• Korean Journal of Clinical Pharmacy
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• v.20 no.2
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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.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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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.

• YAKHAK HOEJI
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• v.52 no.3
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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.

• Journal of Korean Public Health Nursing
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• v.15 no.2
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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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• v.1 no.1
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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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• v.5 no.2
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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.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.131-157
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• 2015

NHIS claimed for damages to doctors that by doing the treatment breaching medical insurance criteria caused by doctors, NHIS paid for medicine cost to pharmacy; as a result, the doctors caused the tort to NHIS. Following consecutive rulings afterwards, NHIS also argued that the medicine cost violating medical law or medical treatment expense paid to medical organizations are both the tort in civil law. NHIS claimed for all the damages, and the Supreme Court confirmed this judgment. However, within our national health insurance system, the subject of insurance payment is NHIS and the subject of medical treatment expense are also NHIS since the treatment expense is also insurance payment by asking the treatment to medical organizations. Further, national health insurance law is not made to control the violation of medical treatment cases; therefore, the breach of medical law cannot be covered by illegality of tort in civil law regarding NHIS. If that is the case, in the case that if the patients are treated according to treatment criteria via the doctors delegated the doctors' permission by Health and Welfare minister, NHIS acquired the benefits to remove the duty to give treatment payment to doctors in civil law; thus, even though the doctors have breached the medical law, NHIS does not have any damages. The fact that supreme court confirmed the ruling that the treatment is the tort in civil law towards NHIS is the judgment not counting the benefits of insurance payment as the subject but only considering the fact that NHIS paid to the doctors and this ruling have gone against the principle under civil code section 750. If the doctors have breached the medical law, the case should be sanctioned by medical law not national health insurance law, and the ruling of supreme court is assumed that they have confused both with the principle of national health insurance law and civil law.

• Natural Product Sciences
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• v.10 no.6
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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.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Korean Journal of Clinical Pharmacy
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• v.13 no.1
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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.