• Title/Summary/Keyword: Ethical drugs

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Comparative Analysis of Ethical-the-counter Drugs and Over-the-counter Drugs for the Adverse Events from the Community Pharmacy (지역약국에서 보고된 전문의약품과 일반의약품의 이상사례 보고현황 비교 분석)

  • Lee, Mo-Se;Park, So-Hee;Kim, Na-Young;Oh, In-Sun;Lee, Jung-Min;Lee, Eui-kyung;Shin, Ju-Young
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.3
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    • pp.230-237
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    • 2018
  • Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.

Pitfalls in Reimbursement Decisions for Oncology Drugs in South Korea: Need for Addressing the Ethical Dimensions in Technology Assessment

  • Cho, Eun;Park, Eun-Cheol;Kang, Myoung Sheen
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.6
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    • pp.3785-3792
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    • 2013
  • This study aimed to discover to what extent ethical issues are considered in the reimbursement decision process based on health technology assessment (HTA) in Korea, especially for oncology medications. Public summary documents (PSDs) published by the Health Insurance Review and Assessment Service (HIRA) were analyzed for empirical and normative factors. For external comparison, PSDs presented by corresponding institutions of Australia and the United Kingdom were employed. Furthermore, the opinions of eight expert oncologists were obtained regarding the accountability of the evidence in PSDs. Among 7 oncology drugs, there were differences in the final decisions and empirical factors considered, such as selected comparators and interpretation of evidence between the PSDs from the three institutions. From an ethical viewpoint, the following matters were deficient in the HTA decision-making process for oncology drugs: clear and reasonable standards; identifying and evaluating ethical values; and public accountability for reasonableness about decisions and due process.

Influencing Factors of Physician's Intention to Use Cyber Salesperson of Ethical Drugs (의사들의 전문의약품 사이버영업사원 사용의도에 대한 영향요인)

  • Shim, Jae-Won;Paik, Soo-Kyung;Han, In-Goo;Ryu, See-Won
    • Korea Journal of Hospital Management
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    • v.14 no.4
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    • pp.124-148
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    • 2009
  • Objectives : The purpose of this study was to investigate influencing factors on physician's intention to use cyber salesperson(cSP) to promote ethical drugs of pharmaceutical company. We considered influencing factors based on technology acceptance model(TAM) such as usefulness, easy of use, and attitude about cSP, and included trust and joyfulness of cSP. Methods : Measure items were developed from the previous studies. Data were collected from 1,012 physicians by using web-based self-administered structured questionnaire. Results : The major findings were as follows; First, attitude and intention to use cSP were not significantly varied by socio-demographic variables, such as sex, age, location, and Internet surfing time per day. Also, physician's characteristics such as training and professional level and type of employment were not significant to the variation of attitude and intention to use cSP. Second, structural equation modeling(SEM) analysis shows that usefulness and joyfulness were influencing factors of intention to use. Attitude was revealed as significant mediating factor to intention to use. Usefulness has indirect effect on intention to use via attitude. However, trust has not significant effect on intention to use, due to suppression effect. Conclusions : This results implies that cSP will be a useful agent to promote the ethical drugs to physician. Usefulness and joyfulness should be considered as important factors in designing and operating cSP in the Internet.

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Awareness about Pandemic Infectious Diseases, Ethical Awareness, and Ethical Decision-making among Nursing Students (간호대학생의 신종 감염병에 대한 인식, 신종 감염병 상황에서의 윤리 인식과 윤리적 의사결정)

