• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Korean journal of food and cookery science
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• v.19 no.3
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• pp.339-353
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• 2003

The rapid increase in food borne illness outbreaks in Korea has been one of the major threats to the Nation's Health. Foodservice establishments have been identified as the major place for these outbreaks, mainly due to the lack of sanitary management and sanitary facility management practices. The purposes of the study were to develop hospital foodservice facility evaluation tools, based on the general HACCP-based standards and guidelines, for hospital food service establishments, to ensure the safety of these foodservices and to reduce the risk of food home illness. The scope of this study included: 1) an assessment of the current foodservice sanitation practices and managements for 6 general hospitals, with more than 400 beds, and 3 general hospitals, with less than 400 beds; 2) the development of foodservice establishments sanitation evaluation tools and sanitation standards, based on the HACCP system. The survey data showed varied results between the hospitals surveyed. Most of the hospital foodservice operations had many problems with ventilation and the plumbing. The total dimensional mean scores for the hospitals with more than 400 beds and less than 400 beds were 31.5 and 27.0, respectively. The highest dimension scores were for the water supply facility and lighting, with the lowest for insect and rodent control and toxic materials management. The levels of the mean scores were very low, especially for the general hospitals with less than 400 beds. These low mean scores may have arisen from critical problems within the hospital foodservice operations. The most needed facility management items for improvement were: storage shelf should be spaced 6 inches from the floor and walls, the use of three compartment sinks, utility sinks and cleaning facilities, with a floor drain for cleaning mops or liquid wastes, a ventilation hood designed to prevent dripping onto food, cooking facilities should be disassembled for washing and sanitizing, a separated hand washing sink and a sanitized food board for each area should be provided, all toxic material must have warning labels attached, and be stored in an area away from food preparation under padlock. The evaluation tool consisted of 14 dimensions, with 65 check-off items. The results of this study will provide basic facilities' guidelines to regulators, or foodservice industry personnel, wishing to build, or expend, and establish an efficient flow of food. As a result, food borne illnesses will be effectively prevented, and the Nation's health will be promoted for the development of their own sanitation standards, with a checklist for the safe production of foods.

• Journal of Food Hygiene and Safety
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• v.19 no.2
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• pp.74-83
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• 2004

Raw-fish food contains a lot of moisture and is a high-protein food. It is a first-stage processed food taking a lot of manual work. Therefore, it is classified as a PHF food, very liable to cause a bacterial food-poisoning. But its manufacturers are usually small-sized and a systematic sanitation management is difficult to expect. But the manufacturer participating in this study produces chilled fresh raw-fish food. Fish are sliced into two fillets, which are packaged under vacuum, kept and distributed in refrigerators, and sold within a day. It is a newly-developed kind of raw-fish food, and a more improved kind of raw-fish food making possible a systematic sanitation management. The HACCP (Hazard Analysis and Critical Control Point) is a systematic and continuous process-control method which is very efficient for controling food sanitation and reducing the expenses. A new HACCP model has been developed to be applied to a large-sized chilled fresh raw-fish food manufacturer. To ascertain its efficiency, the baterial examination was done to its workplace and products. The significance test was done on its data by "SPSS 12.0 for Window" and "Mann-Whitney U Test". The numbers of bacteria on its final products were significantly different in flatfish and porgy. The number of bacteria tended to decrease in each time-differential sampling (P＜.00l). The final food products showed no food-poisoning bacteria in all the time-differential tests and in all the samplings, which proves that the CCP of the HACCP system is under control. After the SSOP program was applied, no pathogenic bacteria were found in the work-place, and the kinds and numbers of bacteria decreased. The numbers of general bacteria and colon bacilli also showed a significant difference from those before the SSOP program in the filleting board (P＜.05), in the skinning board (P＜.0l), in the neck-removing knife (P＜.05), and in the filleting knife (P＜.01). The working equipments, periodically disinfected, also showed a significant difference in sanitary conditions (in the dehydrator, P＜.05). The number of bacteria found on the food-touching surface was within the standard (below 500/l00 cm$^2$) After the SSOP program was applied, the general bacteria and colon bacilli were not found. The quality of water used in the food processing was also within the standard. The numbers of bacteria falling from the air in the work-place were negligible in all the samplings (＜30CFU/l000ι). The staphylococci and fungi were not found.

