• Title/Summary/Keyword: History of Korean medicine

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Drug Use Evaluation on Ceftazidime (입원환자에 대한 Ceftazidime의 약물사용 검토)

  • Kim, Sang Hyun;Choi, Hyun Suk;Kim, Hyang Suk;Shin, Wan Gyoon;Shon, In Ja;Cho, Nam Chun;Choi, Kang Won
    • Quality Improvement in Health Care
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    • v.1 no.1
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    • pp.44-54
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    • 1994
  • A drug use evaluation (DUE) program has been defined as an "authorized a quality assurance process designed to ensure that drugs are used appropriately, safely, and effectively". A retrospective DUE study on ceftazidime has been conducted by reviewing patients charts following criteria for drug use evaluation established by Am.S.Hosp.Pharm. Total 60 charts of patient treated with ceftazidime in Seoul National University Hospital from Jan. 1.1993 to July.31.1993 were retrospectively reviewed. As a result, 44 cases(73%) were met with the criteria for the justification of use. In analysing process indicators including culture and sensitivity test, CBC, LFT, history of anaphylaxis monitoring before initial dose, vital sign monitoring were relatively well documented showing the accepted level above 80%, while appropriated dose were infrequently documented with low accepted level. In outcome analysis, blood culture after discontinuing drug were rarely documented, with accepted level of 46%. For using effectively and safely, ceftazidime is recommended to be administrated to optimal indication, and monitored actively for preventing adverse effect.

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Bone mineral density in type 2 diabetic patients aged 50 years or older in men and postmenopausal women in Korea

  • Cho, Jeong-Ran;Chung, Dong Jin
    • Journal of the Korea Society of Computer and Information
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    • v.26 no.8
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    • pp.197-207
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    • 2021
  • Relationship between bone mineral density (BMD) and type 2 diabetes is still inconsistent. Recently, many epidemiologic data show that fracture risk is increased in type 2 diabetic patients regardless of BMD status. In this study, we used nation-wide data from 2008 to 2011 Korea National Health and Nutrition Examination Survey (KNHANES) to analyze the BMD status in patients with type 2 diabetes compared to non-diabetics. We included subjects aged 50 years or older in men (N=2,959, 2,430 without diabetes, 529 with type 2 diabetes) and postmenopausal women (N=2,902, 2,479 without diabetes, 423 with type 2 diabetes). Subjects with history of medication for osteoporosis or with illness or malignancy affecting bone metabolism were excluded. Data of anthropometric measurements and demographic characteristics were collected by trained examiner. Serum was separated from peripheral venous blood samples obtained after 8 hours of fasting. BMD was measured at lumbar spine and femur using dual-energy X-ray absorptiometry (DXA). There was a significant positive association between lumbar spine BMD and type 2 diabetes after adjusting age, gender, body mass index, monthly house income, education level, physical activity, daily calcium intake and vitamin D concentration by multiple regression analysis in all subjects. In the subgroup analysis by gender, this association was maintained both in male and female after adjusting those confounding factors. However, femur BMD was not different between type 2 diabetic and non-diabetic subjects. In conclusion, lumbar spine BMD was significantly higher in type 2 diabetic patients aged 50 years or more in men and postmenopausal women compared to non-diabetic subjects.

A study on Huh-Joon's medical thoughts in Dong-Eui-Bo-Kham (동의보감(東醫寶鑑)을 통한 허준의 의학사상에 관한 고찰)

