2019 Volume 9 Issue 3 Pages 165-174
A system for prescription drugs to OTC switch was revised in Japan in May 2015. As a result of this change, when apply for approval of ingredients published to be a proper switch from prescription drugs, it was decided to submit the results of the user test about the package inserts as reference materials in principle. The purpose of this study is to clarify the issues to conduct “Proposal guidance to determine the level of understanding of package inserts for pharmaceuticals requiring guidance” issued on January 21, 2016. This study was conducted on a trial basis according to the proposed guidance. We composed package inserts of fictional drugs containing the minimum information based on the instructions. We studied whether subjects can understand the package inserts by interview. As a result, it did not meet the criteria for the level of understanding. However, we concluded it was possible to conduct the test according to the proposed guidance by devising the issues clarified in this study.
