International Journal of Clinical Pharmacy最新文献

Background

Medicine shortages are a challenge in upper, lower and middle-income countries, including South Africa. In recent years, community pharmacists, in Durban, South Africa, have experienced the COVID-19 pandemic, flooding, civil unrest and electricity disruptions. Little is known about the impact of these disruptions on medicine shortages in community pharmacies.

Aim

To explore community pharmacists' perceptions and their experiences with medicine shortages during the COVID-19 pandemic and other disruptive situations.

Method

Convenience and snowball sampling were used to recruit participants. Semi-structured interviews were conducted in person or via an online video conferencing platform, which were audio-recorded and transcribed verbatim. Using the Framework Method, the transcripts were analysed thematically on NVivo 14 software.

Results

Fifteen community pharmacists were interviewed. Five major themes emerged from thematic analysis: general perceptions of medicine shortages, the impact of disruptive situations, the consequences of medicine shortages, mitigation strategies; and further suggestions and resources. Disruptive situations were perceived to exacerbate shortages. Participants perceived a negative financial impact on patients and pharmacies, with out-of-pocket costs affecting the former and loss of income affecting the latter. The mitigation strategies used were contacting stakeholders, medicine substitution and stock management.

Conclusion

Community pharmacists felt that improved communication, collaboration, policies, notification systems and guidelines would mitigate shortages.

Background

While the effects of anticholinergic drug use have been increasingly highlighted, trends in anticholinergic use remain poorly understood.

Aim

To determine the changes in frequency and pattern of anticholinergic drug use within a low- and middle-income country.

Method

Comparisons were made between population-based datasets collected from Malaysian residents aged 55 years and older in 2013–15 and 2020–22. Anticholinergic exposure was determined using the anticholinergic cognitive burden (ACB) tool. Drugs with ACB were categorised according to the Anatomical Therapeutic Chemical (ATC) classification.

Results

A total number of 5707 medications were recorded from the 1616 participants included in the 2013–15 dataset. A total number of 6175 medications were recorded from 2733 participants in 2020–22. Two hundred and ninety-three (18.1%) and 280 (10.2%) participants consumed (ge 1) medication with ACB (ge 1) in 2013–15 and 2020–22 respectively. The use of nervous system drugs with ACB had increased (27 (0.47%) versus 39 (0.63%). The use of ACB drugs in the cardiovascular (224 (3.9%) versus 215 (3.4%)) and alimentary tract and metabolism (30 (0.52%) versus 4 (0.06%)) classes had reduced over time. Participants in 2020–22 were significantly less likely than those in 2013–15 to have total ACB = 1 − 2 (odds ratio [95% confidence interval] = 0.473[0.385–0.581]) and ACB (ge) 3 (0.251[0.137 − 0.460]) compared to ACB = 0 after adjustment for potential confounders (p < 0.001).

Conclusion

Although anticholinergic exposure has decreased over time, the use of medications with anticholinergic effects in the nervous system class has risen. This increase is attributable to antipsychotic use, which is of concern due to potential cardiovascular complications, and deserves further evaluation.

Background

Immunotherapy provides new hope to individuals with small cell lung cancer (SCLC). Predicting biomarkers for clinical effects is crucial for SCLC patients receiving programed death-ligand 1 (PD-L1) inhibitor treatment.

Aim

The aim of this study was to clarify the value of serum lipids as predictors of immune related adverse events (irAEs) and the anti-tumour effects in SCLC patients who received PD-L1 inhibitors as first-line treatment.

Method

This study included patients with SCLC who received at least one cycle of PD-L1inhibitors at Shanghai Pulmonary Hospital from August 2020 to December 2023. We collected the clinical data of the SCLC patients, including basic information and serum lipid levels, before immunotherapy.

Results

The irAEs rate was 16.1% of 124 enrolled patients. In multivariate analysis, the triglyceride (TG)/high-density lipoprotein cholesterol (HDL-C) ratio was an independent predictor of irAEs (p = 0.045). Tumour response analysis indicated that the objective response rate (ORR) was 43.4% and the disease control rate (DCR) was 79.5%. Seventy-seven patients experienced any progression-free survival (PFS) event. The median PFS was longer in the HDL-C-high group (10.03 months) than in the HDL-C-low group (6.67 months) (p = 0.043). In Cox regression analysis, the serum HDL-C level was an independent predictor of PFS (p = 0.002). For patients of the high TG/HDL-C ratio, the ORR significantly differed between patients who suffered from any irAEs and those who did not (p = 0.0139).

Conclusion

This study found that serum lipid levels might predict the responses to anti-PD-L1 as first-line treatment for SCLC.

Background: Community pharmacy practice is rarely considered in ethical research, although various ethical conflicts are known for this setting. Data on the actual frequency and perceived burden of ethical conflicts occurring in the community pharmacy setting are required.

Aim: The survey aimed at investigating the frequency and perceived burden of ethical conflicts, reasons for the perceived burden and influences on decision-making in ethical conflicts in German community pharmacists.

Method: An online survey was conducted among community pharmacists. It contained 15 ethical conflicts in which the ethically required action conflicts with another principle (e.g. law). Basing on these conflicting principles, 12 considerations relevant for decision-making were defined (e.g. solidarity principle). Participants were asked to rate the ethical conflicts in terms of frequency and perceived burden and to rate the influence on decision-making for the considerations. Results were analysed descriptively.

