• YAKHAK HOEJI
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• v.54 no.4
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• pp.309-315
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• 2010

The Positive List System was newly introduced in South Korea as of January 2007. This study aims to survey and compare perception of and attitudes toward the Positive List System in the process of new drug listing that health professionals and pharmaceutical companies have. 50 professionals and 52 companies answered the questionnaire regarding health policy environments, policy decision/enforcement process, policy effects and satisfaction related to introducing the Positive List System. SAS 9.1 was used for statistical analyses. The results showed that participants had the general sympathy with health policy environments for the introduction of the Positive List System into South Korea. However, the response rates of policy decision/enforcement process and effects were negative and these tendencies were more striking in pharmaceutical companies. As for policy satisfaction, participants marked positive responses more than negative ones. It is necessary to remedy and supplement problems with policy decision/enforcement policy and effects revealed in this study and to improve the Positive List System through gathering opinions among groups and organization concerned.

• Health Policy and Management
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• v.21 no.1
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• pp.132-157
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• 2011

The purpose of this article is to examine the cause of policy non-compliance in the case of pharmaceutical rebates from the perspective of rational choice institutionalism. In Korea, there have been rebates practices between pharmaceutical companies and hospitals since the introduction of the Actual Remuneration System for insured medicine in 1999. The government has chosen the policy means of punishment to eliminate pharmaceutical rebates but the illegal practices are still widespread. Institution in rational choice institutionalism usually reflects the incentives and preferences of actors, and the Actual Remuneration System has resulted in a the lack of procedures to ensure savings on drug expenditures. Pharmaceutical rebates are the product of the institutions which reflect their incentives: the Actual Remuneration System, the current pricing policy for generic drugs, the drug distribution system, and so on. In the end, the problem of the rebates is the consequence of policy non-compliance as actors' rational choice because their incentives lead to opportunistic behaviors. We should therefore understand the incentive structure of policy stakeholders, which is derived from the view of new institutionalism; also, the newly designed Korean drug pricing policy reform must be compatible with the incentive structure.

• Journal of the Korean Applied Science and Technology
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• v.25 no.4
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• pp.539-555
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• 2008

It is well understood that developing new drugs is one of the highest value-added businesses in a country; however, the current governments' spending in pharmaceutical research and development(R&D) is minimal in Korea. This paper suggests that different governmental bodies should take in charge of different stages of the R&D process in order to maximize the use of limited government research funding. First, during the initial phase of the drug development, including clinical trials, the Ministry of Education, Science and Technology is the most appropriate governmental organization to support the research. For later procedures such as supporting the industries for exporting developed drugs, legislative approvals, and building infrastructure for future clinical trials should be supported by the Ministry of Knowledge and Economy and the Ministry of Health and Welfare along with the Korea Food and Drug Administration(KFDA). The KFDA, which is the main governmental agency approving newly developed drugs in the market, will need to take a crucial responsibility in the initial phase of the pharmaceutical R&D by guiding the industries with timely and proper information. As a first step, it is recommended to set up and operate a center for supporting new drugs, so that the industries can facilitate the development of marketable drugs which meet customers' needs. Later, in order to expedite the process of exporting and getting approvals of the newly developed drugs from foreign countries, it is necessary to develop new approval system, which includes introduction of the Good Manufacturing Practice (GMP), mandatory validation system, and education program for supporting expertise. Lastly, the KFDA needs to take an active role in developing Korean pharmaceutical industries by communicating with other foreign governments with regards to the globalization of the Korean pharmaceutical industries. For example, as a follow up after the Free Trade Agreement(FTA), active discussion on GLP of Mutual Recognition Agreement(MRA) with the United States of America, should be seriously considered.

• The Korean Journal of Nuclear Medicine
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• v.38 no.2
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• pp.171-174
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• 2004

Angiogenesis, the formation of new capillaries from existing vessels, increases oxygenation and nutrient supply to ischemic tissue and allows tumor growth and metastasis. As such, angiogenesis targeting provides a novel approach for cancer treatment with easier drug delivery and less drug resistance. Therapeutic anti-angiogenesis has shown impressive effects in animal tumor models and are now entering clinical trials. However, the successful clinical introduction of this new therapeutic approach requires diagnostic tools that can reliably measure angiogenesis in a noninvasive and repetitive manner. Molecular imaging is emerging as an exciting new discipline that deals with imaging of disease on a cellular or genetic level. Angiogenesis imaging is an important area for molecular imaging research, and the use of radiotracers offers a particularly promising technique for its development. While current perfusion and metabolism radiotracers can provide useful information related to tissue vascularity, recent endeavors are focused on the development of novel radioprobes that specifically and directly target angiogenic vessels. Presently available proges include RGD sequence containing peptides that target ${\alpha}_v\;{\beta}_3$ integrin, endothelial growth factors such as VEGF or FGF, metalloptoteinase inhibitors, and specific antiangiogenic drugs. It is now clear that nuclear medicine techniques have a remarkable potential for angiogenesis imaging, and efforts are currently continuing to develop new radioprobes with superior imaging properties. With future identification of novel targets, design of better probes, and improvements in instrumentation, radiotracer angiogenesis imaging promises to play an increasingly important role in the diagnostic evaluation and treatment of cancer and other angiogenesis related diseases.