  • Kim, Yunsoo;Hong, Sungsil
    • Journal of Korean Public Health Nursing
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    • v.33 no.3
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    • pp.326-339
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    • 2019
  • Purpose: This study attempts to identify the level of awareness, ethical awareness, and decision-making among nursing students, in response to pandemic infectious diseases. Methods: Subjects were 210 nursing college students attending colleges in 5 cities and provinces nationwide. Data were collected from November 2017 to April 2018 using a self-administrated questionnaire, and analyzed utilizing descriptive statistics. Results: Considering the awareness of pandemic infectious diseases, the nursing students expressed high concern about the possibility of future outbreaks of pandemic infectious diseases and seriousness of the situation. There were numerous negative views on the response and stockpiling of drugs by the government. Ethical awareness of pandemic infectious diseases was high, with demands for accurate information and proper protective equipment. Overall, ethical decision-making when responding to pandemic infectious diseases represented a high score. Also, higher awareness levels of pandemic infectious diseases would result in increased ethical and ethical decision-making. Conclusion: In conclusion, we propose the introduction of an ethical education program for medical personnel and nursing university students, to enable the handling of future pandemic outbreaks of new infectious diseases.

A Study on Doping Test of Bojungchisheup-tang (보중치습탕(補中治濕湯)의 도핑검사 대상약물(對象藥物)에 관(關)한 연구(硏究))

  • Kim, Sung-Yong;Geum, Dong-Ho;Lee, Myeong-Jong
    • Korean Journal of Oriental Medicine
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    • v.3 no.1
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    • pp.289-319
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    • 1997
  • Non-medical use of drugs to enhance performance at Olympic Games by athletes has been prohibited by the International Olympic Committee(IOC) since 1968 on medical and ethical grounds. IOC wants to protect athlete from harmful side effect of drugs due to misuse of it. It also, ethically, wants to have Games run on fair base, not fortified by performance enhancing drugs, The banned substances include stimulants, narcotic analgesics, anabolic sterolds, ${\beta}-blockers$ and diuretics. In order to prevent the positive reaction in the doping test induced by herb medicine, this study was done on about Bojungchisheup-tang. The laboratory set up doping analyses methods to cover as many drugs as possible without sacrificing sensitivity and specificity within one procedure. Its screening method consisted of four different procedures. The results were negative. According to the above results, Bojungchisheup-tang taken by athletes would show the negative reaction in the doping test. So its prescription for athletes can be given without worries of the doping test.

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Characteristics of Some Animal Models of Experimental Renal Failure (실험적 신장해 모델의 특성 비교)

  • Shim, Chang-Koo
    • Journal of Pharmaceutical Investigation
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    • v.17 no.4
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    • pp.205-211
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    • 1987
  • Renal dysfunction can have pronounced effects on the pharmacokinetic and pharmacodynamic characteristics of drugs. Because the exploration of these effects in patients may be limited by ethical and practical considerations, it often become necessary to perform studies on animals with experimental renal failure(ERF). ERF was produced in rats by the administration of uranyl nitrate, glycerol, salicylate, gentamicin and folate in this study. Changes in glomerular filtration rate(GFR) and renal secretion clearance of tetraethylammonium bromide$(CL^{scn}_{TEA})$, together with morphological changes of kidney cortex were evaluated and compared among ERF models. GFR(or glomeruli) and $CL^{scn}_{TEA}$(or renal tubules) were not damaged parallelly in some ERF model rats. Therefore, it seemed to be necessary to adjust dosage regimen of some basic drugs like TEA in renal dysfunction considering the functional changes of renal secretion in addition to glomerular filtration.

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Recent Developments in Analytical and Preparative Scale Enantioseparations

  • Chankvetadze, Bezhan
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.161-162
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    • 2002
  • Field of enantioseparations represents one of the actual topics of chemistry. Significant, in some cases dramatic differences in a desired activity as well as in toxic properties of enantiomers of chiral drugs, food additives, agrochemicals, cosmetic products, etc. represents a driving force in this field. The enantiomers of all chiral bioactive compounds have to be isolated and to be tested. Besides the ethical or environmental reasons for developing single enantiomers, it may be a real therapeutic benefit and in some cases, it has been used as a strategy for extending patent life. (omitted)

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Analysis and Ethical Review of the Compensation System for Clinical Trial Injury in India (인도 임상시험 피해보상제도 분석 및 윤리적 고찰)

