• The Korea Journal of Herbology
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• v.27 no.2
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• pp.25-29
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• 2012

Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.

• Journal of The Korean Society of Clinical Toxicology
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• v.16 no.1
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• pp.42-48
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• 2018

Purpose: On November 15, 2012, sales of OTC (Over-The-Counter) drugs began at convenience stores, which changed the accessibility of some drugs. As a result, the exposure and access patterns of these drugs could have changed. In this study, we reviewed the changes in the characteristics of drug poisoning patients because of the reposition of nonprescription drugs according to the revised Pharmaceutical Affairs Act. Methods: A retrospective study was conducted to evaluate changes in characteristics of drug poisoning patients between 2008 and 2016. A registry was developed by an emergency medical center in a local tertiary teaching hospital, and patients who visited the center were enrolled in this registry. We compared two periods, from 2008 to 2012 (Pre OTC) and from 2013 to 2016 (Post OTC), for type of intoxicant, time from poisoning to visiting the emergency center, intention, psychiatric history, previous suicidal attempt, alcohol status, and emergency room outcomes. The primary outcome was the number of patients who took acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Secondary outcomes were ICU admission rate, mortality rate, and number of patients who visited the ER when the pharmacy was closed after taking acetaminophen and NSAIDs (nonsteroidal anti-inflammatory drugs). Results: Among 1,564 patients, 945 and 619 patients visited the emergency room during pre and post OTC periods. The number of patients with acetaminophen and NSAIDs poisoning decreased from 9.2% to 6.1% (p=0.016). The ICU admission rate and mortality rate in the emergency room did not show significant results in the relevant patient groups, and so was the number of patients visiting ER when the pharmacy was closed taking acetaminophen and NSAIDs. Conclusion: Despite the sales of nonprescription drugs at convenience stores, the number of acetaminophen and NSAIDs poisoning patients decreased.

• The Journal of KAIRB
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• v.3 no.2
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• pp.19-27
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• 2021

Purpose: This study aimed to analyze the knowledge levels, attitudes, and factors affecting the choices on the education of the participants who completed their education of persons conducting clinical trial workers, and to assess the problems of the current education system for clinical trial workers, leading to improvements. Methods: Clinical trial workers (including principal investigators/subinvestigators, members of the Institutional Review Board [IRB], clinical research coordinators) who were affiliated to one of the 4 university hospitals running their own clinical trial center and IRB in Daegu and completed their education of persons conducting clinical trial workers were the subjects of this study. One hundred seven online questionnaires were answered from 2021-04-02 to 2021-04-17. Descriptive statistics and Pearson correlation analysis were used to analyze the acquired data. Independent t-test and 1-way analysis of variance were used to analyze the differences in the knowledge levels and attitudes following the characteristics of the education participants. Results: The baseline characteristics of the 107 participants were as follows: the majority of the participants were female (72.0%), were in their 30s (36.4%), had a nursing major (29.0%), were clinical research coordinators (63.6%), had never experienced a principal investigator (79.4%), had participated 3 or more educations (58.9%), had completed their maintenance course (55.1%), had 5 or more years of clinical trial experiences (34.6%). The fields on which participants had low levels of objective knowledge were "types and preparations on audits of clinical trials," "regulations on clinical trials (Pharmaceutical Affairs Act, Korea Good Clinical Practice)." The difficulties that the participants faced were on "annual educations" and "lack of information regarding the educations." Factors that showed significant differences in objective knowledge were sex (p=0.02), number of educations (p=0.004), the curriculum of 2020 (p=0.001). Age (p=0.004), having experienced a principal investigator (p=0.006), number of educations (p<0.001), the curriculum of 2020 (p<0.001), clinical trial career (p=0.001) were factors that significantly affected subjective knowledge. Attitudes toward the education were positively correlated with objective knowledge (r=0.20, p=0.04) and subjective knowledge (r=0.32, p=0.001). Major sources through which information on educations was acquired were "institutional notices," and major factors affecting the choices on the education were "when the education took place" and "where the education took place." "Within the affiliated institution," "Online classes (recorded)" and "IRB and review processes" were each the most preferred place, mode, and content of the education. Conclusion: Knowledge levels varied largely among participants who completed their education of persons conducting clinical trial workers, depending on their characteristics such as the number of educations. Participants also complained about their lack of information on educations. The quality of education may be improved if clinical trial organizations are designated as education facilities. Education programs must be developed considering the knowledge level and demand of the participants. Furthermore, as offline classes may be impossible due to pandemics such as the coronavirus disease 2019, the development of diverse and sophisticated online classes is looked forward to.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• Journal of Global Scholars of Marketing Science
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• v.17 no.4
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• pp.23-49
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• 2007

