• 제목/요약/키워드: emergency medicine

검색결과 2,478건 처리시간 0.027초

가정간호 서비스 질 평가를 위한 도구개발연구 (A basic research for evaluation of a Home Care Nursing Delivery System)

  • 김모임;조원정;김의숙;김성규;장순복;유호신
    • 가정간호학회지
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    • 제6권
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    • pp.33-45
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    • 1999
  • The purpose of this study was to develop a basic framework and criteria for evaluation of quality care provided to patients with the attributes of disease in the home care nursing field, and to provide measurement tools for home health care in the future. The study design was a developmental study for evaluation of hospital-based HCN(home care nursing) in Korea. The study process was as follows: a home care nursing study team of College of Nursing. Yonsei University reviewed the nursing records of 47 patients who were enrolled at Yonsei University Medical Center Home Care Center in March, 1995. Twenty-five patients were insured at that time, were selected from 47 patients receiving home care service for study feasibility with six disease groups; Caesarean Section (C/S), simple nephrectomy, Liver cirrhosis(LC), chronic obstructive pulmonary disease(COPD), Lung cancer or cerebrovascular accident(CVA). In this study, the following items were selected : First step : Preliminary study 1. Criteria and items were selected on the basis of related literature on each disease area. 2. Items were identified by home care nurses. 3. A physician in charge reviewed the criteria and content of selected items. 4. Items were revised through preliminary study offered to both HCN patients and discharged patients from the home care center. Second step : Pretest 1. To verify the content of the items, a pretest was conducted with 18 patients of which there were three patients in each of the six selected disease groups. Third step : Test of reliability and validity of tools 1. Using the collected data from 25 patients with either cis, Simple nephrectomy, LC, COPD, Lung cancer, or CVA. the final items were revised through a panel discussion among experts in medical care who were researchers, doctors, or nurses. 2. Reliability and validity of the completed tool were verified with both inpatients and HCN patients in each of field for researches. The study results are as follows: 1. Standard for discharge with HCN referral The referral standard for home care, which included criteria for discharge with HCN referral and criteria leaving the hospital were established. These were developed through content analysis from the results of an open-ended questionnaire to related doctors concerning characteristic for discharge with HCN referral for each of the disease groups. The final criteria was decided by discussion among the researchers. 2. Instrument for measurement of health statusPatient health status was measured pre and post home care by direct observation and interview with an open-ended questionnaire which consisted of 61 items based on Gorden's nursing diagnosis classification. These included seven items on health knowledge and health management, eight items on nutrition and metabolism, three items on elimination, five items on activity and exercise, seven items on perception and cognition, three items on sleep and rest, three items on self-perception, three items on role and interpersonal relations, five items on sexuality and reproduction, five items on coping and stress, four items on value and religion, three items on family. and three items on facilities and environment. 3. Instrument for measurement of self-care The instrument for self-care measurement was classified with scales according to the attributes of the disease. Each scale measured understanding level and practice level by a Yes or No scale. Understanding level was measured by interview but practice level was measured by both observation and interview. Items for self-care measurement included 14 for patients with a CVA, five for women who had a cis, ten for patients with lung cancer, 12 for patients with COPD, five for patients with a simple nephrectomy, and 11 for patients with LC. 4. Record for follow-up management This included (1) OPD visit sheet, (2) ER visit form, (3) complications problem form, (4) readmission sheet. and (5) visit note for others medical centers which included visit date, reason for visit, patient name, caregivers, sex, age, time and cost required for visit, and traffic expenses, that is, there were open-end items that investigated OPD visits, emergency room visits, the problem and solution of complications, readmissions and visits to other medical institution to measure health problems and expenditures during the follow up period. 5. Instrument to measure patients satisfaction The satisfaction measurement instrument by Reisseer(1975) was referred to for the development of a tool to measure patient home care satisfaction. The instrument was an open-ended questionnaire which consisted of 11 domains; treatment, nursing care, information, time consumption, accessibility, rapidity, treatment skill, service relevance, attitude, satisfaction factors, dissatisfaction factors, overall satisfaction about nursing care, and others. In conclusion, Five evaluation instruments were developed for home care nursing. These were (1)standard for discharge with HCN referral. (2)instrument for measurement of health status, (3)instrument for measurement of self-care. (4)record for follow-up management, and (5)instrument to measure patient satisfaction. Also, the five instruments can be used to evaluate the effectiveness of the service to assure quality. Further research is needed to increase the reliability and validity of instrument through a community-based HCN evaluation.