Results: Five hundred and thirty-five questionnaires were evaluated. The participant's median age was 39 (min-max: 20-78) years, 378 (71%) were female. Seven of the 15 predefined ethical conflicts were rated as occurring predominantly at least once a week. "Generic drug is not most suitable" was rated as the most frequent. Three ethical conflicts were rated mainly with a (very) strong burden. "Concerns for an unborn child" was rated as the most burdensome. Three of the 12 predefined decision-making considerations: pharmaceutical knowledge, legal requirements and personal values were rated primarily as having a very strong influence on decision-making.

Conclusion: Pharmacists in community pharmacies are frequently affected by burdensome ethical conflicts in patient care situations.

Background: While there is an accumulation of evidence that pharmacist prescribing is safe and effective, there is a lack of research on processes of implementation into practice, particularly for patients with complex clinical conditions such as chronic kidney disease (CKD).

Aim: The aim was to explore the facilitators and barriers to the implementation of pharmacist prescribing for patients with CKD in the United Kingdom (UK).

Method: Semi-structured interviews were conducted with UK Renal Pharmacy Group members who were independent prescribers. The Consolidated Framework for Implementation Research (CFIR) underpinned the interview schedule. Interviews were recorded, transcribed, and independently coded by two researchers. A thematic approach was used for analysis, with data generation continuing until saturation of themes. Ethical approval was granted.

Results: Data saturation was achieved following 14 interviews. Most interviewees were female (n = 11), all had secondary care as their main practice setting, and were highly experienced prescribers with 8 having 11 or more years of prescribing practice. Interviewees were positive regarding the development of their prescribing practice. Facilitators and barriers emerged across all 5 of the CFIR domains. Key facilitators were aspects of inner setting (e.g., organisational support and communication) while key barriers were also related to inner setting, specifically the need for adequate structural and financial resources.

Conclusion: This theory-based study has illuminated the facilitators and barriers for the implementation of pharmacist prescribing in CKD. There is a need to consider the resources required for implementation of prescribing practice at an early stage of planning and development.

Background: Inclisiran, the newest lipid-lowering drug, has not shown significant safety problems in major clinical studies. However, its recent market introduction and limited clinical use have produced few reports of adverse reactions, leaving a comprehensive understanding of its long-term safety yet to be established.

Aim: The aim of the study was to conduct a signal detection analysis of adverse events (AEs) associated with inclisiran using FDA Adverse Event Reporting System (FAERS) datasets.

Method: Data on AEs associated with inclisiran were collected from the FAERS database from 2021 to 2023. Signal detection was conducted using the reporting odds ratio (ROR) and the information component (IC). The analysis was standardized using the Medical Dictionary for Regulatory Activities (MedDRA) and focused on System Organ Classes (SOCs) and Preferred Terms.

Results: Of 17,307,196 AE reports, 2976 were relevant to inclisiran. The male-to-female ratio of these events was 0.74:1, predominantly in patients aged 45 to 74 years. A total of 102 AE signals associated with inclisiran were identified in 15 SOCs. Among these, 86 involved muscle injuries, liver injuries, diabetes, neurocognitive dysfunction, and other events not listed on the drug label.

Conclusion: The findings confirm all AEs documented on the drug label and in current clinical trials while also revealing new AEs such as muscle pain, elevated liver enzymes, increased blood glucose levels, and neurocognitive dysfunction. This study contributes to real-world research data, providing valuable references for rational drug use.

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: 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.

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: QTc interval prolongation can result in potentially lethal arrhythmias. One risk factor is QTc-prolonging drugs, including some antifungals often used in hemato-oncology patients. Screening tools for patients at risk have not yet been investigated in this patient population.

Aim: Our aim was to evaluate the sensitivity and specificity of five QTc risk scores in hemato-oncology patients receiving systemic antifungal therapy.

Method: Data were retrieved from an internal study database including adult hemato-oncology patients prescribed systemic antifungal therapy. Data on QTc-prolonging medication, risk factors for QTc prolongation, and electrocardiograms (ECG) were collected retrospectively for a period of 12 months. The QTc risk scores according to Tisdale, Vandael, Berger, Bindraban, and Aboujaoude as well as their sensitivity and specificity were calculated.

Results: During the evaluated period, 77 patients were prescribed systemic antifungals resulting in 187 therapy episodes. Regarding therapy episodes, median age was 56 years (IQR 44-68), 41% (77) were female, and a median of 3 QTc-prolonging drugs were prescribed (range 0-6). ECGs were available for 45 (24%) of the therapy episodes 3-11 days after initiation of the antifungal therapy, 22 of which showed QTc prolongation. Regarding these 45 therapy episodes, sensitivity and specificity of the risk scores were calculated as follows: Tisdale 86%/22%, Vandael 91%/35%, Berger 32%/83%, Bindraban 50%/78%, Aboujaoude 14%/87%.

Conclusion: The QTc risk scores according to Tisdale and Vandael showed sufficient sensitivity for risk stratification in the studied patient population. In contrast, risk scores according to Berger, Bindraban, and Aboujaoude cannot be considered suitable due to poor sensitivity.