• Proceedings of the Korean Society of Applied Pharmacology
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• 2002.07a
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• pp.73-78
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• 2002

Microfluidic lab-on-a-chip (LOC) systems have enabled a new generation ofassay technologies in chemical and biomedical sciences. Caliper's microfluidic LOC systems contain a network of microscopic channels through which fluids and chemical are moved in order to perform experiments. The main advantages of these continuous-flow devices are integration and automation of multiple steps in complex analytical procedures to improve the reproducibility of the results, and eliminated the manual labor, time and pipetting errors involved in analyses. The present talk is devoted to give a brief introduction of microfluidic basics and to present in applying continuous-flow microchips to drug screening with model enzyme assays.

• Health Policy and Management
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• v.16 no.2
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• pp.49-76
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• 2006

The aim of this study was to explore the effects of a computerized review program which was introduced in August 1, 2003, using claims data for acute respiratory infection related diseases. National Health Insurance (NHI) claims data on respiratory infection related diseases before and after the introduction, with six month intervals respectively, were used for the analysis. Clinic was the unit of observation, and clinics with only one physician whose specialty was internal medicine, pediatrics, otorhinolaryngology and family medicine and clinics with a general practitioner were selected. The final sample had 7,637 clinics in total. Indices used to measure practice pattern was prescription rates of antibiotics, prescription rates of injection drug per visit, treatment costs per claim, and total costs per claim. Changes in the number of claims for major disease categories and upcoding index for disease categories were used to measure claiming behavior. Data were analysed using descriptive analysis, t-test for indices changes before and after the introduction, analysis of variance (ANOVA) for practice pattern change for major disease categories, and multiple regression analysis to identify whether new system influenced on provider' practice patterns or not. Prescription of antibiotics, prescription rates of injection drug, treatment costs per claim, and total costs per claim decreased significantly. Results from multiple regression analysis showed that a computerized review system had effects on all the indices measuring behavior. Introduction of the new system had the spillover effects on the provider's behavior in the related disease categories in addition to the effects in the target diseases, but the magnitude of the effects were bigger among the target diseases. Rates of claims for computerized review over total claims for respiratory diseases significantly decreased after the introduction of a computerized review system and rates of claims for non target diseases increased, which was also statistically significant. Distribution of the number of claims by disease categories after the introduction of a computerized review system changed so as to increase the costs per claims. Analysis of upcoding index showed index for 'other acute lower respiratory infection (J20-22)', which was included in the review target, decreased and 'otitis media (H65, H66)', which was not included in the review target, increase. Factors affecting provider's practice patterns should be taken into consideration when policies on claims review method and behavior changes. It is critical to include strategies to decrease the variations among providers.

• Journal of Yeungnam Medical Science
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• v.37 no.4
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• pp.277-285
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• 2020

Tuberculosis (TB) is still a major health problem worldwide. Especially, multidrug-resistant TB (MDR-TB), which is defined as TB that shows resistance to both isoniazid and rifampicin, is a barrier in the treatment of TB. Globally, approximately 3.4% of new TB patients and 20% of the patients with a history of previous treatment for TB were diagnosed with MDR-TB. The treatment of MDR-TB requires medications for a long duration (up to 20-24 months) with less effective and toxic second-line drugs and has unfavorable outcomes. However, treatment outcomes are expected to improve due to the introduction of a new agent (bedaquiline), repurposed drugs (linezolid, clofazimine, and cycloserine), and technological advancement in rapid drug sensitivity testing. The World Health Organization (WHO) released a rapid communication in 2018, followed by consolidated guidelines for the treatment of MDR-TB in 2019 based on clinical trials and an individual patient data meta-analysis. In these guidelines, the WHO suggested reclassification of second-line anti-TB drugs and recommended oral treatment regimens that included the new and repurposed agents. The aims of this article are to review the treatment strategies of MDR-TB based on the 2019 WHO guidelines regarding the management of MDR-TB and the diagnostic techniques for detecting resistance, including phenotypic and molecular drug sensitivity tests.

