• 제목/요약/키워드: pharmacy law

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국내 약사 및 의료인면허 국가시험 제도 비교 (Comparison of Pharmacist and other Healthcare Professionals License Examination in Korea)

  • 유봉규
    • 한국임상약학회지
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    • 제23권1호
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    • pp.71-76
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    • 2013
  • Background (Purpose): The objective of this study was to investigate regulations on pharmacist and other healthcare professional license examination in Korea. Specific aim was focused on the implementation of new regulatory system governing pharmacist license examination particularly on naming of the subjects, method of the examination, and discrimination of pass or fail. Method: Laws and regulations of Korea on the examination system were retrieved from sources posted in Ministry of Government Legislation. Results: Two major regulatory differences were found between pharmacist and other healthcare professionals license examination systems. Firstly, the regulation on pharmacist license examination was ruled by the enforcement ordinance of parent law (Pharmacy Law) while it was ruled by enforcement regulation of parent law (Medical Law). Secondly, minimum grade requirement for pharmacist and other healthcare professionals was differently set up: 40% for each single subject in pharmacist and average of 40% for each group of several subjects in other healthcare professionals. Conclusion: Since pharmacist profession has drastically changed from drug-makers to drug-users during the recent decades, it is desirable to have the regulations on pharmacist license examination system amended in harmony with other laws and regulations of Korea and other major developed countries. Two-step examination for pharmacist license appears worthwhile to implement for balancing the two key functions of the pharmacist being drug-makers and drug-users.

환자의 알권리 - 의약품의 처방 및 조제와 관련하여 - (Patients' Right to Know about the Physicians' Prescription and the Pharmacists' Compounding of Medicines)

  • 김천수
    • 의료법학
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    • 제4권1호
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    • pp.255-294
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    • 2003
  • This paper is relating to the debates upon the physicians' duty to issue the prescription documents to their patients. The duty should be approached in light of the patients' right to know about the prescription and pharmacy. The Korean Constitution is construed to protect the citizens' right to know as a fundamental right. The Constitution article 10 reads as follows: "All citizens shall be assured of human dignity and worth and have the right to pursue happiness. It is the duty of the State to confirm and guarantee the fundamental and inviolable human rights of individuals." The rights confirmed and guarantee by this article include the patients' right to know about what happens to their body, that is the treatments taken for them and so on. One of the treatments is the prescription and pharmacy. The information is necessary for them to establish their action for the damages in case of their harm resulted in by the negligence in prescription and pharmacy. Now that the prescription is written about by a physician and then the pharmacists compound the prescribed medicines, the patients need to get the documents signed by the pharmacists about the pharmacy. It should be noted that the patients right to know is the right to know and remember. Therefore the patients, who are laymen about the pharmacy, need two prescription documents one of which should be kept by them even after they take the prescribed and compounded medicines for the potential trial.

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우리나라와 캐나다 약사면허 국가시험제도 비교 (Comparison of Pharmacist License Examination between Korea and Canada)

  • 강민구
    • 한국임상약학회지
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    • 제25권1호
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    • pp.1-8
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    • 2015
  • A newly-structured Korean pharmacist license exam has been launched in 2015, reflecting upon the changes in the pharmacy curriculum from a 4 year program to a 6 year program in 2009. In order to provide new ideas to ensure that the new exam is one of the most effective pharmacist evaluations that have taken place thus far, this study was done to compare the pharmacy exams in Korea and Canada. One of the major differences noted between the two countries' exams is that along with paper based MCQ portion of the exam, Canada's exam also includes a performance-based section, known as OSCE, which the Korean Pharmacy Exam (KPE) does not have. Furthermore, with the MCQ portion of the exam, the Canadian exam asks about 300 questions, with 450 minutes of test time allocated and taken during a period of two consecutive days, the KPE asks 350 questions, with 325 minutes of test time allocated in one day. Although, similarly, many of the questions in both exams place emphasis on clinical or patient care, Canada's exam puts significantly more emphasis (50.5% of exam questions) on these types of questions than Korea (29.7% of exam questions). However, this percentage does not reflect the exact weight placed for the specific areas of knowledge it requires to answer these questions, since the types of questions asked in this section in Canada could be placed in another section on the KPE. Canada's exam also has more questions (10% +150 questions for BC) on the topics of law and ethics compared to the KPE (5.7%). The reason for this may be that the Canadian society puts emphasis on the legal and ethical duties of pharmacists as a leader. However, since each country is unique in their social, economical, and cultural points of view, comparing the KPE to the Canadian licensing exam and applying these differences to the new KPE may not be appropriate. One last thing to consider is that, as WHO/FIP mentioned, in good pharmacy practice, continually updating and developing an appropriate pharmacy exam with consideration of societal changes, is key to success in developing the scope of practice for current and future pharmacists.

제조물책임법상 제조물로서의 의약품의 개념 (Study on the Concept of Medical Supplies in the Product Liability Law)

  • 전병남
    • 의료법학
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    • 제7권2호
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    • pp.331-364
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    • 2006
  • Medical supplies have contradiction of efficacy and side effect to the various diseases together. Therefore, people have tried to reduce the side effects and also provide various methods to cope with any damages from the medicine quickly. In the case of accidents by medical supplies, the victim can be protected with advantage by the Product Liability Law rather than the Torts. The limit of Product Liability Law's application depends on whether medical supplies belong to the product or not. According to Product Liability Law, the product should be processed. Therefore, medical supplied should be processed to be the category of product. It can be said that the medical supplies in pharmacy, Chinese medicine, medical herbs, biological medicine manufactures, blood manufactured medicine, cord blood, hemopoietic progenitior cell and stem cell belongs to the manufactured products. The mixture by the prescription of doctor or preparation of pharmacist can be recognized as the product because prescription or preparation is a manufacturing act. Therefore, applying Product Liability Law to manufacturer, doctor or pharmacist would achieve the goal which is protecting the victims extensively.

