International Journal of Clinical Pharmacy最新文献

Introduction: The PIDO-P (Pharmacist Intervention and Dose Optimization of Phosphate-binding medication) was designed to improve high serum phosphate concentration (SPC) in haemodialysis patients with a high pill burden of phosphate-binding medication (PBM). This intervention consisted of three pharmacist-patient consultations, in which barriers to adherence to PBM were addressed and PBM dose was reduced. Although this intervention improved PBM adherence, SPC remained high.

Aim: To determine the implementation fidelity (IF) of the PIDO-P intervention.

Method: This mixed-methods implementation study had a convergent design using the intervention mixed-methods framework. Data from all patients included in the PIDO-P study (n = 75) were used to assess IF using Carroll's Framework for IF. Six key components were identified [A: identifying barriers, B: assessing medication-related health literacy; C: providing information and advice, D: discussing patient preferences, E: providing a summary/dose reduction advice, F: performing a follow-up consultation]. Two researchers independently rated the extent to which the different aspects of the key intervention components were carried out as planned. Data sources were research administration (quantitative and qualitative), oral surveys from patients (quantitative and qualitative) and pharmacists (quantitative), semi-structured interviews with six patients, two pharmacists, and three prescribers (qualitative), and electronic medical records (quantitative). Data from semi-structured interviews were thematically analysed according to Braun and Clarke with Atlas.ti, quantitative data were analysed using descriptive statistics in SPSS. Where possible, data integration was performed.

Results: The adherence to the intervention was moderate to high, except for the screening process. The written summary was delivered to a moderate degree (65.3%). Facilitation strategies were helpful, and pharmacists considered the intervention not too complex. The quality of delivery and participant responsiveness were good. Four IF themes could be identified: (1) patient knowledge and understanding, (2) correct use of PBM, (3) PBM treatment individualisation, (4) relationship between pharmacist and patient. To increase its feasibility, the intervention should be targeted at patients with SPC > 2.0 mmol/L, and patient selection should be improved.

Conclusion: The lack of effect of the PIDO-P intervention on SPC cannot be explained by low IF. Targeting patients with higher SPC and improving patient selection may increase its effectiveness.

Introduction: Medication history taking at hospital admission is still prone to errors. Despite numerous quality improvement initiatives, new strategies to improve medication history taking are still sought and evaluated. Unfortunately, the gold standard research methodology for evaluation is resource-intensive, as it requires each patient to complete two medication history interviews. Therefore, a new study design and quality parameter were developed.

Aim: We aimed to pilot our newly developed study design and quality parameter in a study on medication history taking by telephone.

Method: In this prospective interventional study, patients with scheduled admissions had their medication histories taken either by telephone before admission (intervention) by a pharmacist or in-person by physicians or medical interns upon admission (control). Following the newly developed design, we compared a patients' new medication histories to the respective pre-visit medication lists available in the medical records to calculate the new endpoint: the difference in the number of updates per patient. Further, we surveyed patients and staff on their satisfaction.

Results: We enrolled 76 intervention and 75 control patients. In the intervention group, a mean of 4.93 (± 4.45, 0-18) updates were found vs. 3.40 (± 3.75, 0-21) in the control group. Accordingly, the incident rate of number of updates per patient was 1.34 times higher in the intervention group (p = 0.044). The distribution of the types of updates was similar with the most common type of update being newly initiated medicines in both groups. Medication history taking by telephone took 15.7 ± 9.8 min (mean ± SD), including preparation, interview, and documentation. Survey results showed that intervention patients felt positive about the telephone interviews. Both groups were open to other digital approaches, e.g., online platforms.

Conclusion: The new study design proved feasible to evaluate medication history taking by telephone with comprehensible results. The telephone approach delivered more updates compared to standard care, however, the proposed endpoint needs to be validated against the gold standard before widespread application Patient acceptance for this and other digital approaches was high in both groups.

Introduction: Monitoring patient-reported symptoms over time may support early detection of medicine-related harms. The Pharmacotherapeutic Symptom Evaluation-20-Australian version (PHASE-20-Australian version) is an 11-point rating scale designed for longitudinal monitoring of medicine-related symptoms; however, its responsiveness and minimum important change (MIC) have not been established.

Aim: To evaluate the responsiveness and MIC of the PHASE-20-Australian version for monitoring changes in medicine-related symptoms over time.

Method: A prospective cohort study was conducted among Australian adults (≥ 18 years) taking medications. Participants completed the PHASE-20-Australian version at baseline and follow-up and reported perceived symptom changes using the Global Rating Scale (GRS) at follow-up. Responsiveness was assessed by correlating score changes with the GRS and calculating the area under the receiver operating characteristic (ROC) curve (AUC). MIC was estimated using ROC anchor-based and 0.5 standard deviation (SD) distribution-based methods and then compared with the Smallest Detectable Change (SDC).

