• 한국임상약학회지
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• 제20권2호
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• pp.114-119
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• 2010

Objectives: We developed a registry guidance to provide a standard for data collection, analysis and methodical management of information on the influence of drug exposure on pregnant women and fetus. Methods: We surveyed guidances and regulations of clinical trials and the pharmaceutical affairs law, compared them with Pregnancy Exposure Registry of other countries and in addition, investigated related references. We found the flaws of the present registry and supplemented it based on better results from other countries. Results: We developed a concrete and detailed report that included pregnancy drug exposure cases necessary for close monitoring, types and characteristics of data on pregnancy drug exposure, the requirements of registry data, and essential items needed to be researched. Conclusions: Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug's influence on pregnant women and fetus, and in addition, accurate information about safety and effectiveness of drug use in pregnant women and fetus can be obtained by sharing data globally and managing it synthetically and systematically.

• 한국임상약학회지
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• 제15권2호
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• pp.82-88
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• 2005

A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

• 약학회지
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• 제52권3호
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• pp.201-211
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• 2008

All pharmacists must provide the drug consultation whenever dispense drugs to patients by the Korean Pharmacy Law. Drug consultation is very important procedure for increasing pharmacotherapy. Because it maximizes the therapeutic effects or/and minimizes adverse drug reaction during the drug therapy. However, it is not easy to do because of the dynamic and hectic pharmacy environment. Especially, if someone has a disabling body function, they required more time and efforts to perform consultation by pharmacist. Currently several auxiliary labels for helping drug consultation are using in pharmacy practice but not for disabling patients. Therefore we developed the total 53 auxiliary labels with size of 0.7 cm (width) and 1 cm (length) by Braillewriter letters for blind patients. This research has been performed for total 12 months (Mar. 15ts, 2007$\sim$Feb. 25th, 2008) and the developing methods are consisted of 4 steps: 1) selection of essential informations, 2) simplification of information, 3) changing for Braillewriter letters, 4) application and revising by blindness patients. Also the labels are consisted of 12 for adverse reactions and precautions, 8 for directions, 2 for storages, 9 for duration, 9 for dosage forms, and 12 for common names. After developed those labels, we revised those labels by discussion with 2 blind people. In conclusion, the new auxiliary labels for blind patients can increase therapeutic effects and decrease risks from pharmacotherapy besides decreasing of pharmacist's work load in the future.

• 한국보건간호학회지
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• 제15권2호
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• pp.398-411
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• 2001

The separation system of pharmacy and clinic has begun on the purpose of preventing drug misuse and abuse since July 1st of 2000. The system revealed some conflicts between doctors. pharmacists and consumers. Consequently pharmaceutical law and related policies undergone some change. Now in an early period of the implementation of the system, the necessity to examine relevance of those policies and law enforcement to medical doctors' prescriptions pattern evolves. This study tries to verify the pattern through a field study. For the purpose, 930 prescriptions collected in May of 2001, from a pharmacy located in Gangnam-gu in Seoul, were analysed. The prescriptions were issued from several clinics: 459 prescriptions from otorhinolaryngological clinic(ENT), 177 from internal medicine clinic(IM), 130 from ophthalmic clinic(Opt), 52 from obstetric and gynecologic clinic(OB & GY), and 112 from miscellaneous clinics. ENT, IM, Opt. OB & GY are situated in a clinic building of 40m distance. The general findings are following: 1) $88.8\%$ of the total patients came from 5clinics in nearby single clinic building. 2) Average prescribing days were 6.2 days and the average number of used drugs were 4.0 drugs, i.e. 2-4 times of WHO criteria 1-2 drugs. 3) Use of antibiotics in the oral administration drugs rated $71.8\%(WHO: \;22.7\%)$ 4) Use of injection rated $31.3\%(WHO:\;17.2\%)$ 5) $96.2\%$ of the patients use multiple antibiotics in the injection and oral administration together. 6) The patients had multiple disease : ENT patients 1.7 disease and 1M patients has 2.7 disease in average and several regular prescribing types evolved particularly in the ENT prescription. With this result we found that drugs. especially antibiotics are still abused a lot, and there were significant differences in the number of used drugs and prescrbing days between the clinics. It implies somes differences of the preparation work and time for pharmacists. And preparation can be done in advance by pharmacists' own efforts through noticing regular prescribing types. The study suggests the followings: 1) Patient counseling should be done to minimize the incidence of adverse events. 2) The enforcement of the standardized differential preparation price system should be reconsidered. 3) Preparation of typical regularly appeared prescription in advance. which is regarded as 'a prearranged work between doctors and pharmacists' and has been prohibited should be reconsidered. 4) Drug utilization review program should be established to prevent drugs abuse. especially antibiotics abuse.