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기초간호자연과학의 병태생리학, 병원미생물, 약물의 기전과 효과 내용별 필요도에 대한 연구 (A study on the degree of need of the knowledge of pathophysiology, clinical microbiology and mechanisms and effects of drugs in clinical nurses)

  • 최명애;변영순;서영숙;황애란;김희승;홍해숙;박미정;최스미;이경숙;서화숙;신기수
    • Journal of Korean Biological Nursing Science
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    • 제2권1호
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    • pp.1-19
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    • 2000
  • The purpose of this study was to define the content of the requisite knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs needed for clinical knowledge for nursing practice. Contents of knowlege on pathological physiology, clinical microbiology, and mechanisms and effects of drugs were constructed from syllabus of basic nursing subjects in 4 colleges of nursing, and textbooks. The degree of need of 72 items was measured with a 4 point scale. The subjects of this study were college-graduated 136 nurses from seven university hospital in Seoul and three in Chonnam Province, Kyungbook Province, and Inchon. They have been working at internal medicine ward, surgical ward, intensive care unit, obstetrics and gynecology ward, pediatrics ward, opthalmology ward, ear, nose, and throat ward, emergency room, rehabilitation ward, cancer ward, and hospice ward. The results were as follows : 1. The highest scored items of the knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs necessary for nursing practice were side effects of drugs, anticoagulants, mechanisms of drugs, antihypertensive drugs, tolerance and addiction of drugs, interactions among drugs, hospital infection in the order of importance. The lowest scored item was structure of microorganisms. 2. The highest order of need according to unit was repair in tissue injury unit, definition etiology classification of inflammation in inflammation unit, transplantation and immunologic response in alterations in immunity unit, thrombus and thrombosis in disorders of cardiovascular function unit, gene disorders in genetic disorders unit, hospital infection in infection unit, virus in microorganisms unit, side reactions of drugs in introduction unit, anticonvulsants in drugs for central nervous system unit, local anesthesia in anesthesia unit, anticoagulants in drugs for cardiovascular system unit, anti-inflammatory drugs in antibiotics unit, anti-ulcer drugs in drugs for digestive system unit, and bronchodilators in drugs for respiratory system unit. 3. The common content of the knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs needed for all clinical areas in nursing were side effects of drugs, anticoagulants, interactions among drugs, and hospital infection. However, the degree of need of each pathological physiology, clinical microbiology, clinical microbiology, and mechanisms and effects of drugs was different depending on clinical areas. 4. Significant differences in the knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs necessary for nursing practice such as tissue changes due to injurious stimuli, degenerative changes of tissue, alterations in metabolism of carbohydrates, ischemia, hyperemia and congestion, hospital infection, structure of microorganism, classification of microorganism, bacteria, virus, antidepressants, antipsychotic drugs, antiemetic drugs, antiparkinsonism drugs, antianxiety drugs, antibiotics, tuberculostatics, antiviral drugs, antifungal drugs, parasiticides, antiulcer drugs, antidiarrheais, and anti constipation drugs were shown according to the work area. 5. Significant differences in the knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs necessary for nursing practice such as transplantation and immunologic response, alterations in the metabolism of uric acid, structure of microorganism, classification of microorganism, immunosuppressants, drugs for congestive heart failure were demonstrated according to the duration of work. Based on these findings, all the 72 items constructed by Korean Academic Society of Basic Nursing science should be included as contents of the knowledge of pathophysiology, clinical microbiology, and mechanisms and effects of drugs.

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심장 스텐트 시술과 의료사고 예방 (Cardiac Intracoronary Stenting vs CABG: Prevention of Medical Accident)

