International Journal of Clinical Pharmacy最新文献

Introduction: The clinical relevance of pharmacists' interventions (PIs) is complex to determine. The CLEO tool is a multidimensional scoring system to assess the relevance of PIs across three dimensions: clinical, economic, and organisational impact.

Aim: This study aimed to nationwide validate the CLEO tool by clinical pharmacists in German hospitals using structured and representative clinical cases.

Method: The German CLEO version was adapted to the German hospital setting and supplemented with practical examples. Fifty up-to-date cases from the inpatient setting were developed in a multistage process following the Identification, Situation, Background, Assessment, Recommendation structure. In the first round, each rater was randomly assigned 20 from the pool of 50 clinical cases, ensuring that all cases were evaluated by multiple raters. After a 14-day washout period, the same 20 cases were reassessed by the same raters. In the second round, all raters from the first round were invited again, and a subset who volunteered assessed another 20 cases after intensified training. Inter- and intra-rater reliability were calculated using Krippendorff's α and the intraclass correlation coefficient (ICC). User feedback was collected through a 16-item questionnaire.

Results: A total of 79 pharmacists from 56 hospitals participated in the first round; 27 completed the second round as well. Inter-rater reliability was poor across all three CLEO dimensions (Krippendorff's α < 0.67), both overall and among experienced clinical pharmacists. Intra-rater reliability was good for all dimensions (ICC 0.63-0.74), highest for the clinical dimension (0.74). Most raters (77%) needed less than one minute per case. Overall, the CLEO tool was perceived by users as appropriate, precise, acceptable and feasible (mean score 5.36; 7-point Likert scale; 1 = strongly disagree, 7 = strongly agree).

Conclusion: Since clinical pharmacy is still a developing discipline in German hospitals, differences in clinical practice and professional expertise complicate the evaluation of PIs. While intra-rater reliability was good, the validation of the CLEO tool in Germany did not achieve satisfactory inter-rater reliability. The CLEO tool may be useful within institutions with shared standards, but broader application across diverse settings in Germany requires additional training, further research and standardisation of clinical pharmacy services.

Introduction: Evidence shows that non-medical prescribing is as effective as medical prescribing in a range of acute and chronic conditions and is well accepted by a diverse range of key stakeholders. Pharmacists in the UK are set to acquire prescribing skills at an earlier stage in their training, with prescribing integrated into the first five years of training and the ability to prescribe from the point of registration from August 2026. Therefore, reliable and reproducible methods of assessing their ability to prescribe safely need to be in place. The UK Prescribing Safety Assessment (PSA) could be a standard method to assess prescribing skills across professions.

Aim: To examine the performance of post-registration Foundation pharmacists in the PSA and to explore their views on its suitability as a development tool before enrolling on an independent prescribing (IP) course.

Method: Pharmacists in Scotland 12 months into the post-registration Foundation programme were invited to sit a 30-question, blueprint-aligned online PSA in September 2024. Mean scores and facility scores were determined. (Facility is a measurement of how easy a question is: higher facility index = question is considered easier; lower facility index = question is considered more difficult). An online evaluation questionnaire gathered feedback on content and appropriateness, analysed using thematic analysis.

Results: Seventy-one of 128 (55.5%) eligible pharmacists sat the PSA; mean total score was 72.5% (SD 10.2). Domain-level mean scores (facility) were: Prescription Review 13.51/16 (0.84); Providing Information 4.96/6 (0.83); Dose Calculations 6.85/8 (0.86); Adverse Drug Reactions 6.51/8 (0.81); Drug Monitoring 5.61/8 (0.70); Planning Management 5.01/8 (0.63); Data Interpretation 3.41/6 (0.57); Prescription Writing 26.62/40 (0.67). The questionnaire was completed by 16/71 (22.5%) PSA sitters: most agreed the assessment was appropriate for their stage and helpful preparation for an IP course; some community pharmacists considered hospital-based content less relevant.

Conclusion: Formative participation in the UK PSA by post-registration Foundation pharmacists provided domain-level performance data and was regarded by respondents as useful preparation for an IP course. Findings suggest potential value in situating the PSA during the Foundation Training Year, with consideration of sector relevance and targeted support for domains such as prescription writing and data interpretation.

Introduction: Prescribing cascades occur when new medications are initiated to treat adverse drug reactions (ADRs) caused by an initial medication (index). Although using lower dose of the index medication is often recommended as a general strategy to address adverse drug reactions that may trigger potential prescribing cascades, evidence supporting a dose-dependent relationship for many prescribing cascades is limited.

Aim: The aim was to examine the dose-dependent relationship across a range of index medications related to various potential prescribing cascades, for which the dose-dependent relationship between the index medication and the ADR was not yet known.

