• YAKHAK HOEJI
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• v.56 no.1
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• pp.60-65
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• 2012

This study examines factors associated with drug approvals and patent issues of the Korean pharmaceutical firms. The 22 firms were selected based on 2006 year's publicly noticed sales amount. Number of approved drugs was identified through Korea Food and Drug Administration and the information regarding the patents that each firm has issued during the year 2000~2006 was collected from the Korea Patent Office. The number of approved drugs has increased annually, especially after the introduction of substance patent system in 1987 and in 2000 again with the policy change into the separation of drug prescribing and dispensing practice. The number of initial approval of NCEs as well as the number of patents per firm decreased during the year 2000~2006. The 12 firms with larger revenue occupied more than 80% of the patents being issued. There was a positive relationship between share of prescription drugs out of approved drugs and the average number of patents issued. However, number of approved drugs did not show positive association with the number of patents issued per firm. Therefore, the study results imply that firms need to invest more in increasing number of approvals for their specific prescription drugs in order to achieve a good performance in the future.

• Korean Journal of Clinical Pharmacy
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• v.15 no.2
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• pp.139-148
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• 2005

Appropriate drug classification is important fur rational drug consumption. This study was conducted to evaluate the appropriateness of current drug classification system and suggest possible ways for improving the system. Nonprescription drug market has been decreased. Since total 27,962 products had been classified (prescription 17,187 vs. nonprescription 10,775 products, 61.5% vs. 38.5%) in July 2000 for implementing separation of drug prescribing and dispensing system, there are no classification changes. Reclassification is not motivated by product holder and regulatory system did not lead classification change either. Consumers' ease access to some nonprescription drugs is demanded. But point of public awareness and cultural and health environmental views, saff drug use rather than advantages from broad supply of nonprescription drugs is more critical. We concluded that current 2-categorized (prescription and nonprescription) drug classification system is appropriate, and addition of general sale category should be approached carefully with long term Preparations such as establishment of better nonprescription drug consuming infrastructure by public information provision and education for improving public medicinal knowledge and strengthening self medication guidance, and review of current classification status of marketed drugs and switching possibilities. For systemizing and encouraging reclassification, introduction of regulatory renewal system as a continuous reevaluation program which is the best way to review appropriateness of drug classification as well as provision of detailed guidance for industry including policy, requirement and process fer reclassification application, are necessary.

• Korean Journal of Clinical Pharmacy
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• v.16 no.2
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• pp.139-146
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• 2006

Objectives: Bio-equivalence(BE) test is important not only to ensure the quality of generic drugs, but also to promote drug substitution under the separation of prescribing and dispensing practice(SPD). This study was intended to investigate the perception of consumers, doctors, and pharmacists on the confidence of bio-equivalence(BE) assured drugs. Methods: Nation-wide telephone interview survey was conducted for 1,018 consumers, 800 doctors, and 806 pharmacists from September to October in 2003. Descriptive analysis and ${\chi}^2$ analysis were conducted. Results: Even though people showed higher confidence level for the Bioequivalent drugs compared with Bio-inequivalent drugs, the confidence was generally low. Among those asked about the therapeutic substitutability of original drugs by BE versions, 95.78% of pharmacists responded "positive", while only 39.33% of consumers and 31.13% of doctors said so. The elderly, the less educated, who takes chronic disease medicine, pays high cost of prescription drugs, and are in the low income responded less aware of that. Also most consumers got information such as effect of drugs from either media or doctors. Conclusions: In order for people to believe that BE drugs and original drugs are equivalent, we need to strengthen health education, and to clarify any misunderstanding. It is also necessary for the national policy to provide accurate information about drugs to the public.

• Korea Journal of Hospital Management
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• v.7 no.1
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• pp.19-40
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• 2002

The purpose of this study is to find out if there has been any change in the outpatient visit to tertiary care hospitals after the introduction of the new healthcare program that divides the roles of doctors and pharmacists and the reason for the change if there is any. Two tertiary care hospitals with the largest capacity of 1200 beds and two tertiary care hospitals with the lowest capacity of 600-700 beds were randomly selected. Data of the outpatient visits from March-May 2(xx), before the new healthcare system was adopted, were compared with the data from March-May 2001, after the new policy was adopted. Outpatient visits have decreased 5.8% after the new system. There has been a dramatic decrease, especially, in the department of OB-GYN and Pediatrics of tertiary hospitals. Decrease in re-visits is much higher than the first visits. Female patients decreased more than the male patients. Outpatient visits by economically active patients group aged 25-44 declined much. Tertiary hospitals in Seoul and Kyonggi Province, as well. Outpatient income of tertiary hospitals has dropped up to 14.7% due to the decline in outpatient visits and pharmaceutical income, and resell price system which in turn has caused the hospital financial deficits. While the new program has succeeded in lowering the use of antibiotics and injections, it has the pitfall of prescribing long days and expensive drugs. A full-fledged review of the system should be conducted for the establishment of the new system and I believe this study may be a useful references. Furthermore, more profound and overall studies on the chance in the patients use of hospitals are needed.