form capturing study characteristics, instrument details, KAP domains assessed, and reported measurement properties. Data was synthesised using descriptive statistics and narrative analysis. The review protocol was registered on the Open Science Framework.</p><p><strong>Results: </strong>Of the 3,821 records screened, 49 met the inclusion criteria. Over two-thirds of the included studies were published since 2020 (n = 33, 67.3%). The evidence base was concentrated in high-income countries (n = 36/46, 78.0%; three multi-country studies were not classified by income level), particularly in the Europe and Central Asia region (n = 19, 41.0%), and most often focused solely on physicians, while studies simultaneously involving all three professional groups (physicians, pharmacists, and nurses) were less frequent (n = 8, 16.0%). Instruments commonly assessed multiple KAP domains, especially knowledge, attitudes, and practices combined (n = 12, 30.0%), whereas evidence on psychometric properties was reported in only a minority of studies (n = 13, 26.5%), among these, internal consistency and content validity were the pair most frequently reported together (n = 4, 31.0%).</p><p><strong>Conclusion: </strong>Instruments assessing healthcare professionals' KAP regarding deprescribing remain limited in scope and psychometric robustness. Expanding interprofessional coverage and strengthening validation efforts are key priorities for advancing research in this field.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792601","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":"Development of a hybrid artificial intelligence framework for pharmacotherapy optimization.","authors":"Olaf Rose, Stephanie Clemens, Andreas Leiherer, Michael Bücker, Finn Petersson, Gerald Lirk, Christopher Mosch, Johanna Pachmayr, Kreshnik Hoti","doi":"10.1007/s11096-026-02205-0","DOIUrl":"https://doi.org/10.1007/s11096-026-02205-0","url":null,"abstract":"<p><strong>Introduction: </strong>Pharmacotherapy optimization in multimorbid patients is increasingly complex due to polypharmacy, fragmented data, expanding electronic health records, and workforce constraints. Conventional clinical decision support systems remain largely rule-based and often fail to adequately incorporate patient-specific context. While artificial intelligence offers new opportunities, stand-alone models remain insufficiently reliable for high-risk pharmacotherapy decision support.</p><p><strong>Aim: </strong>To develop a relevance-driven, clinician-supervised hybrid AI framework for pharmacotherapy optimization.</p><p><strong>Method: </strong>Using a design science-informed approach, an interdisciplinary research group developed a conceptual framework for AI-supported pharmacotherapy optimization. Framework development was informed by prior feasibility work, published literature, clinical practice requirements, and iterative interdisciplinary discussions. Hybrid AI was defined as the combination of retrieval-augmented generation, deterministic safety rules, and large language model reasoning.</p><p><strong>Results: </strong>Seven design principles were identified, including decomposition of clinical activities, relevance-based prioritization, hybrid reasoning under clinician oversight, integration of patient goals, transparency of evidence sources, longitudinal optimization within a governed closed loop, and evaluation as a design requirement. These principles informed a conceptual architecture integrating structured clinical data, patient preferences, longitudinal patient information, and evidence retrieval within a clinician-governed decision-support framework.</p><p><strong>Conclusion: </strong>The proposed framework conceptualizes AI as a relevance-structuring, clinician-governed decision-support layer rather than an autonomous decision-maker. By combining hybrid reasoning, patient-specific context, and professional oversight, it provides a conceptual foundation for future development, implementation, and evaluation of AI-supported pharmacotherapy systems.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792598","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":"Codesigning a pharmacist-led transition of care program in the emergency department: a qualitative participatory study.","authors":"Eman Alhmoud, Raja Barazi, Binny Thomas, Almunzer Zakaria, Lubna Andraous, Rasha El Enany, Palli Valapila Abdulrouf, Sameer Pathan, Hamde Nazar, Mohamed Izham Mohamed Ibrahim, Muhammad Abdul Hadi","doi":"10.1007/s11096-026-02210-3","DOIUrl":"https://doi.org/10.1007/s11096-026-02210-3","url":null,"abstract":"<p><strong>Introduction: </strong>Transitions from the emergency department (ED) to home are high-risk periods for medication-related harm. Pharmacist-led interventions may improve medication safety and care continuity, however, co-designed approaches to developing such interventions remain limited.</p><p><strong>Aim: </strong>This study aimed to co-design a pharmacist-led transition-of-care (ToC) program to improve medication management for adults discharged from the ED, with the intention of subsequently evaluating it in a pilot randomized controlled trial.