Original articleSimplifying contraception requirements for iPLEDGE: A decision analysis
Section snippets
Contraception identification
This study was conducted in accordance with the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement.4 Contraception options were classified according to the framework outlined by the Centers for Disease Control and Prevention. Tier 1 includes the subdermal hormonal implant, permanent surgical contraception, and the hormonal and nonhormonal IUD. Tier 2 includes the DMPA injection, and the combined hormonal (including estrogen and progestin hormones) contraceptive pill,
Results
Without any secondary form of contraception, tier 1 contraception options, such as the subdermal hormonal implant (99.98%), the hormonal IUD (99.90%), and the nonhormonal IUD (99.60%), each had effectiveness >99.5% during the first 6 months of typical use. The effectiveness of most tier 1 contraception options increased by less than 0.1% with the addition of a secondary form of contraception such as barrier methods. Without any secondary form of contraception, tier 2 contraception options, such
Discussion
In this study, we identify variation in effectiveness for contraception strategies approved by iPLEDGE for reduction of fetal exposure to isotretinoin. Tier 1 contraception options, including long-acting reversible contraception, such as the subdermal hormonal implant and IUDs, are more effective alone than other acceptable contraception options in combination. As a result, for patients using tier 1 contraception for >30 days before initiation of isotretinoin, it may be reasonable to abandon
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Funding sources: Dr Barbieri is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under award number T32-AR-007465 and receives partial salary support through a Pfizer Fellowship in Dermatology Patient Oriented Research grant to the Trustees of the University of Pennsylvania. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Conflicts of interest: Dr Roe serves as a Nexplanon trainer for Merck and as a site principal investigator for an investigational contraceptive device developed by Sebela Pharmaceuticals. Dr Mostaghimi receives consulting fees from Pfizer, hims, and 3derm, has equity in Lucid and hims, receives licensing fees from Pfizer, is on the medical advisory board for hims, and is a clinical trial investigator for Incyte, Lilly, Aclaris, and Concert.
IRB approval status: Not applicable.
Reprints not available from the authors.