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Purpose@#Improving survival and health-related quality of life (HRQOL), along with symptom relief, is important for the treatment of metastatic breast cancer (MBC). This study measured HRQOL and analyzed its influence on sociodemographic and clinical factors in patients with MBC. @*Methods@#We interviewed 298 patients with MBC to investigate their sociodemographic characteristics and HRQOL by using EuroQol-5D-5L (EQ-5D) between September and October 2014. We also reviewed medical records to examine the clinical condition of the patients, including disease progression, adverse events, treatments, chronic disease, and metastatic areas. The distribution of the EQ-5D index was compared between different clinical conditions by using the Kruskal-Wallis test. We also conducted multiple regression analyses to identify the factors affecting HRQOL in patients with MBC. @*Results@#The mean EQ-5D index was 0.79 for all patients surveyed. The mean EQ-5D index score was significantly lower in patients in the progressed state than in those in the progression-free survival state (0.73 vs. 0.80, p = 0.0002). The HRQOL of patients treated with chemotherapy alone was significantly lower than that of patients treated with hormonal or targeted therapy (0.76 vs. 0.82 or 0.85; p = 0.0020). Regression analysis revealed that the clinical factors associated with lower HRQOL were progressed state, chemotherapy, and adverse events, such as hair loss or stomatitis. Finally, young age, high income, and employment were the sociodemographic factors that were positively associated with better HRQOL. @*Conclusion@#This study provides new information on the health utility of MBC patients on the basis of various patient characteristics and offers insights that can assist medical professionals in treating patients with MBC and help policymakers implement cancer strategies. Further research is needed to reflect the changing environment of cancer treatment and enrich available evidence.
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Background@#Although coronavirus disease 2019 (COVID-19) vaccines have been distributed worldwide under emergency use authorization, the real-world safety profiles of mRNA vaccines still need to be clearly defined. We aimed to identify the overall incidence and factors associated with adverse events (AEs) following mRNA COVID-19 vaccination. @*Methods@#We conducted web-based survey from December 2 to 10 in 2021 with a 2,849 nationwide sampled panel. Study participants were individuals who had elapsed at least twoweeks after completing two dosing schedules of COVID-19 vaccination aged between 18–49 years. We weighted the participants to represent the Korean population. The outcome was the overall incidence of AEs following mRNA COVID-19 vaccination and associated factors.We estimated the weighted odds ratios (ORs) using multivariable logistic regression models to identify the factors associated with AEs. @*Results@#Of the 2,849 participants (median [interquartile range] age, 35 [27–42] years; 51.6% male), 90.8% (n = 2,582) for the first dose and 88.7% (n = 2,849) for the second dose reported AEs, and 3.3% and 4.3% reported severe AEs, respectively. Occurrence of AEs was more prevalent in mRNA-1273 (OR, 2.06; 95% confidence interval [CI], 1.59–2.67 vs. BNT162b2), female sex (1.88; 1.52–2.32), and those with dermatologic diseases (2.51; 1.32–4.77). History of serious allergic reactions (1.96; 1.06–3.64) and anticoagulant medication use (4.72; 1.92–11.6) were associated with severe AEs. @*Conclusion@#Approximately 90% of participants reported AEs following mRNA COVID-19 vaccination. Substantial factors, including vaccine type (mRNA-1273), female sex, and dermatologic diseases were associated with AEs. Our findings could aid policymakers in establishing vaccination strategies tailored to those potentially susceptible to AEs.
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Objective@#To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. @*Methods@#We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. @*Results@#Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. @*Conclusion@#We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.
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Objective@#To explore the perception of drug utilization review (DUR) system and DUR modernization pilot project among healthcare professionals and patients. @*Methods@#We conducted 8 times of focus group interviews (FGI) between August 1, 2019 to December 31, 2019. The healthcare professionals and patients who participated in the DUR modernization pilot project were included in the present study. Based on the type of project participation or medical institution, the participants were divided into the following four groups: group 1, hospital; group 2, clinic; group 3, pharmacy; and group 4, patient. Within each group, interviews were conducted under a pre-defined agenda to identify the implicit perceptions of the participants; the contents of the interviews were, then, categorized. @*Results@#Healthcare professionals established a consensus on the positive aspects of the DUR system and DUR modernization pilot project. However, substantial concerns remain, such as additional workload associated with monitoring adverse events or acquiring consents from patients. Furthermore, a difference of opinion over the DUR convenience system was observed. Among 3 DUR convenience system, the personal medication history review service was highly utilized, but pop-up hold function and communication system was rarely used. @*Conclusion@#We observed that systematic intervention using the DUR system is effective for both healthcare providers and consumers. Adverse events caused by inappropriate drug use can be prevented by continuous patient monitoring. Therefore, the role of DUR system needs to be expanded to establish a safe drug management system.
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OBJECTIVE: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. METHODS: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. RESULTS: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84–0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10–315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16–244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11–15.35). Regarding the attitude toward spontaneous ADR reporting system, ‘lack of time for reporting’ (OR, 0.29; 95% CI, 0.15–0.53) and ‘complexity of reporting procedure’ (OR, 0.51; 95% CI, 0.31–0.84), were associated with a low likelihood of reporting. CONCLUSION: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.
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Humanos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Modelos Logísticos , Métodos , FarmacêuticosRESUMO
PURPOSE: Statins, metformin, angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs) have been suggested for treating age-related macular degeneration (AMD) due to their pleiotropic effects. Therefore, we investigated whether these drugs prevent AMD. MATERIALS AND METHODS: We conducted a nested case-control study using the Korean National Health Insurance Service database. Using risk-set sampling of age, sex, cohort entry date, and follow-up duration, we identified incident patients with AMD and 10 matching controls in cohorts with diabetes mellitus or cardiovascular diseases. Exposure was assessed within one year before the index date using patient prescription records. We conducted conditional logistic regression to estimate the odds ratios (ORs) and 95% confidence intervals (CIs) to evaluate the association between cardiovascular medications and AMD. RESULTS: Our study included 2330 cases and 23278 controls from a cohort of 231274 patients. The ORs (95% CI) for AMD occurrence in users prescribed with statins, metformin, ACE inhibitors, and ARBs were 1.12 (0.94–1.32), 1.15 (0.91–1.45), 0.90 (0.61–1.34), and 1.21 (1.05–1.39), respectively. A duration-response was not observed. CONCLUSION: Statins, metformin, ACE inhibitors, and ARBs did not inhibit AMD in elderly patients. The absence of a duration-response supports the lack of a causal relationship.