International Journal of Clinical Pharmacy最新文献

Background: Diabetes prevalence among individuals of Chinese background in Australia is about three times higher than the general population.

Aim: The aim of this study was to identify specific barriers and enablers of medication-taking among adults of Chinese background living with type-2 diabetes mellitus (T2DM) in Australia.

Method: Qualitative semi-structured interviews were conducted with: (1) adults (18 + years) with T2DM of Chinese heritage currently prescribed diabetes medications; (2) health professionals involved in the care of people with T2DM of Chinese heritage. Participants were recruited from a national registry and single specialist clinic. Interviews were audio-recorded, transcribed verbatim, and analyzed using deductive content analysis based on the 14 domains of the Theoretical Domains Framework (TDF). The most relevant TDF domains were identified based on frequency counts across cohorts.

Results: A total of 25 people living with T2DM (60% male; age range: 31-72), and 11 healthcare professionals (5 endocrinologists; 5 pharmacists; 1 credentialled diabetes educator; 10 of Chinese background) participated. Barriers and enablers influencing medication-taking behaviors were identified across 13/14 TDF domains (except for 'Reinforcement'). Relevant domains most frequently identified were: Social Influences; Environmental Context and Resources; Beliefs About Consequences, and Behavioral Regulation.

Conclusion: Drawing on the TDF, potential targets for future interventions aimed at improving the uptake and maintenance of medication-taking behavior among adults with T2DM of Chinese heritage were identified. These data may support the development of culturally relevant and theoretically informed healthcare professional strategies and diabetes education programs, and ultimately, improve health outcomes for individuals with T2DM.

Introduction: In 2011 clinical pharmacy (CP) almost did not feature in the Czech Republic. As the complexity of pharmacotherapy increased, the need for comprehensive medication reviews (CMR) became increasingly important which led to extension of pharmacy practice beyond merely drug-oriented pharmacy-based services.

Aim: To outline the development, implementation and outcomes of the methodology that established standards for CP practice in the Czech Republic and which contributed to establishing CP as an independent postgraduate specialization with its own workplaces and full-time employment positions.

Setting: Inpatient and outpatient healthcare settings in the Czech Republic.

Development: Legislative changes in 2011 incorporated CP care into the healthcare system and the national CP methodology was published in 2014. Proactive screening of the medication lists and patient healthcare documentation was introduced. Results of CMRs are discussed with attending physicians and the plans for drug therapy adjustment are added to patient documentation. Clinical pharmacists have become standard partners for physicians on medical wards and outpatient facilities. A comprehensive clinical postgraduate training program (fully interlinked with accredited CP wards) has been established to maintain high standards of CP care.

Implementation: Based on the CP care methodology approved by professional medical and pharmaceutical societies and accepted by the Ministry of Health and health insurance companies, three inpatient procedures and one outpatient procedure became eligible for reimbursement thus facilitating the further development of CP practice and independent CP departments. Currently, the Czech Republic has 58 CP facilities and nearly 200 specialized clinical pharmacists.

Evaluation: The provision of CP care according to current national guidelines was shown to provide an effective and cost-effective approach by the results of two extensive studies; the calculated economic cost-benefit ratio was determined at 1:3-4.2. The number of clinical pharmacy specialists and facilities is steadily increasing.

Conclusion: The development of methodological approach accompanied by changes concerning reimbursement in the Czech Republic have led to the establishment of a stable and well-defined environment for clinical pharmacists to become full-time experts in both inpatient and outpatient settings. Clinical pharmacists are now recognized as skilled experts who are respected for their valuable contribution to inter-professional cooperation within medical teams.

Background: Over three million people annually experience myocardial infarction (MI). As MI survival rates increase, so does the importance of secondary prevention medications. International guidelines recommend using several medications to prevent further morbidity.

Aim: To synthesise the qualitative literature on the facilitators and barriers faced by MI survivors and their families/caregivers regarding medication management and, thus, medication adherence post-discharge.

Method: This systematic review was conducted and reported following the PRISMA-2020 guidelines. Five databases were searched from inception until the 13th of August 2024. The inclusion criteria were articles focused on people aged 18 years or older who experienced MI and were discharged from acute care settings to home settings, as well as caregivers of individuals who met the above-mentioned criteria. Qualitative and mixed-methods studies with qualitative elements were deemed eligible for inclusion. The theoretical domain framework was used to analyse the findings. The quality of the included studies was assessed using the JBI Critical Appraisal tool for qualitative research. The Confidence in the Evidence from the reviews of qualitative research approach was applied to assess confidence in qualitative evidence synthesis.

