• 간호행정학회지
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• 제22권2호
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• pp.199-208
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• 2016

Purpose: The purpose of this study was to investigate the influence of patient safety culture and perceived teamwork on the safety control of nurses. Methods: This study was conducted as a descriptive cross-sectional survey with 141 nurses who worked in a tertiary hospital with over 1,000 beds in S city, Gyeonggi province. Data were collected using structured questionnaires from July 20, to July, 31, 2015. Results: The average work period for nurses participating in the research was 8.84 years. The perceived teamwork and patient safety culture were positively correlated with safety control. The regression model with patient safety culture, perceived teamwork and clinical career against safety control was statistically significant (F=10.16, p<.001). This model also explained 37.1% of safety control (Adj. $R^2=.37$). Especially, communication (${\beta}=.27$, p=.023) of patient safety culture, clinical career (${\beta}=.26$, p<.001), mutual support (${\beta}=.24$, p=.042), and team leadership (${\beta}=.24$, p=.018) in perceived teamwork were identified as factors influencing safety control. Conclusion: The findings of this study imply that a broad approach including teamwork and patient safety culture should be considered to improve the safety control for nurses.

• 대한예방한의학회지
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• 제20권1호
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• pp.125-144
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• 2016

Objectives : About 13% of the medicines used by traditional korean medicines(TKM), are called animal medicines and are derived from non-herbal sources such as animals and insects. However, the clinical use of these preparations from animal medicines is often based on tradition and belief, rather than on evidence of toxicity and efficacy. As a result, animal medicines containing toxin have caused serious problems from injecting patients with venom. Here, various venoms frequently used as TKM were reviewed in terms of their instinct toxity and tried to estimate their safety classification. Methods : The estimation of safety classification was based on human equivalent dose(HED)-based MOS (margin of safety) and clinical dose applied for patients. Results and Conclusions : Except that of snake venom due to no clinical dose, they were evaluated as class 3 for bee venom, class 4 for cantharidin, toxin from blister beetle, and class 1 for venom from scolopendrid. In conclusion, animal medicines showed a wide range of safety classification from class 1 to class 4. This wide range is estimated to result from extremely limited applications of each venom for patients because of their strong toxicity. However, it should be cautious for application in clinics since animal medicines can produce anaphylactic reactions particularly after veinous administration even with a tiny amount of venom.

• 간호행정학회지
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• 제20권2호
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• pp.215-226
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• 2014

Purpose: This study was done to suggest policies for nurse workforce based on patient safety. Methods: The two steps in developing the items were items related to what would be desirable policies and items on how the policies should be developed for patient safety regarding nurse workforce. A literature review was done and suggestions from experts through two rounds using the Delphi technique were outlined. The fifteen experts who participated in this study were six representatives of service consumers and nine representatives of service providers (four medical doctors and fives nurses). Results: To guarantee patient safety, accreditation of nursing practice and nursing education were found to be necessary, and to prevent medical and nursing accidents in clinical practice, the professional judgement of the nurses was found to be pivotal to the provision of safe nursing services. Conclusion: Polices on nursing for the nurse workforce based on patient safety in clinical settings should be established to ensure that nursing care is provided according to the nurses' clinical judgements based on their professional knowledge and assessment skills.

• 간호행정학회지
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• 제13권3호
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• pp.321-334
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• 2007

Purpose: The objectives of this study were to understand and compare perception and experience between clinical staffs(nurses and pharmacists) and Quality Improvement managers. Method: A qualitative study was conducted with 14 clinical staffs and QI managers who are working at tertiary hospitals in Korea. Interviews were recorded and transcribed for systematic analyses of qualitative data. Results: Most critically, while QI managers acknowledged that establishment of the patient safety culture and reduction of medical errors are urgent tasks for QI effort, clinical staffs don't seem to share such perceptions. All participants agree that staff shortage and no compliance to safety procedures were major reasons for medical error occurrences. Many suggested that an organizational culture where errors were perceived as a systematic problems rather than individual failures or carelessness should be formed to promote voluntary reporting of medical errors. Conclusion: A more systematic effort and attention at the hospital leadership and public policy level should be promoted to constitute societal consensus on the urgence of promoting patient safety culture and more specific approaches to tackle the patient safety problems.

• Journal of Ginseng Research
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• 제44권2호
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• pp.179-193
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• 2020

Ginseng products on the market show high variability in their composition and overall quality. This becomes a challenge for both consumers and health-care professionals who are in search of high-quality, reliable ginseng products that have a proven safety and efficacy profile. The botanical extract standardization is of crucial importance in this context as it determines the reproducibility of the quality of the product that is essential for the evaluation of effectiveness and safety. This review focuses on the well-characterized and standardized ginseng extract, G115, which represents an excellent example of an herbal drug preparation with constant safety and efficacy within the herbal medicinal products. Over the many decades, extensive preclinical and clinical research has been conducted to evaluate the efficacy and safety of G115. In vitro and in vivo studies of G115 have shown pharmacological effects on physical performance, cognitive function, metabolism, and the immune system. Furthermore, a significant number of G115 clinical studies, most of them double-blind placebo-controlled, have reinforced the findings of preclinical evidence and proved the efficacy of this extract on blood glucose and lipid regulation, chronic obstructive pulmonary disease, energy, physical performance, and immune and cognitive functions. Clinical trials and 50 years of presence on the market are proof of a good safety profile of G115.

