• Journal of Society of Preventive Korean Medicine
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• v.22 no.3
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• pp.11-19
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• 2018

Objectives : The aim of this study is to investigate the current research trend of herbal medicine based on the published articles in pharmacoepidemiologic journals. Methods : A total of 3 electronic journals, Pharmacoepidemiology and Drug Safety(PDS), Drug Safety and Journal of Pharmacoepidemiology and Risk Management(JPERM) from January 2013 to August 2018 were used for searching articles about herbal medicine. Selected articles were reviewed and classified under 5 categories-collection of adverse events in herbal medicine, statistical modeling and methodology, pharmaco-epidemiologic outcome study, drug utilization review(DUR), risk management system and regulation. Results : A total of 8 articles were finally included for analysis. 2 articles were categorized in collection of adverse events in herbal medicine, 1 was statistical modeling and methodology, 2 were pharmacoepidemiologic outcome study and 3 were risk management system and regulation. There was no article in DUR. And then pharmacoepidemiologic research trends of herbal medicine were summarized in classification of 5 categories. Conclusions : To sum up with these 8 articles of herbal medicine in pharmacoepidemiologic journals, herbal medicine was of interesting concern among researchers. The need for research on safety and risk management of herbal medicine is steadily increasing, pharmacoepidemiologic research about herbal medicine must be activated in Korea.

• The Journal of the Korea Contents Association
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• v.19 no.8
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• pp.303-315
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• 2019

In 2018, 14.3 percent of South Korea's elderly population aged 65 or older entered an aged society and is expected to enter a super-aged society with more than 20 percent of the elderly population around 2025. Older adults often visit different medical institutions to take medicine, which requires medication management, such as interaction between each drug. In this study, we wanted to analyze the U.S. system, which specializes in drug management for the elderly, and Korea's system, which is about to enter a super-aged society, to find a systematic way to manage drugs for the elderly. The method of study was a systematic literature study on elderly drug management in Korea and the United States. Studies have shown that the United States has enacted the Medication Therapy Management (MTM) for the elderly and has been running the Senior Drug Enforcement Program. In Korea, a community care business is underway to manage drugs for senior citizens, but it is analyzed that the elderly need to have a special medicine system for senior citizens to use them more safely.

• Health Policy and Management
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• v.15 no.3
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• pp.40-59
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• 2005

The objective of this paper is to examine what impact the newly introduced Purchasing Price Reimbursement System, where insurance drugs are reimbursed at the prices as they were purchased by medical care providers under the maximum allowable cap, has upon the health insurer's financing situation. The impact of the Purchasing Price Reimbursement System is considered to be confined mainly to the inpatient department among three drug reimbursement fields such as inpatient department, out-patient department and pharmacy. Hypothesis was set and tested in this study for each of three components of inpatient drug reimbursement in health insurance, i.e. average price level, composition of drugs and their overall volume. Drug price level calculated in this study from 403 selected reimbursement drugs according to the Laspayres methodology revealed faster decline under the new Purchasing Price Reimbursement System than previously by $1.53\%$ on the annual average basis. However, additional 1.4 percent financial burden in the ratio of the total inpatient reimbursement was owed by the health insurer. This was analysed to be a combined result of both 2.0-3.1 percent of reduced reimbursement due to drug price decline and 3.4-4.5 percent of additional reimbursement due to drug volume increase. These results suggest that recalling the Purchasing Price Reimbursement System would not have so much impact upon the health insurer's financial situation given that the current compulsory separation between doctor's prescribing and pharmacist's dispensing is irrevocable.

• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.329-338
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• 2007

The quality assurance issue of drug products is more important than the general product because it is highly related to the human health and life. In this reason, the regulatory guide lines have continuously been intensified all around the world. In order to achieve effective quality assurance and real-time product release (RTPR) of drug products, process analytical technology (PAT), which can analyze and control a manufacturing process, has been proposed from the United States. With the PAT process, we can obtain significant process features of materials, quality characteristics and product capabilities from a raw material to the final product in the real-time procedure. PAT can also be utilized to process validation using information system that can analyze the risk of drug products through out an entire product life-cycle. In this paper, we first offered a new concept for the off-line process design methods to prepare the improved quality assurance restrictions and a real-time control method by establishing an information system. We also introduced an automatic inspection system by obtaining surrogate variables based on drug product formulations. Finally, we proposed an advanced PAT concept using validation and feedback principles through out the entire life-cycle of drug product manufacturing processes.

• Journal of Korea Society of Digital Industry and Information Management
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• v.17 no.4
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• pp.133-146
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• 2021

In the field of food and drug, the role of the Ministry of Food and Drug Safety is becoming more important for national and public safety as well as national development and improvement of public welfare. Food and drug statistics are being used to determine the priorities and directions of policy for the promotion of public health and the development of the health industry. This study focuses on statistics from the MFDS. Through the analysis of the MFDS's statistics, the current status of the MFDS's production statistics was identified, and the survey of utilization and satisfaction of the MFDS's statistics was conducted on food and drug experts who actually use the statistics of the MFDS. In order to identify problems of the MFDS statistics, environmental factors affecting the MFDS statistics were derived, and the priorities of improvement tasks for its statistics were identified using AHP and IPA. In addition, the current situation of the statistical system, which serve as the basic coordinate for the establishment and execution of domestic food and drug policies, was identified and implications were provided.