  • Kwon, Hak-Cheol;Park, Chan-Guk
    • Journal of Korean Medical classics
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    • v.6
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    • pp.89-130
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    • 1993
  • Huh-joon's medical thoughts shown on his medical book of the Doog-Eui-Bo-Kham can be summerized as follows. 1. The general trend of medical science in Koryo dynasty is that much more interests were concentrated upon the books about curative means rather than upon the books about theoretical knowledge of medical science. With the development of Hyang Yak(鄕樂) (the term referring either various kinds of domestic medical stuffs such as herbs or the curative methods using those stuffs) and the writing of books on Hyang Yak, independent medical science of the nation's own was established in late Koryo dynasty. And the national medical science was continuously further developed until early Choson dynasty. Briskly-expanded mutual exchanges with China in early Choson dynasty provided Choson opportunities to import Chinese medical science and to examine it. Under this circumstances, he wrote the Dong-Eui-Bo-Kham. 2. As we look over the preface and Chip-Rae-Muo(集例文), we can find the characterstic of Doog-Eui-Bo-Kham is that the philosophical theory of Taoism was quoted in explaining the principles of his medical science and that the main idea of Naekyuog is the basis in explaining the way of curing diseases. 3. 83 kinds of medical books were quoted in the Doog-Eui-Bo-Kham. Besides, as many as 200 kinds of books including Tao-tzu's teaching books(道書), history books(史書), almanac(曆書), and Confucius' teaching books(儒家書籍) were quoted in total. Naekyuog and Eue-Hak-Ip-Mun, Dan-Kye-Sim-Bup were the most frequently quoted books among them. 4. Huh-Joon's medical thoughts about health care were like these. 1) The reason why Huh-Joon regarded the idea of health care as of great importance was that he laid much more emphasises on the preventive medicines rather than on the remedial medicines. The direct reason was that he was greatly influenced by profound knowledge of Taoist's study of discipline and who participated in the editing the books from the beginning. 2) Huh-Joon's outlook on human body started from the theory of "Unity of Heaven and Man"(天人合一論), which implied man was a kind of miniature universe. In addition to that, he largely theory of essence(精), vital force(氣), and spirit(神) which were regarded very important as the three most valuable properties in Taoism. However, he took his medical ground on practical and pragmatic idea that he did not discuss fundamental essence(元精), fundamental vital force(元氣), and fundamental spirit(元神) which were given by Heaven from the received only the theory of essence, vital force, and spirit which were acquired after birth and worked mainly on realistic activity of life. 3) Huh-loon accepted Do-In-Bup(導引法) sharply as a method to prevent and cure diseases. 5. Huh-loon's medical thoughts on remedial aspects are as 1) Naekyung was considered so important in Dong-Eui-Bo-Kham that not only each paragraph was begun with the Quotations from Nackyung but also the edited order of the content of the book the same with that of Naekyung. And differently from the former korean medical books he accepted at large and recorded the theories of the four noted physicians of the Geum-Won era(金元四大家) by Dong-Eui-Bo-Kham. 2) For the first time, Huh-Joon introduced the theory of Un-Ki (運氣論) in the Dong-Eui-Bo-Kahm. However, he accepted it as a pathological function of human body but he did not apply physical constitution, physiological function, pathological function, and remedial methods. 3) Huh-loon liked to use Hyang Yak that he recorded korean name of Hyang Yak(鄕名), places of the production(産地), the time of collecting(採取時月), and the way of drying herbs(陰陽乾正法) in the remedial method of a single medicine prescription for diseases at the end of each paragraph. By doing so, he developed, arranged, and revived Hyang Yak. 4) He believed that since the natural features of China were different from those of Korea the reasons of being attacked with its remedial methods couldn't be the same with different from Chinese medical books which primarily focused on paralysis and the injury of the cold has his own structure in his book that he founded independent science of this nation. He consulted enormous documents He discovered and wrote the theory and therefore concrete methods for diseases so that the book hadthe principles of outbreak of diseases(理), methods of cure(法), prescription(方), and a single medicine prescription(藥) and set system of medical science in a good order. By doing so, he and pragmatic development of medical science.

