• Quality Improvement in Health Care
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• v.22 no.1
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• pp.41-57
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• 2016

Objectives: This study aimed to investigate how many healthcare professionals experienced near misses, what types of near misses occurred most often, and healthcare professionals' opinions about near misses at one university hospital in Korea. Methods: The authors developed a questionnaire including 26 core types of near misses and 4 questions about preventability and reporting barriers. The survey was conducted from Oct. 31st to Nov. 18th 2011, about 3 weeks, using a self-administrated questionnaire that was administered to 697 healthcare professionals (registered nurses, pharmacists, technicians, and nurses aides) who worked at a university hospital. Medical doctors and employees working in the department of administration were excluded. Results: About half of hospital workers experienced at least one or more near misses during the past one year. The drug dispensing process was the most common subcategory of near misses. Among the 26 items, patient falls was highest. Over 95% of respondents reported that the near miss they experienced was preventable. Also, more than half of respondents did not report the near miss and the main reason for omission was fear of blame. Conclusion: Regarding patient safety issues, a near miss is a very significant factor because it can be a potential adverse event. Therefore, we should grasp the size of the problem through tracking and analyzing near misses and should make an effort to reduce them. To do so, we should check whether our reporting system is well designed and functioning.

• Journal of Korean Academy of Nursing
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• v.47 no.1
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• pp.110-120
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• 2017

Purpose: The purpose of this study was to describe the lived experience of patients with heart transplantation in Korea. Methods: Individual indepth interviews and a focus group interview were used to collect the data from nine patients who had heart transplantations in 2015. All interviews were audio-taped and verbatim transcripts were made for the analysis. Data were analyzed using Colaizzi's phenomenological method. Results: Among the nine participants, eight were men. Mean age was 57.30 years. Six theme clusters emerged from the analysis. 'Joy of rebirth obtained by good luck' describes the pleasure and expectation of new life after narrow survival. 'Suffering from adverse drug effects' illustrates various psychosocial difficulties, such as low self-esteem, helplessness, alienation, and burnout, arising from the side effects of medications. 'Body and mind of being bewildered' illustrates disintegrated health and haunting fear of death. 'Alienation disconnected with society' describes isolated feeling of existence due to misunderstandings from society. 'Suffering overcome with gratitude and responsibility' includes overcoming experience through various social supports and suitable jobs. Finally, 'acceptance of suffering accompanied with new heart' illustrate changed perspective of life itself. Conclusion: The findings in this study provide deep understanding and insights of the lived experience of heart related illness for these patients and should help in the development of tailored-interventions for patients with heart transplantation.

• Korean Journal of Clinical Pharmacy
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• v.29 no.3
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• pp.209-214
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• 2019

Doxycycline is frequently prescribed to treat urogenital infections or acne vulgaris. A 39-year-old man was prescribed doxycycline as a treatment for his skin infection. He took each tablet on an empty stomach in the morning, and just before going to bed with insufficient water. After taking the prescribed medication for approximately 3 weeks, he was diagnosed with esophageal ulcer. He had not experienced these symptoms before, and the drug label says that doxycycline rarely causes esophageal ulcer. After discontinuing the medication, the symptoms disappeared. Using the World Health Organization-Uppsala Monitoring Center criteria, the causality for doxycycline-induced esophageal ulcer was evaluated as "possible." Additionally, using the Naranjo scale and Korean causality assessment algorithm (Ver. 2), the causality was evaluated as "probable." Previous reports have stated that most patients who took doxycycline with insufficient water just before going to bed or in the supine position developed esophageal ulcer. Therefore, all patients taking doxycycline must be provided with detailed instructions about the appropriate administration methods.

• Journal of Veterinary Clinics
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• v.41 no.3
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• pp.165-169
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• 2024

A 10-year-old, spayed female Maltese dog was tentatively diagnosed with granulomatous meningoencephalitis (GME) on magnetic resonance imaging. The meningoencephalitis was classified as aseptic GME because cerebral fluid analysis did not reveal an infectious aetiology. Two months after leflunomide treatment (Arava; Sanofi; 4 mg/kg/day), the patient developed non-regenerative, macrocytic, and normochromic anemia. As the patient's anaemia began after the administration of leflunomide, and other differentials for anaemia had been ruled out, the leflunomide was determined to be the cause and this treatment ended. After 15 days, the anaemia resolved spontaneously. This is the first report of reversible aplastic anaemia following treatment with leflunomide in a canine patient with GME.

