• 제목/요약/키워드: separation of dispensary

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국소용 후발의약품의 생물학적동등성시험을 위한 가이드라인 (Guideline for Bioequivalence Studies of Generic Products for Topical Use)

  • 최선옥;정성희;엄소영;정서정;김주일;정수연
    • Journal of Pharmaceutical Investigation
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    • 제34권4호
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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.

국소 피부용 부신피질 스테로이드제제의 생물학적동등성시험 가이던스 (Guidance for Industry - Topical Dermatologic Corticosteroids: In Vivo Bioequivalence)

  • 정성희;최선옥;엄소영;정서정;김주일;정수연
    • Journal of Pharmaceutical Investigation
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    • 제34권6호
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    • pp.529-540
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    • 2004
  • After 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 drugs are hot issues in Korea. It will be obligatory to submit bioequivalence reports for getting licenses of all generic prescription drugs in the near future. Like other countries such as US and Japan, the KFDA also has a plan to re-evaluate the already approved drugs by bioequivalence studies. Therefore, it becomes more necessary to develop bioequivalence-demonstrating methods for specific preparations such as topical drug products among already approved drug products. There are some differences between US and Japanese guidances of bioequivalence studies of generic drug products for topical use. The information on Japanese guidance and the guidance's Q&As is already provided in our previous paper. In this paper, we examined the US guideline published in 1995 and compared with the Japanese guideline, which will give a useful information to make a guidance on bioequivalence studies of topical drug products in Korea.

일부 지역사회 노인들의 의료서비스 접근성에 관한 조사 연구 (Accessibility of Medical Care in an Elderly Population)

  • 조경순;이현주
    • 성인간호학회지
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    • 제12권4호
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    • pp.641-653
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    • 2000
  • A quantitative descriptive survey was conducted to assess the needs of elderly people in relation to accessibility of medical care. Identifying their functional status was done and accessibility of medical care was ascertained. Using a convenient sampling method, 856 elderly aged 65 and over in Taejon-city participated. A multi-dimensional questionnaire containing sections on health status, Activities of Daily Living(ADLs) and accessibility of medical care in terms of use, time, distance, transport, cost and feeling at ease was developed by the researchers of this study to collect data. Data were collected between October and December, 1999. In general, the result of the self-reports from this study found that approximately 40% of participants had difficulties with their health status and ADLs while about 45% of the population did not access medical care. The majority of respondents stated that they had no difficulties with time distance and transport to access medical care. About two-thirds of the respondents felt that they had many or some difficulties with expenses and strategies for emergency to access medical care. Even though these findings need to be generalized, several recommendations for appropriate medical care delivery for the elderly still can be outlined from the study findings. Recommendations suggested are: To identify impediments to access medical care in emergency in elderly people and to remove those factors preventively are required. Responsible governmental involvement for solving problems of the medical care cost and additional costs in relation to separation of dispensary from medical practice for the elderly is required. More constructive and practical uses of public health community centers are recommended.

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원외처방환자에 대한 복약지도 현황 및 만족도 조사 (Survey on the Satisfaction of the Medication Counseling for Outpatient Prescription)

  • 김현지;강진숙;박정연;나현오
    • 한국임상약학회지
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    • 제16권2호
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    • pp.92-95
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    • 2006
  • Medication counseling improves patients' compliance, which enhances the effectiveness of treatment and reduces the medical cost consequently. Since separation of dispensary from medical practice took place, most patients have had to go to pharmacy after receiving prescription from hospital. The importance of medication counseling in pharmacy thus has been emphasized. To study the present conditions of medication counseling from the pharmacists and the patients satisfaction with them, we conducted a survey with questionnaires. The subjects were 146 outpatients and 55 pharmacies located in Yeongdeungpo-gu. The research showed that 69.9% of the outpatients had received medication counseling and only 35.5% of them were satisfied with it. The main reason for their unsatisfaction was insufficiency of explanation. A number of patients(75.3%) were thinking that medication counseling from the pharmacists is necessary for appropriate administration and optimal efficacy of the medicine. Among 55 pharmacies involved in the research, 17 of them(30.9%) answered that they have been giving patients medication counseling, which were mostly verbally done. Only 8 of them(l4.5%) were providing medication information sheets for some specific drugs. The pharmacists referred to a few problems disturbing optimal medication counseling like these: 1) Lack of time, 2) insufficient information, 3) inappropriate counseling skills. To improve these problems, they hope to get more information about prescription and specific medicines from pharmacy in hospital. If hospital decides to hold the lectures on medication counseling, about 80% of the pharmacists tend to take part in them.

