Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
The notification “Instructions for package inserts of prescription drugs” has been revised in 2017 to make the package inserts easier to understand and use, because the circumstances surrounding medical care have been drastically changed, such as advancement of medicine, aging of society, and development of IT technology after the prior instructions were issued in 1997.
In the new instructions, the section “9.6 Breast-feeding Women” was established in “9. Precautions for Patients with Special Characteristics”.
The following directions are written in the notification;[1] Necessary information shall be provided while considering not only transfer to breast milk but also effects on breastfed babies anticipated from pharmacokinetics and pharmacological actions, clinical use experience, and other relevant matters. [2] Matters concerning the effects on breast milk secretion shall be included separately from the effects on breastfed babies. [3] Precautions shall be described using basically “Women should be instructed to avoid breastfeeding,” “it is advisable not to breastfeed” or “the continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits and the benefits of maternal feeding.”
All of the package inserts of prescription drugs are going to be changed to the new instruction format by March 2024, and PMDA has been consulted what to be written in each drug’s package insert.
In this symposium, I’ll explain the instructions for package insert of “Breast feeding Women” section with same examples.