Salespeople act at the point of MOT with customers and deliver the enterprise's message to the customers. They build up relationships with customers as well as deliver the customer's message to the enterprise. The salespeople's activity at the point of MOT with the customers and the degree of satisfaction of the customers' needs will affect the customers' attitude toward the enterprise, brand loyalty, and retention intention. Ultimately, it will influence the enterprise's financial performance. The control of salespe1ople is one of the most interesting topics of marketing. This research investigates the relationships of the control types over salespeople(positive/negative outcome control, positive/negative behavior control) and job satisfaction and their mediating variables. The mediating variables in the relationships have been identified as outcome/behavior-related role clarity and self-efficacy. The purpose of this study is more specifically as follows: First, it investigate how the perception of salespeople control types affect role-clarity. Second, it examines how the perception of salespeople control types influence self-efficacy. Third, it investigate the mediating role of role-clarity between the perception of salespeople control types and self-efficacy. Fourth, it investigates how role-clarity affect self-efficacy and job satisfaction. Finally, it will investigates how self-efficacy influences job satisfaction. Data were collected from the pharmaceutical industry salespeople and analyzed by SPSS 12.0 and AMOS　6.0. The data were collected by 400 respondents and 377 valid questionnaires were analyzed. The results are summarized as follows: First, positive/negative outcome controls had a positive relationship with outcome-related role clarity. Also positive behavior control had a positive effect on behavior-related role clarity, but negative behavior control didn't influence behavior-related role clarity. Second, positive outcome control influenced self-efficacy positively, but positive behavior control didn't have a positive effect on self-efficacy. In addition negative outcome control and negative behavior control had a positive effect on self-efficacy due to the mediating role of outcome-related and behavior-related role clarity. Third, outcome-related role clarity and behavior-related role clarity influenced self-efficacy positively. Behavior-related role clarity had a positive effect on job satisfaction, but outcome-related role clarity didn't influence job satisfaction. Finally, self-efficacy didn't have any effect on job satisfaction. The contributions of this study are as follows: First, existing studies have investigated the direct causal relationship between salespeoples' control type and performance, but this study investigates the structural causality between salespeoples' control types, responses, and performances. Second, this study found the mediating role of outcome-related/behavior-related role-clarity between outcome/behavior control and self-efficacy. Finally, the findings of this study further insight to existing studies on the relationship between job satisfaction and self-efficacy. The confidence of salespeoples' task influenced job satisfaction positively in existing articles,field studies, but the relationship between these two variables was not significant in this study. This means that there can be a different relationship between confidence and job satisfaction according to salespeoples' business. That is, the business environment may not be satisfying, even if the salespeople say that they have ability and confidence about their business. This means that able salespeople who have ability and confidence about their business are not satisfied with their job advancement in the company. Therefore, enterprise need to provide training that can establish a business environment that can satisfy the salespeole's expectation level which will secure good salespeople. This study may have limitation when applied to future studies. First,in this study as with existing studies it investigates the control level that salespeople feel is being measured. Actuality, the control level that a manager enforces and the control level that salespeople perceive when one is late can be different. There is need to measure lateness from both the perspective of the manager and salespeople should be done to supplement this study in the future Second, this study used variables that were connected with action result but salespeople's job satisfaction is due to the result of control. But, focusing on result of control can provide a more important financial result than sales performance. This study is also limited in that it did not consider financial result by result of control. Further studies on this will need to be done in the future. Third, this study may have a further limitation,because the investigation was restricted to pharmaceutical salespeople selling to hospitals. It is necessary to execute investigations in various industries to increase the generalization of the study findings Fourth, in this study, role clarity and self-efficacy by response variable for control and considered job satisfaction by outcome variable of control was considered. But, can other variables be considered beside response variable and result variable for control? For example, can financial affairs and change of post by outcome variable along with business stress by response variable for control be considered? Therefore, future studies need to consider various control variables. Finally, there is limited supporting research in the field of marketing which restricts the generalization of the study finding along with collecting material through random sampling of a limited size. This research summarizes the research in this area, the difference from the previous research, and provides a discussion of its limitations and the need and direction for further future research.