Revisions to the Instructions for Package Inserts: Current Status and Challenges Facing Pharmaceutical Companies

Abstract

The Instructions for Package Inserts of Prescription Drugs were revised in June 2017 to make them easier for the healthcare professionals who actually use them to understand, and more helpful for explanation to patients. The revisions made included the elimination of duplicate descriptions in package inserts, which was identified as an issue to be addressed in the previous version, and the consolidation of precautions previously referred to in different sections of the package inserts. In addition, a change was made to the format with which package insert information was digitized. This report summarizes the changes made to the Instructions for Package Inserts of Prescription Drugs in their latest revision, and provides their current status and the challenges facing pharmaceutical companies in relation.