• Korea Journal of Hospital Management
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• v.5 no.1
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• pp.200-231
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• 2000

The price systems of the hospital drug services play key roles in the provision of quality services and the development of pharmacy service technologies. Under the premises, this study attempted to determine the costs of hospital drug service, to compare the costs calculated with the fees publicly fixed by the Government, and based on the results of the analysis, to propose directions for the improvement of the price systems. A Costing model for the study was developed based on the cost-fee relationship analysed of the Korean fee-for-service systems. Data on costs and workloads of the 25 hospitals were collected through survey forms designed for the costing' and analysis for the duration of 12 months of 1998. The results of the analysis show that a tremendous unbalance between cost and price levels of the drug services, and that overally the price level of the services is extremely low when compared to the costs of services. Based on these findings, this study suggests that unfairly high or low price level be corrected, and that service items newly developed and being practiced at tertiary hospitals, such as TDM and TPN consultation services, be compensated by fixing a proper level of price.

• The Journal of the Korea Contents Association
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• v.20 no.2
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• pp.462-471
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• 2020

The Zolpidem, commonly used as a sleeping pill, binds to GABA receptors to increase neuro-inhibiting transporters. There are many cases where people take Zolpidem for more than four weeks in a row. The Drug Utilization Review, currently in effect in South Korea, can identify the use patterns of Zolpidem. It is necessary to prevent Zolpidem's misuse. The study was conducted from May 10, 2019 to May 15, 2019. Primary and secondary screening was performed out of 125,197 total retrieved documents. The final 254 literature cases directly related to Zolpidem's misuse were selected. Through systematic literature research through meta-analysis, we tried to find a way to prevent Zolpidem's misuse through the Drug Utilization Review. The distortion was minimized by applying it in the screening process. Zolpidem's misuse was severe and continued to increase its use. There has also been an increase in crime using Zolpidem. It has been analyzed that Zolpidem can be managed through Narcotics Integrated Management System and Drug Utilization Review. In order to reduce the use of Zolpidem, the supply through the Narcotics Integrated Management System and the demand through long-term user education should be suppressed.

• YAKHAK HOEJI
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• v.58 no.2
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• pp.112-124
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• 2014

This study aimed to develop a regulation system for off-label drug use to secure the safe use of marketed drugs. We searched governmental documents for national and global regulating systems of off-label drug uses and a body of academic literature to explore current regulating trends. We included European Union, United Kingdom, United States of America, Australia and Japan, and critically reviewed the regulation of off-label drug use in four issues, which were a regulatory structure, safety control before and after off-label use, and information management. The findings of the present investigation called for several measures in off-label drug uses: enhancing prescribers' self-regulation, providing up-to-date information to prescribers for evidence-based practice and to patients for their informed consent, making evidence with scientific rigor, building an official registering process for off-label use in good quality and extending the role of pharmaceutical industry in pharmacovigilance. At last, we proposed a new system so as to regulate and evaluate off-label drug uses both at national and institutional level. In the new system, we suggested a clear-cut definition for clinical evidence that applicants would submit. We newly introduced an official 'Off-Label Drug Use Report' to evaluate the safety and clinical efficacy of a given off-label drug use. In addition, we developed an algorism of the regulation of off-label drug use within an institution to help set up the culture of evidence-based practices in off-label drug uses.

• Journal of the Korea Society of Computer and Information
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• v.14 no.3
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• pp.183-192
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• 2009

ADESS(Adverse drug event surveillance system) is the system which distinguishes adverse drug events using adverse drug signals. This system shows superior effectiveness in adverse drug surveillance than current methods such as volunteer reporting or char review. In this study, we built clinical data mart(CDM) for the development of ADESS. This CDM could obtain data reliability by applying data quality management and the most suitable clustering number(n=4) was gained through the reproducibility assessment in unsupervised learning techniques of knowledge discovery. As the result of analysis, by applying the clustering number(N=4) K-means, Kohonen, and two-step clustering models were produced and we confirmed that the K-means algorithm makes the most closest clustering to the result of adverse drug events.

• YAKHAK HOEJI
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• v.51 no.5
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• pp.318-326
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• 2007

The elderly are more likely to have chronic medical conditions that require multiple drug therapies. Purposes of this study are to reveal necessity of elderly patient education by pharmacists, and to induce appropriate policy. We carried out literature research. Taking several drugs together increases risk of drug interactions and adverse reactions. We suggest that pharmacists have the legal authority to monitor prescription for efficient drug management, pharmacovigilance system be efficiently operated, and medication education fee be provided to allow pharmacists give more time to the elderly.