International Journal of Clinical Pharmacy最新文献

Introduction: The profession of pharmacy has been continuously evolving, redefining scope of practice in every practice settings to meet the ongoing needs of the health care system and to meet patient expectations and need. Pharmacists are increasingly becoming part of primary care teams in countries such as Canada, the United Kingdom and Australia. In British Columbia, Canada, the Pharmacists in Primary Care Network (PCN) Program integrated primary care clinical pharmacists (PCCPs) as core members of the interprofessional team (IPT). The IPT members' experiences of collaborating with a pharmacist in a team-based primary care setting have not been extensively studied.

Aim: To describe the experiences of IPT members and PCCPs while working collaboratively for the shared care of mutual patients to identify the enablers, barriers, and development of interprofessional collaborations within the primary care setting in a province-wide program.

Method: Based upon the evaluation of the Pharmacists in the PCN Program, this work was informed by Qualitative Description methodology. Interview and focus group data were performed during two time periods (T1 and T2) of program implementation. Study participants included PCCPs, prescribers (family physicians and nurse practitioners), and PCN IPT members (social workers, dieticians, physiotherapists, and clinical counsellors). Each participant was invited via e-mail to attend a Zoom interview or focus group session.

Results: In T1 we interviewed 15 PCCPs and in T2, we interviewed 39 PCCPs, 12 IPT members and 11 prescribers. Data analysis developed four themes: (i) awareness shaping early acceptance and role clarity; (ii) deepening interprofessional collaboration over time; (iii) communication strategies which facilitated relationship building with the PCN providers; and (iv) impact of the co-location model on teamwork and improved care coordination.

Conclusion: The interprofessional collaboration between PCCPs, prescribers, and IPT members was strengthened through efforts of relationship building, improved role clarity, and easily accessible communication methods. The PCN teams addressed the initial integration challenges and provided the support for effective shared patient care.

Introduction: Teicoplanin is widely used to treat pulmonary infections, particularly in critically ill patients with gram-positive bacterial infections. However, its plasma concentration varies substantially between individuals owing to heterogeneity in renal function, comorbidities, and concomitant medications, leading to subtherapeutic or toxic exposures. Therapeutic drug monitoring (TDM) remains the standard approach for individualized dosing; however, its application in intensive care unit (ICU) is limited by resource and timing constraints. Hence, developing reliable predictive models to estimate teicoplanin plasma concentrations could enhance the precision and efficiency of TDM, and support pharmacist-led dosing decisions.

Aim: This study aimed to develop and validate machine learning (ML)-based models to predict the teicoplanin plasma concentration in ICU patients with pulmonary infections using real-world clinical data, thereby advancing personalized antibiotic therapy in clinical pharmacy practice.

Method: This retrospective cohort study was conducted between June 2018 and September 2023 in ICU patients receiving teicoplanin therapy at a tertiary hospital in China. After the univariate analysis to exclude irrelevant factors, sequential forward selection was performed to identify the optimal feature subset. The dataset was divided into a training set (80%) and a test set (20%), and ten ML algorithms were developed to predict teicoplanin plasma concentrations. Model performance was evaluated by ten-fold cross-validation of the training set and validated using an independent external cohort.

Results: A total of 270 eligible patients were included in the training and test sets, and additional 118 patients formed the external validation cohort. Seven variables were identified as the most predictive features: daily dose, diabetes, hemodialysis, imipenem, human serum albumin, urea, and red blood cell count. Among the ten algorithms tested, the TabNet model achieved the best predictive performance on the test set (R² = 0.88, RMSE = 3.24, MAE = 2.64, MAPE = 17.88%, ± 30% accuracy = 81.54%) and maintained robust external validation (R² = 0.79, ± 30% accuracy = 85.59%).