  • 김경례;박국양
    • 의료법학
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    • 제18권2호
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    • pp.163-194
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    • 2017
  • 관상동맥 질환은 2017년 고령사회로 진입한 우리나라에서 앞으로 더 많은 관심을 가질 것이다. 고령화가 될수록 고혈압, 당뇨 등 복합적인 질환이 합병되어 혈관상태도 상대적으로 더 나빠져 관상동맥 질환에 걸릴 가능성이 높기 때문이다. 심혈관 질병은 심장외과와 심장내과와의 긴밀한 협진이 필요하다. 따라서 협심증이나 심근경색증환자를 먼저 진료하게 되어 있는 우리나라의 임상현장에서 객관적인 심장내과 의사의 치료방침에 대한 판단은 매우 중요하다. 최근 심장내과의 비수술적 중재술이 발전하고 있지만 무리한 스텐트 시술로 의료사고도 발생하고 있다. 특히 관상동맥 3개혈관이 모두 막힌 삼중혈관이거나 석회화가 심해 혈관 상태가 좋지 않은 경우가 문제이다. 또한 심장외과 의사가 없는 병원에서 무리하게 경피적관상동맥중재술을 실시하다가 응급상황이 발생할 경우 관상동맥이식술 등 외과적 대처가 어려운 경우가 종종 발생한다. 최근 2년간 한국소비자원(소비자분쟁조정위원회) 의료분쟁 조정결정 8사례를 분석한 결과, 심장 중재술을 시행한 병원 중 심장외과 의사가 상주한 곳은 2곳으로 확인됐다. 8사례 모두 심장내과 진료 후 풍선확장술 및 스텐트 삽입한 경우로 7명이 사망했고 이중 5명은 시술 당일에 사망했다. 8사례 중에 3중혈관 환자는 5건이고, 나머지도 석회화가 심하거나 완전폐쇄로 혈관상태가 좋지 않은 상태였다. 2017년 심장내과 스텐트 시술 건수 조사 보고에 의하면 3개 이하 약물 방출 스텐트 시술이 98%로 보고됐다. 2015년 스텐트 시술 건수가 38,922건으로 약800건(2%)은 스텐트가 4개 이상 사용된 것으로 추정된다. 무리한 스텐트 시술로 마지막 여명에 급사함으로써 신변정리 기회상실은 물론 여명단축에 따른 손해로서 '지도 설명의무' 책임을 물어 전 손해에 대한 배상을 신중하게 고려할 필요가 있다. 최근 심평원 보험적용 스텐트 시술 개수 제한규제가 없어지면서 무리한 시술과 심장외과 의사 확충에 대한 문제가 있다. '다학제통합진료' 같은 병원차원의 해결방안은 물론 필수요원에 해당하는 심장외과를 공무원으로 확충하는 등 국가차원의 해결방안이 요구된다.

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배양림프구에서 Paraquat의 세포독성에 대한 Vitamin C와 Deferoxamine의 항산화 효과 (The Antioxidant Effect of Vitamin C and Deferoxamine on Paraquat-induced Cytotoxicity in Cultured Lymphocytes)

  • 어은경;김경희
    • 대한임상독성학회지
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    • 제4권1호
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    • pp.7-16
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    • 2006
  • Purpose: As basic information of antioxidant treatments for the patient with paraquat intoxication, in human peripheral lymphocytes, the cytotoxicity of paraquat was measured, and to evaluate the antioxidant effect of vitamin C and deferoxamine against this cytotoxicity, malondialdehyde (MDA), superoxide dismutase (SOD) activity and total antioxidant status (TAS) were measured. Methods: From 10 healthy adults, after obtaining a consent, 20ml peripheral blood was collected. Experimental groups were divided to (1) control group, the group treated with an identical amount of saline, (2) P group: the group treated with paraquat only, (3) PV group: the group treated with paraquat followed by vitamin C 30 minutes later, (4) PD group: the group treated with paraquat followed by deferoxamine 30 minutes later, (5) PVD group: the group treated with paraquat followed by vitamin C 30 minutes later and subsequently deferoxamine one hour later, and (6) PDV group: the group treated with paraquat followed by deferoxamine 30 minutes later and subsequently vitamin C 1 hour later, and thus to total 6 groups. In each group, 10 samples of peripheral blood was assigned and $100{\mu}M\;paraquat,\;100{\mu}M$ vitamin C, and $100{\mu}M$ deferoxamine were used as reagent. Lymphocytes were isolated, cultured, and cytotoxicity was measured by the Microculture Tetrazolium method (MTT assay), MDA and SOD activity, and TAS concentration were measured. Results: In regard to the cytotoxicity measured in each group, their cytotoxicity was decreased in the group treated with antioxidants, in comparison with the group treated with paraquat only. In the cases that the order of the treatment of these two antioxidants was altered, viability in the PDV group $(1.077{\pm}0.121)$ was increased more that the PVD group $(0.888{\pm}0.152)$ statistically significantly (p=0.018). Concerning the amount of MDA, in comparison with the P group $(6.78{\pm}0.93{\mu}mol/L)$, after the treatment of each antioxidant, the concentration of MDA was decreased statistically significantly (p<0.05). In the group treated with two antioxidants together, in comparison with the group treated only with one antioxidant, the amount of MDA was increased statistically significantly $(PV:\;3.96{\pm}0.98{\mu}mol/L,\;PD:\;4.92{\pm}1.50{\mu}mol/L,\;PVD:\;3.22{\pm}0.83{\mu}mol/L,\;and\;PDV:\;3.42{\pm}0.95{\mu}mol/L,\;p=0.007)$. The concentration of SOD measured in the blood in each group after the administration of paraquat, in comparison with the control group, a pattern of the elevation of SOD activity and subsequent decrease was detected, however, it was not statistically significant. In the comparison of the groups treated with antioxidants, in comparison with the P group $(1419.9{\pm}265.9{\mu}mol/L)$, SOD activity was decreased statistically significantly in only the PDV group $(1176.4{\pm}238.9{\mu}mol/L)$ (p=0.017). In regard to TAS measured in each group, in comparison with the P group $(0.87{\pm}0.05{\mu}mol/L)$, in all groups treated with the antioxidants, the PV group was $1.00{\pm}0.03{\mu}mol/L$ (p=0.005), the PD group was $9.01{\pm}0.24{\mu}mol/L$ was $4.64{\pm}3.98{\mu}mol/L$ (P=0.005), and the PDV group was $9.41{\pm}0.27{\mu}mol/La$ (p=0.005), and thus total antioxidant activity was increased statistically significantly In a multiple comparison test, the PDV group showed the highest total antioxidant activity (p<0.0001). Conclusion: The result of the assessment of the antioxidant effect of vitamin C and deferoxamine on paraquat-induced cytotoxicity showed that in regard to cytotoxicity, SOD activity and TAS measurement, the best result was observed in the PDV group. Therefore, it was found that vitamin C and deferoxamine were effective antioxidants for the paraquat-induced cytotoxicity, and it suggests that the administration of deferoxamine followed by vitamin C may improve their antioxidant effect more.