Results: Of the 14,002 titles, 11,354 remained after duplicates were removed. Of the 234 full-text screenings, fifteen were included. A total of 533 people who experienced MI and 25 spouses from eight different countries were included. The most prominent facilitator that emerged was "beliefs about consequences", whilst "lack of knowledge" and "environmental context and resources" were the most prominent barriers to medication management reported.

Conclusion: Patients face multiple challenges that affect their medication adherence post-MI. These findings highlight important considerations for creating an individualised, tailored approach to enhance medication adherence post-MI.

Systematic review registration: PROSPERO CRD42023424844.

Introduction: Polypharmacy, typically defined as the use of five or more medications, has become increasingly common among older adults due to the rising prevalence of multimorbidity. While polypharmacy can be clinically necessary, it poses substantial risks for adverse drug events, including acute kidney injury (AKI). Drug-induced AKI accounts for a significant proportion of hospital-acquired cases and can result in prolonged hospitalization, increased healthcare costs, and higher mortality. Despite growing concern over these risks, the incidence of AKI associated with polypharmacy and the specific clinical and pharmacological factors contributing to this risk remain poorly quantified across different populations and setting.

Aim: To estimate the incidence of AKI among adults exposed to polypharmacy and identify key drug-related and clinical risk factors.

Method: A systematic review and meta-analysis were conducted and reported following PRISMA guidelines. We searched eight international and Chinese databases from inception to April 2025 for observational studies involving adults (≥ 18 years) receiving polypharmacy that reported AKI incidence or related risk factors. Eligible studies were assessed using the Newcastle-Ottawa Scale. Random-effects meta-analysis was used to calculate pooled AKI incidence. A narrative synthesis summarized the definitions of polypharmacy and identified associated risk factors.

Results: Ten studies comprising over 302,000 participants were included; six studies provided data suitable for meta-analysis. The pooled incidence of AKI among patients exposed to polypharmacy was 18% (95% CI 2%, 45%). Key risk factors included high medication burden (≥ 5 or ≥ 10 medications), cardiovascular drug combinations, use of nephrotoxic agents, pre-existing renal impairment, frailty, and exposure to intensive care. Definitions of polypharmacy varied substantially across studies, including count-based thresholds, class-specific definitions, and risk-based exposure models.

Conclusion: Polypharmacy is significantly associated with an increased incidence of AKI, particularly among hospitalized and clinically vulnerable individuals. The lack of standardized definitions for polypharmacy complicates evidence synthesis and cross-study comparisons. Standardized terminology and risk-adjusted prescribing practices are essential to improve medication safety and renal outcomes in at-risk populations.

Introduction: Medication misadventure is associated with the use of polypharmacy and is highly prevalent in the older population living in the community, especially among women.

Aim: This study aimed to determine the impact of Home Medicines Reviews (HMRs) on continuous polypharmacy, the prevalence of continuous polypharmacy, and inflation-adjusted differences in costs among women who did and did not receive HMRs.

Method: The study included 9347 participants from the Australian Longitudinal Study on Women's Health who fulfilled the eligibility criteria from 77-82 years in 2003 to 91-96 years in 2017. Generalised estimating equations were used to estimate the association between HMRs and continuous polypharmacy. Out-of-pocket costs and benefits paid to government were presented as median costs for each participant from 2003 to 2017, alongside interquartile ranges.

Results: Only a small percentage of women received HMRs in 2003 (1.14%) but this percentage increased over time to 2017 (3.95%). The prevalence of continuous polypharmacy in 2017 was 39.06% amongst women who received an HMR and 28.05% amongst women who did not receive an HMR. There was evidence for an association between the use of HMRs and continuous polypharmacy in the following calendar year (OR 1.12; 95% CI 1.03, 1.21). There was an increase in out-of-pocket (OOP) medication costs in both women with and without HMRs, with the HMR group demonstrating higher OOP medication costs (AUD$26 to AUD$57) than the non-HMR group (AUD$22 to AUD$50).

Conclusion: HMRs were associated with a modest increase in the odds of continuous polypharmacy in the subsequent year. Increase in OOP medication costs over time highlights the need to further optimise cost-effective medications for individuals.

Introduction: Potentially inappropriate prescribing (PIP) increases the risk for medication-related harm amongst older adults, with those in long-term care at particular risk.

Aim: This study sought to evaluate a medicines optimisation pharmacist case management model for older adults in care homes in Northern Ireland (NI).