Conclusion: This study developed a TabNet model based on real-world data, which can accurately and interpretably predict the teicoplanin plasma concentration of patients with pulmonary infection in the ICU. The derived online prediction tool provides references for the application of artificial intelligence-assisted precision medicine in antibacterial treatment and the optimization of drug monitoring for ICU patients.

Introduction: Sophora flavescens film (SFF), a topical traditional Chinese medicine that primarily contains matrine, has been approved in China since 2009 for chronic gynecological inflammation. However, evidence regarding its clinical value in the management of postpartum vaginal dysbiosis (PVD) remains limited.

Aim: This study aimed to evaluate the effectiveness, safety, and pharmacoeconomic profile of SFF as an adjunct to conventional therapy in women with PVD.

Method: This single-center, open-label, non-randomized controlled trial was conducted among postpartum women (6-8 weeks after delivery) diagnosed with PVD. Participants were self-selected into either the SFF group (SFF plus conventional therapy) or the control group (conventional therapy alone). The primary outcome was the overall therapeutic effectiveness based on composite vaginal ecosystem indicators. Secondary outcomes included Vaginal Health Index Score (VHIS), Vaginal Inflammation Score (VIS), EQ-5D-5L health utility, EQ-VAS, and adverse events (AEs). Pharmacoeconomic evaluation was performed using a decision tree model to estimate the incremental cost-effectiveness ratio (ICER). Statistical analyses incorporated logistic regression and analysis of covariance (ANCOVA) with directed acyclic graph (DAG)-based confounder adjustments.

Results: In total, 126 participants (63 per group) completed the study. The SFF group demonstrated a significantly higher overall effectiveness than the control group (adjusted odds ratio = 3.68, 95% confidence interval [CI]: 1.49-9.09, P = 0.005). Significant post-treatment improvements were observed in VHIS (mean difference [MD] = 2.420, 95% CI: 1.808-3.032, P < 0.001, η² = 0.332), VIS (MD = - 0.425, 95% CI: - 0.642 to - 0.208, P < 0.001, η² = 0.109), EQ-5D-5L (MD = 0.029, 95% CI: 0.016-0.041, P < 0.001, η² = 0.150), and EQ-VAS (MD = 6.329, 95% CI: 2.978-9.680, P < 0.001, η² = 0.102). No serious AEs occurred, and the mild local irritation resolved spontaneously. Pharmacoeconomic analysis showed that SFF achieved a 1% increase in treatment effectiveness at an incremental cost of ¥244.23 compared with conventional therapy.

Conclusion: When combined with conventional care, SFF significantly improved clinical, symptomatic, and quality-of-life outcomes in women with PVD, with favorable tolerability and short-term cost-effectiveness. These results support its potential clinical utility. However, confirmation through multicenter, double-blind, randomized controlled trials is warranted.

Introduction: Health inequalities and medication management challenges are apparent for people with disabilities, including those who are visually impaired (VI). Community pharmacists are well placed to provide advice and support to VI patients. It is imperative for appropriate care that they are adequately prepared to adapt practice for these patients.

Aim: The study aimed to elucidate current experiences, perceived confidence and priorities of community pharmacists when caring for VI patients. It also aimed to understand current barriers and recommendations for practice adaptations to improve care of this cohort.

Method: This study utilised an online cross-sectional questionnaire comprising multiple choice, Likert scale and open text questions. This questionnaire was disseminated to registered community pharmacists in Ireland. Responses were coded and analysed quantitatively using descriptive and inferential statistics-whereby p < 0.05 denotes statistical significance. Open-text responses were analysed using conventional content analysis.