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폴리에칠렌 옥사이드 정제로부터 니페디핀의 방출양상 (Release of Nifedipine from Poly(ethylene oxide) Tablets)

  • 홍성인;허영림;오승열
    • Journal of Pharmaceutical Investigation
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    • 제30권3호
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    • pp.207-211
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    • 2000
  • The objective of this work is to investigate the effect of molecular weight of poly(ethylene oxide) (PEO) and release medium on the release of nifedipine (NP) from PEO tablets containing NP and to get some mechanistic insights into the release of NP. The tablets containing NP were prepared by direct compression, using a flat-faced punch and die. The molecular weights of PEOs used were 200K, 900K, 2000K and 7,000K. The release kinetics were studied for 24 hours in aqueous ethanol solution, using a dissolution tester at $36.5^{\circ}C$ and 100 rpm. Drug release rate increased, as the concentration of ethanol in the dissolution medium increased, due to the increased solubility of NP. As the molecular weight of PEO increased, release rate decreased, due to the slower swelling and dissolution of PEO. The power values obtained by fitting data to the power law expression $(M_t/M_{\infty}=kt^n)$ indicated that, at low ethanol concentration, the release of NP is governed by anomalous diffusion. However, as the ethanol concentration increases, diffusional release becomes to prevail over anomalous or zero-order release. Overall, these results provided some insights into the release of NP from PEO tablet.

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Ecotoxicology of Micro Oorganic Pollutants in Water

  • Ose, Youki
    • Archives of Pharmacal Research
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    • 제4권2호
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    • pp.141-153
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    • 1981
  • In Japan, rapid development of economy during the 1960s caused the problems of environmental pollution, and hazards occurred in many places of Japan, water pollution had increased in those days, and water used for drinking, agriculture, fishing, industry nd recreation were demaged. By water-born diseases like as Minamata and Itai-Itai diseases, many patients suffered as you know well. In 1967, Japanese Government set up Basic Law for Environmental Pollution Control and in 1970 Water Pollution Control and in 1970 Water Pollution Control Law.

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Determination of Buprenorphine in Raw Material and Pharmaceutical Products Using Ion-pair Formation

  • Amanlou, Massoud;Khosravian, Peghah;Souri, Effat;Dadrass, Orkideh Ghorban;Dinarvand, Rasoul;Alimorad, Mohammad Massoud;Akbari, Hamid
    • Bulletin of the Korean Chemical Society
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    • 제28권2호
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    • pp.183-187
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    • 2007
  • A simple and sensitive extractive spectrophotometric method has been described for the determination of buprenorphine either in raw material or in pharmaceutical formulations. The developed method is based on the formation of a colored ion-pair complex (1 : 1 drug/dye) of buprenorphine and bromocresol green (BCG) in buffer pH 3 and extracting in chloroform. The extracted complex shows absorbance maxima at 415 nm. Beer's law is obeyed in the concentration range of 1.32-100.81 μ g mL-1. The proposed method has been applied successfully for the determination of drug in commercial sublingual tablets and injectable dosage form. No significant interference was observed from the excipients commonly used as pharmaceutical aids with the assay procedure.

글로벌 조화에 부합하는 국내 의약품 분류체계 개선방안 (New drug classification system in accordance with global harmonization)

  • 손성호;유봉규
    • 한국임상약학회지
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    • 제22권3호
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    • pp.260-267
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    • 2012
  • The objective of this study was to investigate drug classification system in Korea and other developed countries. Laws and regulations of Korea regarding the system were retrieved from sources posted in Ministry of Government Legislation. We also reviewed previous research reports performed as part of government's effort to reform the system The system in the foreign countries was retrieved from the official homepage operated by each country's government. There have been two research funded by Korean government, which strongly suggested that the system should be reformed. However, we found that the system was never reformed and still effective. Drug classification system in US and most western countries consists of two categories, i.e., prescription drugs and non-prescription drugs except UK, which classifies into three categories: Prescription Only Medicines, Pharmacy Medicines, and General Sales List Medicines. Interestingly, in Japan, non-prescription drugs are further classified into three groups: Group 1, 2, and 3. Recently, Ministry of Health and Welfare (MOHW) in Korea proposed a plan to reclassify all the approved drugs according to purportedly rational and scientific criteria. However, the plan does not include reform of the existing laws and regulations, which appears that it is just one-time action rather than a sustainable administration backed up by law. Therefore, it is recommended that Korean MOHW take appropriate action on laws and regulations with regard to the system to meet global harmonization standard.

Studies of Complex Formation between the Bromophenol Blue and some Important Aminoquinoline Antimalarials

  • Saadia-Mohamed-El-Ashry;Aly, Fatma-Ahmed;Amina-Mohamed-El-Brashy
    • Archives of Pharmacal Research
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    • 제17권6호
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    • pp.415-419
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    • 1994
  • A simple nad rapid colorimetric method for the assay of amodiaquine hydrochloride, chloroquine phosphate and primaquine phosphate is described. The method is based on the interaction of the drug base with bromophenol blue to give a ion-pair complex. The spectra of the complex shows a maxima at 415-420 nm with high apparent molar absorptivities. Beer's law was obeyed in the concentration range 1-8, 2-10 and $2-12{\;}{\mu}{\cdot}ml^{-1}$ for amodiaquine hydrochloride, primaquine phosphate and chloroquine phosphate respectively. The proposed method was applied to the determination of these drugs in certain formulations and the results were favourably comparable to the official methods.

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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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