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Development of Health Promotion Program through IUHPE : Possibilities of Collaboration in East Asia

  • Moriyama, Masaki
    • 보건교육건강증진학회지
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    • 제22권3호
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    • pp.97-107
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    • 2005
  • This paper considers the possibilities of health promotion from the following perspectives; (1) IUHPE, (2) socio-cultural similarities, (3) action research, and (4) learning from our past. 1. The IUHPE values decentralized activities through regions, and countries such as Japan, Korea, Hong Kong, Taiwan and China belong to NPWP region. Since IUHPE World Conference was held in Japan in 1995, Japan used to occupy more than 60% of NPWP membership. After 2001, membership is increasing rapidly in Chinese speaking sub-region. The transnational collaboration is still in its beginning phase. 2. Confucianism is one of key points. Confucian tradition should not be seen only as obstacles but as advantages to seek a form of health promotion more acceptable in East Asia. 3 Within the new public health framework, people are expected to create and live their health. However, especially in Japan, the tendency of 'lacking of face-to-face explicit interactions' is still common at health-promotion settings as well as academic settings. Therefore, the author tried participatory approaches such as asking WIFY(interactive questions designed for subjects to review their daily life and environment) and as introducing round table interactions. So far, majority of participants welcome new trials. 4. The following social phenomena are comparatively discussed after Japanese invasion and occupation of Korea ended in 1945; status of oriental medicine, separation of dispensary services, and health promotion specialist as a national license. In contrast to Japanese' tendency of maintaining the status quo and postponing of substantial social change, trend toward rapid and dynamic social changes are more commonly observed in Korea. Although all of above possibilities are still in their beginning stages, they are going to offer interesting directions waiting for further challenges and accompanying researches.

서방성 경구제형의 개발과 평가 및 생체내.외 상관성 연구를 위한 가이드라인 (Guideline for Extended Release Oral Dosage Forms : Development, Evaluation, and Application of In Vitro/In Vivo Correlations)

  • 최선옥;정성희;엄소영;정서정;김주일;김옥희
    • Journal of Pharmaceutical Investigation
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    • 제35권6호
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    • pp.471-481
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    • 2005
  • In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

첩약의 보험급여 적용을 위한 과제 및 접근방안에 대한 연구 (A Study of Task and Approach for the Insurance Fee Application of Packed Medical Herbs)