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Comparison of Subjective Symptoms of Fatigue and Salivary pH among Teachers between Special School and Elementary (피로자각증상(疲勞自覺症狀)과 타액(唾液) pH에 관(關)한 조사연구(調査硏究) - 특수학교(特殊學校) 및 국민학교(國民學校) 교사군간(敎師群間)의 비교(比較) -)

  • Lee, Soon-Ja;Kim, Doo-Hie
    • Journal of Preventive Medicine and Public Health
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    • v.22 no.4 s.28
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    • pp.506-517
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    • 1989
  • Two hundred and fifty teachers of special school (for the disabled) and 414 elementary school teachers were selected for the targets in order to compare their degrees of fatigue symptoms and to find what kind of ralationship is between subjective symptoms of fatigue and pH is the saliva. It was 30 minutes before their closing hours on April 21th, 1989 that their physical, mental and neuro-sensory symptoms and salivary pH were examined. The test results are summarized as fallows : It is observed that an interrelation between subjective fatigue and pH in their saliva shows a significant relationship between physical and neuro-sensory symptoms in a sense of statistics. The rate of subjective fatigue complained by the special teachers is higher than that by the elementary teachers. In the case of salivary pH, the special teachers' is as a whole lower than the elementary teachers'. The complain rates in each item, checked, of special teachers are generally higher than those of the elementary teachers. It is in the mental symptom related item that there are many sub-items which show significant difference. According to the average of salivary pH based on the degrees of complained symptoms shown in the pH related items, the salivary pH of the group with complained symptoms is lower than that of the group without complained symptoms. In the rate of complaints, by sex, both sexes of the special teachers show high ones, but salivary pH is low. The complain rate of mental symptoms shown by female group from the special teacher Is significantly higher(p<0.05). By age, the group in their thirties from the special teachers show the higher complain rate of mental symptoms (29.3%) and the lower salivary pH (p<0.05) than that (15.1%) of the elementary teachers belonging to the same age catagory. However, the special teachers in their forties show the lower complain rate of physical symptoms that of the elementary teachers (p<0.05). From the viewpoint of their working years, the special teachers below 14 years and elementary teachers above 15 years in their career show high complain rates. Among those who belong to the catagory of 10-14 working years, the special teachers show the higher complain rate of mental symptoms than that of their counterparts. In the case of the salivary pH, the special teachers of all working-year catagories show the higher pH than that of the elementary teachers. But there is not significantly difference. From the viewpoint of sleeping hours in the previous night of the questionaire surveyed, among those who slept for over 7 hours, the special teachers show the higher complain rate of mental symptoms with a significant difference, but the lower salivary pH than that of their counterparts. From the viewpoint of their marital status, existence of disease history, the special teachers show the higher complain rate of subjective fatigue, but the lower salivary pH than that of the elementary teachers respectively. According to the above results, the special teachers generally show the higher complain rate of subjective fatigue, the lower salivary pH, and the higher complain rate of mental symptoms. To prevent the possible accumulation of mental fatigue of the special teachers, ways and means to make use of leisure time, recreational facilities are necessarily provided. Since the degree of fatigue and salivary pH have a correlation to some extent, it is necessary that further continuous studies on the correlation between the degrees of fatigue and salivary pH should be pursued.

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A Survey on the Perception of the Counterplans of Medical Accident and Dispute of Dental Hygienist (의료사고 및 의료분쟁에 대한 치위생사의 인식도 조사)