• 한국임상약학회지
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• 제31권1호
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• 한국임상약학회지
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• 제27권2호
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• pp.105-112
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• 2017

Background: Generic medications are approved on the basis of bioequivalence with brand medications in healthy volunteers rather than the target population, there remains a substantial uncertainty regarding their clinical effectiveness and safety. The object of this paper is to compare the clinical equivalence of generic statin drugs in patients. Methods: Literature published before September 2016, which is indexed in PubMed, EMBASE, RISS, comparing generic to brand products in statins. Outcomes included blood lipid level, proportion of days covered (adherence), hospitalization and mortality. Results: 511 citations were screened, of which 11 studies met eligibility criteria (6 randomized clinical trials, 5 observational studies). Generic atorvastatin was clinical equivalent with brand drugs in blood lipid level (3 RCTs) and generic simvastatin was also clinical equivalent with brand drugs (2 RCTs). 2 of 3 studies reported no significant difference in proportion of days covered except 1 study which reported generic statin significantly enhance proportion of days covered (p<0.001). Hospitalization was no significant difference in all studies (p>0.05). 1 study reported that all cause of mortality was significantly low in generic drugs (p<0.0001). Conclusion: Published data on comparing clinical efficacy of generic and brand statins were insufficient in both quantity and quality. This systematic review suggests that additional studies on clinical equivalence and safety of generic medications in patients would be needed.

• 중환자간호학회지
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• 제14권3호
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• pp.62-72
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• 2021

Purpose : This study aimed to identify factors influencing clinical nurses' intention to report medication administration errors. Methods : This cross-sectional study collected data from 121 nurses in charge of administering medication at a university hospital in Korea using structured questionnaires. Data were analyzed using descriptive statistics, independent t-test, one-way ANOVA, Pearson's correlation coefficient, and multiple linear regression. Results : Participants' mean age was 26.90±3.99 years, and 89.3% were women. Their mean clinical career duration was 3.88±4.26 years. The average levels of patient safety culture, attitude toward reporting medication administration errors, and intention to report medication administration errors were 7.51 out of 10, 3.36 out of 5, and 4.85 out of 6, respectively. The multiple regression analysis results indicated that the statistically significant influencing factors were patient safety culture (𝛽=.21, p =.018) and attitude toward reporting medication administration errors (𝛽=.22, p =.015). Conclusion : To improve the intention to report medication administration errors among clinical nurses, a patient safety culture must be established, along with an education provision for improving their attitudes toward reporting such administration errors.

• 한국의료질향상학회지
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• 제19권1호
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• pp.16-26
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• 2013

Health information technology (HIT) is one of the most familiar tools to healthcare providers. It is used in routine practice to reduce cost, to improve clinical performance, and to improve patient safety. Patient safety is the driving force of recent expansion of HIT industry. But there are many evidences that it can be harmful to patient safety. Role of HIT and HIT-related error became big issues because more and more healthcare providers and healthcare organizations are willing to adopt it. Adoption rate of HIT in Korea is higher than that of United States. But researches of HIT regarding patient safety are rare. In this article, types of HIT, their mechanisms of improving patient safety and HIT-related errors were reviewed. Status of HIT in terms of patient safety in Korea was also reviewed. Knowledge of how HIT can improve patient safety, its' limitation, and how to make it safer is crucial to whom have to use it to improve patient safety. Impact of HIT on patient safety must be evaluated actively in Korea. HIT which was proven to improve patient safety must be widely adopted. Government must prepare a strategic plan to improve HIT quality, support hospitals financially and institutionally to introduce qualified HIT, and develop HIT infrastructures and standard designed for patient safety.

• 한국의료질향상학회지
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• 제24권1호
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• pp.23-29
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• 2018

Background: The purpose of this study was to examine undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkships. Methods: Cross-sectional and self-administered questionnaire survey was conducted on 34 students from one medical school using a modified version of the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS). We assessed $4^{rd}-year$ medical students' perceptions of the cultures ('safety', 'teamwork', and 'error disclosure'), 'behavioural intentions' concerning patient safety issues and 'overall patient safety'. The overall response rate was 66.4%. Results: Among safety domains, "teamwork culture" was rated highest. "Error disclosure culture" received the lowest ratings. Regarding the error disclosure domain, only 10% of respondents reported that they have received education or training on how to disclose medical error to patients. Independent of survey domains, when students were asked "Overall, do you think your hospital is safe based on your clinical rotation?", 61.8% reported that the hospital was safe. Conclusions: Assessing students' perceptions of safety culture can provide clerkship directors and educators with information that enhances the educational environment and promotes patient safety. Discussions of medical errors, patient safety, and how best to incorporate an analysis of these issues into the existing curriculum are needed.