• Korean Medical Education Review
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• v.21 no.1
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• pp.1-12
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• 2019

This study is a narrative review introducing global trends in patient safety education within medical schools and exploring the status of Korean education. Core competences for patient safety include patient centeredness, teamwork, evidence- and information-based practice, quality improvement, addressing medical errors, managing human factors and system complexity, and patient safety knowledge and responsibility. According to a Korean report addressing the role of doctors, patient safety was described as a subcategory of clinical care. Doctors' roles in patient safety included taking precautions, educating patients about the side effects of drugs, and implementing rapid treatment and appropriate follow-up when patient safety is compromised. The Korean Association of Medical Colleges suggested patient safety competence as one of eight essential human and society-centered learning outcomes. They included appropriate attitude and knowledge, human factors, a systematic approach, teamwork skills, engaging with patients and carers, and dealing with common errors. Four Korean medical schools reported integration of a patient safety course in their preclinical curriculum. Studies have shown that students experience difficulty in reporting medical errors because of hierarchical culture. It seems that patient safety is considered in a narrow sense and its education is limited in Korea. Patient safety is not a topic for dealing with only adverse events, but a science to prevent and detect early system failure. Patient safety emphasizes patient perspectives, so it has a different paradigm of medical ethics and professionalism, which have doctor-centered perspectives. Medical educators in Korea should understand patient safety concepts to implement patient safety curriculum. Further research should be done on communication in hierarchical culture and patient safety education during clerkship.

• Quality Improvement in Health Care
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• v.26 no.2
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• pp.56-65
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• 2020

Purpose:This study aims to understand and explore the subjective experiences of patient safety education among health care professionals in developing a patient safety curriculum in South Korea. Methods: A qualitative descriptive study was conducted through two focus group interviews in the period October-December 2018. Eleven participants who underwent patient safety education participated in each session. All interviews were recorded and transcribed as spoken, and qualitative content analysis was used to identify categories of discussion depicting participants' subjective experience with patient safety education. Results: A total of three categories and seven themes were identified out of 77 units of analysis. Topics were identified in the dimensions of a patient safety curriculum, as follows: (1) activities for patient safety; (2) principle of patient safety (five rights, ethics, patient participation) and patient participation; (3) leadership, teamwork, and communication; and (4) reporting and learning system for patient safety events. In the dimension of methods, (5) case and evidence-based education and (6) multidisciplinary and small group teaching were identified. Finally, in the dimension of the system, (7) policies for patient safety education were identified. Conclusion: Our findings indicate that patient safety education is a significant area for health care professionals. Health care professionals suggested that a systematic patient safety curriculum would improve their knowledge and attitude toward patient safety. Moreover, it enables them to better construct a safety environment in a hospital.

• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• The Journal of Internal Korean Medicine
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• v.28 no.2
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• The Journal of Internal Korean Medicine
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• v.40 no.1
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• pp.89-116
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• 2019

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

• The Journal of Internal Korean Medicine
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• v.26 no.2
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• pp.440-452
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• 2005

Objective: In the winter of 2002, severe acute respiratory syndrome(SARS) began to spread throughout the world. More than 5,000 cases were reported in China, including over 1,700 cases in Hong Kong Special Administrative Region(Hong Kong SAR). The total number of cases reported from Canada and Singapore was more than 200. The total number of SARS cases world-wide reached 8,437 with incidences in 29 counties. Mortality from SARS is estimated at $10{\sim}12%$. When the SARS outbreak occurred in China, the State Administration of Traditional Chinese Medicine of China immediately initiated clinical research projects on the use of integrated herbal medicine and Western medicine for treating SARS. and, in Hong Kong SAR, research on the use of herbal medicine for the prevention and treatment of SARS. Reports were released during convalescence. The objective of this study is to overview twelve clinical SARS reports of WHO on the treatment of SARS with herbal medicine and evaluate the efficacy and safety of treatment of SARS with herbal medicine, and further to share experiences and knowledge of the treatment of SARS. Methods: Twelve clinical reports about SARS from the WHO were selected, overviewed and evaluated for efficacy and safety of treatments of SARS. Results and Conclusion: Twelve clinical reports about SARS showed that the integrated treatment may have advantages, and the advantages are reflected in the following findings: Firstly, herbal medicine is not targeted only at a specific etiology or a certain pathological link, but also at the pathological status of the patients at that particular time. Therefore, comprehensive readjustment was made through various angles, targets and channels to restore the balance of the body. Secondly, there are advantages in the differentiation of the disease and the treatment. Based on the various symptoms, herbal medicine enables the physician to adopt the most suitable principle, provide individual treatment, and to administer medicine in accordance with the actual process and nature of the illness. Thirdly, there are advantages in the results of the treatment; herbal medicine can relieve symptoms, promote absorption of lung inflammation, improve the degree of blood oxygen saturation, regulate immunological functions, reduce the required dosage of glucocorticoid and other Western medicines, and reduce case fatality rate, in addition to lowering the cost of treatment.

