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A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries

Contraception Feb 11, 2020

Frye LJ, et al. - Researchers examined package inserts from medical abortion commodities collected in low- and middle-income countries to evaluate their characteristics, clinical information, and storage instructions. Collection of mifepristone, misoprostol, and combined mifepristone-misoprostol (combipack) products was done to populate the Medical Abortion Commodities Database from November 2017 to February 2018. From 20 countries, they identified 41 package inserts; 19 (46%) listed medical abortion as an indication including all 7 combipacks, all 7 mifepristone products, and 5/27 (19%) misoprostol products. The analysis suggests that from low- and middle-income countries, medical abortion product package inserts from a variety of field settings had inadequate storage instructions and outdated gestational age limits and regimens. The revision date of the last insert varied from 1991 to 2016. Variation in gestational age limits for early medical abortion was observed ranging from 49 days to “first trimester.” Three (43%) mifepristone products recommended a 600mg oral dose and two (29%) recommended regimens with gemeprost. The recommendation of protection from moisture was inscribed in 18 (67%) misoprostol and one (14%) combipack inserts.
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