  • 박용신;조병희;김호;이시백
    • 대한예방한의학회지
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    • 제7권1호
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    • pp.17-28
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    • 2003
  • We met results like the followings through the literatures and questionnaires about the tasks and solutions about the insurance fee of packed medical herbs. 1) It's turned out that 74.8% of herb doctors agrees to the insurance fee of packed medical herbs. However, in comparison with the same survey of the herb doctor association the percentage of general approval went somewhat lower, and especially the percentage of 'positive approval' became notably lower$(43.7%{\rightarrow}26.5%)$ and the percentage of 'active objection' raised about 2 times$(6.8%{\rightarrow}12.9%)$. Inquiring into the approval reasons on the insurance fee application of packed medical herbs some heads such as 'development toward treatment medical science' and 'decrease of publics burden' were higher than the one of 'management income and expenditure.' 2) As a result of the research, 36.0% of the patients and 42.8% of the residents recognized that the pay range of Chinese herb health insurance is narrow. They recognized that less people have the experiences of Chinese medical hospital use and internal application of the packed medical herbs as they are older, men rather than women. 85.4% of the patients and 74.9% of the residents agreed on the insurance pay of packed medical herbs. It's shown that they agree on the Chinese medical hospital use more as the economic standard is lower, on the insurance pay as they have ever taken the packed medical herbs. In the aspect of increase of insurance fee, 66.7% of the patients and 44.3% of the residents agreed on the insurance pay of packed medical herbs, and 18.1% and 36.1% disagreed on the insurance pay of packed medical herbs. The main objective reason why they disagree on the insurance pay of packed medical herbs was 'because the insurance fee goes up higher,' which answered 95.2% of the patients and 78.8% of the residents. 7.22% of the patients and 1.80% of the residents answered that they can pay more insurance fee in case of the insurance pay of packed medical herbs. However, in the priority order of the insurance pay, it hold the 5th position between 2 target research groups which was less than medical examination, charges for hospital accommodation and taking MRI. 3) According to the result of analysis about the cost of packed medical herbs, current practice price is 115,000 won and the average prime cost of a packed medical herb is 73,000 to 106,000 won. It's examined that the herb doctors regard that 95,000 won will be reasonable when the packed medical herb is payed in insurance. However, it was found out that the public generally thinks that the price would be appropriate on the level of 30,000 to 40,000 won and the percentage of the answers of 20,000 won to 30,000 was fairly high. 4) the central system of a prescription should be change into the central system of demonstration and the sick and wounded. 5) To solve this problem, the government should regulate it to pass by the circulation gradation of [importer, $peasantry{\rightarrow}manufacturer{\rightarrow}wholesaler{\rightarrow}distributor$(Chinese medical hospital, pharmacy dispensary of Chinese medicine)]And it should intervene into the quality and the circulation steps of Chinese medicine through 'the office or organization which is in charge of certification of Chinese medicine' and 'the office or organization which is in charge of the circulation of Chinese medicine.' And some actions such as simple severance, lavation, drying should be included into the conception of manufacture and the boundary between food and medical supplies should be made at a manufactory. And the regulation of standardized goods at one's own house should be improved so that, the peasantry can sell the materials of Chinese medicine only to the manufacturer. 6) In company with the insurance pay of packed medical herbs, the study about the separation of dispensary from medical practice in the Chinese medicine should be accomplished.

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한의원의 경영 현황과 정책 인식도에 대한 조사 연구 (Survey on the current status of the management of traditional Korean medical clinics and perception of the policies)

  • 박요한;강병갑;신현규
    • 대한한의진단학회지
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    • 제18권3호
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    • pp.205-216
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    • 2014
  • Objectives The purpose of this study is to help improve the management of traditional Korean medical(TKM) clinics and the policies for supporting them, by conducting a survey of the practitioners of TKM. Methods Stratified sampling was conducted based on regional location, and 700 samples were selected in a random manner from the membership list. The questionnaire was delivered and returned by mail. The survey was conducted between 20 July and 31 August 2010. A total of 177 questionnaires (recovery rate: 25.28%) were recovered and analyzed for the study. Results 1. The the survey indicate that the overall size of TKM clinics has fallen compared with previous survey, while the average number of beds per clinic has remained unchanged at 7.9. The sale of medicine as a proportion of total monthly sales has increased. 2. There has been no change in the composition of clinical staff as there are three nursing assistants. Although the average daily number of patients to clinics has remained at around 33.90 compared with ten years ago, the number of patients requiring seeking acupuncture treatment has increased while the number of those treated with medication has decreased. 3. Clinicians in TKM have indicated their preference for a binary system that separates TKM from western medicine (57.4%). The respondents do not favor the separation of dispensary from medical practice (81.5%), marks of origin for medicinal herbs (68.9%), disclosure of the prescriptions (67.2%), and the overseas expansion of Korean medical services (70.4%). However, they indicated that they are very much in favor of being granted the authority to employ and give orders to medical technicians (96.0%). 4. The respondents selected Korea as the country that maintains a proper academic system for traditional medicine (45.5%), and are not in favor of opening Korea's traditional medicine market under an Free Trade Agreement(FTA) with China (72.7%). Conclusion The overall status of the management of TKM clinics has declined compared with the preceding decade. There has been only a slight change in clinicians' opinion of the related policies and regulatory issues.