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기초간호자연과학의 인체구조와 기능 내용별 필요도에 대한 연구 (A Study on the Degree of Need of Human Structure and Function Knowledge in Clinical Nurses)

  • 최명애;변영순;서영숙;황애란;김희승;홍해숙;박미정;최스미;이경숙;서화숙;신기수
    • Journal of Korean Biological Nursing Science
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    • 제1권1호
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    • pp.1-24
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    • 1999
  • The purpose of this study was to define the content of requisite human structure and function knowledge needed for clinical knowledge of nursing practice. Subjects of human structure and function were divided into 10 units, and each unit was further divided into 21 subunits, resulting in a total of 90 items. Contents of knowledge of human structure and function were constructed from syllabus of basic nursing subjects in 4 college of nursing, and textbooks published by nurse scholars prepared with basic nursing sciences. The degree of need of 90 items was measured with a 4 point scale. The subjects of this study were college graduated 136 nurses from seven university hospitals in Seoul and three university hospitals located in Chonnam Province, Kyungbook Province, and Inchon. They have been working at internal medicine ward, surgical ward, intensive care unit, obstetrics and gynecology ward, pediatrics ward, opthalmology ward, ear, nose, and throat ward, emergency room, rehabilitation ward, cancer ward, hospice ward, and their working period was mostly under 5 years. The results were as follows: 1. The highest scored items of human structure and function knowledge necessary for nursing practice were electrolyte balance, blood clotting mechanism and anticoagulation mechanism, hematopoietic function, body fluid balance, function of plasma, and anatomical terminology in the order of importance. The lowest scored items of human structure and function knowledge necessary for nursing practice was sexual factors of genetic mutation. 2. The highest order of need according to unit was membrane transport in the living unit, anatomical terminology in movement and exercise unit, mechanism of hormone function in regulation and integration unit, component and function of blood in oxygenation function unit, structure and function of digestive system in digestive and energy metabolism unit, temperature regulation in temperature regulation unit electrolyte balance in body fluid and electrolyte unit, concept of immunity in body resistance unit, and genetics terminology in genetics unit. The highest order of importance according to subunit was membrane transportation in cell subunit, classification of tissues in tissue unit, function of skin and skin in skin subunit, anatomical derivatives of the skeleton subunit, classification of joints in joint subunit, an effect of exercise on muscles in muscle subunit, function of brain in nervous system subunit, special sense in sensory subunit mechanism of hormone function in endocrine subunit, structure and function of female reproductive system in reproductive system unit, structure and function of blood in blood unit, structure of heart, electrical and mechanical function in cardiovascular system unit, structure of respiratory system in respiratory system subunit, structure and function of digestive system in digestive system subunit, hormonal regulation of metabolism in nutrition and metabolism subunit, function of kidney in urologic system subunit, electolyte balance in body fluid, electolyte and acid-base balance subunit. 3. The common content of human structure and function knowledge need for all clinical areas in nursing was structure and function of blood, hematopoietic function, function of plasm, coagulation mechanism and anticoagulation mechanism, body fluid, electrolyte balance, and acid-base balance. However, the degree of need of each human structure and function knowledge was different depending on clinical areas. 4. Significant differences in human structure and function knowledge necessary for nursing practice such as skin and derivatives of the skin, growth and development of bone, classification of joint, classification of muscle, structure of muscle, function of muscle, function of spinal cord, peripheral nerve, structure and function of pancrease, component and function of blood, function of plasma, structure and function of blood, hemodynamics, respiratory dynamics, gas transport, regulation of respiration, chemical digestion of foods, absorption of foods, characteristics of nutrients, metabolism and hormonal regulation, body energy balance were demonstrated according to the duration of work. 5. Significant differences in human structure and function knowledge necessary for nursing practice such as classification of tissue, classification of muscles, function of muscles, muscle metabolism, classification of skeletal muscles, classification of nervous system, neurotransmitters, mechanism of hormone function, pituitary and pituitary hormone, structure and function of male reproductive organ, structure and function of female reproductive organ, component and function of blood, function of plasma, coagulation mechanism and anticoagulation mechanism, gas exchange, gas transport, regulation of respiration, characteristics of nutrients, energy balance, function of kidney, concept of immunity, classification and function of immunity were shown according to the work area. Based on these findings, all the 90 items constructed by Korean Academic Society of Basic Nursing Science should be included as contents of human structure and function knowledge.

