[Survey of Description on Package Inserts of OTC Drugs].

In this study, we first checked whether the items, as required in the notifications of the Japanese Ministry of Health, Labour and Welfare, are described in the package inserts of cold remedies and analgesic antipyretics in OTC drugs. The descriptions of almost all packages checked in this study were based on the notifications, but those of a small number of them were not. Next, we examined the description of the items, unrequired in the notification, but worthy for proper use of drugs; e.g., the description of prohibition for use by "patients with severe hypertension" in case of ibuprofen-containing products, and the description was found in only seven of 180 products. Manufactures should make package inserts along with notifications, including the description for proper use of drugs.
PMID: 29386439 [PubMed - in process]

Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan - February 3, 2018 Category: Drugs & Pharmacology Authors: Shimauchi A, Naganuma M, Sasaoka S, Hatahira H, Motooka Y, Hasegawa S, Fukuda A, Nakao S, Sakai C, Yokoyama S, Ino Y, Nakamura M, Iguchi K Tags: Yakugaku Zasshi Source Type: research