International Journal of Clinical Pharmacy最新文献

Introduction: Low-molecular-weight heparin (LMWH) is widely used for thromboprophylaxis and treatment in hospitalized patients; however, LMWH-related severe clinical bleeding (LSCB) remains a major concern. Existing risk scales have been developed for oral anticoagulants and have limited applicability to LMWH, leaving clinicians without reliable bedside tool.

Aim: This study aimed to evaluate the discriminatory performance of existing scales for predicting LSCB and develop a tailored nomogram for individualized risk prediction.

Method: Hospitalized medical patients prescribed LMWH between July 2021 and August 2024 at three tertiary hospitals in Hangzhou, China were retrospectively analyzed. Each LSCB case was matched with three non-LSCB controls from the same department and period. The prevalence of LSCBs, bleeding sites, and clinical characteristics are described. Receiver operating characteristic (ROC) curves were used to assess the predictive performance of existing scales. Variables with p < 0.10 in univariate analysis were entered into logistic regression, a backward stepwise elimination (stay p < 0.05) was applied to identify independent predictors and subsequently incorporated into a nomogram. Discrimination, calibration, and external validation were performed.

Results: Among 22,096 patients, 369 (1.67%) developed LSCB, most commonly severe gastrointestinal bleeding (74.3%), with a mean onset of 5.68 days. A total of 1,089 patients with non-LSCB were matched as controls. Existing scales performed limited predictive value (AUC 0.52-0.68). Logistic regression identified 12 independent predictors: hypoproteinemia (albumin < 30 g/L), anemia (Hb < 90 g/L), active gastrointestinal ulcer, thrombocytopenia (platelets < 75 × 10⁹/L), coagulation abnormalities (PT or aPTT > 1.2 × ULN), cefoperazone/latamoxef exposure > 7 days, hypocalcemia ([Ca²⁺] < 2.10 mmol/L), aspirin therapy, dual antiplatelet therapy, renal dysfunction (GFR < 60 mL/min), hepatic impairment (AST or ALT ≥ 3 or TBIL ≥ 2 × ULN), and age > 65 years. Odds ratios ranged from 6.16 (hypoproteinemia) to 1.47 (age > 65 years). A nomogram, named LSCB-Score, incorporating these factors achieved AUC 0.890 in the derivation cohort. Calibration was good (Hosmer-Lemeshow p = 0.312), and predictions closely matched the observations. External validation yielded an AUC of 0.876, confirming robustness.

Conclusion: The existing scales for predicting LSCB lack accuracy in hospitalized patients. This newly developed nomogram (LSCB-Score) provides a practical framework for individualized bleeding risk assessment and facilitates safe management of LMWH in hospitals.

Introduction: Pharmacist roles in primary care are evolving, with increasing involvement in long-term condition management. An example is their crucial role in the management of atrial fibrillation (AF), particularly in prescribing and monitoring oral anticoagulation therapy. However, their experiences and challenges in this area remain underexplored, particularly within the context of general practice.

Aim: This study aimed to explore the experiences, perceptions, and challenges of independent prescribing pharmacists when managing and prescribing for AF within general practice, using the Theoretical Domains Framework (TDF) to guide enquiry and analysis.

Method: We conducted a qualitative study underpinned by the Theoretical Domains Framework (TDF), which informed both the interview guide and the analytic coding framework. Independent prescribing pharmacists working in general practice in England were purposively recruited via professional networks; eligible participants were patient-facing and had experience prescribing for atrial fibrillation. One-to-one, semi-structured interviews were conducted via Microsoft Teams® in August 2024, audio-recorded, transcribed verbatim, and returned to participants for checking. Recruitment proceeded until thematic saturation. Two researchers independently applied the framework method, resolved discrepancies by consensus, and mapped final themes to relevant TDF domains.

Results: Twenty pharmacists took part in the study (9 men, 11 women; age 25-52 years), providing perspectives from a range of experience levels. Four overarching themes emerged: (1) confidence and experience in prescribing, (2) perceived role and responsibilities, (3) barriers to effective prescribing, and (4) strategies for effective prescribing. Pharmacists with extensive AF experience demonstrated higher confidence, whereas less experienced pharmacists relied on guidelines and colleagues. Perceived roles ranged from central to supportive within multidisciplinary teams, with some uncertainty about role boundaries. Key barriers included incomplete access to patient records, limited training, and workload pressures. Strategies to support prescribing included continuous professional development, decision support tools, and peer consultation.