Results: Data were collected from 235 pharmacists (5.4% response rate). Approximately 70% (69.8%, n = 164) had previous experience providing care to VI patients, while over 90% (91.9%, n = 214) believed that VI patients are at increased risk of medication related harm. Pharmacists with over 10 years' experience (75.4% n = 98) were significantly more likely to feel confident caring for VI patients than those less experienced (52.9%, n = 18), p < 0.05. Only 10.3% (n = 24) believed the pharmacy teams they work with were adequately trained to care for VI patients, while 69.0% (n = 162) do not believe they have been provided with sufficient training and guidance on this topic. Most pharmacists would welcome training to identify (90.6%, n = 213) and guide management of VI patients (92.3%, n = 216). Open text responses revealed recommendations of adaptions to care. Respondent recommendations related to pharmacy physical layouts, patient identification, tailored medication dispensing practices, use of technology and improved communication methods.

Conclusion: This study revealed valuable insights into Irish community pharmacists' experiences, confidence and recommendations for adapting care for VI patients. Current barriers in addition to confidence and knowledge deficits and a lack of relevant training amongst pharmacists were identified. Further emphasis on this topic in undergraduate pharmacy programmes and continuing professional development training can help community pharmacists provide equitable care to VI patients.

Introduction: Tacrolimus is a critical immunosuppressive agent in kidney transplantation, but its pharmacokinetic variability, especially intra-patient variability (IPV), can lead to suboptimal outcomes. Genetic polymorphisms in CYP3A5 and ABCC2 may influence tacrolimus metabolism and transport, affecting dosing requirements and IPV. However, their combined impact during the first year after kidney transplantation remains insufficiently characterized.

Aim: This study aimed to evaluate the influence of CYP3A5*3 (rs776746) and ABCC2 (rs3740066, rs2273697) polymorphisms on tacrolimus exposure, IPV (C0-IPV and C0/D-IPV), and short-term renal allograft function in kidney transplant recipients, with a focus on the first post-transplant year.

Method: A prospective cohort of 60 kidney transplant recipients was followed for one year. Tacrolimus trough concentrations (C0) were measured on postoperative Day 7, Day 14, Month 1, Month 3, Month 6, and Year 1. IPV was assessed using C0-IPV and dose-adjusted C0/D-IPV. Genotyping was performed using the SNaPshot platform. Multivariable regression models identified predictors of IPV and renal allograft function was evaluated by estimated glomerular filtration rate (eGFR) at Year 1.

Results: CYP3A5*3 expressers required significantly higher tacrolimus doses than non-expressers from Day 7 through Month 3 (P < 0.05) and showed correspondingly lower C0/D values during this period (P < 0.01). ABCC2 rs3740066 was associated with C0/D at Month 6 (P = 0.037) and with the daily dose at Year 1 (P = 0.045). In the multivariable analysis, the ABCC2 rs2273697 variant (β = 8.429, 95% CI: 1.301-15.557, P = 0.021) was independently associated with tacrolimus C0-IPV. No significant associations were observed between IPV (C0-IPV or C0/D-IPV) and eGFR at Year 1.

Conclusion: CYP3A5 genotyping remains valuable for optimizing initial tacrolimus dosing, while ABCC2 polymorphisms, particularly rs2273697, contribute to tacrolimus C0-IPV during the first post-transplant year. Personalized dosing strategies using pharmacogenetic data could improve tacrolimus exposure stability. Larger studies with extended follow-up are needed to assess the long-term clinical implications of these findings.

Background: The rapid expansion of available pharmacotherapies and increasingly complex medication regimens has increased the risk of medication-related complications in clinical practice. Concerns have been raised that physicians' pharmaceutical competencies may not fully meet the demands for safe and rational medication use. Existing assessments of physicians' pharmaceutical competency have largely focused on theoretical pharmacology, with limited multidimensional evaluations incorporating medication monitoring, guidance, and interprofessional collaboration.

Aim: This study aimed to comprehensively assess pharmaceutical competency among Chinese physicians during the continuing medical education phase and examine its association with professional titles, presence of clinical pharmacists, hospital-provided pharmaceutical training, and implementation of rational drug use systems.