Method: Secondary analysis of prospective data collected during the case management model delivered to older adults (≥ 65 years) across 32 care homes in NI (N = 1,095). Medication Appropriateness Index (MAI) scores were compared at baseline and post-intervention. Variability in MAI per medication score change (ΔMAI) was examined using multiple linear regression. Multiple logistic and Poisson regressions examined potential associations between ΔMAI and secondary outcomes, including unplanned hospital admissions (all-cause); general practitioner (GP) call-outs; out-of-hours (OOH) GP call-outs; and emergency department (ED) visits.

Results: PIP was highly prevalent at baseline (83.5%; n = 914). A significant reduction in MAI (per medication) score was observed from pre to post-intervention; 82% (n = 898) of participants experienced some MAI score improvement. Overall, 3,044 clinical interventions were delivered; 2,062 medications were stopped, 141 medications were started, and 438 dosages were changed. Several unexpected significant associations were observed between ΔMAI and GP call-outs during follow-up; sensitivity analyses suggested these findings were likely due to confounding. No association was observed between ΔMAI (per medication) and likelihood for unplanned hospital admission.

Conclusion: PIP is highly prevalent in NI care homes and was significantly reduced by a medicine optimisation pharmacist case management model. Clinical pharmacist input in long-term care is warranted to lessen medication-related harm for older adults.

Introduction: Deucravacitinib is a novel, highly selective tyrosine kinase 2 allosteric inhibitor recently approved for the treatment of moderate-to-severe psoriasis in adults, though post-marketing safety data remain limited.

Aim: The purpose of this study was to perform a post-marketing safety evaluation of deucravacitinib based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Method: This study collected adverse event (AE) reports of deucravacitinib as primary suspected drug in the FAERS database from the third quarter of 2022 to the fourth quarter of 2024. Four main methods of the disproportionality analysis, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for signal detection. Potential risk signals were deemed significant only when all four algorithms simultaneously met their thresholds. The important medical event (IME) terms list was used to identify IMEs of deucravacitinib. Additionally, the Weibull distribution was used to evaluate the time-to-onset (TTO) characteristics.

Results: Thirty-nine preferred terms were identified as potential risk signals. The most commonly reported AE were acne, mouth ulceration and folliculitis. Sixteen AEs with potential risk signals not mentioned on the label were also identified, including urticaria, oral pain, oropharyngeal pain, swelling face, lip swelling, eye swelling, cellulitis, ear pain, pharyngeal swelling, Bell's palsy, mouth swelling, cheilitis, mycobacterium tuberculosis complex test positive, facial paralysis, hepatitis A, and central nervous system (CNS) infection. Rhabdomyolysis, Bell's palsy, facial paralysis, and CNS infection were identified as the IMEs associated with deucravacitinib in this study. The Weibull distribution indicated that the TTO characteristics of deucravacitinib-associated AEs followed an early failure type.

Conclusion: This study provides new safety data for deucravacitinib in real-world settings, uncovering previously unrecognized risks and identifying several IMEs. These findings have somewhat supplemented the safety data for deucravacitinib. Given the limitations of the FAERS database, further post-marketing safety surveillance studies on deucravacitinib remain necessary in the future.

Background: Effective management of rheumatoid arthritis (RA) often requires the use of biological disease-modifying antirheumatic drugs (bDMARDs). Biosimilar drugs (biosimilars), licensed pharmaceutical products that exhibit high similarity to their reference biological products (originators), have emerged as more affordable alternatives.

Aim: To compare the real-world effectiveness and safety of biosimilars and originators of bDMARDs in the management of RA at treatment initiation.

Method: A systematic literature search was conducted using PubMed, MEDLINE, Embase, Scopus, International Pharmaceutical Abstract and CINAHL from database inception to 18th April 2025. Observational studies utilising real-world data (e.g., electronic health records, biologics registries) that compared clinical outcomes between patients initiating treatment with either a biosimilar or an originator for RA were included. Quality assessment was conducted using the Newcastle-Ottawa Scale (NOS) and a narrative synthesis was conducted to summarise key findings.

Results: A total of 13 retrospective cohort studies were included, providing data on 34,280 patients initiating treatment with bDMARDs for RA. Treatment retention was the most investigated effectiveness outcome (n = 11), and all studies found that biosimilars were associated with comparable retention profiles compared to originators. No significant differences were identified for other effectiveness outcomes (e.g., disease activity indices). For safety outcomes, adverse events (AEs) were documented in eight studies. However, seven of these studies were of poor quality in assessing safety outcomes due to inadequate control for confounding factors.

