• Title/Summary/Keyword: Drug package

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New Drug Listing Process and Reimbursement Standard Management (약제의 신규등재 절차와 급여기준 관리)

  • Yoon Kyeong Bai;Mi-Young You
    • Journal of Digestive Cancer Research
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    • v.11 no.2
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    • pp.104-107
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    • 2023
  • The Ministry of Health and Welfare of Korea has implemented various social security programs to ensure a basic standard of living and raise overall quality of life for all citizens. The Korean social security system provides social insurance, public assistance, and social welfare services. To achieve adequate drug benefits, the Drug Management Department of Health Insurance Review and Assessment Service (HIRA) implement drug management duties including drug listing, upper price limit setting, scope of benefits, and post-factum management. When a manufacturer or an importer wants to apply for National Health Insurance (NHI) coverage of the drug that has obtained safety and efficacy approval, the pharmaceutical benefit assessment committee of HIRA evaluates the drug's clinical efficacy and cost-effectiveness to determine whether or not to include the drug into the benefit package. The benefit standards for a listed drug (ingredient) are set either for the whole permitted range or a part of range with conditions. To increase the coverage rate for new drugs, the listed drugs are regularly reviewed for their value. The status of listed drugs can be adjusted or eliminated from the benefit package if the clinical efficacy turns out to be insignificant. Therefore, through these pharmaceutical management procedures, high-quality drugs are provided at reasonable prices, which save healthcare expenditure by price determination and selective coverage in consideration of economic evaluation.

A Comparison Study Between International Standard and Statistical Analysis on LED Package Life (국제표준과 통계적 분석을 통한 LED Package 수명 비교 연구)

  • Park, Se Il;Kim, Gun So;Kim, Chung Hyeok
    • Journal of the Korean Institute of Electrical and Electronic Material Engineers
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    • v.31 no.2
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    • pp.122-127
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    • 2018
  • In an attempt to estimate the life projection of LED packages, IESNA published a paper regarding an LED package measurement test method in 2008, and a life projection technical document in 2011, to be used for LED life estimation. IESNA's publications regarding LED package measurement methods were functional, but they were not internationally standardized before 2017. In order to develop a standardized method, the International Standard chose to use the LM-80 as a measurement method for LED life projection in their publication in 2017. Many projection methods have been discussed by the IEC Technical Committee 34 working group, including the method using an exponential function, which reflects lumen degradation characteristics well. This study is designed to explore alternative LED package life estimation methods using an exponential function with statistical analysis, other than the one suggested by the International Standard.

A Study of Plasticizer in Food and Drug PVC Packaging (PVC포장재에 사용된 가소제에 관한 조사연구)

  • Yoon Mi-Hye;Eom Mi-Na;Do Young-Sook;Jung Hong-Rae;Jeong Il-Heoung;Ko Hoan-Uck;Son Jin-Seok
    • Journal of environmental and Sanitary engineering
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    • v.20 no.2 s.56
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    • pp.39-46
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    • 2005
  • This study was Performed to survey and evaluate the contents of Plasticizers such as DEP(diethyl phthalate), DPrP(di-n-Phthalate), DBP(di-n-butyl Phthalate), DPP(di-n-pentyl Phthalate), DCHP(dicyclohexyl phthalate), BBP (butylbenzyl phthalate), DEHP(di-(2-ethylhexyl) phthalate) and DEHA(di-(2-ethylheryl) adipate), which are suspected as endocrine disruptors, in food and drug PVC packaging. Tested samples were 5 food wraps, 35 food containers, 40 food and drug packages(type of tablet and capsule) in Gyeonggi-Do area. The contents of DEHA in wrap were 188.9g/kg, 203.1g/kg, 238.4g/kg, 290.9g/kg and 308.3g/kg, respectively, while the other plasticizers were not detected. DEHP was used in 4 samples of food containers and DEHP contents were 4.7g/kg, 30.7g/kg, 35.8g/kg and 53.4g/kg, respectively. In food and drug packaging materials(type of tablet and capsule), the plasticizers were not detected.

