International Journal of Clinical Pharmacy最新文献

Background: Clobazam (CLB) is an effective, safe and well-tolerated adjunctive treatment for refractory epilepsy. However, the cost-effectiveness of CLB in China remains unclear.

Aim: The aim of this study was to evaluate the cost-effectiveness of CLB as an adjunctive therapy for patients with refractory epilepsy in China.

Method: A Markov model was established to simulate the lifetime epilepsy process in patients. The epilepsy remission rate, health state utility and mortality data were derived from clinical trials and the literature. The costs were collected from the health care system in the hospital. The primary outcome was the incremental cost-effectiveness ratio (ICER), which was calculated by comparing CLB as an add-on therapy with conventional therapy and was assessed in the context of the Chinese health system. One-way and probabilistic sensitivity analyses were conducted to evaluate parameter uncertainty, and several scenario analyses were also conducted.

Results: Compared with maintaining conventional therapy, adding CLB as an adjuvant therapy increased the cost of Chinese Yuan (CNY) 1770.17 over a lifetime, with an incremental quality-adjusted life years (QALYs) value of 1.02, resulting in an ICER of CNY 1737.10 per QALY gained. The daily dose of CLB had the strongest effect on the ICER. The probabilistic sensitivity analyses revealed that the probability of CLB being cost-effective was 77.35% at a willingness to pay (WTP) of CNY 85698/QALY.

Conclusion: CLB is a cost-effective add-on therapy for refractory epilepsy in the Chinese population.

Background: Potentially inappropriate prescribing (PIP) is usually associated with a higher risk of adverse health outcomes. It is therefore important to identify PIP in older adults. However, there are no clear prioritisation strategies to select patients requiring prescription reviews.

Aim: The aim of this study was to assess the association between the identification of seniors at risk (ISAR) score and the number of PIPs.

Method: A 12-month retrospective hospital-based study was conducted. PIPs, including potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), were detected using the STOPP/START tool. Multivariate linear regressions were conducted to identify factors associated with the number of PIPs. Sensitivity, specificity, Youden index, and ROC curve were calculated to determine the predictive power of ISAR score.

Results: This study included 266 records. The analysis led to the detection of 420 PIMs and 210 PPOs, with a prevalence of 80.1% and 54.9%, respectively. Multivariate linear regression revealed that the ISAR score (p = 0.041), and the number of medications (p < 0.001) were determinants of PIP. The number of medications remained the sole determinant of the number of PIMs (p < 0.001), while living in a nursing home was the only determinant of the number of PPOs (p = 0.036).

Conclusion: The study showed that the ISAR score and the number of medications were independently associated with the number of PIPs. Considering the use of the ISAR score and the number of medications may be useful strategies to prioritise patients for whom prescribing appropriateness should be assessed using explicit criteria.

Background: Clozapine has shown great efficacy in treating treatment-resistant schizophrenia, but it is associated with a variety of medication- related safety problems. Despite this, there remains a lack of research on medication errors (MEs) associated with its use.

Aim: To characterize the nature and contributory factors of clozapine-related MEs reported from government hospitals and primary care centres in Saudi Arabia (SA).

Method: A cross-sectional analysis was carried out on MEs related to clozapine use reported to the General Administration of Pharmaceutical Care at the Ministry of Health (MOH) in Saudi Arabia between 2018 and 2022. The data were analysed descriptively to examine the nature and contributory factors of MEs.

Results: A total of 1,165 MEs were reported. The majority of reported errors involved patients aged > 18 years old, with 72.2% (n = 841) being male. The central region was found to report errors more frequently (32.3%, n = 376). Pharmacists were reported to detect errors most frequently (59.6%, n = 695). MEs most often occurred in the prescribing stage (77.8%, n = 906), with "missing prescription information" (30.1%, n = 351) being the most frequent finding. The most frequent contributing factor was the lack of policy (33.1%, n = 351). The majority of errors did not reach the patients (92.3%, n = 1,075), and those that did reach patients rarely resulted in harm (0.3%, n = 2).

Conclusion: This study identified areas for improvement which could expedite the development of remedial interventions to reduce the risk of errors.

Background: Tirzepatide was approved to treat type 2 diabetes and obesity, but its efficacy and safety in patients without diabetes has not been investigated.

Aim: This meta-analysis aimed to evaluate the efficacy and safety of tirzepatide compared to placebo in overweight or obese patients without diabetes.

Method: PubMed, Embase and Cochrane were searched on January 18, 2024. Randomized controlled trials (RCTs) that used tirzepatide in overweight or obese adults without diabetes were included. Efficacy outcomes included the proportion of participants achieving weight loss targets, changes in body weight (%), body mass index (BMI), waist circumference (WC), and blood pressure (BP). Safety outcomes were commonly reported adverse events. Standardized mean differences (SMD) or odds ratios (OR) with 95% confidence intervals (CIs) were used for continuous and dichotomous outcomes, respectively.

