Discrepancies found in prescription drug labeling pregnancy information across four countries

A study comparing the evidence and recommendation levels of pregnancy information in new prescription drug labeling found significant discrepancies in labeling information among the United States, the United Kingdom, Japan, and Korea. Inconsistent labeling information may hinder informed decision making and optimal patient care, according to the authors of the study published in Journal of Women's Health.

Yunha Noh, PharmD and colleagues from the School of Pharmacy, Sungkyunkwan University, South Korea, selected 81 drugs approved in all four countries from 2008 to 2016 and estimated the agreement of evidence and recommendation levels of the labeling information between the countries. In the article entitled, "Discrepancies in the Evidence and Recommendation Levels of Pregnancy Information in Prescription Drug Labeling in the United States, United Kingdom, Japan, and Korea," the researchers report that agreement in evidence levels was the lowest for US-Japan, whereas agreement in recommendation levels was the lowest for US-UK. Consistency of evidence and recommendation levels was highest for Korea-UK, indicating a substantial degree of agreement. The authors recommend efforts to provide internationally harmonized and reliable safety information to assist healthcare professionals and patients in making appropriate decisions regarding prescription drug use during pregnancy.

"Drug labeling is extremely important in guiding clinical decisions about prescribing," states Susan G. Kornstein, MD, Editor-in-Chief of Journal of Women's Health and Executive Director of the Virginia Commonwealth University, Richmond, VA. "The discrepancies among countries found in this study are concerning and should be addressed on a global level to better assist clinicians and patients in the safe and effective use of prescription drugs during pregnancy."