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입원환자의 투약체계와 방법의 개선을 위한 현장연구 (Field Study For The Improvement of Medication System and Method for Inpatients at General Hospital)

  • 유형숙;권영미;송미숙;김형애;박경숙
    • 간호행정학회지
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    • 제1권1호
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    • pp.147-211
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    • 1995
  • Medication is a kind of medical service and a therapeutic nursing function which takes large portion of nursing service and requires complicated procedures. So many different medical personnel should be involved and cooporate each other in order to accomplish medication. Medication is also a vital nursing service, So nurse feels heavy responsibi lity in that she gives medication to the patient finally, so she has much responsibility if medication error is happened. Therefore it seems very important to clarify the problem of medication system and method, and find the subculture of medication situation because it may promote nursing productivity. The study was conducted to 1. Describe and interpret medication situation. 2. Find out the problem of medication system and method and on alternatives. 3. Compare the medication system and method of hospitals which are located in Seoul with object hospital Ethnographic methodology was used to study medication situation by doing participant observation and interview of health care personnel. Ten nurses and three nurse aids were interviewed. Two residents and internists, two phamacists and two accountants were also interviewed. Data was obtained and analized according to Developmental Research Sequence introduced by Spradly. On the basis of this data the results were as follows. 1. The overall flow of medication system was devided into six stage : first, checking doctor's order : second writing doctor's order, : third, transfering slip into the related departments such as account department, pharmacy : fourth, distribution of medication from pharmacy to unit : fifth, identifing medication by nurses : and finally, medicating to the patient. Behaviorors have been under a lot of stress in that they have to do much works, especially paperworks, So too much time were needed. They also have been suffered interpersonal conflicts among health care personnel and role conflicts in the process of doing medication service. 2. In the process of checking order, the problem was that too much time was required for checking order and paperwork. The more the order changes the more the paperwork is. Nurses have been suffering difficulties in calling internist in order to get bill. Even if writing down slip for medication order is doctor's job, Sometimes nurse has been expected to write slip by doctors or nurse would write slip beacuse of two much complexities and efforts for calling doctors. If the slip were incorrect, much time complicated procedures were more required for correcting it. So delay of administering drug would be resulted consequently. Drugs were delivered from pharmacy to units by delivery agent and phamacist. But because drugs were delivered without arranging room number of patient. Nurse should rearrange drugs in order of the room number So it had made waste time and effort, and Even when emergency drugs were needed, Prompt delivery of drug was not easy because of many reasons. For nurses, it took too long in the identification of the right drug. Actually nurses have heavy burden when medication error happens because nurse is the final actor who gives medication to the patient, So every three shift nurse ought to check drugs as soon as every shift begins. That's why it took too much time due to repeated confirming procedure. When nurses had to go patient room in order to give medications, there were difficulties in watching patient until the patient take medicine correctly. So it was impossible to check every patient wheather he took medicine or not especially in hectic situation. 3. There were many hospitals in Seoul which have similar medication system and method as object hospital according to the results of questionaire. This means that many hospitals have been suffering srimilar problems which were identified in object hospital. 4. Recommendations for promoting simplification of medication system and method were the following : Redesigning of slip from two pieces of paper into one : early discharge announcement system, and slip confirming through computer and controlling of period of prescreption from one day to two or three days : designing personal drug storage box for each patient and using it. If nurses follow the recommendations, they will make medication short & simple, and also have enough time of direct nursing care 5. Even though there were many difficulties in medicating patients. Medication itself has been considered as a caring among nurses because it makes rapport between nurse and patient. So nurses had better accept medication as a portion of nusing service not a original portion of phamacist. There are some limits in this research in terms of confining to only one unit of one hospital, and treating it especially in view of nurses' aspects, So further researchs should be continnued from various kmds of viewpoints of doctors, phamacists and so on. ${\cdot\cdot\cdot}$. Especially esthnographic study of computerized medication system and method seems to be followed.

