• Perspectives in Nursing Science
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• v.6 no.1
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• pp.67-76
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• 2009

Recently, small and medium-sized hospitals which are located in rural areas have many difficulties in securing high quality nurses. That is because working environments for nurses in small and medium-sized hospitals in rural areas are poor compared with those of big hospitals in urban. As a result, the migration of nurses from small and medium-sized hospitals in rural areas to big hospitals in urban is continuously happening. In general, big hospitals provide nurses with high level of salary and fringe benefits. To prevent the migration of nurses, chief executive officers of small & medium hospitals in rural areas have been interested in improving nurses' working conditions including wages. Also, they have raised nurses' salary and improved working conditions. But, basically these individualized efforts have some limit. In connection with this, medical interest groups have produced various voices in terms of interpretation and solutions for these issues. However, from the future perspectives, it seems evident that two approaches for both manpower supply and demand plans of nurses are necessary. They should contain not only accurate estimation of the supply-demand of nursing manpower but also the improvement of working conditions and wages of nurses. Estimation of nursing manpower supply-demand depends on the standards and criteria being used. Supply and demand may be met or not in accordance with the points emphasized on the decision. In the articles, issues regarding nursing manpower, levels of salary, other working conditions and social support system for child care are discussed. According to Joe's report (2005), most health institutions did not meet the guidelines of nurse staffing in Medical Law. The wages of nurse vary on every hospital and there is a big difference in wages' range. The average starting salary for a nurse is 22 million won a year. In case of tertiary hospitals, it reaches up to 30 million won a year. Nurse as a profession should have a strong responsibility and should take care of the patients for 24 hours with three working shifts. Also, most of them are female who have the burden of child rearing. Therefore, it is suggested to increase the salary, to provide comfortable working conditions, and to have social support system for nurses with household affairs.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.82-88
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• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• Journal of Pharmaceutical Investigation
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• v.34 no.4
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• pp.333-340
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• 2004

A new medical system of separation of dispensary from medical practice was started in 2000 in Korea. To expand bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are hot issues in Korea. The KFDA also has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drugs should be submitted to the KFDA in the application for drug approval. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. In this paper, we examined the recently published Japanese guideline, Guideline for Bioequivalence Studies of Generic Products For Topical Uses, and Q&A of the guideline, which will be references to make a guidance on bioequivalence studies of topical drug products in Korea.

• Journal of Korean Academy of Nursing Administration
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• v.5 no.1
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• pp.113-136
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• 1999

There are some new trends in judgments concerning medical malpractice. which include emphasis on medical professionals' explanation duty in order to materialize patient's rights of self-determination. Now, patient is not a mere subject of medical and nursing care any more, but a subject, participating in medical practice on equal terms with medical professionals. Legal accountability is no limited to nurses in advanced practice: it is a recognized fact of life for every practicing nurse. whether she is an RN employed as a staff nurse in a hospital, a Certified Nurse-Midwife in independent practice or a patient's home. Therefore, it is essential for nurses to be as familiar as possible with the legal guidelines that govern their patient care responsibilities. However there are only a few studies focused on nursing negligence. To define nurse's civil liability in medical malpractice, it is necessary to indentify both legal nursing behaviors and nurse's due care in those nursing behaviors. So this paper focused on nurse's due care, especially in nursing malpractice. To clarify nurses' due care. chapter II has focused on nursing behavior and the scope of nursing practice based on the medical law and health care related study results. Chapter III deals with the content and scope of nurse's due care. Generally. negligence is defined as not doing something which a resonable person. guided by those ordinary considerations which or dinarily regulate human affairs. would do. or doing something which a resonable and prudent man would not do. Next. it describes how we can set the standard of due care in nursing practice. There is objective factors and subjective factors. And we also discuss about the limitation of due care in nursing practice. Finally. chapter IV deals with the case studies related to nursing negligence in the situation of determination. Now', patient is not a mere subject of medical and nursing care any more, but a subject participating in medical practice on equal terms with medical professionals. Legal accountability is not limited to nurses in advanced practice; it is a recognized fact of life for every practicing nurse. whether she is an RN employed as a staff nurse in a hospital. a Certified Nurse-Midwife in independent practice or a patient's home. Therefore, it is essential for nurses to be as familiar as possible with the legal guidelines that govern their patient care responsibilities. However. there are only a few studies focused on nursing negligence. To define nurse's civil liability in medical malpractice, it is necessary to identify both legal nursing behaviors and nurse's due care in those nursing behaviors. So this paper focused on nurse's intravenous injection. post operation nursing care. blood transfusion. and patient nursing care. The result of this paper is as follows. First. there are several cases dealing with nurse's negligence in nursing practice. however, those cases didn't judge nurse's due care based on individual -specific standard but general-objective standard. Second, there is a tendency to put an emphasis on the principal of belief to distinguish who has the liability in the case of medical malpractice among medical care team. So nurses shoud practice nursing care more actively to protect themselves and patients because there is an effort to form professional nurse system and the scope of nursing practice will be deeper and broader. Third, standard of care is a necessary element in establishing negligence. If a nurse is able to meet the standard of care, no breach will be found.

