• Safe Food
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• v.2 no.2
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• pp.11-18
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• 2007

• Health Policy and Management
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• v.24 no.2
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• pp.164-171
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• 2014

Background: Safety of drugs has become a major issue in public healthcare. Spontaneous reporting of adverse drug reaction (ADR) is the cornerstone in management of drug safety. We aimed to investigate the awareness and knowledge of spontaneous ADR reporting in general public of Korea. Methods: A total of 1,500 study subjects aged 19-69 years were interviewed with a questionnaire for their awareness and knowledge related to spontaneous ADR reporting. Computer assisted telephone interview was performed from 27th February 2013 to 4th March 2013. Target population was selected with quota sampling, using age, sex, and residence area. Healthcare professionals such as physicians, pharmacists, and nurses were excluded. The survey questions included awareness of spontaneous ADR reporting, opinions on ways to activate ADR reporting, and sociodemographic characteristics. Results: Overall awareness of spontaneous ADR reporting system was 8.3% (${\pm}2.53%$) among general population of Korea. Major source from which people got the information regarding ADR reporting was television/radio (69.9%), followed by internet (19.3%), and poster/brochure (6.1%). Awareness level differed between age groups (p<0.0001) and education levels (p<0.0001). Upon learning about the ADR reporting system, 88.5% of study subjects agreed on the necessity of ADR reporting system, while 46.6% thought promotion through internet and mass media as an effective way to activate ADR reporting. Conclusion: The overall awareness of spontaneous ADR reporting should be enhanced in order to establish a firm national system for drug safety. Adequate promotions should be performed targeting lower awareness groups, as well as various publicity activities via effective channels for the general population.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.286-294
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• 2019

Background: At the end of the'Waste Drug Disposal Project', collection and disposal of waste drugs remain a social issue. Objective: This study aimed to provide suggestions to improve the drug waste management system in Korea by comparing domestic and overseas relevant programs. Methods: This is a comparative study between South Korea, Australia, Canada, France, and the US. These overseas countries were selected because they have been operating waste drug management programs continuously to date. Comparison was conducted by a pre-determined analysis frame including legal regulation, enforcement program and its performance. Results: All selected countries except Australia had legal regulations on drug wastes. The US had the largest variety of drug waste disposal methods. Canada had recommended that pharmacies actively participate in drug waste withdrawal programs. France had the largest variety of methods to promote relevant programs, including window sticker, SNS, and app, as well as the highest level of awareness and participation. Australia had the lowest level of awareness and participation in pharmaceutical waste management programs. Pharmaceutical companies took responsibility of paying for these programs in the selected overseas countries. Conclusion: Further efforts should be made to establish a clear guideline including the role of pharmaceutical companies, and to develop various methods for the public to be aware of appropriate ways of disposing drug wastes in Korea.

• KSII Transactions on Internet and Information Systems (TIIS)
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• v.16 no.2
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• pp.424-444
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• 2022

In hospitals and pharmacies, the distribution of medicines is an important part. Any mistakes, misses, fake medicines and expired medicines can cause medical accidents. With the widespread application of the Internet of Things technology (IoT), traditional drug distribution methods need to be upgraded. This article proposes a drug distribution management scheme based on the Internet of Things technology. In the production of drugs, a flexible RFID tag was printed on the packaging box, which stored a series of information such as drug name, dosage, raw materials, efficacy, production date, expiration date, and manufacturer. The use of a drug distribution management system combined with RFID readers can identify drug information and effectively prevent the occurrence of erroneous, missed, counterfeit, and expired drugs. It can also improve management efficiency, reduce management costs, and control management risks. Through the circuit design and software system development, the test results show that this solution is effective and feasible, the proposed method can achieve the expected results.

• Journal of Sensor Science and Technology
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• v.17 no.3
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• pp.229-235
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• 2008

In order to monitor the anticancer drug in stable conditions, the Web based anticancer drug management system and alarm services were constructed and assessed in this study. Anticancer drug should be exact to the correct patient in the right environment. To overcome the restriction of existing equipment that only monitors fragmentarily, temperature and humidity were continuously monitored to maintain stable environments using sensor networks and RFID for the monitoring and management of anticancer drug. Construction drug identification and the effect of normal air outside the anticancer dispensary with obstacles were evaluated in working hour. Pre-installed control system in the dispensary could be alternated with auto sensing and alarming. We expected that the efficiency of anticancer drug management and the reliability of drug medication by handwork would be increase accordingly.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• Tuberculosis and Respiratory Diseases
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• v.78 no.3
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• pp.168-174
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• 2015

Drug-resistant tuberculosis (TB) is still a major threat worldwide. However, recent scientific advances in diagnostic and therapeutic tools have improved the management of drug-resistant TB. The development of rapid molecular testing methods allows for the early detection of drug resistance and prompt initiation of an appropriate treatment. In addition, there has been growing supportive evidence for shorter treatment regimens in multidrug-resistant TB; and for the first time in over 50 years, new anti-TB drugs have been developed. The World Health Organization has recently revised their guidelines, primarily based on evidence from a meta-analysis of individual patient data (n=9,153) derived from 32 observational studies, and outlined the recommended combination and correct use of available anti-TB drugs. This review summarizes the updated guidelines with a focus on the medical management of drug-resistant TB.

• 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.

• Toxicological Research
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• v.17
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• pp.211-216
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• 2001

Drugs can have various adverse effects on the immune system including unintended immun-osuppression, induction of both drug-specific immune responses (including drug allergies) and non-specific immunostimulation (including autoimmune reactions), and direct activation of effector mechanisms (such as histamine release). As a practical matter, the Center for Drug Evaluation (CDER) relies on standard non-clinical toxicology studies to detect unintended immunosuppression. Specific assays using guinea pigs and mice are available to identify drugs that can induce immune-mediated dermal hypersensitivity reactions. Respiratory and systemic hypersensitivity and autoimmune reactions are more difficult to model in non-clinical studies. Unintended nonspecific immunstimulation can be detected in animal studies. CDER is currently developing specific guidance for evaluating potential drug immunotoxicity.

• Korean Journal of Clinical Pharmacy
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• v.23 no.4
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• pp.344-364
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• 2013

Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are immune-complex-mediated hypersensitivity reactions that predominantly involve skin and mucous membranes. Despite the low incidence, both are considered medical emergencies as the mortality rate has been estimated at 30-50%. Although as many as half of cases are idiopathic, several drugs have been implicated as main cause of SJS/TEN. This review therefore aimed to identify drugs that were potentially associated with SJS/TEN and compare the relative risk of the medications. Method: A comprehensive search was performed using MEDLINE, EMBASE and 5 Korean databases. We defined study drugs as non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, antiepileptics, and allopurinol. Only epidemiologic studies investigating associations between the above drugs and drug-induced SJS/TEN were included. Two reviewers independently selected and evaluated candidate papers and extracted odds ratios or incidence rates. Meta-analysis was performed only for drugs that were reported from 4 or more studies. Results: We found 8 case-control studies, 3 cohort studies and 1 RCT. The ranges of adjusted ORs were 0.6-34.0 for NSAIDs, 1.6-302.0 for antiepileptics, 0.3-10.0 for antibiotics and 1.0-187.0 for allopurinol. The drug with the highest incidence of SJS/TEN was carbamazepine (40 persons/1,000 DDD). Conclusion: Finally, the risk was highest in first 8 weeks after onset of treatment in all drugs.