Therapeutic Advances in Drug Safety最新文献

Background: Self-treatment of dietary supplements may contribute to interactions and severe side effects. Limited studies have constructed a scale that can measure the disclosure practice of supplements to healthcare providers and the influencing factors.

Objective: The study aims to investigate the supplement disclosure practice among the public in the UAE using a developed and validated supplement disclosure assessment scale tool.

Design: A cross-sectional survey study that targeted those residing in the United Arab Emirates (UAE) aged 18 years and above from both genders through an online survey.

Methods: A novel scale tool was developed and examined for its validity and reliability through three pilot studies.

Results: The study included three validity and reliability pilot studies before the main study evaluation: pilot 1 (n = 104), pilot 2 (n = 101), pilot 3 (n = 37), and study data (n = 407). A total of 407 respondents provided feedback from which 137 stated that they consumed supplements. A significant indirect effect of healthcare provider initiation of enquiry (HPE) on patient-informing practice (PI) was observed through two mediating variables, patient's beliefs (PB) and pharmacist counseling regarding supplements interactions (PC) (B = 0.106, t = 2.120, p = 0.03 and B = 0.077, t = 2.011, p = 0.04, respectively). Most respondents were not asked about their supplement consumption by the hospital and community pharmacists (52.94 and 50.74, respectively). Most respondents (54.89%) stated that pharmacists did not counsel them about any possible interaction of supplements with laboratory tests. The mean construct scores were 1.096 for PI, 2.618 for PC, 1.552 for HPE, and 1.412 for PB.

Conclusion: The instrument demonstrates desirable validity and reliability. The study results revealed a direct effect of PB and PC on the supplement disclosure practice. HPE indirectly affected PI through two mediating variables: PB and PC. The results showed a moderate HPE and PC and an excellent PB and PI construct.

Background: Deprescription of medications for older people in long-term care settings is crucial to enhance medication safety by reducing polypharmacy and minimizing related adverse events. Nurses as the member of the multidisciplinary healthcare team can support deprescription initiatives, but there is a gap in comprehensive knowledge about their roles.

Objectives: To investigate the role and contribution of nurses in deprescribing medications within the multidisciplinary pharmaceutical care context of long-term healthcare for older people.

Design: A systematic review utilizing an integrative approach was performed.

Methods: Multiple databases were searched, including PubMed (covering MEDLINE), Scopus, CINAHL, ProQuest and Embase, focusing on studies published in English from 2014 to 2024. The preliminary search yielded 4872 studies, which were then refined to 32 qualitative and quantitative studies chosen for data analysis and narrative synthesis. Thematic comparisons and analysis led to the creation of meaningful categories integrating the studies' findings to meet the review's objective.

Results: The review findings were classified into categories: 'necessity and benefits of deprescribing', 'multidisciplinary collaboration for deprescribing', 'nurse role in deprescribing', 'identified challenges to deprescribing', 'involvement of older people and families in deprescribing'. They illustrated and exemplified various aspects of nurses' roles and contributions in deprescription initiatives within the multidisciplinary pharmaceutical care team, such as support for reducing doses, discontinuing medications or transitioning to safer alternatives, as well as factors influencing this process.

Conclusion: The main dimensions of nurses' roles and contributions in deprescription initiatives encompass monitoring, communicating and educating. Challenges to nurses' active participation in deprescribing, such as the need for increased knowledge, confidence and inclusion in team discussions, should be addressed through education, training and changing attitudes. These steps are essential for improving the safety of medication deprescribing in long-term care settings.

Trial registration: The review was registered under PROSPERO ID: CRD42023486484, and can be accessed at crd.york.ac.uk/PROSPERO/display_record.php?RecordID=486484.

Background: As prostaglandin medications, crucial in glaucoma treatment, become more widely used, their local adverse events are increasingly observed.

Objectives: To evaluate the common adverse events of four clinically commonly used prostaglandin F (FP) receptor agonists in the treatment of glaucoma in the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Design: We screened and analyzed the generic and brand names of latanoprost, bimatoprost, travoprost, and tafluprost in the FAERS database and summarized and cleaned the baseline information of subjects receiving the above-mentioned drugs.

Methods: Perform descriptive statistical analysis on the baseline information of subjects using the drugs. Conduct disproportionality analysis of drug-related adverse events. The criteria for positive signals of adverse events are established by simultaneously meeting the thresholds set by four methods: the ratio of reported odds, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Additionally, assess the cumulative risk curves for drug-induced time of the aforementioned drugs and use one-way ANOVA to compare differences in drug-induced time across different groups.

Results: The study included 1567 latanoprost, 1517 bimatoprost, 696 travoprost, and 82 tafluprost subjects. Adverse events mainly affected eye disorders, with significant issues in iris hyperpigmentation, ocular pemphigoid, corneal endothelial cell loss, periorbital fat atrophy, corneal irritation, eyelash growth, and ocular hyperemia. The time to onset varied among drugs, with latanoprost showing the longest (mean days = 344.37) and bimatoprost the shortest duration (mean days = 155.65; p < 0.001).