• The Journal of Korean Medicine
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• v.28 no.3 s.71
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• pp.144-155
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• 2007

Background : In western medicine, there has been much interest in medication teaching since the separation of dispensary from medical practice in 2000. On the other hand, few investigations have been carried out about medication teaching for herbal medicine. Objectives : The purpose of this study wasto investigate the current status of medication teaching of herbal medicine and develop a better guide. Methods : Pharmaceutical affairs law in Korea was searched and some medication teaching guides were compared and analyzed to develop a better guide suitable for herbal medicine. Results and Conclusions : The future guide should be based on scientific evidence and include the following: (1)the origin of each herbal formula (2)the constitution of each herbal formula and proportion of each herb included (3)the chief virtue of each herbal formula (4)the efficacy of each herbal formula (5)the safety of each herbal formula (6)combined treatment with herbal formulas and western drugs (7)the way of decocting each herbal formula (8)the way of safekeeping and period of circulation of each herbal formula (9)a summary and evaluation for each herbal formula (10)references of each herbal formula.

• Journal of Korean Academic Society of Home Health Care Nursing
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• v.10 no.1
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• pp.5-14
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• 2003

Recently, there has been an increasing need for long-term care and comprehensive health care services in community settings. The Ministry of Health and Welfare introduced the Hospital-Based Home Nursing Care Program in 2000. Before this initiative, there was a Home Nursing Demonstration Center, affiliated with the Seoul Nurse Association, had offered home nursing services with the financial support from the local government. since 1993, the Center's nursing staff has been engaged in a general hospital in an effort to provide home nursing care services within Korea's health care system. The purpose of this study was to analyze and identify characteristics of community-based home nursing care supplied by a community-based home nursing team engaged in a general hospital. Also. visit nursing care services provided by public health centers were evaluated in terms of accessibility and supply versus demand, to enhance the accessibility of low-income patients living in Seoul to home nursing care services. Data were collected from home nursing insurance reimbursement claims submitted by the community-based home nursing care team from March 1 to October 30 in 2001 and a questionnaire survey on home-visit nursing services of 25 public health centers in Seoul. The subjects consisted of 197 patients and 12 public health centers. The result were as follows. First, medical institution's community-based home nursing care program was better in technical quality than health-center-based home-visit nursing care. In addition. the pattern of the subject patients was similar to that of hospital-based home nursing care program. Second, there was a high demand for community-based home nursing care while only a small number of home-visiting nurses served at public health centers in Seoul. As a result, many patients could not receive adequate care. Finally, we suggest that community-based home nursing care program should be introduced in the national health system to meet the at-home care needs of severely ill low-income patients. Furthermore, to better utilize home nursing and visit-nursing care resources and offer continued care for patients in community settings, an efficient referral network should be built among related institutions. This would require improvement of reimbursement system and amendment of the law related to health insurance system and community-based home nursing care services.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.263-291
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• 2015