• Quality Improvement in Health Care
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• v.22 no.2
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• pp.43-73
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• 2016

Purpose: The aims of this study were to assess the presence of core patient safety practices in Korean hospitals and assess the differences in reporting and learning systems of patient safety, infrastructure, and safe practices by hospital characteristics. Methods: The authors developed a questionnaire including 39 items of patient safety staffing, health information system, reporting system, and event-specific prevention practices. The survey was conducted online or e-mail with 407 tertiary, general and specialty hospitals. Results: About 90% of hospitals answered the self-reporting system of patient safety related events is established. More than 90% of hospitals applied incidence monitoring or root cause analysis on healthcare-associated infection, in-facility pressure ulcers and falls, but only 60% did on surgery/procedure related events. More than 50% of the hospitals did not adopted present on admission (POA) indicators. One hundred (80.0%) hospitals had a department of patient safety and/or quality and only 52.8% of hospitals had a patient safety officer (PSO). While 82.4% of hospitals used electronic medical records (EMRs), only 53% of these hospitals adopted clinical decision support function. Infrastructure for patient safety except EMRs was well established in training, high-level and large hospitals. Most hospitals implemented prevention practices of adverse drug events, in-facility pressure ulcers and falls (94.4-100.0%). But prevention practices of surgery/procedure related events had relatively low adoption rate (59.2-92.8%). Majority of prevention practices for patient safety events were also implemented with a relatively modest increase in resources allocated. Conclusion: The hospital-based reporting and learning system, EMRs, and core evidence-based prevention practices were implemented well in high-level and large hospitals. But POA indicator and PSO were not adopted in more than half of surveyed hospitals and implementation of prevention practices for specific event had low. To support and monitor progress in hospital's patient safety effort, national-level safety practices set is needed.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

• Korean Circulation Journal
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• v.48 no.11
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• pp.989-999
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• 2018

Background and Objectives: We aimed to compare outcomes of complete revascularization (CR) versus culprit-only revascularization for ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) in the $2^{nd}$ generation drug-eluting stent (DES) era. Methods: From 2009 to 2014, patients with STEMI and MVD, who underwent primary percutaneous coronary intervention (PCI) using a $2^{nd}$ generation DES for culprit lesions were enrolled. CR was defined as PCI for a non-infarct-related artery during the index admission. Major adverse cardiovascular event (MACE) was defined as cardiovascular (CV) death, non-fatal myocardial infarction, target lesion revascularization, or heart failure during the follow-up year. Results: In total, 705 MVD patients were suitable for the analysis, of whom 286 (41%) underwent culprit-only PCI and 419 (59%) underwent CR during the index admission. The incidence of MACE was 11.5% in the CR group versus 18.5% in the culprit-only group (hazard ratio [HR], 0.56; 95% confidence interval [CI], 0.37-0.86; p<0.01; adjusted HR, 0.64; 95% CI, 0.40-0.99; p=0.04). The CR group revealed a significantly lower incidence of CV death (7.2% vs. 12.9%; HR, 0.51; 95% CI, 0.31-0.86; p=0.01 and adjusted HR, 0.57; 95% CI; 0.32-0.97; p=0.03, respectively). Conclusions: CR was associated with better outcomes including reductions in MACE and CV death at 1 year of follow-up compared with culprit-only PCI in the $2^{nd}$ generation DES era.

• Journal of Food Hygiene and Safety
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• v.27 no.4
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• pp.395-400
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• 2012

In this study, we analyzed the database for items reported to Korea Food and Drug Administration as for manufactured health/functional food during 2010. There were 183 health functional food products manufactured in domestic having over 2 functional ingredients (hereinafter, combinational health functional food) among total 7319 products. Among 183 products, there were 177 products having over two kinds of functional ingredient and 6 products were over 3 ingredients. The most commonly used functional ingredients in the combinational health functional food were Garcinia cambogia extracts which were used in 41 products, Octacosanol and Saw Palmetto extract. When we searched the safety information for the pair of ingredients used in combinational health functional food using several database, there were no reports for safety concern. However, as there are still safety concerns when intake various functional ingredients at once, we suggested to enforce the reporting system of adverse event in order to strength safety management of health functional food. With these complement, the safety management of health functional food might be achieved including a combinational products.

• Journal of Korean Medicine Rehabilitation
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• v.31 no.4
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• pp.157-166
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• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times - screening, pre administration, post administration and follow up-during the whole trial. The difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.215-225
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• 2022

Background: Patients with hematologic cancers have a risk of drug-related problems (DRPs) from medications associated with chemotherapy and supportive care. Although the role of oncology pharmacists has been widely documented in the literature, few studies have reported its impact on cost reduction. This study aimed to describe the activities of oncology pharmacists with respect to hematologic diseases and evaluate the associated cost avoidance. Methods: From January to July 2021, patients admitted to the department of hemato-oncology at Seoul National University, Bundang Hospital were studied. The activities of oncology pharmacists were reported by DRP type following the Pharmaceutical Care Network version 9.1 guidelines, and the acceptance rate was calculated. The avoided cost was estimated based on the cost of the pharmacy intervention, pharmacist manpower, and prescriptions associated with the intervention. Results: Pharmacists intervened in 584 prescriptions from 208 patients during the study period. The most prevalent DRP was "adverse drug event (possibly) occurring" (32.4%), followed by "effect of drug treatment not optimal" (28.6%). "Drug selection" (42.5%) and "dose selection" (30.3%) were the most common causes of DRPs. The acceptance rate of the interventions was 97.1%. The total avoidance cost was KRW 149,468,321; the net profit of the avoidance cost, excluding labor costs, was KRW 121,051,690; and the estimated cost saving was KRW 37,223,748. Conclusion: Oncology pharmacists identified and resolved various types of DRPs from prescriptions for patients with hematologic disease, by reviewing the prescriptions. Their clinical service contributed to enhanced patient safety and the avoidance of associated costs.