一般用医薬品点鼻薬の適正使用に対する外箱情報提供とリスクマネジメントに関する日米比較

Abstract

Labeling on the packages of over-the-counter (OTC) drugs contains very important information to help consumers select and use them safely and effectively. In the present study, we investigated the differences in drug information and risk management given for OTC nasal decongestants and sprays between the United States and Japan. The American products had the new standardized Drug Facts label demanded by the Food and Drug Administration, but there was still no standardized label in Japan. The Drug Facts list the active ingredients, uses, warnings, inactive ingredients, purpose, and directions. They use plain language so that consumers may easily understand the benefits and risks. There were “Specific Warnings” consisting of one telling people under what circumstances they should consult a doctor or pharmacist, a pregnancy/nursing warning, and those concerning accidental overdose and side effects. For the Japanese labeling, “Precaution” was used instead of “Warning”, and there were no specific precautions. While age limits were given on all of the American labeling to prevent overdosing in infants, some of the Japanese labels did not provide such information.In addition, the American labeling included emergency contact numbers that consumers could phone in case of accidents. There were 65 poison control centers, which could be called 24 hours a day toll-free. In contrast, numbers were only given for 2 such centers in Japan, and they were not toll-free, deterring wide use due to the cost involved.We found many differences in the labeling of OTC nasal decongestants and sprays between the U.S. and Japan, which would depend on consumers' rights and product liability. The results of this study suggest that OTC drug labeling in Japan must be improved and a standardized format established for this purpose.