Conclusion: The study emphasises the challenges pharmacists encounter in managing AF, highlighting the need for clearer role definitions, improved access to patient data and ongoing peer support. Addressing the identified barriers through targeted interventions could enhance the effectiveness of pharmacist-led AF management in general practice. Future research should evaluate interventions designed to support pharmacists in this evolving role.

Introduction: Transitions of care (ToC) services are essential for maintaining care continuity. The complex and fast-paced nature of care and high patient turnover in emergency departments (EDs) create unique challenges and opportunities for improving transitional care. Although the benefits of pharmacy-supported ToC interventions are established in non-ED settings, there is a lack of evidence exploring their characteristics and outcomes in EDs.

Aim: We aimed to identify and present the available evidence regarding the characteristics and outcomes of pharmacy-supported ToC interventions beyond medication reconciliation, as the sole intervention, in EDs.

Method: This review was conducted in accordance with the Joanna Briggs Institute methodology and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Extension for Scoping Reviews guidelines. A literature search was performed across PubMed, Embase, CINAHL, Web of Science, and grey literature from their inception until 22/12/24. The search included terms related to pharmacy, transitional care, and EDs. Data was extracted using a custom tool adapted from the Template for Intervention Description and Replication checklist, which was used to assess the articles' compliance with the items.

Results: A total of 64 publications were included. Most studies (n = 58) enrolled adult patients, with 13 focusing on older adults. Most interventions were delivered by pharmacists in collaboration with other healthcare providers in 64% of studies. Interventions were most implemented post-discharge (54.7%), followed by arrival to the ED (42.2%). Around 90.6% of interventions included two or more activities, combining medication reconciliation, discharge planning, and follow-up care. Most studies focused on health utilization metrics (e.g., readmission rates) as their outcomes (28.8%). Positive effects were observed on medication safety, antibiotic stewardship, patient satisfaction, and resource use. However, pediatric populations and intrahospital transitions were underrepresented.

Conclusion: This scoping review highlights the potential of pharmacist-supported transitional care interventions within EDs. The role of pharmacists in ToC interventions in emergency settings is evidently growing. Despite this, critical gaps persist in reporting and implementing these interventions. Future research is needed to systematically explore such initiatives and evaluate their implementation and long-term impact.

Introduction: Vancomycin is a widely used antibiotic for the treatment of serious Gram-positive bacterial infections. However, its clinical utility is often limited by the risk of nephrotoxicity, typically reflected by abnormalities in serum creatinine levels, which may indicate the occurrence of acute kidney injury (AKI). Timely identification of patients at increased risk is essential for early intervention and improved clinical outcomes.

Aim: This study aimed to identify clinical risk factors associated with vancomycin-induced abnormalities in serum creatinine levels and to develop predictive models capable of identifying high-risk hospitalized patients during vancomycin therapy.

Method: We conducted a retrospective cohort study including 1,008 hospitalized patients who received vancomycin treatment between January 2018 and June 2022 at the First Affiliated Hospital of Shandong First Medical University. Patients were grouped based on the presence or absence of serum creatinine abnormalities, defined as an increase of ≥ 26.5 μmol/L or ≥ 50% from baseline. Multivariate logistic regression was applied to identify independent risk factors. Five machine learning algorithms-logistic regression, random forest, support vector machine, extreme gradient boosting, and gradient boosting machine (GBM)-were trained and compared. Model performance was evaluated using the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, and specificity.

Results: The incidence of serum creatinine abnormalities was 9.22%. Chronic kidney disease, respiratory failure, pancreatitis, pneumonia, and mechanical ventilation were identified as significant risk factors (all p < 0.05). Among the models tested, the GBM algorithm showed the highest predictive performance with an AUC of 0.783, along with good balance between sensitivity and specificity. The final model was deployed as a freely accessible web-based prediction tool using the R Shiny framework.

Conclusion: Abnormalities in serum creatinine levels during vancomycin therapy remain a clinically significant concern, especially in patients with comorbidities or critical illness. The machine learning-based predictive model developed in this study offers a practical tool for individualized risk assessment, enabling early risk stratification and proactive management. Incorporating such tools into clinical workflows may enhance patient safety and optimize antibiotic use.

