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Discrepancies found in prescription drug labeling pregnancy information across four countries

July 17, 2018

New Rochelle, NY, July 17, 2018--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, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free on the Journal of Women's Health website.

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."
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About the Journal

Journal of Women's Health, published monthly, is a core multidisciplinary journal dedicated to the diseases and conditions that hold greater risk for or are more prevalent among women, as well as diseases that present differently in women. Led by Editor-in-Chief Susan G. Kornstein, MD, Executive Director of the Virginia Commonwealth University Institute for Women's Health, Richmond, VA, and President of the Academy of Women's Health, the Journal covers the latest advances and clinical applications of new diagnostic procedures and therapeutic protocols for the prevention and management of women's healthcare issues. Complete tables of content and a sample issue may be viewed on the Journal of Women's Health website. Journal of Women's Health is the official journal of the Academy of Women's Health and the Society for Women's Health Research.

About the Academy

Academy of Women's Health is an interdisciplinary, international association of physicians, nurses, and other health professionals who work across the broad field of women's health, providing its members with up-to-date advances and options in clinical care that will enable the best outcomes for their women patients. The Academy's focus includes the dissemination of translational research and evidence-based practices for disease prevention, diagnosis, and treatment of women across the lifespan.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including LGBT Health, Transgender Health, Population Health Management, and Breastfeeding Medicine. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

Mary Ann Liebert, Inc. 140 Huguenot Street, New Rochelle, NY 10801 http://www.liebertpub.com Phone: (914) 740-2100 (800) M-LIEBERT Fax (914) 740-2101

Mary Ann Liebert, Inc./Genetic Engineering News

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