Conclusion: Although signal detection analysis based on the FAERS database cannot establish a definitive causal relationship, our study found that FP receptor agonists used in glaucoma can cause various adverse events. Assessing their clinical suitability and potential side effects is crucial for providing personalized treatment and ensuring medication safety.

Background: Closed-loop electronic medication management systems are effective measures for preventing medication errors (MEs). However, there is limited evidence supporting this, and few studies have evaluated the long-term effects of these systems on safe medication.

Objective: To evaluate the long-term effects of implementing a closed-loop medication order executive system on the safe clinical use of medications.

Design: A quasi-experimental design.

Method: Data from 2017 to 2023 were extracted and retrospectively analyzed. The primary outcome indicator was the ME rate. Secondary outcome indicators were the accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing. The autoregressive integrated moving average (ARIMA) model in time-series analysis was used to evaluate the level and trend changes in ME rates using SPSS 25.0 before and after system implementation. Root cause analysis and descriptive statistics were used to assess changes in types, stages, and causes of ME rates. The independent samples t-test was used to analyze secondary outcomes.

Results: Overall, 295 MEs were reported with a mean of 0.26 ± 0.26 ME rates per month during 2017-2023. The ARIMA model showed a decrease in the average level of ME rates after system implementation, with no statistically significant decrease in the long term, and a significant drop in the ME rate in the short and medium term (p < 0.01). Nurses' administration accounted for more than 60% of errors post-implementation, and lack of communication was a prominent factor. The accuracy of order verification and patient identification and the implementation rate of fresh medicine dispensing all increased after implementation.

Conclusion: Adopting a closed-loop executive system is beneficial for ensuring patient medication safety, but a single integrated system does not completely eliminate MEs. Optimizing system functionalities and applying structured handoff tools are recommended to meet clinical needs and enhance system usability.

Background: Adverse drug reactions (ADRs) contribute significant clinical and economic burden to the country's healthcare system globally. Prompt reporting of ADRs by the community pharmacist is essential to the active pharmacovigilance program.

Objectives: This study assesses private community pharmacists' knowledge, attitude, and practice (KAP) about ADRs and reporting.

Design: A cross-sectional, qualitative study was performed using a pre-validated self-administered questionnaire.

Methods: This self-administered questionnaire was conducted at community pharmacies between March and July 2022. The data collected were analyzed using the Mann-Whitney and Kruskal-Wallis tests to examine the differences in overall KAP scores with a subgroup of sociodemographic characteristics of the study participants. Logistic regression analysis was used to analyze the predictors of practice.

Results: In total, 156 fully completed questionnaires were collected by the community pharmacists. A positive association between the designation, qualification, and work experience with the total scores of the respondents was observed (p < 0.05). Among the predictors of ADR reporting practice, a significant association was observed with knowledge score (⩾6, p = 0.0219), designation (pharmacists, p = 0.0102), qualification (masters, p = 0.0002), and work experience (⩾11 years, p = 0.0184). Most community pharmacists had good knowledge and attitude but poor practice toward reporting ADRs. Uncertainty of how and where to report, lack of training, lack of reporting forms, and insufficient clinical knowledge were the practice-based barriers in the ADR reporting process.

Conclusion: Though the study found sufficient understanding and favorable views on ADR reporting, participants reported poor practices and barriers to reporting ADR. Therefore, structured continuing professional development programs for community pharmacists are needed to overcome the barriers and enhance the practice of ADR reporting.

Background: Polypharmacy and potentially inappropriate medications are significant challenges in older adults' medication management. The Consolidated Framework for Implementation Research (CFIR) is a comprehensive approach used to explore barriers and enablers to the healthcare system in guiding the effective implementation of evidence-based practices.

Objectives: This study examines the barriers and enablers to promote safe medication management among older adults in Qatar from healthcare professionals' perspectives. This includes identifying critical factors within the healthcare system influencing medication management and suggesting practical solutions to improve it.

Design: The study employs a qualitative design. Focus Groups (FGs) were conducted with healthcare professionals from the geriatric, mental health and medicine departments of Hamad Medical Corporation (HMC), the leading governmental sector in Qatar serving the older adult population.

Methods: Utilising the CFIR, this study analysed feedback from healthcare professionals through FGs at HMC. A combined inductive and deductive thematic analysis was applied to transcripts from five FGs, focusing on identifying barriers and enablers to safe medication management among older adults. Two researchers transcribed the audio-recorded FG discussions verbatim, and two researchers analysed the data using a mixed inductive and deductive thematic analysis approach utilising CFIR constructs.