Method: A cross-sectional survey was conducted using purposive sampling among physicians from public Grade A tertiary hospitals in 11 provinces, autonomous regions, and municipalities in China. Pharmaceutical competency was assessed using the combined approach of subjective self-assessment and objective testing. Descriptive statistics and subgroup analyses were performed to evaluate differences across professional titles, departmental allocation of clinical pharmacists, hospital pharmaceutical training, and rational drug use system implementation.

Results: In total, 1,044 valid questionnaires were included in the analysis. The median (Q1, Q3) subjective self-assessment score for pharmaceutical competency (maximum score = 5) was 3.92 (3.72, 4.28), while the median (Q1, Q3) objective accuracy rate (maximum = 100%) was 51.11% (41.11%, 61.11%). No significant differences in pharmaceutical competency were observed across professional titles (all P > 0.05). With the exception of self-directed pharmaceutical learning, clinicians working in departments with clinical pharmacists and those receiving hospital-provided pharmaceutical training reported significantly higher subjective competency scores (P < 0.05). In addition, hospital pharmaceutical training and the implementation of rational drug use systems were associated with significantly higher objective assessment scores across multiple competency domains (P < 0.05).

Conclusion: Physicians demonstrated relatively high self-assessed pharmaceutical competency, but comparatively low objective performance, suggesting a tendency to overestimate pharmaceutical competency. These findings highlight the need to strengthen the pharmaceutical education and medication management support for physicians. Pharmacist involvement, pharmacist-led training, and rational drug use systems may play important roles in supporting physicians' pharmaceutical competency and promoting safer and more rational medication use.

Introduction: 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.

Aim: 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.

Method: 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.

Results: 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.

Conclusion: 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.

Introduction: Medication reconciliation at hospital discharge is essential to prevent medication discrepancies and ensure continuity of care. Competing clinical priorities often delay reconciliation, reducing discharge efficiency and increasing the risk of medication-related harm. Collaborative pharmacist-doctor models have potential to improve the quality and timeliness of discharge medication processes.

Aim: To evaluate the impact of a pharmacist-doctor collaborative discharge medication reconciliation model on discharge timeliness, reconciliation quality, and pharmacist resource utilisation.

Method: This observational study was conducted in a large tertiary hospital across two inpatient units over 12 weeks: six weeks usual care (1 September-12 October 2025) followed by 6 weeks intervention (13 October-28 November 2025). In the intervention phase, clinical pharmacists performed reconciliation planning, which involved preparing the draft discharge medication reconciliation plan for subsequent medical officer review and authorisation. Time-and-motion methodology captured discrete intervals across the discharge workflow. Quantile regression analysed time-based outcomes, and Poisson regression evaluated count-based outcomes including prescription adjustments. The primary outcome was time from discharge confirmation to patient departure; secondary outcomes included reconciliation completion rates, prescribing adjustments, and pharmacist workload.

Results: A total of 116 patients were included (control n = 65; intervention n = 51). The collaborative model improved discharge efficiency, reducing the median time from discharge confirmation to leaving the ward by 78 min (p = 0.022). Time from decision to discharge to reconciliation completion was more than halved (30 vs 76 min, p < 0.001). Reconciliation completeness was significantly higher in the intervention group (90.2% vs 67.7%, p = 0.007), with fewer partial completions and no missing reconciliations. Analysis demonstrated earlier availability of discharge prescriptions (40 vs 80 min, p = 0.011) and shorter intervals between reconciliation completion and medication list preparation (14 vs 32 min, p = 0.008). Importantly, reconciliation planning by the pharmacist required a median of only 3 min per patient, confirming that improved timeliness required minimal additional pharmacist resourcing.

Conclusion: A pharmacist-doctor collaborative discharge medication reconciliation model improved discharge efficiency and reconciliation accuracy without increasing pharmacist workload. These findings support broader implementation of collaborative models to enhance patient safety and hospital workflow performance. Further research should explore cost-effectiveness and patient-centred outcomes.