Treatment packages of persistent allergic rhinitis for developing PRCT protocols : An expert survey (통년성 알레르기 비염의 표준 치료 모델 개발 : 실용임상연구 프로토콜 개발을 위한 기초 연구)

  • Kim, Nam-Kwen;Lee, Dong-Hyo;Seo, Eun-Sung;Choi, Eun-Ji;Jang, Bo-Hyeong;Choi, In-Hwa;Ko, Seong-Gyu
    • Journal of Society of Preventive Korean Medicine
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    • v.17 no.3
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    • pp.143-153
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    • 2013
  • Objective : This study was done to define the treatment protocol of Traditional Korean Medicine for persistent allergic rhinitis, which might be necessary for conducting PRCT study. Methods : Data were collected by questionnaire from Korean Medicine doctors participated in the Conference of The Korean Oriental Medical Ophthalmology & Otolaryngology & Dermatology Society in October 2012. We investigated their treatment procedures for persistent allergic rhinitis in ordinary clinical settings. Their treatment patterns including annual treatment period, frequencies and treatment times were also investigated. Finally, we combined the national insurance covered or out-of-pocket treatments as treatment packages according to the response rates of each contents, and displayed them as treatment protocols for PRCT study. Results : 50 Korean medicine doctors described the informed consent and questionnaire. Response rates of each treatment procedure were listed in Table 2 to Table 5. Treatment periods, frequencies and treatment time of each visit were listed in Table 6. Finally, treatment packages which would be defined for PRCT were listed in Table 7 as treatment package 1(response rates were over 50%), package 2(response rates were over 25%), package 3(response rates were over10%). Conclusion : These results provide the rational background and preliminary sources of defining treatment packages for developing PRCT protocols.

Assessment of Readability and Appropriate Usability Based on the Product Labelling of Over-The-Counter Drugs in Korea (일반의약품 설명서의 이해도와 적정 사용가능성 평가)

  • Lee, Iyn-Hyang;Lee, Hyung Won;Je, Nam Kyung;Lee, Sukhyang
    • YAKHAK HOEJI
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    • v.56 no.5
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    • pp.333-345
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    • 2012
  • A product labelling is one of key tools in ensuring that a patient uses drugs safely and effectively in self-care without professional support. This study aimed to explore the readability and comprehensibility of the information contained on two package inserts of medicines. Two package inserts were tested with first year college students. Fifty-one potential consumers underlined words they could not understand and answered 10 scenario questions. Any differences among groups with different characteristics were statistically tested. Secondly, the readability of two package inserts was assessed with comparison to the level of the 6th grade Korean textbooks. As results, more than 80% of participants properly replied to straightforward questions concerning indication, dosage, duplication, use in pregnancy and contraindication, and 73% about formulation. Less than half answered correctly in multiple choice questions about pediatric use (41%) and side effects (35%). Little discrepancy was observed in the comprehensibility between participants' characteristics. Drug inserts contained about 20% more professional-level words than 6th grade textbooks. In conclusion, Korean consumers may face challenges to understand drug information due to professional terminology and outdated expressions in the current package inserts. To secure safe and effective use of over-the-counter agents, greater efforts should be made to develop more consumer friendly labels. In the other hand, educational supports are required to prepare consumers in a proper level of knowledge for the safe use of drugs.

Package Design Proposal to Improve Medical Information Transmission on Regular Medicine Sold in Convenience Stores (편의점 판매용 안전상비의약품의 정보 전달 개선을 위한 포장디자인 제안)

  • Kim, Min Ji;Jung, Eui-Tay;Paik, JinKyung
    • Design Convergence Study
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    • v.15 no.4
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    • pp.17-29
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    • 2016
  • Over-the-counter pharmaceuticals sold in convenience stores are accurate and easy to understand on its containers, packaging, or attached materials for the prevention of drug misuse. The limited space of the packaging, however, makes the information difficult to read and consequently, consumers have had difficulty in purchasing the products. This research conducted an analysis of 8 packages of pill-type drugs and conducted a survey and interviews targeting 10 foreigners and 20 Korean consumers to analyze the user consciousness. The findings of this study showed that fever remedies are the most frequently bought drug. And consumers first looked for the information of the drugs in the following order: the effects, dosage, and warnings. While domestic consumers had little difficulty in comprehending the information, more than 40% of the foreigners who were studies failed to comprehend it, which was because the package was entirely written in Korean. This study presented some ideas for improving the design by using English and foreign expressions and pictograms, consumers can easily and quickly understand, and by placing the information on the symptoms, dosage and age information so that the type of drugs will be easily discernible.