Results: Three RCTs with 3901 participants were included. Tirzepatide was associated with increased proportion of participants achieving weight loss targets, reduced body weight (SMD - 1.61, 95% CI - 2.20 to - 1.02), BMI (SMD - 2.13, 95% CI - 3.08 to - 1.18), WC (SMD - 0.91, 95% CI - 1.14 to - 0.69), and BP versus placebo. However, the risk of adverse events such as nausea (OR 4.26, 95% CI 2.60 to 3.81), vomiting (OR 8.35, 95% CI 5.19 to 13.45), and diarrhea (OR 3.57, 95% CI 2.80 to 4.57) was significantly higher for tirzepatide versus placebo.

Conclusion: Tirzepatide significantly reduced weight and improved metabolic markers among overweight or obese without diabetes. However, increased adverse events highlights the need for benefits versus risks assessment before initiation and continuous monitoring.

Background: Anticholinergic medications are now widely acknowledged for their unfavorable risk-to-benefit profile owing to their adverse effects. Health-related quality of life (HRQoL) is commonly regarded as a crucial person-centered outcome.

Aim: This study aimed to investigate the association between anticholinergic burden and HRQoL in hospitalized and ambulatory patients seen in Ethiopia.

Method: This cross-sectional study utilized a questionnaire and medical records to collect data from a convenience sample of adult patients attending both inpatient wards and ambulatory clinic of University of Gondar Comprehensive Specialized Hospital between April and September 2022. Anticholinergic burden was measured by anticholinergic cognitive burdens scale (ACBS), while HRQoL was measured using EQ5D-index (Euroqol-5 dimensions-5-Levels index) and EQ5D-VAS (visual analogue scale). Linear regression was used to assess the influence of high anticholinergic burden (ACBS score ≥ 3) on EQ5D-index and EQ5D-VAS, with adjustments made for sociodemographic and clinical confounders.

Results: A total of 828 patients participated in this study (median (IQR) age was 45.0 (30, 60) and 55.9% were female). On multiple linear regression analysis, high anticholinergic burden was associated with a statistically significant decline in HRQoL, as evidenced by reductions in both EQ5D index (- 0.174 (- 0.250, - 0.098)) and EQ5D-VAS scores (- 9.4 (- 13.3, - 5.2)).

Conclusion: A significant association between high anticholinergic burden and diminished HRQoL was found among a relatively younger cohort in a resource-limited setting, even after adjustment for important confounding variables. Clinicians should be cognizant of the cumulative impact of anticholinergic burden on HRQoL outcomes and strive to minimize anticholinergic burden.

Background: Timely diagnosis of heart failure (HF) and rapid optimisation of guideline-directed medication therapy (GDMT) improves patients qualities of life, reducing mortality and morbidity. Previous papers describe the role of pharmacists in medication optimisation, but not in the diagnosis of HF.

Aim: To describe the development, implementation, and evaluation of pharmacist-led heart failure clinics with respect to time from referral to diagnosis, time from diagnosis to first review with a specialist, and the proportion receiving optimal GDMT 180 days after diagnosis.

Setting: Community outpatient clinics in rural west Wales, United Kingdom.

Development: Two experienced non-medical prescribing pharmacists, one of whom had additional diagnostic qualifications in cardiology, delivered the clinic.

Implementation: Patients referred with suspected HF were risk-stratified to urgent (within 14 days of referral) or routine (within 42 days) review, based on natriuretic peptide levels. Patients attended the clinic for assessment, including physical examination, electrocardiogram, and echocardiogram. Those with HF with reduced ejection fraction were initiated on drug treatment and referred to the follow-up pharmacist-led GDMT clinic.

Evaluation: A sample of 100 patients was evaluated (50 from pre-existing and 50 from new service). Median time from referral to diagnosis reduced from 61 days (IQR 47-115) to 16 days (IQR 10.5-27.5) for urgent and 19 days (IQR 11.5-33) for routine. Median time to first appointment following diagnosis reduced from 54 days (IQR 36-60.5) to 14 days (IQR 9.75-28.75) (p value < 0.0001), and proportion of patients achieving GDMT at 180 days following diagnosis improved from 24 to 86% (p value < 0.0001).

Conclusion: This pharmacist HF diagnostic clinic and medication optimisation clinic improved time to diagnosis, time to first specialist review, and proportion of patients' achieving GDMT optimisation in a rural healthcare setting.

Background: Although several pharmacoeconomic studies have assessed the cost-effectiveness of maintenance immunosuppressive regimens for heart transplant recipients, economic comparisons between various combination drug therapies remain sparse.

Aim: This study used an economic evaluation based on network meta-analysis to assess the cost-effectiveness of four immunosuppressive regimens for adult heart transplant recipients in China.

Method: We conducted a systematic search for clinical trials in PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP database. A validated Markov model was adapted to reflect the Chinese medical landscape. Four maintenance immunosuppression regimens were considered: tacrolimus/mycophenolate mofetil (TAC/MMF), cyclosporine/mycophenolate mofetil (CSA/MMF), everolimus/cyclosporine (EVL/CSA), and sirolimus/tacrolimus (SRL/TAC). The probabilities of health events were derived from a comprehensive literature review. Direct medical costs, adjusted for 2022 values, were from public documents and websites, while utilities for quality-adjusted life-years (QALYs) were taken from previous studies. Primary outcomes were mean lifetime cost, QALYs, and cost-effectiveness, with a willingness-to-pay (WTP) threshold set at three times China's GDP per capita in 2022. Sensitivity analyses were conducted to test the robustness of the results.