  • Oh, Jin-Ho;Kwon, Jeong-Seung;Ahn, Hyoung-Joon;Kang, Jin-Kyu;Choi, Jong-Hoon
    • Journal of Oral Medicine and Pain
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    • v.32 no.1
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    • pp.9-33
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    • 2007
  • In the field of dentistry, there existed relatively few emergency patients or patients who need intensive care and thus had low medical dispute rates. However, these days, there is a general tendency of increased medical disputes. Although many medical disputes are caused by medical accidents of the dentists, because dental assistants are also lawfully involved in practicing dentistry, there is a possibility of medical disputes or medical accidents caused by dental assistants. Therefore, the role of the dental assistants cannot be ignored. This study consists of a survey given to dental hygienists currently working in general hospitals, dental hospitals and private dental clinics. Following is the results of the analysis of 275 respondents' backgrounds, medical disputes rates including patients' complaints, their understanding of medical regulations and their general understanding of overall dental practice and medical disputes. 1. 251 of 274(91.6%) respondents doubted the risk of medical accident and dispute. 2. 81(29.5%) dental hygienist experienced complaint from patients. They have been working in the private dental clinic, the rate of this experience was high. 3. 349 case of 1805(19.3%) the complaints by patients, highest percentage among its category, were those regarding dental fees and poor service. 4. 129 case of 1805(7.1%) patients' complaints, highest percentage among it's subcategory, were those regarding the absence of explanations of precautions or request of agreements before dental treatment. 5. 252 of 267 (94.4%) dental hygienists chart after a scaling treatment. However, only 55(20.7%) dental hygienists chart the fact of explaining the precautions. 6. 6(2.2%) dental hygienists do not inspect patients' medical history, if patients don't mention it. 7. 104 of 274(38.0%) dental hygienists responded to be capable of administering first aid treatment. 8. 115(41.8%) dental hygienists have a first aid kit and equipment. 9. In case of medical dispute, 268(97.8%) dental hygienists respond that, charting plays a big role in resolving the dispute. 10. In case of medical dispute, 272(93.3%) dental hygienists respond that, explanation and agreement before treatment have an important role in settlement of dispute 11. Only 160(58.4%) dental hygienists responded correct answer that the duration of keeping medical records is 10 years. 12. 124(45.3%) respondents thought that it is legal for a dental hygienist to take a panoramic dental X-ray, 71(25.9%) respondents thought that it is legal practice cervical resin treatment by dental hygienist, and 37(13.5%) respondents thought that it is legal extract primary teeth by dental hygienist. 13. 24(18.76%) respondents thought that it doesn't matter to tell patient's state to others 14. 272(99.27%) responded that receiving education for the prevention of medical disputes was needed and of them, 61.0% thought it was urgent. 15. 186(64.2%) has never had classes regarding the prevention of medical disputes while in school and 212(77.4%) has not had the same type of classes after graduating from school. 16. 256(93.4%) responded that there will be even more of an increased number of medical disputes. Among them, 83.3% of respondents though that due to the increased opportunity of acquiring information through the internet and mass media. The study shows that 29.5 percentage of dental hygienists have experienced the medical disputes and complaints and they are lack of recognition of medical regulations and dental hygienist's official duty. So, there is a big potential of the percentage to increase. Therefore, the correct understanding of explaining precautions and requesting agreement before dental treatments and performing them are mandatory. Moreover, classes regarding the prevention and counterplans of medical disputes need to be widely offered.

Clinical Observation about the Extent of Improvement of Low Back Pain Patient through Medi-acupuncture Therapy (약침치료(藥鍼治療)를 통한 요통환자(腰痛患者)의 호전도(好轉度)에 관한 임상적(臨床的) 관찰(觀察))