Introduction: The practice of prescribing by healthcare professionals other than physicians is called non-medical prescribing. Pharmacist prescribing (PP) is established in various countries and is expanding globally. In Middle Eastern Arab countries, there are significant developments in pharmacy education and practice with an expansion in the scope of practice; however, little is known about PP in these nations.

Aim: This scoping review aimed to explore the current status of PP in Middle Eastern Arab countries. The objectives were to identify countries reporting on proposed or developing PP initiatives and to describe pre-implementation planning, including reported qualifications, models of prescribing, and contributing barriers and facilitators.

Method: A search was conducted for published studies using nine databases from inception to October 2024. Full texts of papers focusing on PP, conducted in Middle Eastern Arab countries, and written in English and Arabic were obtained. All eligible papers were uploaded into Covidence. Duplicate papers were removed, and titles and abstracts were independently screened by two reviewers. Full-text screening was conducted by two reviewers. Data were extracted into a charting table with the following characteristics: author, publication year, aim, study design, setting, country, model of prescribing, qualifications, facilitators, barriers, and study recommendations. Data were synthesised narratively in line with the review objectives.

Results: In total, 202 papers were identified and following screening, 16 papers were included in this review. Most studies (n = 9) originated from Saudi Arabia, with others from Qatar (n = 5), Jordan (n = 1), and the United Arab Emirates (n = 1). The included studies were published between 2019 and 2024 in English. Most studies were conducted in hospital settings (n = 12), particularly within specialised clinics describing two prescribing models: collaborative and independent. The findings reflect inconsistency in reporting the qualifications required for prescribing. Facilitators were categorised into regulation, education/training, professional competence, interprofessional collaboration, infrastructure, awareness, and international collaboration. Barriers encompassed regulatory gaps, organisational deficiencies, professional limitations, interprofessional resistance, resource constraints, and limited evidence.

Conclusion: This review provides an overview of the current landscape of pharmacist prescribing in Middle Eastern Arab countries, key facilitators, and barriers. While the evidence base remains limited, findings suggest growing interest and early developments.

Introduction: Afatinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), is an effective treatment agent for lung cancer with uncommon epidermal growth factor receptor (EGFR) mutations. EGFR-TKIs should be administered with caution in patients with a history of interstitial lung disease (ILD); however, such patients are often excluded from clinical trials, and evidence on afatinib safety in this population remains limited.

Aim: To exploratorily evaluate the safety profile of afatinib in patients with a history of ILD using an administrative claims database and investigate whether severe ILD events occur uniformly across patient backgrounds or cluster within specific patient profiles.

Method: We analyzed data of patients who received afatinib between May 1, 2014 and November 30, 2020 from the administrative claims database provided by Medical Data Vision Co., Ltd. Severe ILD was defined using two claims-based operational definitions: (1) a broader primary definition combining ILD diagnostic codes and high-dose intravenous corticosteroid administration; (2) a stricter definition requiring intravenous methylprednisolone for sensitivity analysis. Classification and Regression Trees (CART) were used to exploratorily identify patient profiles associated with severe ILD.

Results: Among 2,174 patients treated with afatinib, 12.3% (267/2,174) had a history of ILD. Using the primary definition, severe ILD occurred in 6.0% (16/267) of these patients, whereas 3.4% (9/267) met the stricter definition. Although CART analyses yielded different split variables and cutoff values across the two definitions, both consistently indicated that severe ILD events were concentrated within specific patient profiles rather than being uniformly distributed across the population.

Conclusion: In patients with a history of ILD, the incidence of severe ILD following afatinib treatment was clarified. CART-derived findings should be interpreted as exploratory signals suggesting clustering of severe ILD events within particular patient profiles. However, as severe ILD was identified using claims-based operational definitions, outcome misclassification cannot be excluded despite sensitivity analyses. Further studies are warranted to validate these findings in independent real-world datasets with richer clinical detail and to support more precise stratification of severe ILD occurrence.