Method: A cohort study was conducted using prescription sequence symmetry analysis with data from over 600 Dutch community pharmacies (2015-2020). We assessed 18 potential prescribing cascades involving ACE inhibitors (ACEIs), statins, antidepressants, dihydropyridine calcium channel blockers (DCCBs), and other drug classes. Index medication doses were categorized based on the World Health Organization (WHO) Defined Daily Dose (DDD) into low (< 0.50 DDD), medium (0.50-1.50 DDD), and high (> 1.50 DDD). The adjusted sequence ratio (aSR) quantified the likelihood of marker drug initiation after vs. before the index drug, corrected for prescribing trends; aSR > 1 indicated a potential prescribing cascade.

Results: Twelve of the 18 potential prescribing cascades showed a dose-dependent relationship. All angiotensin converting enzyme inhibitor (ACEI) related cascades demonstrated increasing aSRs with higher doses. ACEIs associated with cough showed increasing aSRs, from 0.86 to 2.09 at low dose to 1.29 to 2.78 at high dose across four cascades. Dose-dependent relationships were also found for statins, antidepressants, and DCCBs. No such relationship was observed for cascades involving proton pump inhibitors, diuretics, and non-steroidal anti-inflammatory drugs.

Conclusion: Medication dose can play a significant role in potential prescribing cascades. Healthcare professionals should be aware of the potential contribution of dose to prescribing cascade development. The study design precludes causal inference, and confirmation is needed to support further clinical recommendations.

Introduction: Hypertension, a leading global cause of death with high prevalence and poor control, faces a critical issue of poor medication adherence. Existing predictive models for medication adherence suffer from limitations such as small sample sizes, insufficient inclusion of multiple factors, and a lack of nationally representative longitudinal data on the Chinese population.

Aim: This study aimed to develop an interpretable machine learning model for predicting medication adherence among Chinese hypertensive patients.

Method: Using data from the China Health and Retirement Longitudinal Study, we categorized medication adherence as "high" or "low" based on consistency across two survey waves. Predictors included demographics, physical/psychological capability, motivation, and social-environmental factors. After missing data imputation via random forest, feature selection was performed using least absolute shrinkage and selection operator regression. Seven machine learning algorithms were trained and evaluated, with interpretability provided by Shapley additive explanations (SHAP) analysis. A Shiny-based web application was developed for model visualization and functions.

Results: Among 2773 hypertensive patients aged ≥ 45 years, 53.2% had low medication adherence. XGBoost performed best (area under the receiver operating characteristic curve = 0.828, accuracy = 0.726, F1-score = 0.713) in the test set. SHAP analysis indicated that better adherence was associated with the presence of multiple chronic conditions, overweight or obesity, cardiometabolic multimorbidity, older age, depression, residence in an urban area, sleep duration exceeding 8 h, a lack of bidirectional financial support, and disability in instrumental activities of daily living. In contrast, residence in the western region, smoking, and being employed were associated with non-adherence. The developed online tool provided real-time, personalized risk assessments, with predictions made interpretable via the SHAP framework to quantify key factors' contributions and offer transparent decision support.

Conclusion: This study developed an XGBoost machine learning model and online tool to predict medication adherence in Chinese hypertensive patients. The tool provided immediately actionable and transparent risk stratification, enabling targeted intervention. Future research should perform external validation of the model using electronic medical records or objective adherence data, thereby enhancing its generalizability and practical utility.

Introduction: Medication-related harm (is a challenge globally and contributes to emergency department (ED) presentations. Accurate medication histories are essential to identify whether medication-related harm contributed to an ED presentation.

Aim: The aim of this study was to explore the perspectives of ED clinicians on prioritising ED patients admitted due to potential medication-related harm.

Method: We conducted semi-structured qualitative interviews with purposively selected ED doctors, pharmacists, and nurses from a hospital and health service in Southeast Queensland, which includes both a tertiary and secondary ED. Participants were interviewed face-to-face May-July 2023. Interviews were guided by a piloted interview guide with seven open-ended questions focusing on clinicians' views of medication management and prioritisation in suspected medication-related harm cases.

Results: Fifteen clinicians with varying ED experience levels were interviewed: five doctors, five pharmacists, five nurses. Average interview time was 19 min (9-44 min). Thematic analysis of the interview data identified two key themes and six subthemes related to the prioritisation of patients with suspected medication-related harm and the role of ED clinicians in medication management. ED clinicians used varied and inconsistent processes to identify and flag patients who were either admitted with or suffered potential medication-related harm during admission and identified a need for a strategic structured process. The value of ED pharmacists was highlighted by all non-pharmacist participants.

Conclusion: Findings indicate that, in the absence of standardised prioritisation processes, ED clinicians rely heavily on individual clinical judgement. This underscores the need for the development of a tool specifically designed for the ED context to guide patient prioritisation.

Introduction: The standard treatment for Hormone Receptor-Positive breast cancer (BC) is Oral Endocrine Therapy (OET). OET reduces BC recurrence rates by ~ 50%, and non-adherence to OET leads to worse outcomes. However, OET adherence remains suboptimal, particularly among low socioeconomic status populations.