• Journal of Biomedical Engineering Research
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• v.44 no.6
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• pp.363-376
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• 2023

According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.

• Journal of Food Hygiene and Safety
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• v.30 no.3
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• pp.217-226
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• 2015

This study was conducted to establish a standardized process for developing food safety health indicators. With this aim, we proposed a standardized process, accessed the validity of the suggested process by performing simulations, and provided a method to utilize the indicators. Developing process for domestic environmental health indicators was benchmarked to propose a standardized process for developing food safety health indicators, and DPSEEA framework was applied to the development of indicators. The suggested standardized process consists of an exploitation stage and a management stage. In the exploitation stage, a total of 6 procedures (initial indicators suggestion, candidate indicators selection, data availability assessment, feasibility assessment, pilot study, and final indicator selection) are conducted, and the indicators are routinely calculated and officially announced in the management stage. The exploitation stage is operated by an interaction between a task force team who manages the overall process, and an advisory committee (minimum of 4 in academia, 2 in research, 4 in specialists of Ministry of Food and Drug Safety) who reviews and performs evaluations on the indicators. The standardized process was simulated with 45 initial indicators, and total of 4 indicators (17 detailed indicators) were selected: 'Proportion of domestic fruit/vegetable receiving 'acceptable' in the evaluation of pesticide/herbicide residues', 'Food-borne disease outbreaks', 'Food-borne legal infectious disease incidence', 'Salmonellosis incidence'. Synthetic food safety health index was derived by calculating percent difference with the data from 2010 to 2012. Results showed that when comparing the year 2010 to 2011, and 2011 to 2012, the overall food safety status improved by 10.37% and 9.87%, respectively. In addition, the contribution of indicators to the overall food safety status can be determined by looking into the individual indicators, and the synthetic index may be illustrated to enhance the ease of interpretation to the public and policy makers. In overall, food health safety indicators can be useful in many ways and therefore, attention should be drawn to conduct further studies and establish related legislations.

• YAKHAK HOEJI
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• v.50 no.3
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• Korean Journal of Community Nutrition
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• v.26 no.6
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• pp.429-440
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• 2021

Objectives: Standardized guidelines and reference points for a food security policy are necessary to guarantee that basic social safety nets work properly. Therefore, this study aimed to explore the basic concepts and detailed dimensions of food security, including the potential relevant indicators, and sought to establish standardized well-being baselines. Methods: A literature review and 14 expert roundtable discussions were carried out to analyze and extract the key concepts of food security. After determining these concepts and detailed dimensions of food security, a conceptual framework was modeled. Then, indicators for each local government that could be monitored and evaluated for each sub-area were suggested. Results: The concept of food security was defined as follows: Individuals should be provided with sufficient, safe, and quality food, which should be accessible to the community and available for use to achieve health and well-being. In addition, food security should be ensured sustainably in a changing environment. Four dimensions were suggested while conceptualizing food security. First, sufficient food, which means sufficient food supply in quantity, quality, and safety. Second, equitable food which includes creating environments in which high-quality and safe food can be purchased at an appropriate price and can be provided regardless of the socioeconomic gap. Third, healthy food which should be provided to promote people's health and happiness through the eco-friendly consumption of food. Fourth, sustainable food, which can be supplied in a sustainable manner and as part of an eco-friendly food system that considers the conservation of natural environments. Conclusions: The basic concepts and detailed areas of food security including the potential indicators proposed in this study, may be useful for developing and implementing various policies and programs to support food and nutrition security in the future.