남북한 보건의료관계법규 비교분석;보건의료자원 중 시설과 인력을 중심으로 (A Comparative Study of The Health laws in North Korea and South Korea.)

  • 김주희
    • 간호행정학회지
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    • 제4권2호
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    • pp.321-349
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    • 1998
  • Since 1990 the effort for unification has been active in each department of our society. But the study for health policy in Unified Korea has been scarce. Unified Korea should be a democracy and a constitutional state. So we should have lively discussion on the health law as well as unified general laws. The purpose of this study is to compare the health law of South Korea and North Korea and to understand the differences in them. We guess both Korea are considerably different each other. But this study found out that there are many health related laws that have same goals and contents. The reason for this is that both health laws have its root in Korea Law. And the right to health is the social basic right. whose characteristic can not be compatible with market economy and demands state intervention for securing the right to health. The health related laws are divided into 4 fileds. 1. There is a field A which is affected by unified political and economic system and differs little from the law system: the license system of medical personnel. 2. There is a field B which is seldom affected by unified political and economic system and differs little from the law system: the right and duty of medical personnel. quarantine law. 3. There is a field C which is affected by unified political and economic system and differs greatly from the law system: health institution law(exclusive of quarantine law), the laws of medical personnel category, of research center(especially per-mission, registration and establishment). of the role of basic health in private and public area. 4. There is a field D which is seldom affected by unified political and economic system and differs greatly from the law system: health equipment law(the laws of drugs, of cosmetics and of medical instrument. of blood management). the laws of health knowledge. of cooperation in chinese medicine and western medicine. the health promotion law. the rules of first-aid. the law of separation of dispensary from medical practice. The laws which are seldom affected by political and economic system can be consolidated. which in turn can be revised and enacted before unification of Korea through the interchange between North Korea and South Korea and the support to North Korea health system.

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약학교과과정의 개국약국실습 방향에 관한 연구 (The Study on Identifying the Components of Community Pharmacy Externship Based on Korean Community Pharmacists' Consensus)

  • 김성현;오정미
    • 한국임상약학회지
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    • 제9권2호
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    • pp.109-118
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    • 1999
  • The need for and components of a contemporary community pharmacy externship for pharmacy students have not been clearly identified in Korea. Mail survey was performed among 20 college of pharmacy deans and 800 community pharmacists to analyze the current status and develop a consensus regarding major focus area and criteria of community pharmacy externship to be implemented under the separation of dispensary from medical practice in year 2000. Mail survey yielded $80\%\;and\;23.5\%$ response rate for pharmacy school deans and community pharmacists, respectively. Of the 16 pharmacy schools that responded 14 said they have externship program in hospital pharmacy, and only 8 pharmacy schools responded of having externship program for community pharmacy. However, these community pharmacy programs lacked criteria and standard guideline for the externship. The results of survey revealed that community pharmacy externship program for students should be organized and directed toward developing expert knowledge and skills in pharmacy practice activities, clinical services, communications, pharmacy management, and professionalism. Pharmacy practice components should include competencies and skills in computer application, prescription processing, dispensing, pharmaceutical compounding, Narcotics Control Law application, maintenance and provision of drug information, and laws and regulations. Clinical service components should include the ability to identify patient's drug-related problems, provide long-term patient care and appreciate drug therapy services. Communication skills should be taught to effectively express his/her professional opinion, deduce the needs of others, utilize appropriate techniques and media to communicate ideas and conduct a patient interview and to obtain patient drug history. Pharmacy management skills should be taught to be efficient in medical insurance and drug control process. It was found that professionalism, morality, pharmacy practice experience, ability to provide clinical services, collect and provide drug information and regality are important criteria of preceptors. Externship sites should possess the ability to stock various drugs, access and provide diverse pharmacy services and should have private patient counseling area. Most pharmacists agreed that top 200 drugs' generic and brand name, indications, dosage, side effects, and contraindication should be instructed during the externship. It was also found that student and preceptor should be evaluated for their performances during the externship. This information will be incorporated into teaming objectives for students and to develop Academic Extemship Program Guidelines.

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