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의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 - (The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 -)

  • 박지혜
    • 의료법학
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    • 제21권1호
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    • pp.223-259
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    • 2020
  • COVID-19가 순식간에 세계적으로 퍼져나가면서 이 바이러스에 대한 치료제 및 백신에 대한 연구 개발 이슈가 뜨겁다. 그 중에서도 렘데시비르(Remdesivir)가 가장 먼저 눈에 띄는 치료효과를 나타내며 본격적인 임상시험에 돌입하였고, 각 국가들은 긴급 승인을 통해 해당 의약품의 사용을 허가하고 있다. 그런데 렘데시비르의 개발사인 주식회사 길리어드는 렘데시비르를 희귀의약품으로 품목허가 신청하여 시민단체들로부터 많은 질타를 받았다. 그 이유는 희귀의약품으로 신약이 품목허가를 취득하는 경우 7년의 독점적 지위를 부여받을 수 있기 때문이다. 희귀의약품에게 장기간 동안 독점적 지위를 부여하는 것은 희귀질환으로 고생하는 환자들에게 치료기회를 부여하기 위해 제약회사에게 개발 동기를 부여하는 정책적 취지로부터 나온 것으로, 감염병 치료제에 적용하기에는 적절하지 않았기 때문이다. 본 논문은 이러한 정책적 의도를 바탕으로 의약품에 독점적 지위를 부여하고 있는 법령에 대하여 미국, 유럽, 일본을 상대로 비교법적 고찰을 통해 국내 제도의 문제점 및 개선 방향에 대해 살펴보는 내용을 담고 있다. 국내 제도는 독점적 지위 부여 방식에 있어 법령에 명시적인 조항을 두고 있지 않고, 재심사제도를 활용하여 우회적으로 독점적 지위를 부여하고 있다는 근본적인 문제를 갖고 있다. 이와 더불어 희귀의약품의 경우 「희귀질환관리법」과 「의약품의 품목허가·신고 심사 규정」에서 중복적으로 재심사기간을 규정하고 있다는 점, 상대적으로 독점기간을 길게 부여하고 있음에도 불구하고 사정변경 발생 시 독점적 지위를 회수할 수 있는 견제 조항이 존재하지 않는다는 점 등이 보완되어야 할 부분으로 보인다. 생물의약품의 경우에는 국내에는 우회적으로라도 의약품의 독점적 지위를 부여할 수 있는 규정이 존재하지 않는다. 생물의약품의 경우 특허를 받기 어렵다는 점에서, 독점권을 부여하는 것이 의약품 개발을 유도하는 큰 동기가 될 수 있음에도 이러한 조항이 없다는 점은 국내 법제의 아쉬운 점이라 볼 수 있다. 미국의 경우 최초의 동등생물의약품에도 1년의 독점기간을 부여한다는 점에 비추어 볼 때, 국내 법제는 생물의약품에 독점적 지위를 부여하는 것에 대하여 상당히 엄격하게 제한하고 있다고 해석된다. 이는 추후 국내 제약사의 생물의약품 개발 의지를 저하시킬 수 있다는 점에서, 또한 국제 규제의 조화를 맞출 필요가 있다는 점에서 국내 제도의 개선의 필요성이 인정된다 할 것이다. COVID-19의 발현을 기회로 삼아, 의약품에 독점권을 부여하고 있는 국내 제도가 가지고 있는 문제점에 대하여 다시 한 번 살펴보고, 통일된 법적 근거를 마련할 수 있도록 관련 법제에 대한 전반적인 개정이 이루어 질 것을 기대해보는 바이다.