</p><p><strong>Method: </strong>A two-phase qualitative study was undertaken at a general teaching hospital in Qatar within a Participatory Health Research (PHR) framework. Phase I involved one-to-one interviews and focus groups with patients, pharmacists, physicians, and nurses. Phase II consisted of a co-design workshop with decision makers, including departmental leaders and hospital administrators, followed by structured refinement through additional stakeholder meetings and an electronic prioritization survey. Data were analyzed using an inductive-deductive approach, guided by two theoretical frameworks, the Theoretical Domains Framework and the Care Transitions Framework. Five proposed interventions were evaluated against the APEASE (Acceptability, Practicability, Effectiveness, Affordability, Safety, Equity) criteria, and identified barriers were mapped to corresponding intervention functions and implementation strategies.</p><p><strong>Results: </strong>Phase I, comprising three focus groups with physicians (n = 6), nurses (n = 7), and clinical pharmacists (n = 6), and four interviews with two patients and two Patient and Family Advisory Council (PFAC) representatives, identified barriers, enablers, and stakeholder priorities related to medicines management that informed the Phase II co-design workshop. Stakeholders rated the five proposed interventions: discharge medication reconciliation, prescription review, patient counseling and education, pharmacist-to-pharmacist handover, and post-discharge follow-up with medication review, as highly feasible (mean 83%). All intervention components were retained due to their interdependence. Eligibility criteria for this intervention were decided as: patients discharged with new chronic diagnoses, newly prescribed high-risk medications, polypharmacy (i.e., taking ≥ 5 regular medications), and chronic disease exacerbations. A standardized workflow was co-developed, outlining patient identification and communication. Stakeholders prioritized key intervention functions and implementation strategies via structured voting.</p><p><strong>Conclusion: </strong>The pharmacist-led transition-of-care program blueprint was co-designed using a participatory, theory-informed process. The finalized program will undergo feasibility testing through a pilot randomized controlled trial and a process evaluation.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759588","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":"Medicine shortages and glaucoma care: a time-series analysis indicating population-level consequences of a national timolol eye drop shortage.","authors":"Erin Fawcett, Lisa Kalisch Ellett, Simi Sarin, Cassandra Haines, Helen Stone, Jack Janetzki","doi":"10.1007/s11096-026-02209-w","DOIUrl":"https://doi.org/10.1007/s11096-026-02209-w","url":null,"abstract":"<p><strong>Introduction: </strong>Medicine shortages can disrupt glaucoma management and necessitate therapeutic substitution. Understanding how shortages affect access to first-line treatments for glaucoma is important for optometrists when monitoring intraocular pressure control, and pharmacists when counselling patients and coordinating care during periods of limited medicine availability. Timolol, a non-selective beta-blocker, is a first-line treatment for glaucoma and ocular hypertension and has experienced international shortages in recent years. Between August 2024 and May 2025, Australia experienced a nationwide shortage of timolol-containing eye drops, raising concerns regarding continuity of care, access to treatment, and therapeutic substitution.</p><p><strong>Aim: </strong>To descriptively examine the impact of the 2024-2025 timolol eye drop shortage on dispensing patterns of antiglaucoma medicines in Australia and assess the contribution of imported products in mitigating the shortage.</p><p><strong>Method: </strong>A retrospective drug utilisation study was conducted using publicly available aggregate Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS dispensing data from January 2020 to August 2025. Monthly dispensings of antiglaucoma preparations (ATC S01E) were standardised per 100,000 population and analysed using descriptive time-series methods. Dispensing trends were compared before, during, and after the shortage, with stratification by timolol formulation, therapeutic class, and product type (locally supplied versus overseas imports).</p><p><strong>Results: </strong>The late 2024 and early 2025 timolol shortage was associated with a sustained decline in dispensing of single-ingredient extended-release timolol, decreasing from approximately 40 dispensings per 100,000 population per month before the shortage to 1.07 by March 2025. Dispensing of standard-release timolol increased temporarily in October 2024 before declining in a similar pattern. Overseas imports accounted for 24.3% of all timolol dispensings during the shortage period and peaked at 87% of timolol dispensings in March 2025. Despite regulatory approval of imported products, overall timolol utilisation remained below pre-shortage levels. Alternative therapeutic classes, including prostaglandin analogues and carbonic anhydrase inhibitors, showed modest increases in dispensing, suggesting potentially limited therapeutic substitution.</p><p><strong>Conclusion: </strong>The timolol shortage disrupted access to a cornerstone first-line treatment for glaucoma. Regulatory intervention through the approval of imported products partially mitigated the shortage but did not restore utilisation to pre-shortage levels in Australia. Future shortage management strategies should prioritise rapid policy activation and closer alignment of imported products with formulations routinely available in Australia.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":""},"PeriodicalIF":3.2,"publicationDate":"2026-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148697367","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}