Results: Among 102 participants, 52% were aged ≥ 60 years and 65.7% were female. Strong correlations were observed for overall score changes (rho = 0.815) with the GRS as well as for 84.2% of individual symptoms (rho = 0.701-0.897). The tool demonstrated good to strong discriminative ability (AUC = 0.739-0.975 for improvement; 0.764-0.977 for deterioration), with sensitivity and specificity ≥ 0.75 for 16 symptoms. The MIC values ranged from 0.5 to 1.5 using the ROC method and 0.9-1.8 using the 0.5 SD approach. The estimated MIC values exceeded the SDC for 84.2% of symptoms. Limited responsiveness (rho < 0.7, AUC < 0.7) and MIC values below the SDC were noted for forgetful, swollen legs/ankles and frequent urination/incontinent of urine.

Conclusion: The PHASE-20-Australian version is responsive for most symptoms, with a clinically meaningful change of approximately 2.0 points on a 0-10 scale. The estimated MIC is applicable at the individual level, although caution is needed for symptoms with an MIC below the SDC.

Introduction: Postoperative fatigue (POF) is a clinically significant complication. Numerous studies have found that ketamine and esketamine show potential in alleviating POF. However, there is currently no systematic evidence to assess its exact effectiveness.

Aim: This study aimed to evaluate the effectiveness of perioperative ketamine/esketamine in alleviating POF in surgical patients.

Method: A systematic review was reported following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement. The study protocol was prospectively registered in the PROSPERO Registry (CRD420251060988). We searched PubMed, Embase, Cochrane Library, and Web of Science from inception to May 31, 2025, using a combination of MeSH terms and free-text keywords related to "ketamine", "esketamine", "surgery", "anaesthesia" and "fatigue". Eligible studies were prospective or retrospective clinical studies comparing ketamine/esketamine with control in surgical patients, reporting fatigue-related outcomes. Two reviewers independently screened studies, another two reviewers independently extracted data and assessed risk of bias. A narrative synthesis was performed due to clinical and methodological heterogeneity.

Results: In total, 556 studies were identified. Nine studies (n = 1606) were included in this review, among which seven were randomized controlled trials (RCTs) and two were observational studies. Four RCTs had low risk of bias, while the remaining three had some concerns. The two cohort studies were of moderate quality. The included studies encompassed various surgical procedures: colorectal cancer resection (n = 2), gastric surgery (n = 1), hysterectomy (n = 1), breast surgery (n = 2), orthopedic surgery (n = 1), and gastrointestinal endoscopy (n = 2). The outcomes varied according to the type of surgery. In studies of major abdominal surgeries, ketamine/esketamine has demonstrated certain potential in improving POF, but the certainty of evidence was graded as low. In contrast, no significant benefits were observed in breast or orthopedic surgeries. In the two studies on gastrointestinal endoscopy, the results were inconsistent.

Conclusion: Current evidence suggests that ketamine/esketamine may be effective in alleviating POF, particularly in major abdominal surgeries. These findings should be interpreted cautiously due to the heterogeneity in study designs, variations in fatigue assessment tools and time, and the limited sample sizes of the included studies. Future high-quality RCTs are needed to confirm these observations and establish the optimal dosing regimens.

Introduction: Pharmacogenomics (PGx) tailors drug treatments to an individual's genetic profile and contributes to improved efficacy and reduced adverse drug reactions. Community pharmacists have shown interest in PGx, and Dutch pharmacists have been early adopters in applying PGx guidelines, particularly through integration of the Dutch Pharmacogenetics Working Group recommendations. Despite growing evidence of its benefits, large-scale implementation in community pharmacies remains limited. This raises an important question for global stakeholders: if PGx adoption is constrained even in a system with robust infrastructure and guidelines, what lessons can be drawn for broader implementation?

Aim: To examine current PGx practices in leading Dutch community pharmacies and to identify key barriers, facilitators, and implementation strategies for integrating PGx into routine pharmacy care.

Method: A cross-sectional survey was conducted among Dutch pharmacy professionals with experience in PGx implementation. Participants were categorized as key opinion leaders (KOLs), involved in national PGx policymaking, research, or representing academia or professional organizations, or local champions (LCs), defined as practicing pharmacists directly involved in local PGx implementation in hospital or community pharmacies. The questionnaire was retrospectively mapped to Consolidated Framework for Implementation Research domains. Quantitative data were analyzed descriptively and qualitative responses were inductively thematically grouped to contextualize findings.