Results: The base case analysis identified TAC/MMF as the most cost-effective regimen, producing a mean of 6.31 QALYs per patient at a cost of Chinese Yuan (CNY) 534,182.89. Sensitivity analyses consistently reinforced TAC/MMF as the most cost-effective and robust choice.

Conclusion: TAC/MMF is the most cost-effective maintenance immunosuppressive regimen for heart transplant recipients within the Chinese health system. The study findings are reinforced by sensitivity analyses, affirming their robustness amid various uncertainties.

Background: Treating multiple myeloma is complex, and providing supportive care through an interdisciplinary approach is essential.

Aim: To report and synthesize pharmacists' clinical activities and impact on the care of patients with multiple myeloma.

Method: This was a scoping review that followed the PRISMA-ScR reporting recommendations. A search was conducted in PubMed, Embase, Web of Science, Scopus, and LILACS from the inception of the database until January 10th, 2024. Papers that reported pharmacists' clinical activities in the care of patients with multiple myeloma were included. Descriptive Elements of Pharmacist Intervention Characterization Tool (DEPICT) version 2 was used to characterize the pharmacists' clinical activities. The results are presented as a narrative and tabular synthesis.

Results: A total of 2885 records were identified, 10 of which met the inclusion criteria. Pharmacists' clinical activities related to 'direct patient care' (n = 8) and 'medication counseling, education, and training' (n = 7) were the most cited. Most were provided for patients (n = 8), by one-on-one contact (n = 9), and through face-to-face communication method (n = 8), with patient counseling being the main action taken by pharmacists (n = 7). Materials that supported pharmacists' actions were cited in five studies. Integrating pharmacists into interdisciplinary teams led to improved process, clinical, humanistic, and economic outcomes.

Conclusion: This scoping review emphasizes pharmacists' clinical activities in improving the care of patients with multiple myeloma. There is a need to develop studies with patient-reported outcomes and comprehensive reporting of pharmacists' clinical activities to ensure reproducibility and effective implementation in clinical practice.

Background: Although amivantamab has shown clinical benefits for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertions, its cost-effectiveness requires further investigation.

Aim: To evaluate the cost-effectiveness of amivantamab plus chemotherapy for the treatment of NSCLC patients with EGFR exon 20 insertions from the United States payer perspective.

Method: A partitioned survival model was developed based on the data from the PAPILLON trial. Costs were derived from the pricing files of Medicare and Medicaid Services and published literature, and utility values were derived from previous studies. A 3% annual discount rate was applied to both costs and outcomes. The primary outcome was the incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis, were conducted to test the model stability.

Results: Amivantamab plus chemotherapy yielded an additional 1.12 quality-adjusted life years (QALYs) while increasing costs by $483,769.50 relative to the chemotherapy regimen, leading to an ICER of $432,401.16/QALY. The combination of amivantamab with chemotherapy was not cost effective at a threshold of $150,000/QALY. In the scenario analysis, the results showed that the ICERs were $263,680.69/QALY and $418,416.35/QALY when different utility values and 10-year time horizons were adopted, respectively. For PSA, the probability that amivantamab plus chemotherapy would be cost-effective was 0% if the willingness-to-pay (WTP) threshold was $150,000/QALY.

Conclusion: Amivantamab plus chemotherapy is unlikely to be a cost-effective option for NSCLC patients with EGFR exon 20 insertions. Reducing the cost of amivantamab may produce favorable economic outcomes.

Background: Suboptimal adherence to direct oral anticoagulants (DOACs) among atrial fibrillation (AF) patients remains currently a major concern due to the increased risk of cardiac and thromboembolic events.

Aim: To identify longitudinal distinct trajectories of DOAC adherence and sociodemographic and clinical factors associated with each trajectory.

Method: Patients with AF who were prescribed with DOAC from July 2016-December 2017 were identified among patients enrolled in the Medicare Advantage Plan. Patients were followed up for a year after the index date to calculate the monthly proportion of days covered (PDC). The monthly PDC was incorporated into the logistic group-based trajectory model to evaluate distinct patterns of adherence. A multinomial regression model was carried out to assess various predictors associated with each trajectory. Sub-group analysis was conducted among incident DOAC users.

Results: Total of 1969 patients with AF, four distinct trajectories of adherence were selected: adherent 36.8%, gaps in adherence 9.3%, gradual decline in adherence 29.7%, and rapid decline in adherence 24.2%. Significant predictors associated with suboptimal adherence trajectories were age (75 years or older), gender (male vs female), low-income subsidy health plan, prevalent users, and presence of comorbidities. Among 933 incident users, three adherence trajectories were identified: adherent trajectory (31.8%), rapid decline in adherence (32.5%), and gradual decline in adherence (35.6%). The significant predictors among incident users were gender (male vs female), low-income subsidy health plan, HAS-BLED score ≥ 2, and presence of coronary artery disease.

Conclusion: Adherence to DOACs was suboptimal among the total population and incident users.