• Safety and Health at Work
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• v.11 no.3
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• pp.383-384
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• 2020

• Safety and Health at Work
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• v.5 no.3
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• pp.152-157
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• 2014

Background: As health care workers face a wide range of psychosocial stressors, they are at a high risk of developing burnout syndrome, which in turn may affect hospital outcomes such as the quality and safety of provided care. The purpose of the present study was to investigate the moderating effect of job control on the relationship between workload and burnout. Methods: A total of 352 hospital workers from five Italian public hospitals completed a self-administered questionnaire that was used to measure exhaustion, cynicism, job control, and workload. Data were collected in 2013. Results: In contrast to previous studies, the results of this study supported the moderation effect of job control on the relationship between workload and exhaustion. Furthermore, the results found support for the sequential link from exhaustion to cynicism. Conclusion: This study showed the importance for hospital managers to carry out management practices that promote job control and provide employees with job resources, in order to reduce the burnout risk.

• The Journal of Internal Korean Medicine
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• v.31 no.3
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• pp.612-619
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• 2010

Background : Low level laser therapy may be an effective method to protect tissue damage in acute stroke. Recently, series of clinical studies on the basis of animal experiments report efficacy and safety of laser therapy at early stages of acute stroke. Laser promotes mitochondrial ATP synthesis to reduce cell death by ischemic infarction. Objectives : To report possibility of non-invasive laser therapy for acute stroke by reviewing literature about its effectiveness, safety and mechanism. Methods : We searched papers using PubMed and 'Web of Knowledge' of Thomson ISI, using the keywords "Laser Therapy, Low-Level" and "Stroke". Limitations were last 10 years of publications and only in English. Search range includes RCTs, clinical reports, reviews and animal experiments. Papers not matched with inclusion criteria were excluded. Results : A total 223 studies were found, 203 excluded during title and extract screening. After scanning 20 papers the final 2 serial RCTs were selected and analyzed. They reported that transcranial laser therapy led in neuroprotective effect for acute stroke patents. Clinical evaluation factors showed favorable trend and initial safety. Conclusions : Non-invasive laser secured safety of clinical application. It may be a favorable choice for the acute stage of stroke.

• Korean Journal of Clinical Pharmacy
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• v.30 no.3
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• pp.143-148
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• 2020

Objective: This study aimed to investigate pharmaceutical care for critically ill neonates and suggest targeted strategies compatible with the Korean health-system pharmacy. Methods: Articles that reported pharmacy practices for critically ill neonates were reviewed. Pharmaceutical care practices and roles of neonatal pharmacists were identified, and criteria were developed for neonates in need of specialized care by clinical pharmacists. Results: Neonatal pharmacists play many roles in the overall medication management pathway. For clinical decision support, multidisciplinary ward rounds, clinical pharmacokinetic services, and consultation for pharmacotherapy and nutrition support were conducted. Prevention and resolution of drug-related problems through review of medication charts contributed to medication safety. Pharmaceutical optimization of intravenous medication played an important role in safe and effective therapy. Information on the use of off-label medicine, recommended dosage and dosing schedules, and stability of intravenous medicine was provided to other health professionals. Most clinical practices for neonates in Korea included therapeutic drug monitoring and nutrition support services. Reduction in medication errors and adverse drug reactions, shortening the duration of weaning medicines, decreasing the use and cost of antimicrobials, and improvement in nutrition status were reported as the outcomes of pharmacist-led interventions. The essential criteria of pharmaceutical care, including for patients with potential high-risk factors for drug-related problems, was developed. Conclusion: Pharmaceutical care for critically ill neonates varies widely. Development and provision of standardized pharmaceutical care for Korean neonates and a stepwise strategy for the expansion of clinical pharmacy services are required.