Results: Of the 67 invited professionals, 46 completed the questionnaire (response rate: 69%). Among respondents, 70% were LCs and 30% KOLs. Among KOLs (n = 14), the most frequently cited barriers included costs (79%, n = 11/14), inadequate Information and Communication Technology (ICT) support (29%, n = 4/14), and legal or regulatory uncertainty (29%, n = 4/14). A positive view on the clinical value of PGx was reported by 81% of LCs (n = 26/32) and 93% of KOLs (n = 13/14). Suggested facilitators by LCs included improved ICT infrastructure (56%, n = 18/32), enhanced education and training (44%, n = 14/32), and stronger interdisciplinary collaboration (25%, n = 8/32).

Conclusion: PGx implementation in Dutch pharmacies is hindered by structural barriers such as fragmented ICT and lack of reimbursement, despite strong professional support. Embedding PGx into pharmacy workflows and aligning policy, infrastructure, and education are essential. These findings may inform broader efforts to integrate PGx into pharmacies across diverse systems.

Introduction: Daily intravenous dosing of cefepime, meropenem and ceftazidime/avibactam is recommended in patients receiving intermittent hemodialysis (IHD), but requires hospitalization or frequent clinic visits. High dose post-HD administration may offer a more convenient outpatient alternative, but supporting data is limited.

Aim: To evaluate the feasibility by assessing predicted pharmacokinetic/pharmacodynamic (PK/PD) target attainment and neurotoxicity risk of high-dose post-HD versus daily dosing strategies for cefepime, meropenem, and ceftazidime/avibactam in patients receiving thrice-weekly IHD, using the Monte Carlo simulation (MCS) techniques.

Method: One-compartment pharmacokinetic models were developed using published data to simulate drug exposure in anuric patients receiving 4-h IHD thrice-weekly. MCS (Crystal Ball, Oracle) assessed the probability of target attainment (PTA) and neurotoxicity risk of various post-HD and daily dosing regimens in 5,000 virtual cohorts for one week. The PK/PD targets were ≥ 60% fT > MIC for cefepime, ≥ 40% fT > MIC for meropenem and ≥ 50% fT > MIC for ceftazidime with ≥ 50% fT > 1 g/mL for avibactam, assuming Pseudomonas aeruginosa or Enterobactarales infections. A PTA ≥ 90% was considered optimal for PK/PD target attainment. Safety was also assessed using the neurotoxicity thresholds.

Results: All daily regimens achieved PTA ≥ 90% on all simulated days. High-dose post-HD cefepime (1-2 g) and meropenem (2 g) maintained acceptable PTA over 2-day interdialytic periods, but failed to sustain targets through the 3-day period. Ceftazidime/avibactam post-HD dosing (0.94 g-0.94 g-2.5 g) maintained ≥ 90% PTA for ceftazidime throughout the week, though avibactam fell slightly below target on the final day. Predicted neurotoxicity risk was negligible for meropenem and ceftazidime/avibactam, but elevated with higher cefepime doses (1-2 g post-HD and 1 g daily). Cefepime 0.5 g daily, meropenem 0.25-1 g daily, and ceftazidime/avibactam 0.94 g daily or 0.94 g-0.94 g-2.5 g post-HD attained both PK/PD targets and safety targets.

Conclusion: High-dose post-HD dosing appears feasible for ceftazidime/avibactam but may be inadequate for cefepime and meropenem over a 3-day interdialytic period. Elevated neurotoxicity risk predicted with higher cefepime doses highlights the importance of cautious dosing and consideration of therapeutic drug monitoring.

Introduction: To prevent acute kidney injury, guidelines recommend temporary adjustment of high-risk medications in patients with impaired renal function during so-called 'sick days'. Sick days are periods with increased risk of dehydration, such as diarrhoea, fever or vomiting. Currently, awareness of sick day guidance among patients and healthcare professionals is low, which hampers implementation in daily practice.

Aim: To develop, implement and evaluate sick day guidance for patients with pre-existing impaired renal function on maintenance treatment with high-risk medication.

Setting: Over a 12 month study period, community pharmacies collaborated with at least one affiliated general practitioner (GP) to implement sick day guidance in primary care.

Development: Training materials, including an E-learning module for healthcare professionals and patient information materials were developed.

Implementation: In total, 21 community pharmacies completed the 12 month study period, in which 373 patients received oral and written instructions to report sick days to the GP or pharmacist. The median age of included patients was 78 years (IQR 73-83), 42% were male, and 68% used ≥ 2 high-risk medications. The implementation process of sick day guidance was evaluated with the Consolidated Framework for Implementation Research (CFIR), including a start interview in every pharmacy, registration of agreements, monthly telephone evaluations and an end-evaluation interview.

