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Comparison of Labeling Items and Characteristics of OTC Drugs between South Korea, Japan and US
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논문 기본 정보

Type
Academic journal
Author
Kim, Hyeonjeong (상명대학교) Lee, Kyungmi (폴스타헬스케어)
Journal
Design Institute, Inje University Journal of Integrated Design Research Vol.18 No.1(Wn.45) KCI Accredited Journals
Published
2019.3
Pages
45 - 62 (18page)

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Comparison of Labeling Items and Characteristics of OTC Drugs between South Korea, Japan and US
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Abstract· Keywords

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Background : Since a system allowing over-the-counter (OTC) drug sales outside pharmacies was introduced in 2012, consumers’ accessibility and convenience of purchasing OTC drugs are increasing, and thus abuse and misuse of OTC drugs are also increasing. In this regard, labeling information on the packaging of drugs can be used as an important source of information for drug use and purchase. This study aimed to compare and analyze the labeling items and characteristics of OTC drugs between South Korea and foreign countries.
Methods : OTC labeling regulations in South Korea, Japan, and the US were reviewed through literature review, and country-specific labeling items and labeling frequency on the packaging of OTC drugs were examined through case studies of 40 kinds of OTC drugs in South Korea, Japan, and the US. In addition, basic statistics were used to review and compare labeling items and characteristics between South Korea, Japan, and the US.
Result : Following a review of the labeling frequency and relative importance of OTC drugs in South Korea, Japan, and the US, a total of 38 OTC labeling items and contents were identified. In terms of actual labeling items, there were 19 labeling items for OTC drugs in South Korea, 25 labeling items for OTC drugs in Japan, and 29 labeling items for OTC drugs in the US, indicating that the number of labeling items for OTC drugs in South Korea was insufficient compared to those in Japan and the US. In terms of the labeling characteristics of OTC drugs, items such as quantity, drug type, some ingredients, additives, manufacturing date, contact information for adverse reactions, package opening method, packaging container storage, and packaging container recycling, were found to be additionally indicated on the labeling of OTC drugs in Japan, compared to that in South Korea. On the other hand, safety-related items,
such as markings for use for children/elderly, some ingredients, notice, contact information for adverse reactions, poison control center, and packaging opening method, as well as drug-related items, such as quantity, drug type, actual size, manufacturing date, and packaging container recycling, were found to be additionally indicated on the OTC drug labeling in the US, compared to that in South Korea.
Conclusion : We compared the labeling items and characteristics of OTC drugs in South Korea with those in foreign countries. In particular, compared to that in Japan and the US, the OTC drug labeling in South Korea lacked items related to safe use and contents about the use, management, and storage of OTC drugs after purchase.
#일반의약품 #정보표시규정 #표시항목 #정보표시빈도 #OTC drugs #Labeling Regulations #Labeling Items #Labeling Frequency

Contents

요약
Abstract
1. Introduction
2. Regulations on OTC drug labeling in Korea and other countries
3. Study of the current state of OTC drug information labeling in Korea, Japan and US
4. Conclusions
References

References (11)

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2018 / Article 75 of the Enforcement Regulations of the Pharmaceutical Affairs Law google schola Ban, D. J / 1996 / Seif-Medication: Health Care Economic Point of View / WooSuk University google schola Choi, S. E / 2016 / A Survey on Regulations of Over-the-counter Drugs in Convenience Store / Ministry of Health and Welfare google schola GMP / Compliance Inspection Concerning Pharmaceuticals (Including APIS) of Foreign Manufacturers (Overview Guidance for Foreign Manufacturers)(Sep.1,) google schola Korea Institute of Drug Safety & Risk Management / 2017 / 2017 Drug Side Effects Report google schola

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