• Journal of Pharmaceutical Investigation
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• 제1권1호
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• pp.47-52
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• 1971

Application of the spectrophotometer to the analysis of 17 ${\alpha}-ethinyl$ estradiol and $17{\alpha}-ethinyl-19-nortestosterone$ acetate mixture in oral contraceptive has been accomplished. It is used Beckman Du Spectrophotometer as a apparatus. The petroleum ether extract of ethinyl estradiol is determined at $535\;m{\mu}$ and the chloroform extract of norethindrone acetate is determined at $380\;m{\mu}$ respectively. This analytical method is formed Lambert Beer's law. This method can be used to the analysis of ethinyl estradiol aid norethindrone acetate mixture in commercial dosage form of routine assay.

• Archives of Pharmacal Research
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• 제5권2호
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• pp.53-60
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• 1982

The mixing of salicylic acid and wheat starch powders was studied using a V-type mixer. After the optimum operating conditions of the mixer were examined, the mixing characteristics relating to dilution ratio, particle size of active ingradient and addition ratio of lubricants were investigated. The coefficient of variation was expressed by a power law relating to the dilution ratio and the particle size of active ingredient. Furthermore, the comparison of results with the theoretically estimated value of mixing index suggested that the mixing of cohesive pharmacceutical powders is a complex stochastic process and cannot be explained fully by a simple theory based on a complete random mixing.

• 의료법학
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• 제16권2호
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• pp.131-157
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• 2015

국민건강보험공단은 의사가 요양급여기준을 위반하여 처방을 함으로써 국민건강보험공단이 약국에 약제비를 지급하게 된 것은 의사가 국민건강보험공단에 대해 민사상 불법행위를 한 것이라고 주장하며 손해배상청구를 하였다. 대법원이 이를 인정하는 판결이 잇따르자, 국민건강보험공단은 의사들이 의료법을 위반하여 진료를 하여 약국에 지급하게 된 약제비나 해당 의료기관에 지급하게 된 요양급여비용에 대해서도 모두 국민건강보험공단에 대한 민법상 불법행위라고 주장하며 손해배상을 청구하였으며, 대법원은 이를 모두 인정하였다. 그러나 우리나라 국민건강보험제도에서 보험급여의 주체는 국민건강보험공단이며, 환자가 의료기관에 진료를 요청하여 의료기관이 행하는 요양급여 역시 보험급여이므로 이러한 요양급여를 행하는 주체 역시 국민건강보험공단이다. 그리고 국민건강보험법은 의사의 의료법위반행위를 규제하기 위해 만든 법이 아니므로 의사의 의료법 위반행위를 국민건강보험공단에 대한 민법상 불법행위책임에서의 위법성으로 포섭할 수 없다. 그렇다면 환자가 보건복지부장관으로부터 부여 받은 면허를 가진 의사에 의해 요양급여기준에 맞는 진료를 받은 경우에는 국민건강보험공단은 민법상 환자에게 요양급여를 해 줄 의무를 면하는 이득을 얻었으므로 설사 해당 의사가 진료를 하는 과정에 의료법을 위반한 행위를 하였더라도 국민건강보험공단으로서는 손해가 없다. 대법원이 의료법위반으로 진료를 한 행위를 모두 국민건강보험공단에 대한 민법상 불법행위책임으로 인정하는 것은 국민건강보험공단이 보험급여의 주체로서 보험급여를 해 줄 의무를 면하였다는 이득은 고려하지 않고, 오로지 의사에게 요양급여비용을 지급하였다는 측면만을 고려한 것으로서 민법 제750조의 법리에 어긋난다. 의사가 의료법을 위반하였다면 의료법에 따라 제재를 받을 일이지, 국민건강보험법으로 규율할 일이 아니며, 대법원이 위와 같이 판결한 것은 국민건강보험법의 법리와 민법의 법리를 혼동한 탓으로 생각된다.

