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

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

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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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.

• Journal of Pharmaceutical Investigation
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• v.35 no.6
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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.

• Korean Journal of Clinical Pharmacy
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• v.9 no.2
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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.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.18 no.3
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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.

• Journal of Korean Academy of Nursing Administration
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• v.4 no.2
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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.

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

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