  • Lee, Chan Joo;Choe, Byung In
    • The Journal of KAIRB
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    • v.3 no.1
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    • pp.1-10
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    • 2021
  • In 2004, India began investing in the clinical trial industry; the country now boasts a 20% market share with the help of a valuable resource - the world's second largest population. The Contract Research Organization has been able to generate profits efficiently conducting clinical trials via a large pool of participants, skilled researchers, and reduced developmental costs. As the demand and sheer number of global clinical trials increased, the International Council of Harmonization-Good Clinical Practice was introduced, and the need for the Institutional Review Board increased. While the clinical trial industry in India boomed, it came at the expense of the participants' civil rights. The increased media attention regarding the ethical issues forced the Indian Supreme Court to take action. Consequently, India is the only country, by law, that specifically compensates participants suffering from injury directly resulting from participation in clinical trials. This research paper will describe and compare the relevant laws of India and Korea including compensation criteria. In addition, the ethical issues and aspects of indemnity in clinical trials will be discussed. While the clear advantage of the compensation is one of the protected rights of a clinical subject, the current system is not perfect. Furthermore, laws created to redeem ethical issues can have unintended, negative consequences.

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A Study on the Classifications of the Traditional Medicinal Prescriptions in Dong-Eui-Bo-Gam for the Modern Applications (동의보감에 수재된 방제의 현대 산업화를 위한 분류 연구)

  • Kim, Yun-Kyung;Kim, Ju-Ho;Oh, Mun-Su;Park, He-Jung;Kim, Eun-Jung;Lee, Je-Hyun
    • Herbal Formula Science
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    • v.15 no.1
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    • pp.117-128
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    • 2007
  • We re-classified traditional medicinal prescriptions in Dong-Eui-Bo-Gam for the modern application using Tradimed database. They could be devided into 6 categories by the definitions of the related laws. Herbal ethical drugs are the majority, 3926 items, account for 60.21% of total items. Herbal Health Functional Foods stands second, 1480 items, 22.70%, Herbal over the counter drugs are 893 items, 13.69%. These three categories are about 83% of total items. Herbal medical supplies are 158 items, 2.42%, Herbal medical tools are 44 items, 0.67%, Herbal cosmetics are 20 items, occupied 0.31 %. Therefore we have known that traditional medicinal prescriptions can be used not only as drugs, but also as funtional foods, cosmetics, and tools. So they should be developed as modern products to make best use of them. And we suggested that we need official criteria of herbs of careful use and higher standards for herbs which can be used as foods.

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An Empirical Study on the Effectiveness of Marketing Activities for Ethical Drugs (ETC) (전문의약품 마케팅활동의 효과 측정에 관한 실증 연구)

  • Seung-Yeoun Noh;Keun-Woo Kim;Nam-Sik Chang
    • Asia-Pacific Journal of Business
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    • v.14 no.4
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    • pp.289-303
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    • 2023
  • Purpose - The purpose of this study is to investigate the types and forms of various marketing activities actually used in pharmaceutical companies and to empirically analyze the impact of these marketing activities on sales. Design/methodology/approach - This study categorize five years' worth of marketing activity data from a foreign pharmaceutical company 'A' which operates in South Korea into five categories. Multiple regression analysis and interaction effects are employed for data analysis. Findings - First, CRM calls, Detail calls, GP, and Web events have a positive impact on sales, but SoV does not show significant differences. Second, in the comparison between HQ1 and HQ2 based on patent ownership, Detail calls and Web events had a stronger impact on sales in HQ2, where the patent period is still in effect, compared to HQ1. However, SoV showed no difference between HQ1 and HQ2. Research implications or Originality - First, Detail Calls are more effective for drugs with active patents, while CRM Calls work better for drugs with expired patents. This emphasizes the need to customize call strategies based on patent status. Second, the significant impact of Web Events on sales in HQ2 compared to HQ1 suggests that online information access is crucial, indicating that customer receptivity varies based on product nature. Third, these insights, derived from data analysis, call for a shift in pharmaceutical marketing analysis methods away from traditional approaches. Finally, this study holds significance as one of the first empirical analyses using actual marketing data from pharmaceutical companies in South Korea.