Results: We engaged 53 healthcare professionals (31 physicians, 10 nurses and 12 clinical pharmacists) in FGs. The analysis identified current barriers and enabler themes under different CFIR constructs, including inner settings, outer settings, individual characteristics and intervention characteristics. We identified 44 themes, with 25 classifieds as barriers and 19 as enablers. The findings revealed that barriers and enablers within the inner settings were primarily related to structural characteristics, resources, policies, communication and culture. On the other hand, barriers and enablers from the outer settings included patients and caregivers, care coordination, policies and laws, and resources.

Conclusion: This study identified several barriers and enablers to promote medication management for older adults using the CFIR constructs from the perspective of healthcare professionals. The multifaceted findings emphasise involving stakeholders like clinical leaders, policymakers and decision-makers to address medication safety factors. A robust action plan, continuously monitored under Qatar's national strategy, is vital. Further research is needed to implement recommended interventions.

Background: With the increasing prescription of reslizumab for severe asthma with an eosinophilic phenotype, a real-world pharmacovigilance analysis of reslizumab is urgently required to detect potential unreported adverse events (AEs) in clinical practice.

Objectives: We aimed to provide a comprehensive evaluation of reslizumab-related AEs in the real world.

Design: Disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.

Methods: Reslizumab-related AEs between the second quarter of 2016 and the fourth quarter of 2022 from the FAERS database were obtained. A disproportionality analysis was performed to evaluate the safety profile of reslizumab using the reporting odds ratio.

Results: A total of 10,450,353 reports were collected from the FAERS database. Of the 403 reslizumab-related AEs, 42 distinct AEs were identified with positive signals. The most common AEs including dyspnea and oropharyngeal pain were identified, consistent with the instruction and clinical studies. Unexpected AEs of disproportionality such as bronchospasm and chest pain were also observed. Drug ineffective was identified as a noteworthy concern that accounted for 13.90% (56/403) of the overall reslizumab-related reports.

Conclusion: While reslizumab offered a promising treatment option for severe eosinophilic asthma, more attention should be paid to the common AEs and new unexpected AEs. Based on the current findings of signal detection, further prospective studies are needed for the next signal validation and confirmation.

Objectives: This pharmacovigilance analysis was conducted to assess the safety signals of FMS-related tyrosine kinase 3 (FLT3) inhibitors in a real-world setting using the United States Food and Drug Administration Adverse Event Reporting System (FAERS).

Design: We analyzed adverse event (AE) reports related to FLT3 inhibitors submitted to the FAERS database from the first quarter of 2015 to the fourth quarter of 2022. Disproportionality analysis was used to identify AEs of FLT3 inhibitors in the FAERS database.

Results: A total of 55,393 AE reports were identified, of which 5938, 44,013, and 5442 were attributed to midostaurin, sorafenib, and gilteritinib, respectively, as primary suspects. Compared to the full database, significant safety signals at the system organ class level were observed for midostaurin (blood and lymphatic system disorders and hepatobiliary disorders), sorafenib (skin and subcutaneous tissue disorders and hepatobiliary disorders), and gilteritinib (investigations, blood and lymphatic system disorders, infections and infestations, and hepatobiliary disorders). All the drugs studied were associated with hepatobiliary disorders. The most prominent AEs associated with midostaurin, sorafenib, and gilteritinib were cytopenia, palmar-plantar erythrodysesthesia syndrome, and increased blast cell count, respectively. Compared with chemotherapy, midostaurin and gilteritinib showed a higher risk of electrocardiogram QT prolongation, gastrointestinal hemorrhage, cerebral hemorrhage, and increased white blood cell count. Gilteritinib had the highest overall death percentage (30.28%), whereas sorafenib had the lowest (23.06%).

Conclusion: Mining AE signals using the FAERS database provides a method for analyzing the safety of FLT3 inhibitors in post-marketing. We found several significant AE signals that corresponded to previous studies; however, some AE signals were not mentioned in the drug instructions. Our study could provide a direction for follow-up real-world studies to verify the results further.

Non-cystic fibrosis bronchiectasis is a long-term lung disease characterised by abnormal dilatation of the bronchi, with patients experiencing chronic productive cough and recurrent exacerbations. Currently, there are no licensed drugs for use in bronchiectasis while clinical trials have been conducted to either test new drugs or repurpose existing ones. These drugs target the underlying pathophysiology of bronchiectasis which is known to include infection, inflammation, mucus hypersecretion and retention. Most of the drugs used in daily clinical practice for bronchiectasis are off-label with no randomised trials exploring their safety. This review aims at exploring the safety profile of drugs frequently used in clinical practice to manage bronchiectasis, including antibiotics (e.g. macrolides, aminoglycosides, polymyxins, fluoroquinolones, aztreonam), mucoactive therapy (e.g. hypertonic saline, mannitol, DNase and carbocisteine), anti-inflammatory therapy (inhaled corticosteroids) and drugs currently in development for use in bronchiectasis (e.g. brensocatib, benralizumab and itepekimab).