  • Yook, Tae-Han
    • The Journal of Korean Medicine
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    • v.16 no.1 s.29
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    • pp.184-197
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    • 1995
  • After 45 patients examined as to the result of medical treatment among the ones who came to Dept. of Pain Clinic, Oriental Medical Hospital, Chunju Woosuk University complaining low back pain chiefly from Dec/19/1994 to Feb/7/1995 for 50 days or so were observed clinically, the results were obtained as follows: 1. In duration of the case history, acute stage(37.8%) was the most predominant, and subacute stage(35.6%) and chronic stage(26.7%) were revealed in turn. 2. In opinions of radiation, Spondylosis(26.7%) was the most predominant, Scoliosis(15.6%) and HIVD(11.1%) were revealed in order, and 3 cases were revealed to be negative. 3. In the radiating pain of the lower limb, the radiating pains of the left lower limb were the most predominant and those of the right lower limb and those of both lower limbs were revealed in turn. By the way, 31.1% of patients didn't suffer from the radiating pain of the lower limb. 4. In the grade of the seriousness of subsective symptom, Grade 2(66.7%) was the most predominant, and Grade 3, Grade 4, and Grade 1 followed it in order. 5. In the period of the treatments of medi-acupuncture, 2-5 day treatments(31.1%) were major and 6-10 day treatments(26.7%), 16-20 day treatments(11.1%), 26-30 day treatments(11.1%), over 31 day treatments(11.1%), 11-15 day treatments(4.4%), and 21-25 day treatments(4.4%) followed it by turns. Thus 2-10 day treatments are 57.8% and under 30 day treatments are 57.8% of all. 6. In the frequency of use of each medi-acupuncture, V was most frequency used in 41 cases(91.1%), and 11 cases of HN(24.4%), 8 cases of MOK(17.8%), 4 cases of OK(8.9%), 2 cases of B(4.4%), and a case of I(2.2%) were revealed in turn. 7. In the effect of treatments, 10 cases(22.2%) were excellent, 25 cases(55.6%) were good, 5 cases(11.1%) were fair, and 5 cases(11.1%) were poor. As the result, 88.9% of all changed for the better and all of these were improved within the third trial. 8. The effect of the treatments per durations was 100% in acute stage, 93.8% in subacute stage, and 66.7% in chronic stage. According to that, it was reavealed that the rate of treatments decreased as it came near to the chronic stage. 9. The effect of treatments per radiating pains was 87.5% in the radiating pains of the left lower limb, 81.8% in those of the right lower limb, 100% in those of both lower limbs, and 92.9% in case that patients have no radiating pains. So in the rate of treatments on radiating pains of the lower limbs, the case of both sides or no radiating pains was higher than that of one side. 10. In the effect of treatments per the condition of patients, Grade 4 showed 100% of improvement, Grade 3 showed 90.9% of improvement, Grade 2 showed 86.7% of improvement, and Grade 1 showed 100% of improvement. 11. In the effect of treatments per contents of treatments, the group treated with medi-acupuncture therapy, herb medication therapy, acupuncture therapy, and physiothrapy at the same time(Group 1) showed 100% of improvement, the group treated with medi-acupuncture therapy, acupuncture therapy, and physiotherapy simultaneously(Group 2) showed 73.7% of improvement, and the group treated with medi-acupuncture therapy and acupuncture therapy at the same time(Group 3) showed 100% of improvement. 12. 2-5 day treatments showed 78.6% of improvement, 6-10 day treatments showed 91.7% of improvement, and over 31 day treatments showed 100% of improvement. As the result, genarally the longer the period of treatment was, the better the effect of treatment was. 13. When only V was used, the rate of treatment was 96.2%. When only HN was used, the rate of treatment was 100%. When only MOK was used, the rate of treatment was 100%. When V and HN were used at the same time, the rate of treatment was 33.3%. When V and MOK were used at the same time, the rate of treatment was 100%. When V and OK were used at the same time, the rate of treatment was 100%. When V, HN, and MOK were used at the same time, the rate of treatment was 100%. When V, OK, and MOK were used at the same time, the rate of treatment was 100%. When V, MOK, and B were used at the same time, the rate of treatment was 100%. When V, HN, OK, and I were used at the same time, the rate of treatment was 100%. When V, HN, and B were used at the same time, the rate of treatment was 100%.

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A Study on Prescription and Management of Medicines by School-Nurses (양호교사(養護敎師)의 투약(投藥) 및 의약품관리(醫藥品管理) 실태(實態))

