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. 2020 Jul;83(1):104-108.
doi: 10.1016/j.jaad.2020.02.022. Epub 2020 Feb 14.

Simplifying contraception requirements for iPLEDGE: A decision analysis

John S Barbieri  1 , Andrea H Roe  2 , Arash Mostaghimi  3
Affiliations

Simplifying contraception requirements for iPLEDGE: A decision analysis

John S Barbieri et al. J Am Acad Dermatol. 2020 Jul.

Abstract

Background: For persons of childbearing potential prescribed isotretinoin, the iPLEDGE program requires use of 2 simultaneous methods of contraception or commitment to abstinence.

Objective: To model the relative effectiveness of a variety of contraception strategies for patients taking isotretinoin, including those that are acceptable according to iPLEDGE.

Methods: We performed a decision analysis modeling the estimated rate of pregnancy with various contraception strategies during a typical 6-month course of isotretinoin.

Results: Tier 1 contraception options (eg, subdermal hormonal implant, intrauterine devices) each had effectiveness of >99.5% alone. When combined with a secondary form of contraception, tier 2 contraception options (eg, depot medroxyprogesterone injections, combined oral contraceptives) each had effectiveness >99%.

Limitations: Sensitivity analyses were conducted to evaluate the impact of uncertain parameters on the results.

Conclusion: There may be opportunities to simplify iPLEDGE by recognizing the high effectiveness of tier 1 contraception options and increasing use of secondary forms of contraception among those using tier 2 contraception options as their primary form of contraception. Future studies are needed to understand the most effective strategies in clinical practice to prevent unintended pregnancy for patients taking isotretinoin to improve outcomes and provide patient-centered care.

Keywords: Abstinence; COC; IUD; OCP; acne; combined oral contraceptives; contraception; iPLEDGE; intrauterine device; isotretinoin; pregnancy; subdermal implant.

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Conflict of interest statement

Conflict of Interests Disclosures: 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. He has equity in Lucid and hims and receives licensing fees from Pfizer. He is on the medical advisory board for hims. He is a clinical trial investigator for Incyte, Lilly, Aclaris, and Concert. The authors have no other conflicts to declare.

References

    1. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945–973.e33. - PubMed
    1. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med. 1985;313(14):837–841. - PubMed
    1. Prevost N, English JC. Isotretinoin: update on controversial issues. J Pediatr Adolesc Gynecol. 2013;26(5):290–293. - PubMed
    1. Husereau D, Drummond M, Petrou S, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013;346:f1049. doi:10.1136/bmj.f1049 - DOI - PubMed
    1. Centers for Disease Control and Prevention. Contraception | Reproductive Health. https://www.cdc.gov/reproductivehealth/contraception/index.htm. Published August 7, 2019. Accessed August 28, 2019.