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KMID : 0941820050150020139
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Korean Journal of Clinical Pharmacy
2005 Volume.15 No. 2 p.139 ~ p.148
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Current Drug Classification System in Korea and Improvement
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Sohn Hyun-Soon
Oh Ock-Hee
Kim Jong-Joo
Lee So-Hyun
Byun Sun-Hye
Shin Hyun-Taek
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Abstract
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Appropriate drug classification is important for 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, safe 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 for reclassification application, are necessary.
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KEYWORD
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Drug Classification System, Prescription Drug, Nonprescription Drug, Switching, Drug Reclassification
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