Evaluation: Successful implementation was facilitated by adequate training, strong team engagement and support, and making pharmacy technicians responsible for information provision as well as providing in-person counselling to patients. Implementation barriers related to a lack of support from the information system, a lack of reimbursement and a low number of reported sick days. Patients reported 8 sick days, although a telephone survey amongst 188 patients showed that 12 more sick days had occurred.

Conclusion: While training healthcare professionals supports appropriate medication adjustments when sick days are reported, patient education alone does not consistently lead to reporting. Additional implementation efforts, such as involving informal caregivers, may be needed to support patients in signalling and managing sick days.

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: Neurological disorders are a leading cause of disability and death worldwide; however, their age- and sex-specific patterns among adolescents and young adults remain poorly characterized. Understanding these trends is essential for developing targeted health strategies and optimizing pharmacotherapy in this population.

Aim: This study aimed to assess global trends and sex-specific patterns in the burden of neurological and neurodevelopmental disorders among individuals aged 10-24 years from 1990 to 2021, providing evidence to inform clinical pharmacy practice and global health policies.

Method: Data for 34 neurological conditions among individuals aged 10-24 years were extracted from the 2021 Global Burden of Disease database. Age-standardized prevalence and disability-adjusted life-year (DALY) rates were analyzed according to sex and disorders. Estimated annual percentage changes were derived using log-linear regression models. Joinpoint regression identified significant shifts in the temporal trends. Heatmaps were generated to rank disorders by prevalence and DALYs across global and specific regions. Analyses were conducted using R, version 4.4.3.

Results: Between 1990 and 2021, infectious neurological diseases, including malaria, cysticercosis, rabies, meningitis, encephalitis, and tetanus, have declined substantially in both prevalence and DALYs. Conversely, perinatal and developmental disorders showed marked increases, particularly neonatal encephalopathy, preterm birth complications, and neonatal sepsis in both measures. Migraine and tension-type headaches remain the most prevalent conditions in 2021 with minimal temporal changes. Pronounced sex disparities emerged: multiple sclerosis increased more rapidly in females, while alcohol use disorders declined faster in males. Regional inequalities persisted, with infectious burdens concentrated in low- SDI areas, and chronic disorders predominant in high-SDI regions.

Conclusion: Neurological disease burden among adolescents and young adults has transitioned from infectious to chronic, neonatal, and behavioral conditions, accompanied by significant sex-specific and regional differences. These results highlight the importance for youth-centered prevention, early diagnosis, and equitable access to care. Integrating pharmacists into multidisciplinary neurological care teams can enhance medication optimization, adherence support, and the long-term management of chronic neurological conditions, ultimately improving health outcomes in this vulnerable population.

Introduction: Model-Informed Precision Dosing (MIPD) is increasingly used to optimize vancomycin therapy in critically ill patients. However, process evaluations randomized controlled trials (RCTs) of MIPD remain rare, particularly in neonatal and pediatric intensive care. They provide however valuable insights about how and why interventions work.

Aim: This study explored healthcare professionals' (HCPs) experiences with using the MIPD software for vancomycin during the BENEFICIAL-RCT in critically ill children and examined contextual factors influencing its use.

Method: A qualitative descriptive exploratory study was conducted after the BENEFICIAL-RCT in 8 Belgian hospitals. Semi-structured interviews and focus groups were held between January and May 2025 with physicians, clinical pharmacists, clinical biologists, and trial nurses. Data were analyzed thematically.

Results: Twenty-one HCPs participated. Four overarching themes emerged: enhanced clinical confidence and professional empowerment, experienced workflow barriers, clinical and healthcare-system implications and conditions for sustained MIPD-adoption. Participants described that beyond faster attainment of target AUC, the software fostered professional empowerment through its visualizations and the ability to retain final decision authority. Experiences also underscored how infrequent clinical exposure to adopting MIPD hindered continuity of MIPD expertise. This was pertinent in settings with low vancomycin case volumes or frequent rotating medical staff. As experienced workflow barriers especially the pivotal role of nurses in ensuring accurate documentation of sampling and infusion times was mentioned. These documentation uncertainties were perceived as affecting trust in the dosing workflow. Participants also highlighted night-time operational challenges for which workarounds set up during the RCT would not be feasible for routine practice. Concerning conditions for sustained MIPD-implementation, HCPs emphasized the importance of MIPD integration in electronic health records and automated dose calculation. The need for local MIPD champions was recurrently emphasized, particularly to support onboarding of new HCPs in MIPD.

Conclusion: The results highlight that to support broader implementation of MIPD in pediatric critical care, hospitals should prioritize electronic record integration, streamline workflows, and appoint internal MIPD champions. These measures may reduce workload and errors, and support sustainable use in daily practice.