Isotretinoin and Contraception: Should iPLEDGE Be Changed?
June 1, 2015
By Rebecca H. Allen, MD, MPH
Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports she is a consultant for Activis and Bayer and receives grant/research support from Bayer.
Synopsis: In this study of female dermatologic patients, knowledge of the typical effectiveness of contraceptive methods increased after viewing a simple information sheet. Given the teratogenicity of isotretinoin, expanding the use of highly effective contraceptive methods among women of child-bearing potential using this medication is essential.
Source: Werner CA, et al. Promoting safe use of isotretinoin by increasing contraceptive knowledge. JAMA Dermatology 2015;151:389-393.
This is an intervention study of 100 women visiting a single dermatology practice in April and May 2014 to test the effectiveness of a one-page information sheet on women’s contraceptive knowledge. A convenience sample of English-speaking women aged 18-45 years completed anonymous surveys assessing their knowledge of the typical effectiveness of contraceptive methods before and after reviewing the sheet. Women were asked to rate the methods as being “most effective, > 99% effective,” “medium effective, 92-97% effective,” “least effective, < 89% effective,” or they had never heard of the method.
Participants were mostly white (66%) with a college education (64%) and had a mean age of 27.5 (SD 6.0) years. At baseline, only 3% of participants correctly identified the typical effectiveness categories of all available contraceptives. The majority of women (75%) overestimated the effectiveness of condoms and half (51%) overestimated the typical effectiveness of oral contraceptives. Women also underestimated the effectiveness of the implant (55%) and intrauterine devices (39%). One-third had “never heard of” the implant and 16% had “never heard of” the intrauterine device (IUD). Women spent a mean of 31 (SD 27) seconds reviewing the contraceptive information sheet. For all methods except the vaginal ring, there was significant improvement in contraceptive knowledge after viewing the information sheet. For women who initially inaccurately identified the typical effectiveness of a method, the proportion who improved was highest among withdrawal (69%), IUD (67%), implant (64%), and patch (62%).
Commentary
Isotretinoin (Accutane® among others) is a very effective treatment for severe acne but is a known teratogen. Congenital anomalies associated with isotretinoin include skull, ear, and eye abnormalities, facial dysmorphia, cleft palate, cerebral malformations, hydrocephalus, cardiovascular abnormalities, and disorders of the thymus and parathyroid gland. The FDA regulates the prescription of isotretinoin to women of childbearing potential through the iPLEDGE program. Pregnancy must be ruled out prior to initiating therapy and on a monthly basis thereafter to continue the prescription. In addition, the patient must use two forms of contraception continuously 1 month before, during, and 1 month after isotretinoin therapy, unless the patient commits to continuous abstinence. The two forms of contraception must include one primary form defined by the iPLEDGE program as IUDs, implants, sterilization, depot medroxyprogesterone acetate, and the combined hormonal pill, patch, or vaginal ring and one secondary form (male condoms, diaphragm, cervical cap, or vaginal sponge).1 The progestin-only pill, female condoms, breastfeeding, withdrawal, and fertility awareness methods are not permitted.
Despite these precautions, studies show that there continue to be about 150 isotretinoin-exposed pregnancies each year.2 These pregnancies are usually due to noncompliance with the iPLEDGE stipulations and/or preferential use of oral contraceptives and condoms, which have higher typical failure rates than IUDs and implants. Research has shown that providers have limited knowledge of correct contraceptive prescribing practice for women using potentially teratogenic medications.3 In addition, studies show that while women understand the teratogenic risk of isotretinoin, they do not feel adequately counseled on how best to avoid pregnancy.4 The point of this study was to test the performance of an information sheet about contraceptive effectiveness in increasing knowledge. Despite a short perusal of the information, most women’s knowledge improved, although how long this information would be retained and whether it would translate into more women on isotretinoin choosing highly effective contraception (IUDs and implants) is unknown.
Although this study focused on patients, it is arguably more important to focus on providers, given that they should be counseling women prior to prescribing isotretinoin and providing them with contraception. I reviewed an iPLEDGE Program Prescriber Contraception Counseling Guide and an iPLEDGE Program Birth Control Workbook for patients.1 Interestingly, these state that the makers of isotretinoin will reimburse one visit for contraceptive counseling. The Guide makes a strong point that the woman should select a primary form of contraception with a low failure rate and references a table of typical-use failure rates. Some of these failure rates are not quite accurate and are likely based on older estimates.5 For example, the typical-use failure rate for the pill is quoted as 5%, the patch 1%, and the ring 1%. In reality, all these methods are estimated to have a typical-use failure rate of 9%. Despite these inaccuracies, the Guide does highlight that oral contraceptives have the highest typical-use failure rate and that they should not be prescribed to women who the clinician thinks will not comply with a daily method. In my opinion, the Guide does recommend too strongly that the patch and the ring are better alternatives than the pill. The Guide also does not emphasize IUDs and implants; however, the etonogestrel implant was not available at the time of the program creation in 2006. In addition, at that time, IUDs were not as popular among adolescents and younger women as they are now.6
Given that the iPLEDGE program has not been as successful as hoped, it may be time to revise it. Several experts argue that the focus of contraceptive counseling for patients considering isotretinoin should be IUDs and implants, the most effective reversible methods.7 In addition, if these methods are used, a secondary form of contraception, such as condoms, should not necessarily be required. Methods requiring high adherence, such as oral contraceptives, are not optimal for use with isotretinoin, and couples do not always use condoms reliably as a backup. With all the new evidence about the real-life efficacy of contraceptives and the resurging popularity of IUDs in the United States, I agree that the iPLEDGE Program Prescriber Contraception Counseling Guide should be revised. Although OB/GYNs do not typically prescribe isotretinoin, we do have a role to play in providing contraception with accurate efficacy data and can partner with dermatologists to accomplish this goal.
References
- iPLEDGE program. Prescriber Information. Available at: https://www.ipledgeprogram.com/PrescriberInformation.aspx. Accessed April, 22, 2015.
- Collins MK, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol 2014;70:55-59.
- Schwarz EB, et al. Documentation of contraception and pregnancy when prescribing potentially teratogenic medications for reproductive-age women. Ann Intern Med 2007;147:370-376.
- Werner CA, et al. Women’s experiences with isotretinoin risk reduction counseling. JAMA Dermatol 2014;150:366-371.
- Trussell J. Contraceptive efficacy. In: Hatcher RA, et al. Contraceptive Technology: 20th revised edition. New York NY: Ardent Media; 2011.
- ACOG Committee Opinion no. 450: Increasing use of contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol 2009;114:1434-1438.
- Pierson JC, et al. We pledge to change iPLEDGE. JAMA Dermatol 2015; April 8 [Epub ahead of print].
In this study of female dermatologic patients, knowledge of the typical effectiveness of contraceptive methods increased after viewing a simple information sheet. Given the teratogenicity of isotretinoin, expanding the use of highly effective contraceptive methods among women of child-bearing potential using this medication is essential.
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