[Study on the Safety of Perinatal Medication]

Area of Science:

• Perinatal pharmacology
• Drug safety evaluation
• Reproductive toxicology

Background:

• Significant discrepancies noted between Japanese drug package inserts and U.S. FDA Pregnancy Risk Categories for perinatal medications.
• Existing research highlights challenges in providing accurate drug safety information to pregnant and lactating individuals.

Purpose of the Study:

• To generate evidence on the safety of perinatal drug use.
• To identify and address discrepancies in drug information for pregnant women in Japan.
• To assess awareness and practices regarding folic acid supplementation for preventing neural tube defects.

Main Methods:

• Review of Drug Information Office inquiries and hospital records.
• Analysis of the Japan Environment and Children's Study (JECS) data (n=97,464 pregnant women).
• Claims database analysis of drug prescriptions during pregnancy.
• Surveys of pharmacists and pharmacy students.
• Examination of data from BOSHI, JECS, and TMM BirThree cohort studies.

Main Results:

• Identified significant discrepancies in perinatal drug information in Japan.
• Antihypertensive drug prescriptions increased in late pregnancy; anti-epileptic and anti-anxiety drug prescriptions decreased postpartum.
• Low awareness of folic acid's role in preventing neural tube defects was found.
• Pre-pregnancy folic acid supplementation rates ranged from 6.3% to 18.0% across multiple cohort studies.

Conclusions:

• Urgent need to align Japanese drug safety information with international standards (e.g., U.S. FDA).
• Clinical application of findings is ongoing to improve patient care and medication safety.
• Further research and improved educational initiatives are necessary to enhance perinatal drug safety and folic acid awareness.