• Journal of Food Hygiene and Safety
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• v.27 no.4
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• pp.366-374
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• 2012

Recently pathogenic E. coli is one of the main foodborne pathogens resulting in many patients in Korea. To understand the characteristics of pathogenic E. coli outbreaks in Korea, the epidemiological investigation reports of pathogenic E. coli outbreak in 2009 (41 reports) and in 2010 (27 reports) were collected in the web site of the Korea Centers for Disease Control and Prevention, reviewed and analysed in this study. The main places of the pathogenic E. coli outbreaks were food catering service area (64.8%) and restaurants (25.0%). The main type of the pathogens were EPEC (44.7%) and ETEC (34.2%). EAEC and EHEC was responsible for 10.5 and 9.2%, respectively. Eight of 68 outbreak cases were caused by more than 2 types of pathogenic E. coli which implicates the complicated contamination pathways of pathogenic E. coli. The incidence rate of pathogenic E. coli was $33.6{\pm}30.5%$ and the main symptoms were diarrhea, stomach ache, nausea, vomiting, and fever etc. The two identified food sources were identified as frozen hamburger pattie and squid-vegetable mixture. To improve the food source identification by epidemiological investigation, food poisoning notification to the agency should not be delayed, whole food items attributed the outbreak should be collected and detection method of the various pathogenic E. coli in food has to be improved. In conclusion, the characteristics between the EHEC outbreaks in the western countries and the EPEC or ETEC outbreaks in Korea needs to be distinguished to prepare food safety management plan. In addition, the development of the trace back system to find the contamination pathway with the improved detection method in food and systemic and cooperative support by the related agencies are necessary.

• Food Science and Industry
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• v.54 no.3
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• pp.184-195
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• 2021

Smart HACCP is a system that can check the monitoring of critical control point (CCP) in real time to implement improvement measures immediately after departure from limit criteria and prevent falsification of data by digitizing handwritten records. In this study, we developed the analysis model for the effectiveness ofsmart HACCP to compare and analyze with existing HACCP. By introducing of smart HACCP system, the evaluation index value of HACCP effectiveness for HACCP-certificated companies on a small scale increased by 9.25 points, corresponding to 11.52% of increase rate. General HACCP-certificated companies showed 4.52 point and 5.00% of increase rate by introducing of smart HACCP system. Thus, it was confirmed that the introduction of smart HACCP system contributes to the improvement of food safety management and especially it would be more effective for HACCP-certificated companies on a small scale than general HACCP-certificated companies.

• Korean Journal of Clinical Pharmacy
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• v.33 no.1
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• pp.22-34
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• 2023

Background: With the increasing use of narcotic analgesics, the Ministry of Food and Drug Safety has been operating the National Narcotics Information Management System (NIMS) since 2018 in Korea. Some studies are related to the narcotic analgesics use, but the evaluation studies of system, including NIMS users are insufficient. Objective: This study evaluated the NIMS enforcement process through in-depth interviews on the experience of using NIMS of doctors and pharmacists who prescribe or dispense opioid analgesics. Methods: Participants in this study were selected through purposeful sampling as three doctors and two pharmacists in the metropolitan area. The interviews were conducted from August 27 to October 19, 2022. Each interview was analyzed using a phenomenological method. Results: Six components of this study included "Doctors and pharmacists come across drug abusers", "They respond individually to drug abusers", "They use NIMS tailored to the needs of system managers", "They are concerned about the role of NIMS in practice settings", "They face challenges against drug abusers" and "They find a way to utilize the system to deal with drug abusers." The interviews confirmed that doctors and pharmacists used NIMS little in their work, and they only reported data. Therefore, it might be difficult for doctors and pharmacists to take measures for the safe use of narcotic analgesics. Conclusion: It is likely that adding data-feedback and medication-check function can reduce the abuse of narcotic analgesics. In the future, further studies on the evaluation of the empirical results of NIMS and review of systems in other countries will be required.