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

  • 이석배
    • 의료법학
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    • 제20권2호
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    • pp.3-39
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    • 2019
  • 헌법재판소가 2012년 8월 23일 낙태죄 규정을 합헌으로 결정한 이후에도 낙태죄 폐지에 대한 논란은 지속되어 왔다. 낙태죄의 존폐논란은 최근에만 일어난 일이 아니라 이미 형법제정 당시부터 있었던 것으로, 대한민국의 근대입법과정과 역사를 같이 한다. 당시 형법제정과정에서 낙태죄의 전면삭제를 주장하면서 수정안을 제출했던 의원들은 사회·경제적 적응사유를 핵심적인 제안이유로 제시하기도 하였다. 이후 개발독재기에도 낙태죄의 폐지가 논의되었으나, 이는 여성의 인권을 보장하기 위한 것이 아니라, 박정희 독재정권의 '산아제한', '가족계획'이라는 국책사업과 관련이 있었다. 이후 인공임신중절을 제한적으로나마 허용하는 「모자보건법」의 제정은 유신으로 국회가 해산된 후 입법권을 대신하게 된 비상국무회의에서 1973년 2월 8일 이루어졌고, 1973년 5월 10일부터 시행되었다. 그나마 일부라도 낙태의 합법화를 포함하는 「모자보건법」이 가능했던 배경은 당시 유신독재가 어떠한 이견도 허락하지 않았기 때문에, 종교계에서도 반대 의견을 표명하기 어려웠기 때문일 것으로 보인다. 이렇게 제정된 「모자보건법」은 지금까지 약간의 수정만을 거치며 그대로 유지되어왔다. 낙태죄 존폐론의 논거들도 형법제정 당시와 큰 차이 없이 그대로 평행선을 달려왔다고 볼 수 있다. 2012년 8월 23일 헌법재판소의 결정에서도 합헌의견과 위헌의견이 4:4로 팽팽하게 맞섰었다. 다만 헌법재판소의 위헌결정을 위한 정족수를 채우지 못하여 합헌으로 결정하였다. 이 낙태죄 폐지 논쟁은 이번 헌법재판소의 헌법불합치 결정으로 일단락되었고, 국회는 새로운 입법이라는 과제를 부담한다. 즉 국회는 적어도 2020년 12월 31일까지 개선입법을 이행하여야 하고, 그때까지 개선입법이 이루어지지 않으면 낙태죄조항들(「형법」 제269조제1항, 제270조제1항)은 2021년 1월 1일부터 효력을 상실한다. 따라서 아래에서 우선 형법상 낙태죄 규정에 대한 헌법재판소 헌법불합치 결정의 논거가 무엇인지를 살펴보고(II), 과거의 헌법재판소와 대법원의 논증구조와 어떠한 점에서 차이를 가지는지, 그리고 헌법재판소 헌법불합치 결정에서 나타난 쟁점을 무엇인지를 검토한 후(III), 헌법재판소가 제시한 기준에 따른 입법재량의 범위 안에서 입법방향과 이미 제출된 「형법」과 「모자보건법」의 개정안에 대하여 검토(IV)하였다.

국내 메르스(MERS) 사태가 남긴 과제와 법률에 미친 영향에 대한 소고(小考) (The Study of Effectiveness of MERS on the Law and Remaining Task)