• Natural Product Sciences
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• 제10권6호
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• pp.310-314
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• 2004

This is the re-arrangement of the 2004 Asia Nutrition & Dietary Supplement Conference organized by ABF(The Asia Business Forum) in Singapore, especially regulatory view of point of health functional foods for Korea, Japan, and China. Foods that may have health benefits beyond the traditional nutrients that they contain are often called 'Functional Foods'. The concept of functional foods has become popular in recent years, first in Japan and later in other countries, including the USA. In USA, The functional foods was controlled by ACSH (the American Council on Science and Health). In Korea, 'Functional Foods'. was defined on the 'The Law for the Health Functional Foods'(Law No. 6727 : effective as of $26^{th}$, Aug. 2002). KFDA(Korea Food and Drug Administration) is the only authority body for approval, advertisement and claims for the Health Functional Foods in Korea. In Japan, the Japan Health Food and Nutrition Food Association controls the approval, regulate functional foods' advertisement and claims under the name of FOSHU (Foods for Specified Health Uses). In China, the State Food and Drug Administration(SFDA) is the only authoritative organization for the application, supervision and administration of health related products. Asia, especially Korea, Japan and China, is one of the leader in the vitamins and dietary supplement(VDS) market. Regulatory issues on restrictions are the most important how to tap into the health functional foods market including Korea.

• 의료법학
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• 제22권4호
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• pp.159-184
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• 2021

첨단재생바이오법의 제정 의의는 본질적으로 '이식'이라는 의료행위인 재생의료를 약사법 규제에서 벗어나 의료기술적 접근으로 환자치료기회를 확대하는 데 있다. 그러나, 법이 시행된 지 1년여가 지난 상황에서 식약처가 승인하는 고위험연구는 1건도 승인되지 않고 있는 등 임상연구가 활성화되지 않고 있다. 그 이유는 환자치료기회 확대를 위한 법률 취지에도 불구하고 법률적 근거가 미흡함에도 임상연구 승인을 위한 자료요건을 의약품 개발과 연결하여 정하고 있어 많은 연구자들이 자료요건을 맞추기가 어려운 실정이다. 법 제정 이전 약사법 체계 내의 세포치료제 임상연구를 위한 제출자료는 품질 및 비임상시험 자료가 상당히 면제되었지만, 첨단재생바이오법이 시행되면서 임상연구 계획 승인신청 시 품질 및 비임상시험자료를 의약품에 준해 요구하고 있다. 이를 바로잡으려면 치료기회 확대를 위한 첨단재생의료 임상연구의 정체성을 고려할 때 의약품 개발과 연결하는 데는 제한점이 있음을 인식하고 첨단재생의료 임상연구의 정체성을 지키고, 한편으로 품목허가 시 임상연구 결과를 활용할 수 있도록 하면서 활용요건을 구체화하여 시장의 힘으로, 임상연구자의 자발적인 동기로 임상연구 승인을 위한 기본요건보다 필요한 자료를 스스로 준비할 수 있도록 해야 한다.

• 한국임상약학회지
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• 제13권1호
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• pp.18-28
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• 2003

An appropriate parent role model for alcohol, tobacco and other drug abuse prevention in adolescence was designed as part of a comprehensive effort to reduce the use of alcohol, tobacco and other drugs by underage youth. The content of the model offers a new and positive chemical health model. The model calls for development of a set of guidelines that can provide the framework for examining alcohol, tobacco and other drug use. The actions of adults in the community, especially parents, are very important factors in whether or not youth use chemicals. So these guidelines can be used to assist parents and other adults with questions such as, what can we say to young people about using alcohol, tobacco or other drugs except that it's against the law? At what age and times are discussions appropriate? What can we do to make our community a healthier place in which young people can make better decisions about alcohol, tobacco and other drug use? The model acknowledges and affirms the legal and appropriate use of alcohol and other drugs as well as supports the decision not to drink. It encourages participants to consider their own guidelines for using and not using alcohol and other drugs. The guidelines can also be used as the basis for early intervention when use is illegal, unhealthy or risky. It is important to note that the model affirms healthy and appropriate use as well as nonuse.