In May, 2015, a 68 years old man, who has been Middle East Saudi Arabia and the United Arab Emirates, had high fever, muscle aches, cough and shortness of breath. he went two local hospital near his house and the S Medical Center emergency center. He was diagnosed MERS(Middle East respiratory syndrome) and the diseases had put South Korea the fear of epidemics for three months. Especially, this disease has firstly reported in Middle East Asia in September 2012 and spreaded to twenty-six countries. In 21, July, 2015, European Center for disease prevention and control reported 533 people were died and in South Korea, 186 people were infected, 36 people were died and 16,693 people were isolated from MERS. South Korea government were faced into epidemic control and blamed from public. Especially, hospital acquired infection, disease control chain, opening of information, ventilation, lack of isolation bed, the problem of function of local health center, the issue of reparation for hospital and insurance cover rate, the classification of disease, the role of Korea Centers for disease control and prevention, the culture of visiting hospital to see sick people, the issue of hospital multiple room and other related social support policy. it is time to study and discuss to solve these problems. South Korea citizens felt fear and fright from MERS. What is wore, they thought the dieses were out of their government control. It was unusual case for word except Middle East Asia. numerous tourists canceled visiting korea. South korea economic were severly damaged especially, tourism industry. South korea government should admit that they had failed initial action against MERS and take full reasonability from any damages. The government have to open information to public in terms of epidemic diseases and try to prevent any other epidemic diseases and try to work with local governments.

• The Journal of Dong Guk Oriental Medicine
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• v.1
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• pp.161-191
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• 1992

The purpose of this study is how have the form and theory of the five element theory in the (黃帝內徑) by the investigation of the course of the course of the five element introduced the ancient oriental medicine from ancient oriental philosophy. The following results were obtained. 1. The five elements in (尙書) meaned the uses of water, fire, earth, wood, metal which were important in living. Because these had very important meaning in ancient political and economic society, emphasized to big law(洪範) 2. The five elements in (左傳) and (國語) mean the five uses too, and there are the phases of "five win metal"(火勝金) and "wather win fire"(水勝火), but these only meaned the physical interrelation. 3. In the five circulating factor theory made by Chu Yen(鄒衍) which have the attribute of the five elements, he more reasonably had argued human affairs like that a dynasty become different in step with the circulating five favors. There is the regular annual policy in the (呂氏春秋) which closely connected nature and human living, and attached the various colors, animals, visceras, flavors, sounds, the sexagenary cycle and so on to the five elements. 4. In the (春秋繁露) writed in fore-period of Han(漢) dynasty, the interactions of the five elements are concretely applicated to policy, Dong Jung Soe(童仲舒) had discrived the interactions of the five elements by Dong Lyu Sang Dong theory(同類相動說) and the misfortune theory(災異說), emphasized the sympathy of nature and human. Thought there is many content which are superstitious and contradictory, I concider which that affcted many effects in the formation of five element theory of oriental medicine. In the (淮南子) the order of matters were explained by the five element theory too, as the interrelations of the five elements were explained by the sexagenary ctcle, I assume that the bud of O-Un theory(五運理論). And there was not founded the fullscale intriduction of the five element theory in the Ma Wang Tye(馬王堆) excavated finds, the Mu Yyi medical writings formed the dynasty(武威漢代醫簡) and the documents about Pyun Jak(偏鵲) and Sun U Ie(淳于意). 5. The application of the five element theory in the (Whang Di Nei Qing) (黃帝內徑) is devided into the attachement to the five elements, the interelations of the five elments, and Un Gi theery(運氣論). In the attachment to the five elemeant theory, it made the attachment of the five viseras of (今文尙書) party a standard and attached the sections of a human body, the whole internal organs of sense, the five colors, the five flavors and the five sounds and so on to the five elements. It put to use by means of the apllivation of the interrelation of the five elements in the transferations of the diseases and the relative severeness of a disease in step with change of time and season. Un Gi theory(運氣論) which synthesized by the attachment to the five elements, the inter-relations of the five elements and the climate which observerd from ancient times systematically argued the effects of weather to human. 6. The application of the five elements theory in (黃帝內徑) have the significant what had get rid of irrational factors like that the emotion and action of human could to influense the weather, what had been formes more rational thingking by the obesrvation of human and nature. It is required more reserches about the possibility of the formation of the doctrinal faction bt the geographical effect of the Yon, Je(燕,薺) region, the application of the five element theory in other ancient medical books and the relationship of the five element theory and Yin Yang(陰陽)