Conclusion: In real-world settings, biosimilars generally demonstrate comparable effectiveness to originators. Future investigations are warranted to examine the comparative safety profiles of biosimilars and originators.

Background: Compared with alteplase, recombinant human prourokinase (rhPro-UK)-a next-generation specific plasminogen activator-offers advantages such as weight-independent dosing and cost effectiveness. While a 35-mg dose of rhPro-UK has been recommended in previous randomized controlled trials (RCTs), its efficacy and safety profile have yet to be fully elucidated, as no relevant systematic reviews or meta-analyses have been conducted to date.

Aim: This meta-analysis aimed to evaluate the safety and efficacy of 35 mg of rhPro-UK compared with those of control treatments, including 50 mg of rhPro-UK and alteplase monotherapy, in patients with acute ischemic stroke (AIS).

Method: Two independent reviewers systematically searched the PubMed, Embase, Cochrane Library, Scopus, and ClinicalTrials.gov electronic databases up to May 24, 2025, to identify RCTs assessing the effects of 35 mg rhPro-UK versus control therapies in AIS patients. Study quality was assessed using the Cochrane RoB 2 tool. A random effects model was employed for the meta-analysis using Stata 18.0.

Results: Four RCTs involving 2412 patients were included. The 35-mg dose of rhPro-UK demonstrated comparable safety and efficacy to those of the other treatments. Notably, this dose was associated with the potential advantages of increasing early neurological recovery at 24 h (SMD = - 0.29, 95% CI - 0.55 to - 0.03, P = 0.03) and reducing systemic bleeding risk at 90 days (RR = 0.59, 95% CI 0.48-0.73, P < 0.001). Subgroup analysis suggested that 35 mg of rhPro-UK might be associated with lower odds of SAEs than 50 mg of rhPro-UK (I² = 0%, P = 0.039); however, there was no significant difference in rt-PA (I² = 0%, P = 0.413) at 90 days.

Conclusion: This meta-analysis suggested that 35 mg of rhPro-UK does not significantly differ from 50 mg of rhPro-UK or alteplase in terms of clinical outcomes among AIS patients. However, the 35-mg dose of rhPro-UK has the potential advantages of enhancing early neurological recovery and reducing the risk of systemic bleeding. Subgroup analysis revealed that 35 mg of rhPro-UK might be associated with a lower risk of SAEs than 50 mg of rhPro-UK.

Introduction: IL-23p19 antagonists, selectively blocking IL-23 signaling via p19 targeting without affecting IL-12, represent a novel therapeutic class for inflammatory bowel disease (IBD). While multiple randomized controlled trials (RCTs) have evaluated their efficacy and safety in IBD, findings remain fragmented and exhibit significant heterogeneity.

Aim: This updated meta-analysis was designed to evaluate the efficacy and safety of IL-23p19 antagonists compared with placebo for induction and maintenance therapy in patients with IBD.

Method: Systematic searches of PubMed, Embase, Web of Science, Scopus, and OVID were conducted until May 13, 2025 for IBD RCTs evaluating IL-23p19 antagonists. Methodological quality was assessed using the Cochrane RoB tool. The data collected included details on study design, participant characteristics, and study outcomes. The risk ratio (RR) and corresponding 95% confidence intervals (95%CI) were calculated using the random-effects model.

Results: The review includes 14 publications involving 8,463 IBD patients. Significantly higher rates of clinical remission (RR 2.18, 95% CI 1.87-2.54), clinical response (RR 1.74, 95% CI 1.54-1.96), endoscopic remission (RR 2.94, 95% CI 2.33-3.70), and endoscopic response (RR 2.71, 95% CI 2.28-3.23) were observed in IBD patients receiving IL-23p19 inhibitors compared to placebo. Safety analyses revealed comparable overall adverse events with active therapy (RR 0.96, 95% CI 0.92-1.01); however, significant reductions occurred in serious adverse events (RR 0.51, 95% CI 0.41-0.64), treatment discontinuations due to adverse events (RR 0.36, 95% CI 0.28-0.47), and serious infections (RR 0.62, 95% CI 0.41-0.96) versus placebo.

Conclusion: This meta-analysis confirms robust therapeutic benefits and acceptable safety of IL-23p19 inhibitors in IBD patients. Subgroup analyses showed IL-23p19 inhibitors maintained comparable efficacy regardless of prior biologic use, disease duration, or baseline C-reactive protein levels, indicating consistent efficacy across these clinical subgroups. Future longitudinal investigations should evaluate durability of treatment response and extended safety outcomes.