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

Abstract

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.