• Journal of Korean Academy of Nursing
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• v.48 no.6
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• pp.720-730
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• 2018

Purpose: The purpose of this study was to investigate patient safety teaching competency of nursing faculty and the extent of teaching patient safety topics in the nursing curriculum. Methods: A national survey was conducted with full-time nursing faculty in 4-year nursing schools. Regional quota sampling method was used. An online survey was sent to 1,028 nursing faculty and 207 of them were completed. Among the 207, we analyzed data from 184 participants. The revised Health Professional Education in Patient Safety Survey was used. Data were analyzed using descriptive statistics, independent t-test, one-way ANOVA, Pearson's correlation analysis, and multiple linear regression analyses. Results: The faculty's self-confidence was lower than their perceived importance of patient safety education. The mean score of teaching patient safety was $3.52{\pm}0.67$ out of 5, and the contents were mostly delivered through lectures. The extent of faculty's teaching varied depending on faculty's clinical career, teaching subjects, participation in practicum courses, and previous experience of patient safety education. The significant predictors of the extent of teaching patient safety were the faculty's self-confidence in teaching patient safety (${\beta}=.39$) during clinical practicum, their perceived importance of patient safety education during lectures (${\beta}=.23$), and the teaching subject (${\beta}=.15$). Conclusion: To enhance the competency of nursing faculty for effective patient safety education, a patient safety education program tailored to faculty characteristics should be developed and continuously provided for faculty. In addition, it is necessary to improve patient safety curriculum, strengthen clinical and school linkages, and utilize various education methods in patient safety education.

• Journal of Biomedical Engineering Research
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• v.40 no.6
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• pp.250-259
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• 2019

Ophthalmic Laser System is widely used in Selective Laser Trabeculoplasty of Open Angle Glaucoma and Ocular Hypertension. Versatile ophthalmic laser system is a medical device with technology that checks the condition of the treatment area by irradiating a continuous laser pulse on the treatment area, and monitoring the microbubble reaction caused by the temperature increase of the melanosome through the ultrasonic signal and the optical signal sensor. It performs selective laser treatment without damaging the photoreceptor by controlling the wavelength of the laser when microbubbles are detected. This study aims to suggest a guideline for evaluating safety, performance and clinical effectiveness of Versatile Ophthalmic Laser System in accordance with the growing technology. International Standards, Regulations, and Clinical Trial Protocols were investigated and analyzed for this study. As a result of this study, the safety, performance and clinical effectiveness test guideline for Versatile Ophthalmic Laser System were proposed. This guideline will ensure the safety and efficacy of Medical device, and furthermore it is expected to be able to promote the development of technology development by supporting a clinical trial plan.

• Korean Journal of Clinical Pharmacy
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• v.29 no.2
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• pp.71-78
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• 2019

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

• Translational and Clinical Pharmacology
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• v.26 no.3
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• pp.118-127
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• 2018

The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

• Toxicological Research
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• v.11 no.1
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• pp.157-159
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• 1995

A study on antigenicity of HRccine (formalin inactivated HFRS virus vaccine) was investigated in guinea pigs and mice. As a part of the safety evaluation of the HRccine, antigenicity tests were carried out according to the Estabilish Regulations of National Institute of Safety Research. In active systemic anaphylaxis (ASA) test no sign was detected when sensitized with up to 120 clinical dose and challenged with up to 1200 clinical dose in guinea pigs. In passive systemic anaphylaxis test guinea pigs showed no sign. In passive cutaneous anaphylaxis (PCA) test, HRccine specific IgE antibody was not detected when sensitized and challenged with up to 1200 clinical dose. Conclusively, there was no adverse antigenic potential at the clinical dose of 120 clinical dose alone and 120 clinical dose with Al(OH)3.

• Neonatal Medicine
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• v.15 no.2
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• pp.119-122
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• 2008

Clinical research is a necessity, not an option, for developing better and new medicines and therapeutic modalities. But in the course of clinical research, there are rules and guidelines that should be followed to ensure the due respect for persons, beneficence, and justice for persons who voluntarily participate in the research as described in the Belmont Report. Good Clinical Practice (GCP) is an "international scientific and ethical quality standard for designing, conducting, recording, and reporting" clinical trials. The main purposes of GCP would be to protect rights, safety, and well-being of trial subjects, in compliance with the principles of Declaration of Helsinki, and to assure that the data obtained from clinical trials are credible. In order to achieve these, investigators must be fully aware of the meanings as well as actual procedures involved in the research and should make the best effort to comply with GCP. For those individuals who belong to vulnerable populations, such as neonates, in addition to the general principles of GCP, further measures to ensure added protection should be implemented. It is our duty to develop and provide better care through clinical research even for neonates. But in doing so, we have to make sure that the importance of protecting the rights, safety, and well-being of the subjects supersede the interests of science and society.