The Institute of Medicine has identified the prevention of birth defects as one of sixpriorities for the nation's health1 because annually, 150,000 infants (3% of all U.S.births) are born with some form of physical or mental birth defect.2 While the causes ofmost birth defects remain unknown, certain medications are known to increase rates ofbirth defects. For example, isotretinoin has been identified as a particularly teratogenicmedication.3 Despite the resources that have been invested in the iPledge program, ithas not been able to significantly reduce rates of adverse pregnancy outcomes related tothe use of isotretinoin.5 We therefore propose to develop and then rigorously evaluatenew educational materials which can be used to inform women about the most effectiveways to prevent birth defects caused by the use of certain medications. Specifically, wewill (1) develop a package insert that provides clear recommendations regarding use ofhighly effective contraception in order to avoid medication-induced birth defects, and(2) evaluate the effect of the new package insert on women's contraceptive choices whileusing isotretinoin. Our hypothesis is that the new package insert and educationalmaterials will significantly increase the proportion of women who use highly effectivecontraception while taking isotretinoin.
Women who take medications that can cause birth defects need clear information about the most effective ways to avoid an unintended pregnancy. This study will develop and evaluate a package insert and educational materials that provide clear recommendations regarding use of highly effective contraception in order to avoid medication-induced birth defects.
| Werner, Carly A; Papic, Melissa J; Ferris, Laura K et al. (2014) Women's experiences with isotretinoin risk reduction counseling. JAMA Dermatol 150:366-71 |