Introduction: Incorporating new medications into clinical practice can present potential risks to staff and patients. Risk assessment of new medicines procured into acute hospitals in the United Kingdom varies between organisations and national guidance is lacking. Existing processes required risk assessment of all new medicines, consuming considerable pharmacist resource.

Aim: To rationalise the risk assessment of new medicines at an acute hospital.

Setting: A 1300 bed, multi-site tertiary-referral teaching hospital, London, United Kingdom.

Development: A pharmacy working group, including formulary, governance, medication safety, and clinical leads, developed a rationalised risk assessment process. An initial triage was proposed to evaluate whether a risk assessment was required. Existing risk assessment tools were combined and adapted for use. A New Drug Panel (NDP) of pharmacy leaders was formed to review risk assessments.

Implementation: The process was piloted for 6 months; minor modifications were made and it was fully introduced in May 2022. Implementation included governance sign off and training of members of the NDP on utilisation of the tools.

Evaluation: Two years after introduction, 646 requests for new medicines were triaged and 196 (30%) required risk assessment. Fourteen requests were cancelled, so 182 risk assessments were reviewed by the NDP. The NDP recommended an additional 46 mitigations. Trends identified issues with unlicensed medicines, safe administration practices, communication and electronic prescribing.

Conclusion: A practical risk assessment process reduced risk assessments by 70%, releasing clinical pharmacist time. An expert NDP identified additional mitigations, reducing patient harm and ensuring safe incorporation of medicines into clinical practice.

Introduction: Hepatic impairment (HI) leads to pharmacokinetic and pharmacodynamic changes demanding adjustment of drug therapy. To increase medication safety, hospital pharmacists need to quickly identify patients at risk. Laboratory parameters and liver scores are often available only with timely delay. Alternatively, screening for typical drugs used in severe HI in electronic prescribing systems could be an option.

Aim: To test a new approach for the timely identification of patients with hepatic impairment. Drugs typically used in severe HI and its complications were evaluated as screening tools in patients with documented liver disease to identify patients who probably require drug adjustment to liver function.

Method: Patients ≥ 18 years and hospitalized in the year 2022 with an ICD-10-GM coding for liver disease were identified retrospectively. ICD-10-GM classes of special interest, reflecting severe HI, were defined (K70 (alcoholic liver disease), K72 (hepatic failure) and K74 (liver fibrosis/cirrhosis)). Drugs typically used in severe hepatic impairment and its complications (index drugs) were defined as carvedilol, propranolol, lactulose, L-ornithin-L-aspartate, rifaximin, spironolactone and ursodeoxycholic acid. For all patients, use of index drugs according to the electronic prescribing system, laboratory liver parameters, MELD (Model of Endstage Liver Disease) and MELD 3.0 were documented. We analysed, how many patients and how many cases of hepatic ICD-10-GM-codes were identified by screening for index drugs.

Result: Of 2319 patients with a hepatic ICD-10-GM-code in 2022, 2012 had electronic charts available. For these, 2916 main class ICD-10-GM codes were documented (4505 including main and sub-classes; median 1; IQR 1-3). Of 2012 patients, 1005 (50%) were treated with index drugs. Of the 2916 main ICD-10-GM classes, 1754 (60%) had index drugs, more often in codes of special interest (K74 82.5%, K70 79.7%, K72 68.9%). Patients in these main classes of special interest had higher MELD (median 14.8-18.2) and MELD 3.0 (18-22.9) compared to the overall patient cohort (MELD 12; MELD 3.0 15.9) and frequently laboratory liver parameters out of normal range.

Conclusion: Screening via index drugs typically used in hepatic impairment is a promising tool to identify patients at risk probably needing drug adjustment to hepatic function. Further studies need to determine the practical use of this tool to increase drug therapy safety.

Background: The combined use of antiplatelet medications with direct oral anticoagulants increases patients' risk of hemorrhage. In 2021, a multistate network of Veterans Affairs medical centers in the United States deployed a successful multicomponent stewardship initiative to reduce inappropriate anticoagulant-antiplatelet therapy.

Aim: Identify barriers, facilitators, and potential adaptations of the initiative to guide broader dissemination.

Methods: Clinical pharmacists and pharmacist managers were invited to participate in semi-structured interviews about their experiences with the initiative. Interviews were transcribed. Thematic analysis was informed by the Consolidated Framework for Implementation Research (CFIR).

