Revision of the Instructions for Package Inserts of Prescription Drugs in Japan

Abstract

In June 2017, instructions for package inserts of prescription drugs in Japan were revised, and they shall be applicable from April 1, 2019. This revision is aimed at eliminating duplicate descriptions and integrating some notes, etc., and making the package inserts easier to understand and use. In particular, the precaution categories for specific patient groups that require attention during administration have significantly changed. In the previous instructions, the cautions for specific patient groups were described separately in “Contraindications”, “Relative Contraindications”, ”Careful Administration”, “Geriatric Use”, “Use during Pregnancy, Delivery or Lactation” and “Pediatric Use”. These are newly described and summarized in the new section, “Precautions concerning Patients with Specific Backgrounds”. In this article, we have introduced the points for checking the package inserts based on the new instructions, including the background of this revision and the differences from the previous instructions.