  • Kim, Jung Hee;Park, Jae Yong;Cha, Byung Jun
    • Journal of the Korean Society of School Health
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    • v.11 no.2
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    • pp.297-307
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    • 1998
  • The purpose of this paper is to understand the prescription and management of medicines by school-nurses. A survey was mailed to 199 school-nurses in elementary and secondary schools in Pusan from February 10 to March 31, 1997. It was shown that 97.0% of the schools have visiting school-doctors and only 29.6% have visiting school-pharmacists. 36.7% of the respondents don't know the amount of this annual health-related budget. Concerning the annual budget of purchasing medicines, 50.4% of the elementary schools spend 210,000 won to 400,000 won and 45.0% of the secondary schools spend more than 610,000 won. 56.3% of the respondents said the budget was enough, but 5% said it was not. 70.9% of the schools purchase medicines twice a year. The average number of students visiting the nurse in a year are 1,892 in elementary schools, 1.6 times per student and 2,471 in secondary schools, 1.7 times per student, respectively. The annual average number of students who were prescribed medicine a year are 1,804 in elementary schools, 1.5 times per student, 2,372 in secondary schools, 1.7 times per student. The percentage of students who are prescribed internal medicines was 45.5% in elementary, schools and 61.3% in secondary schools, respectively. To the preralence sicknesses, the wound was the most common, accounting for 42.7% in elementary and 22.6% in secondary schools. Next was abdominal pain, indigestion, and headaches in elementary schools; and colds, indigestion, and abdominal pain in secondary schools, respectively. To the dirersity of medicines prescribed: internal medicines 29 for abdominal pain, 25 for indigestion, 8 for physiological pain, 13 for headaches, 30 for colds, and 10 for eye disease; external medicines 2 for skin disease, 10 for toothaches and 31 for other sicknesses. 42.7% of the respondents said the schools have enough medicines, but 7.6% said that schools need more. 50.8% of the respondents said they get information on medicines from TV advertisements or medicine-related books, 16.6% get information from visiting pharmacists. More experienced nurse-teachers are likely to get information from visiting pharmacists, but 37.5% of the respondents who have less then four year experience in school get information through other nurse-teachers before deciding to buy medicines. To the choice of medicines: 83.9% of the respondents said that they choose safe medicines with less side-effects. 40.7% responded that they write down the prescription history daily, but 6.1% said they do this only once in two or three months. To the confidence in prescriptions, 37.7% of the respondents said they are sure of the effectiveness of the medicines they prescribe. To what extent the nurse-teachers prescribe, 50.3% said they prescribe to the level of anagelics, and 21.1% prescribe to anti-histamines and antibiotics. 80.4% said that the details of illnesses and medicines to be prescribed in school should be regulated by a school health-care law. To the problems in prescription, 79.9% of the respondents worry about abuse by students who want prescriptions but have no serious illnesses, 57.8% worrg about the lack of information on medicines and dosage. And 55.8% said they can't tell the difference between medicines whose brands are different, but bare the same ingredients. The conclusion of this study is that a health education program is necessary to prevent the misuse or abuse by students and a continuing education program for school-nurses is needed to solve the problems related to the purchasing and prescription of medicines. The criteria of the prescription of medicines also should be regulated by a school health-care law or management acts.

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A Review on Constitutional Discordance Adjudication of the Constitutional Court to Total Ban on Abortion ('낙태죄' 헌법재판소 헌법불합치 결정의 취지와 법률개정 방향 - 헌법재판소 2019. 4. 11. 선고 2017헌바127 전원재판부 결정에 따라 -)