• Journal of Korean Neurosurgical Society
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• v.58 no.1
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• pp.1-8
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• 2015

Treatment of Leptomeningeal carcinomatosis (LMC) from solid cancers has not advanced noticeably since the introduction of intra-cerebrospinal fluid (CSF) chemotherapy in the 1970's. The marginal survival benefit and difficulty of intrathecal chemotherapy injection has hindered its wide spread use. Even after the introduction of intraventricular chemotherapy with Ommaya reservoir, frequent development of CSF flow disturbance, manifested as increased intracranial pressure (ICP), made injected drug to be distributed unevenly and thus, the therapy became ineffective. Systemic chemotherapy for LMC has been limited as effective CSF concentration can hardly be achieved except high dose methotrexate (MTX) intravenous administration. However, the introduction of small molecular weight target inhibitors for primary cancer treatment has changed the old concept of 'blood-brain barrier' as the ultimate barrier to systemically administered drugs. Conventional oral administration achieves an effective concentration at the nanomolar level. Furthermore, many studies report that a combined treatment of target inhibitor and intra-CSF chemotherapy significantly prolongs patient survival. Ventriculolumbar perfusion (VLP) chemotherapy has sought to increase drug delivery to the subarachnoid CSF space even in patients with disturbed CSF flow. Recently authors performed phase 1 and 2 clinical trial of VLP chemotherapy with MTX, and 3/4th of patients with increased ICP got controlled ICP and the survival was prolonged. Further trials are required with newly available drugs for CSF chemotherapy. Additionally, new LMC biologic/pharmacodynamic markers for early diagnosis and monitoring of the treatment response are to be identified with the help of advanced molecular biology techniques.

• Biomaterials Research
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• v.22 no.4
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• pp.303-310
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• 2018

Background: Photodynamic therapy (PDT) is photo-treatment of malignant or benign diseases using photosensitizing agents, light, and oxygen which generates cytotoxic reactive oxygens and induces tumour regressions. Several photodynamic treatments have been extensively studied and the photosensitizers (PS) are key to their biological efficacy, while laser and oxygen allow to appropriate and flexible delivery for treatment of diseases. Introduction: In presence of oxygen and the specific light triggering, PS is activated from its ground state into an excited singlet state, generates reactive oxygen species (ROS) and induces apoptosis of cancer tissues. Those PS can be divided by its specific efficiency of ROS generation, absorption wavelength and chemical structure. Main body: Up to dates, several PS were approved for clinical applications or under clinical trials. $Photofrin^{(R)}$ is the first clinically approved photosensitizer for the treatment of cancer. The second generation of PS, Porfimer sodium ($Photofrin^{(R)}$), Temoporfin ($Foscan^{(R)}$), Motexafin lutetium, Palladium bacteriopheophorbide, $Purlytin^{(R)}$, Verteporfin ($Visudyne{(R)}$), Talaporfin ($Laserphyrin^{(R)}$) are clinically approved or under-clinical trials. Now, third generation of PS, which can dramatically improve cancer-targeting efficiency by chemical modification, nano-delivery system or antibody conjugation, are extensively studied for clinical development. Conclusion: Here, we discuss up-to-date information on FDA-approved photodynamic agents, the clinical benefits of these agents. However, PDT is still dearth for the treatment of diseases in specifically deep tissue cancer. Next generation PS will be addressed in the future for PDT. We also provide clinical unmet need for the design of new photosensitizers.

• Journal of Preventive Medicine and Public Health
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• v.33 no.4
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• pp.484-494
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• 2000

Objective : To evaluate the relative benefits and the costs associated with the introduction of the new pharmaceutical provision called 'Mandatory Prescription System' which separates the role of physicians from that of pharmacists with respect to the prescription and dispensation of from the perspective of consumers (i.e., patients). Methods : The costs of the system were measured by considering both direct and indirect costs. Direct costs included additional payments for ambulatory care and dispensing fees that occurred under the new system. indirect costs consisted of transportation expenses and costs related to time spent for physician consultation, waiting for the prescriptions to be filled, and extra traveling. Benefits identified in this study were the reduction of drug misuse and overuse, and the overall decrease in drug consumption among the Korean population. Sensitivity analysis was peformed for the inclusion of benefits for outpatients of hospitals, price elasticity, and increased fees for established patients. Results : The net benefit was estimated to be about minus 1,862 billion won and the benefit-cost ratio was 0.478. This indicates that the costs of 'Mandatory Prescription' outweigh its benefits, relative to the previous system. The sensitivity analysis results for all the variables considered in this study consistently showed the benefit-cost ratio to be less than 1. Conclusion : The results of this study suggest that implementing Mandatory Prescription System in Korea might be inefficient from the consumer's perspective. The results of this study do not coincide with the results of previous studies, presumably because of the differences in study design and in which items of costs and benefits were considered.