  • 윤종태
    • 의료법학
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    • 제16권2호
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    • pp.263-291
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    • 2015
  • 2015년 5월 중동 사우디아라비아와 아랍에미레이트를 다녀온 68세의 남자가 고열, 근육통, 기침 호흡곤란으로 자택부근 2개 병원)과 삼성서울병원(SMC) 응급실을 거치면서 시작된 메르스(MERS)라는 전염병은 거의 3개월에 걸쳐 최근까지 대한민국을 유행성 전염병의 공포로 몰아넣었다. 특히 이 전염병은 중동지역 아라비아 반도를 중심으로 2012년 9월부터 현재까지 총 26개국에서 1,392명에게 발생하여, 538명의 사망환자가 보고(유럽질병센터, 2015.7.21. 기준)되었고, 우리나라의 경우에도 총 확진자 186명, 사망자 36명(치사율 19.4%) 격리자 16,693명이라는 기록을 남기고 점차 우리의 뇌리에서 사라져가고 있다. 이 전염병의 파급으로 인하여 현 정부의 전염병 관리체계에 대한 많은 비판과 문제점을 제기하는 계기가 되었다. 특히 병원내 감염문제, 민간의료기관-지역 보건소-질병관리본부를 연결하는 감염병 관리전달체계의 미작동, 정부의 전염병과 관련된 정보 공개 거부, 냉난방 공조설비의 환기 등과 관련된 시설문제, 감염병 격리병상의 절대부족 문제, 지역보건소의 기능 및 권한의 제한문제, 격리자 및 의료기관에 대한 보상문제, 제도적으로는 감염병에 대한 건강보험 수가 개선문제, 법정감염병 재분류 문제, 질병관리본부의 역할 재정립 문제, 전염병 관련 전문인력 양성을 위한 제도적 보완문제, 병원 이용문화의 개선으로서 다인실 조정과 간병인 대체문제, 사회적 후유증을 치유하기 위한 정책적 배려문제 등이 있으며, 이에 대한 광범위한 논의와 해결방안이 필요한 때이다. 국민들은 2015년 5월 이전에는 아주 낯설었던 메르스라는 외부유입 전염병에 국가 방역체계가 흔들리는 모습을 보고 극도의 공포감을 느꼈으며, 외국에서는 중동지방을 제외하고는 전세계적으로 유례가 없는 메르스라는 전염병이 대유행하는 대한민국에 발길을 끊었다. 국민의 건강권이 심각하게 위협받았음은 물론이고 관광산업과 유통업계 등의 경제도 얼어붙었다. 정부는 메르스라는 전염병 확산의 초기대응 실패를 인정하고, 사태를 악화시킨 점에 대한 책임을 통감하여야 한다. 국민들에 대한 신뢰상실을 반성하고 향후 각종 필요한 정보를 공개함으로써, 메르스와 같은 전염병에 대한 정부정책을 투명하게 집행하고, 지방자치단체와 국민들이 지역사회 감염에 대처하고 확산방지에 나설 수 있도록 제도를 개선하며, 변경된 제도를 홍보하여 전염병 전파 예방에 노력해야 할 것이다.

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영유아의 급성 장염에서 혈청 아연농도 (Serum Zinc Concentration in Children with Acute Gasrtoenteritis)

  • 이현주;염혜원;서정완
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제9권1호
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    • pp.14-22
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    • 2006
  • 목 적: 아연은 인체의 성장, 발육 및 면역기능에 필요한 미량 영양소이다. 아연의 만성결핍은 장성선단 피부염(acrodermatitis enteropathica)이 알려져 있지만 급성결핍에 관한 보고와 그에 따른 치료 기준은 알려져 있지 않다. 영유아의 급성 장염에서는 섭취량이 감소하고, 설사로 인한 아연의 배설이 증가하여 아연의 체내 영양상태에 대한 평가가 요구된다. 본 연구에서는 급성 장염 영유아에서 아연의 영양 상태 표지자인 혈청 아연농도를 측정하고 이에 영향을 주는 인자들을 알아보고자 하였다. 방 법: 2005년 5월부터 8월까지 이대목동병원 소아 응급실에 급성 장염으로 방문하였거나 입원한 5세 미만의 환아 중 32명(남아 15명, 여아 17명)을 대상으로 하여 임상적, 혈액학적, 생화학적 인자가 아연의 혈청 농도에 미치는 영향을 분석하였다. 아연농도의 측정은 유도결합 플라즈마 발광분광법을 이용하였다. 결 과: 임상적으로 구토 유무, 설사 기간, 탈수 정도, 혈변 유무에 따른 혈청 아연농도의 유의한 차이는 없었다. 혈청 아연농도는 발열 환아에서 열이 없었던 환아보다 유의하게 낮았다($67.0{\pm}25.3$ vs $85.5{\pm}14.2{\mu}g/dL$, p=0.012). 혈청 아연농도는 CRP 양성인 경우에 유의하게 낮았으나($63.9{\pm}25.4$ vs $85.7{\pm}13.8{\mu}g/dL$, p=0.002) 로타바이러스 감염 유무에 따른 차이는 없었다. 혈청 아연농도는 CRP (r=-0.494, p<0.05)와 유의한 음의 상관관계를 보였다. 혈청 아연농도는 헤마토크릿(r=0.370, p<0.05), 총단백질(r=0.474, p<0.05), 알부민(r=0.636, p<0.05)과 유의한 양의 상관관계를 나타내었다. 혈청 아연농도가 $70{\mu}g/dL$ 이상인 군과 미만인 군을 비교하였을 때, $70{\mu}g/dL$ 미만인 군에서 CRP 양성인(91.7% vs 40%) 환아와 CRP 양성이면서 발열이 동반되었던 환아의 빈도(91.7% vs 35%)가 유의하게 많았다(p<0.05). 결 론: 급성 장염 소아에서 혈청 아연농도는 발열, CRP, 헤마토크릿, 총단백질, 알부민 등의 다양한 인자의 영향을 받으므로 체내 아연의 영양 상태를 평가할 때 고려하여야 한다.

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