• Journal of Acupuncture Research
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• v.32 no.4
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• pp.147-156
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• 2015

Objectives : This study aims to evaluate the effectiveness and safety of Korean medicine for a thoracolumbar compression fracture. Methods : We searched six Korean databases (DBPIA, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, National Digital Science Library, Research Information Sharing Service, KoreaMed) (up to June 2015) and the Journal of Korean Acupuncture and Moxibustion Society. Unpublished studies were also searched. Clinical research, other than case reports involving less than 10 patients, were eligible. The effectiveness and safety of Korean Medicine was analyzed. The 'Risk of Bias' was assessed using the 'Risk of Bias' assessment tool for non-randomized studies as well as the Cochrane Collaboration's 'Risk of Bias' tool. Results : We found 12 before-after studies (374 patients). There was no randomized trial. All studies combined at least three different types of Korean medicine treatments. The period of treatment varied between less a week and 154 days. All the included studies reported improvements in pain, functional disability related to lower back pain, global assessment, and benefits in the compression ratio of a fractured vertebrae and skin temperature measured by digital infrared thermal imaging in comparison with the baseline. However, all studies had a high risk of bias and three studies reported mild adverse events. Conclusions : There is no randomized trial for the role of Korean medicine for patients with a thoracolumbar compression fracture. The effectiveness and safety of Korean medicine for this population remains unclear. Findings in this review are seriously biased due to observational design and a high risk of bias included in the studies. Future high-quality randomized trials are warranted.

• Korean Journal of Clinical Pharmacy
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• v.23 no.4
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• pp.327-333
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• 2013

Background: Antihistamine and anti-allergy medications are widely used during pregnancy. Reading label information is one of the easiest ways to get safety information. But there are content gaps among countries. Objective: To compare the risk level and the recommendation level of antihistamine/anti-allergy drug's label information in pregnant women among Korea, the USA, the UK, and Japan. Method: Study drugs of antihistamine/anti-allergy medications were selected according to Korea drug classification codes. Based on the label information of selected product, risk level was classified into 5 categories as follows: 'Definite', 'Probable', 'Possible', and 'Unlikely', 'Unclassified' according to the level of evidence. Recommendation level was classified into 4 categories as follows: 'Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'. Frequency and proportion were presented according to the each category. To estimate agreement of each category among 4 countries, percent agreement and kappa (k) coefficient were calculated. Results: Total 13 drug ingredients were selected for antihistamine/anti-allergy medications. In risk level, Korea (46%) and Japan (69%) were mostly classified in the category of 'Unclassified', but 'Unlikely' category was more frequent in the UK (62%) and the USA (46%). In recommendation level, the proportion of 'Contraindicated' was highest in Korea (46%) compared to other countries. In contrast, the category of 'Cautious' was 77%-85% in the USA, the UK, and Japan. The percent agreement for risk level was highest in the USA-UK (54%). The recommendation level of Korea-USA showed lowest agreement for percent agreement (46%) and kappa coefficient (k=0.02). Conclusion: We confirmed the differences among safety information provided by four different countries. 'Contraindicated' was more likely in Korea compared with other countries.

• Herbal Formula Science
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• v.20 no.1
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• pp.13-24
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• 2012

Objectives : Yukmijihwang-tang(Wan), a well-known formula for invigorating yin-particular kidney yin, was first recorded in "Xiao er Yao Zheng Zhi Jue", consisting of Radix Rehmanniae Preparata, Fructus Macrocarpii, Rhizoma Dioscoreae Oppositae, Poria, Rhizoma Alismatis and Cortex Moutan Radicis with dose proportion of 8:4:4:3:3:3. Although clinical trials have been lacking, various pharmacological actions for Yukmijihwang-tang has been identified newly using animal models. In addition, it was reported that Yukmijihwang-tang increases structural chromosome aberrations significantly in Chinese hamster lung cells. In this article, it is purposed that new studies for pharmacology and toxicology of Yukmijihwang-tang are reviewed. Insight into new studies of Yukmijihwang-tang at the cellular and animal levels will enhance our understanding of Yukmijihwang-tang against various diseases will provide new tools to diagnose and treat patients. Methods : Recent researches for Yukmijihwang-tang were reviewed and summarized in terms of pharmacological action and toxicity. All sources for review were based on recent studies loaded on data base of web sites such as Science Direct and National Center for Biotechnology Information. Results and Conclusions : Recently, reports showed that YMJ had antiaging effects, antioxidant and free radical scavenging activities, anti-renal hypertension and prevented tumors, and diabetes mellitus. However, there is little information on its safety except general toxicity, acute and sub-chronic oral toxicity, or genotoxicity. In addition, clinical trial for Yukmijihwang-tang was limited even though Yukmijihwang-tang has been used extensively in Korean traditional medicine. Thus, further studies are necessary to focus on safety evaluation and clinical trial for Yukmijihwang-tang.

• Korean Journal of Biological Psychiatry
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• v.2 no.2
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• pp.281-286
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• 1995

Objects : Manic phase of bipolar disorder is treated with a combination of mood stabilizer and antipsychotic drug, especially in the acute phase. Such combined treatment is often required for the clinical management of manic symptoms until therapeutic effects of mood stabilizer become evident. The present study was the first open trial to evaluate the efficacy of risperidone, and safety of the combination of mood stabilizer and risperidone in the treatment of acute manic patients. Method : This study was performed as an open clinical study. The subjects of this study were 42 patients who had been admitted with first manifestations or acute exacerbations of illness were selected, using DSM-III-R criteria for bipolar disorder, manic episode. Patients were rated using the the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI), Extrapyramidal Symptom Rating Scale(ESRS). Other adverse events were assessed by a symptom checklist and by observation by medical personnel. Vital signs were monitored in a standard way and electrocardiography, routine laboratory analysis were performed. Results : Thirty patients(67%) completed the 12-week trial period. The CGI showed a good therapeutic effect with a minimal incidence or severity of side effects. The majority of patients showed a continuos reduction in their BPRS scores. The extrapyramidal symptoms assessed on ESRS generally showed mild to moderate degree. laboratory porameters showed no significant changes during the course of treatment. Conclusion : The results of the study showed a good efficacy of the risperidone in manic patients and further controlled studies are warranted.