Aim: This study assessed 12-month OET adherence and identified factors associated with non-adherence among BC patients at a multispecialty hospital in Edinburg, Texas in the Rio Grande Valley region.

Method: A 12-month single-center retrospective study of BC patients taking OET was conducted. Information on patient demographics, tumor characteristics, and prescription details was gathered from electronic medical records. Inclusion criteria included patients 18 years or older who filled at least one OET prescription. OET adherence was assessed using the proportion of Days Covered. Differences between the adherent and non-adherent groups were analyzed using chi-square and Student's t-tests, while multivariable logistic regression was employed to identify factors associated with non-adherence.

Results: Of the total 346 adult female patients, 322 (93%) were Hispanic/Latino. The mean age was 60.8 years, and the mean body mass index was 30.7. Only 122 (35.3%) patients were adherent at 12 months. Patients with diabetes were less likely to be adherent (odds ratio, 0.44; 95% confidence interval: 0.25-0.80). Longer duration of therapy was associated with higher OET adherence, which was estimated to increase 1.84-fold with each additional year of therapy.

Conclusion: Approximately two-thirds of BC patients were non-adherent to OET. Diabetes and shorter time on therapy predicted poorer adherence. These results present the urgent need to address barriers to OET adherence among BC patients in the underserved area of South Texas.

Background: People who inject drugs (PWID) are at high risk of acquiring hepatitis C virus (HCV) infection, yet many remain undiagnosed due to testing barriers. Pharmacy-based point-of-care testing could improve access; however, little is known about its acceptability among PWID.

Aim: To explore the experiences of PWID with HCV testing and their perceptions of a pharmacy-based HCV testing option.

Method: A qualitative study involving interviews with eleven PWID between June and August 2022. Participants were asked about their perceptions and experiences about HCV testing as well as their views on a proposed pharmacy-based HCV testing model which was being proposed for a separate research study. Data were analyzed using reflexive thematic analysis.

Results: Regarding their experiences with HCV testing, participants recognized the importance of testing to know their status both for their health and that of others. Several challenges to testing were described, and participants described the impact of the primary care provider on testing. It was suggested that opioid agonist therapy programs were a missed opportunity for testing, and many potential advantages to pharmacy testing were described. Privacy and confidentiality within the pharmacy, as well as the impact of the relationship with pharmacists and staff were key factors influencing uptake.

Conclusion: Pharmacy-based HCV testing is viewed by participants as a convenient and acceptable testing option. Addressing stigma, ensuring privacy, and building trust with pharmacy staff appear to be critical for uptake. This approach may help to engage PWID in HCV testing as part of HCV elimination efforts.

Introduction: The development of anti-drug antibodies against tumor necrosis factor inhibitors, such as infliximab and adalimumab, is a major cause of therapeutic failure in patients with immune-mediated inflammatory diseases (IMIDs). However, immunogenicity responses are heterogeneous, and drug exposure can be restored in selected cases through individualized management.

Aim: To evaluate the clinical management and pharmacokinetic (PK) outcomes of immunogenicity in IMIDs treated with infliximab or adalimumab, by assessing its prevalence and phenotypes, associated factors, and the effectiveness of therapeutic interventions in reversing its PK impact.

Method: This retrospective cohort study included 997 patients treated with infliximab (n = 278) or adalimumab (n = 719). Immunogenicity was defined by detectable anti-drug antibodies and/or undetectable serum drug levels. Patients were stratified into three phenotypes based on anti-drug antibody titers and serum concentrations. Therapeutic drug monitoring guided clinical decision-making in cases of suspected treatment failure, immunogenicity, or subtherapeutic exposure, in accordance with institutional protocols. PK reversal was defined as the reappearance of detectable drug levels after intervention without switching therapy.

Results: Immunogenicity was identified in 240 patients (24.1%), more frequently among those treated with infliximab (28.4%) than with adalimumab (22.4%; p = 0.064). Multivariable analysis confirmed treatment with infliximab (OR: 1.43; 95% CI: 1.04-1.97) and prior immunogenicity (OR: 3.69; 95% CI: 1.50-9.11) as risk factors, while concomitant immunosuppressants were protective (OR: 0.62; 95% CI: 0.45-0.84). Among 77 patients managed actively, PK reversal was achieved in 76.7%. The rate of reversal was higher with adalimumab (80.0%) than with infliximab (62.5%; p = 0.039), and in patients with undetectable antibodies and low drug concentrations (Group 3) than in those with low-level antibodies (77.5% vs 50.0%; p = 0.024). Dose intensification and supervised administration were effective in achieving PK reversal (79.2% and 70.8%, respectively). Median serum drug concentrations increased significantly after intervention in both groups (p < 0.001).

Conclusion: Therapeutic drug monitoring-guided interventions tailored to immunogenicity phenotype can restore drug exposure in a substantial proportion of patients treated with tumor necrosis factor inhibitors. Recognition of reversible immunogenicity is essential for optimizing long-term therapeutic success and avoiding premature drug discontinuation.