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Simplifying contraception requirements for iPLEDGE: A decision analysis - 19/06/20

Doi : 10.1016/j.jaad.2020.02.022 
John S. Barbieri, MD, MBA a, , Andrea H. Roe, MD, MPH b, Arash Mostaghimi, MD, MPA, MPH c
a Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 
b Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 
c Department of Dermatology, Brigham and Women's Hospital, Boston, Massachusetts 

Correspondence to: John Barbieri, PCAM, 7 South Pavilion, 3400 Civic Center Blvd, Philadelphia, PA 19104.7 South Pavilion3400 Civic Center BlvdPhiladelphiaPA19104

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.

Le texte complet de cet article est disponible en PDF.

Key words : Abstinence, acne, COC, combined oral contraceptives, contraception, intrauterine device, iPLEDGE, isotretinoin, IUD, OCP, pregnancy, subdermal implant

Abbreviations used : DMPA, IUD


Plan


 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.


© 2020  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 83 - N° 1

P. 104-108 - juillet 2020 Retour au numéro
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