Consumer Perspectives and Utilization of Drug Information in Korea (국내 의약품정보에 대한 소비자의 시각 및 활용도)

  • Lee, Iyn-Hyang;Kye, Seunghee;Lee, Sukhyang
    • Korean Journal of Clinical Pharmacy
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    • v.23 no.4
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    • pp.334-343
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    • 2013
  • Purpose: This study aims to investigate consumers' demand of and perspective on drug information domestically available and uncover hurdles that they faced while utilizing information. Methods: We conducted a survey of 101 consumers, face-to-face after obtaining informed consent. Chi-squared, or Fisher's exact tests, and multivariate logistic models were used to investigate the association between participants' perceptions and characteristics. Results: As results, participants showed the highest demand for "Adverse effects >90%"; "Drug interactions/Dosage/Drug-food interactions/Indication >80%", and utilized package inserts (52%), doctors (41%) and pharmacists (36%) most often as information sources. Generally, the most common difficulty consumers suffered with was that "it is hard to understand (51%)". With public sources of drug information, sixty one percent of participants were "unaware of the provision of information", resulting in strikingly low usage rates (5~11%). Subgroup analyses indicated that the older (${\geq}50$ years) and the disadvantaged might have been placed in the blind spot of information mostly developed online (p<0.05).Conclusion: In conclusion, public sources of drug information that have been developed online might fail to meet consumers' demand. Greater efforts should be made to balance the development of the information sources between online and offline, and to increase accessibility of the established information sources.

Analytical Survey on the Package Source, Components, and Various Characteristics of Processed Foods in Korea (국내 가공식품의 포장 재질, 형태 및 다양한 특징 분석 연구)

  • Song, Hyun Ju;Chang, Yoonjee;Park, Se-Jong;Choi, Jae Chun;Han, Jaejoon
    • KOREAN JOURNAL OF PACKAGING SCIENCE & TECHNOLOGY
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    • v.23 no.3
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    • pp.173-181
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    • 2017
  • This study was conducted to investigate the packaging characteristics including pack sources and pack components of processed foods in Korea. For the survey, 704 food package samples were selected based on the consumption of top 10 brackets in each food item. They were consisted of 1,245 packaging components. Seven specific items were firstly investigated including product name, capacity of the food, package component, package source, food contact area, food contact ratio, and package thickness. The processed foods in Korea can be classified into 16 pack sources and 21 pack components, respectively. By using this information, the data were analyzed specifically. The collected data were analyzed in 8 major categories: frequency of use by pack components and pack sources, pack components by the products, pack sources by the products and pack components, pack thickness/food contact ratio by the products, food contact ratio by pack components and pack sources. Consequently, this survey will provide various information of the packaging characteristics of processed foods in Korea.

Identifying the Patterns of Adverse Drug Responses of Cetuximab

  • Park, Ji Hyun
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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    • pp.226-237
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    • 2022
  • Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

A Study on the Actual condition of the Middle School Students on Drug use (중학교 학생들의 약물사용실태에 관한 연구)

  • 성윤진;안숙자
    • Journal of Korean Home Economics Education Association
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    • v.10 no.2
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    • pp.145-161
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    • 1998
  • The purpose of this study was to survey the actual condition of the Middle School Students on a Drug. In this study, 500 middle school students in Seoul response to a questionnaire which is composed to analyse two categories, i.e. general facts, the actual condition of drug use (the frequency of drug use, the degree of perception on drugs, the people using a drug surrounding the degree of purchase on drugs). And the students are classified by satisfactory degree on their home backgrounds, satisfactory degree on their school life, and school record. The data is analysed by means of frequency, percentage, chi-square test and Pearson's correlation using the $SPSS-PC^+$ package program. The results of this study were as follow : The frequency of drug use except a alcohol and the degree of perception on a drug among female students are higher than among male. The female students are more permissive on the drug use and they are also tend to think more easily the purchase of a drug. The frequency of drug use and the degree of perception on drugs are higher in the group of the lower satisfactory degree on their home background. Especially, there are many people using drugs surrounding the students in the lower group. The frequency of drug use and the degree of perception on drugs are higher in the group that has the lower satisfactory degree on school life. The students in the group having low school record have more dangerous thought about the use of drugs than the students of high record. The degree of perception on a drug is higher in a higher group, and the students in a higher group also think more easily the purchase of drugs. The percentage of students using drugs are not high, but the high percentage of students are interested in the drugs and they have permissive attitudes on drugs. Thus, the preventive education for drug abuse must be done rapidly.

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