Results: Fifteen interviews were completed (response rate 68%). The initiative was considered important and worth disseminating, and the addition of a visual alert to flag potential deprescribing candidates on an anticoagulation population management dashboard was considered especially beneficial. Three primary themes were identified using the CFIR. First, pharmacists often encountered barriers to coordination across specialties, with some clinicians unconvinced of the clinical evidence favoring antiplatelet deprescribing; breaking down these clinical silos, through targeted education and identifying meaningful clinician champions, is essential to increasing success of this initiative. Second, pharmacists sought clarification about how their deprescribing efforts, a relatively new activity, would be accounted for in performance evaluations, and how clinics would meet increased staffing needs. Third, adaptability of the initiative to local context was considered valuable.

Conclusion: As part of a multicomponent oral anticoagulant-antiplatelet stewardship initiative, preventing clinical silos, clarifying expectations around performance and staffing, and permitting adaptations to local context are important to maximizing impact.

Introduction: Initiation of direct oral anticoagulants (DOAC) for the management of venous thromboembolism (VTE) typically includes a lead-in dosing phase. However, some patients may receive a shortened course due to comorbid conditions and/or numerous days of parenteral therapy. Limited data exist on the outcomes of an abbreviated lead-in therapy regimen.

Aim: To investigate the clinical outcomes of patients receiving abbreviated versus standard/non-abbreviated DOAC lead-in regimens following parenteral anticoagulation therapy for VTE.

Method: We conducted a retrospective cohort study including adults (≥ 18 years of age) who were admitted for acute VTE between 04/01/2019 and 12/31/2023 and received ≥ 24 h of parenteral anticoagulation before being transitioned to a DOAC with abbreviated versus non-abbreviated DOAC lead-in dose. The primary outcome was death or readmission from a thrombotic event within 30 days of discharge. Data were presented using descriptive statistics, logistic regression, and time-to-event analysis.

Results: Across 590 patients, the median (IQR) age was 67 (58-76) years and 280 (47.5%) were female. Over half had a pulmonary embolism (54.9%; N = 324), 21.0% (N = 124) had a deep vein thrombosis, and the remainder experienced a combination. Most patients received the non-abbreviated lead-in dose (83.2%; N = 491). When compared to the non-abbreviated cohort, a higher proportion of those who received an abbreviated lead-in therapy had prior VTE and heart failure. There were no significant associations between an abbreviated lead-in dose and the primary outcome (aOR 0.44; 95% CI 0.13-1.52; P = 0.20). Bleeding events were also similar between the abbreviated and non-abbreviated dose cohorts at the longest follow-up (3.0%, N = 3 vs. 2.9%, N = 14; P = 0.92; aOR 0.82; 95% CI 0.22-3.1; P = 0.77) and within 30 days of DOAC initiation (HR 1.24; 95% CI 0.26-5.82; P = 0.79).

Conclusion: An abbreviated DOAC lead-in therapy was not associated with short-term mortality, readmission due to recurrent thrombosis, or bleeding. Further prospective studies are needed to confirm these findings and provide insights into more personalized regimens.

Background: Adverse drug events (ADEs) resulting from nonoptimized medication therapy significantly drive-up healthcare costs. Clinical pharmacists are pivotal in managing medication regimens, effectively reducing these associated expenses.

Aim: Given the scarcity of similar studies in the region, this study aimed to evaluate the overall economic impact of clinical pharmacists' interventions against ADEs at the Women's Wellness and Research Center (WWRC) in Qatar.

Method: Analysis of the total economic benefit of clinical pharmacists' interventions was performed through a retrospective chart review of patients' records admitted during the periods of March 2018, July-August 2018, and January 2019. The current analysis was based on WWRC's perspective, in which the cost savings and cost avoidance associated with the interventions were used to determine the total economic benefit. A sensitivity analysis was conducted to determine the robustness of the results. The study was approved at the main public healthcare provider.

Results: A total of 331 interventions for 162 patients were included in the analysis. The total economic benefit was estimated to be QAR169,320 (USD46,503), comprising cost avoidance of QAR170,995 (USD46,964) and negative resource-use cost savings of QAR-1675 (USD-460). The increase in resource use was primarily due to the addition of other medications to therapy. The sensitivity analysis confirmed that the outcomes are robust, demonstrating a 100% probability for positive economic benefits in all simulated cases.

Conclusion: Although there was an observed increase in resource utilization resulting from clinical pharmacists' interventions, this study highlights their crucial role in mitigating the costs associated with preventable adverse drug events.