  • Lee, Seok-Bae
    • The Korean Society of Law and Medicine
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    • v.20 no.2
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    • pp.3-39
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    • 2019
  • Even after the Constitutional Court decided on August 23, 2012 that the provisions of abortion were constitutional, discussions on the abolition of abortion continued. The controversy about abortion is not only happening recently, but it has already existed since the time when the Penal Code was enacted, and it shares the history of modern legislation with the Republic of Korea. Legislators whom submitted amendment while insisting upon the eradication of abortion in the process of enacting criminal law at that time, presented social and economic adaptation reasons as the core reason. From then on, the abolition of abortion has been discussed during the development dictatorship, but this was not intended to guarantee women's human rights, but it was closely connected to the national policy projects of "Contraception" and "Family Planning" of the Park's dictatorship. Since then, the enactment of the Mother and Child Health Law, which restrictively allow artificial abortion, was held on February 8, 1973, in an emergency cabinet meeting that replaced the legislative power after the National Assembly was disbanded. It became effected May 10th. The reason behind the Mother and Child Health Law that included legalization of abortion in part was that the Revitalizing Reform at that time did not allow any opinion, so it seem to be it was difficult for the religious to express opposition. The "Maternal and Child Health Law" enacted in this way has been maintained through several amendments. It can be seen that the question of maintenance of abortion has been running on parallel lines without any significant difference from the time when the Penal Code was enacted. On August 23, 2012, the Constitutional Court decided that the Constitutional Opinion and the unonstitutional Opinion were 4: 4. However, it was decided by the Constitution without satisfying the quorum for unconstitutional decision of the Constitutional Court. This argument about abolition of abortion is settled for the the time being with the decision of the constitutional inconsistency of the Constitutional Court, and now, the National Assembly bears the issue of new legislation. In other words, the improved legislation must be executed until December 31, 2020, and if the previous improved legislation is not implemented, the crime of abortion (Article 269, Paragraph 1, Article 270 of the Criminal Code) Article 1 (1) will cease to be effective from 1 January 2021. Therefore, in the following, we will look into the reason of the Constitutional Court's constitutional discordance adjudication on criminal abortion(II), and how it structurally differs from the previous Constitutional Court and the Supreme Court. After considering key issues arised from the constitutional discordance adjudication(III), the legislative direction and within the scope of legislative discretion in accordance with the criteria presented by the Constitutional Court We reviewed the proposed revisions to the Penal Code and the Mather and Child Health Act of Korea(IV).

Critical Essay on the Notice of the Price Adjustment of Generic Drugs (제네릭 의약품 약가 조정 고시에 대한 비판적 고찰)

  • Park, Jeong Yeon
    • The Korean Society of Law and Medicine
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    • v.22 no.1
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    • pp.91-124
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    • 2021
  • In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

Reevaluation of Clinical Efficacy of Peripheral Vasodilator: Ethaverine HCl (말초혈관(襪梢血管) 확장제(擴張劑) Ethaverine HCl의 임상효과(臨床效果)의 재평가(再評價))

  • Kim, Yoon-Young;Cho, Young-W.
    • The Korean Journal of Pharmacology
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    • v.11 no.1 s.17
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    • pp.33-38
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    • 1975
  • The clinical efficacy of Ethaverine, a peripheral vasodilator, was studied according to a double-blind, non-cross over method in 29 diabetic patients with peripheral arterial diseases. The clinical improvement was assessed from the history of patients including the incidence and frequency of intermitten claudication. Ethaverine, after 4 weeks of therapy, was not effective in improving clinical symptoms compared to placebo. Ethaverine, however, was an efective vasodilator than placebo. The quality of vasodilation induced by Ethaverine, was similar to that of alcohol. A new clinical method of studying peripheral vasodilator was presented. The clinical symptoms of peripheral vascular arterial disease in the lower extrimities include reduced intensity of palpable pulses, coldness, and discoloration of the skin. Intermittent claudication may be present. Pathologic changes in vessel architecture precede the symptoms, and recognition of impending vascular insufficiency is a determining factor in selecting vasodilating therapy or surgical management. Also, post-operative patients who have chronic peripheral vascular arterial disease may be candidates for subsequent vasodilating therapy. Peripheral vasodilators, according to the series of reports, may be indicated in vasospastic peripheral vascular condition rather than an occlusive vascular disease and the vessel responds best when a relatively large vascular beds are involved rather than a small, capillary beds. Recently, the clinical efficacy of peripheral vasodilators have been challanged by many clinical investigators and clinicians. In this study, we have re-evaluated the efficacy of Ethaverine HCl as peripheral vasodilator in patients with vasospastic peripheral arterial disease. Ethaverine is claimed to be two to four times as potent a spasmolytic agent as papaverine in a variety of laboratory and clinical work.

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