2015 Jul 1;151(7):701-2.
The US Food and Drug Administration’s mandatory pregnancy prevention program iPLEDGE has the noble intention of reducing the incidence of exposure to the teratogenic acne medication isotretinoin during pregnancy. Unfortunately, it is not working. Nearly a decade into the iPLEDGE era, the pregnancy rate among isotretinoin users is no lower than it was under the prior program, SMART (System to Manage Accutane-Related Teratogenicity); it is estimated that 2.7 isotretinoin-exposed pregnancies occur per 1000 treatment courses.1 Our country can do better, and we propose overhauling iPLEDGE in 2 areas: (1) by emphasizing the relative effectiveness of contraceptive measures for the target audience, women of child-bearing potential, and (2) removing other requirements that do not contribute to the mission of the program.
People respond to the notion of what works best. Unfortunately, despite scaring patients about the risks of medication-induced birth defects, iPLEDGE’s information on pregnancy prevention is not organized in a what-works-best fashion. Because 72% of women who became pregnant while using isotretinoin used condoms and oral contraceptives, which typically have failure rates of 15% and 8%, respectively, during their first year of use,2,3 we cannot condone continued pursuit of the current strategy.
Instead, iPLEDGE materials must be revised to provide clear information on how women can avoid isotretinoin-associated birth defects, emphasizing contraceptive options that are over 20 times more effective than oral contraceptives: subdermal implants and intrauterine contraceptives.3,4 A previous study found that many women enrolled in iPLEDGE had misconceptions about these highly effective reversible contraceptives and that many were dismayed that their superior effectiveness had not been highlighted before they began using isotretinoin.5 A user-friendly contraceptive information document, highlighting subdermal implants and intrauterine contraceptives at the top of a column labeled “How well it works,” depicts the more than 99% effectiveness of these options, followed by less successful methods in descending order.4 Wider distribution of this simple summary of the relative effectiveness of available contraceptives could improve on the status quo when it comes to isotretinoin-exposed pregnancies. Also, those patients who do opt to use an intrauterine or subdermal contraceptive should be permitted to use this 1 highly effective method in place of 2 less effective forms.
In addition, given teenagers’ high risk for unintended pregnancy, plans to abstain from sexual intercourse with male partners during isotretinoin therapy should always be questioned. In 1 study of adherence to pregnancy prevention measures during isotretinoin therapy, 19% of women who committed to abstinence while receiving isotretinoin later admitted to having intercourse, all of whom had previously been sexually active.6 This is not to say that women who identify as homosexual should be required to use contraception in order to be treated with isotretinoin but rather that we must be realistic about the typical failure rates of the “abstinence” method of pregnancy prevention among teens.
We also believe that strong consideration should be given to removing the requirement of acknowledging potential mood changes prior to starting isotretinoin therapy because this verbiage likely has the unintended consequences of obfuscating and detracting from the program’s primary intent of reducing the incidence of fetal exposures to isotretinoin. Whereas we should always maintain awareness of our patients’ psychological well-being, even more so in the vulnerable population of patients with severe acne,7 currently, this issue that is unrelated to pregnancy makes up more than 50% of the universal consent form. Information overload distracts from actionable information.4
Finally, we suggest that the iPLEDGE program remove the requirement for monthly confirmations of patients (male or female) who are not of child-bearing potential. Although education and registration of these patients prior to treatment is warranted, subsequent formal monthly confirmations regarding both not sharing isotretinoin and avoidance of blood donations during therapy and 1 month after discontinuation are not needed. There is no evidence to suggest that repeating such mandatory monthly electronic verifications is effective. Rather, the time, energy, and resources currently diverted to these individuals who are not of child-bearing potential may be better spent on maintaining and heightening the focus on the primary target audience for iPLEDGE, women of childbearing potential.
While we respect the good intentions of those who designed the iPLEDGE program, we believe that sufficient time has elapsed to concede that this program has not achieved the desired goals. Streamlining the iPLEDGE program and prioritizing its most important goal will benefit many patients and clinicians who are currently diverting considerable effort to nonproductive iPLEDGE activities. Please join us in asking the Food and Drug Administration to replace the current iPLEDGE program with an evidence-based “version 2.0” by signing our 1-click online petition at http://www.ipetitions.com/petition/we-pledge-to-change-ipledge.
Pierson JC, Ferris LK*, Schwarz EB**
Corresponding Author: Joseph C. Pierson, MD, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT 05401 ([email protected]).
*Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
**Division of General Internal Medicine, University of California, Davis Medical Center, Sacramento
Conflict of Interest Disclosures: None reported.
REFERENCES
2.Food and Drug Administration. Briefing document for iPLEDGE year one update:http://www.fda.gov/ohrms/dockets/ac/07/briefing/20.... updated February 28, 2007. Accessed February 17, 2015.
3.Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.
4. Werner CA, Papic MJ, Ferris LK, Schwarz EB. Promoting Safe Use of Isotretinoin by Increasing Contraceptive Knowledge. JAMA Dermatol. 2015 Feb 4 [Epub ahead of print]
5. Werner CA, Papic MJ, Ferris LK, et al. Women's experiences with isotretinoin risk reduction counseling. JAMA Dermatol. 2014;150(4):366-71.
6.Collins MK, Moreau JF, Opel D, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55-9.7.Borovaya A, Olisova O, Ruzicka T, Sárdy M. Does isotretinoin therapy of acne cure or cause depression? Int J Dermatol. 2013;52(9):1040-52.
Updates
Reached 250 supporters
August 21, 2015
Reached 100 supporters
April 10, 2015
63 Comments
the 7 day window for females to fill prescription is too short. because of scheduling conflicts, many patients miss window and need unnecessary repeat urine tests.. The website is poorly designed: print is too small and hard to read.
We need to absolutely change this ineffective system. Another reason: it makes it impossible to use isotretinoin for men and post-menopausal women for off-label indications. This is a HUGE loss for many afflicted patients.
iPLEDGE has not decreased the number of pregnancies. It has caused more work for the doctors, staff, pharmacy and patients. I think that instead or protecting patients, it has made it less available to those in need of it.
iPledge has created countless wasted manhours and wasted resources in my practice. It is an unnecessary headache. Isotretinoin is a great medication when used appropriately. Just as we routinely prescribe other medications that have many potential side effects, we should be able to prescribe Isotretinoin without all of the bureaucracy. As physicians, we are more than capable of educating our patients.
Imagine being post-menopausal for five years and still being required to submit to monthly CBC labs to prove I am not pregnant. Isotretinoin is the only medication that has ever cleared my skin. However, it is a hardship to have these unnecessary blood tests as they take too much out of my work schedule.
The iPledge program is long overdue for a major overhaul. The program is meant to prevent fetal exposure, but what is really does is prevent patient access.
I'd like to see iPledge abolished completely and any similar programs be placed on moratorium for it's clearly thinly-veiled patriarchy.
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2015 Jul 1;151(7):701-2.
The US Food and Drug Administration’s mandatory pregnancy prevention program iPLEDGE has the noble intention of reducing the incidence of exposure to the teratogenic acne medication isotretinoin during pregnancy. Unfortunately, it is not working. Nearly a decade into the iPLEDGE era, the pregnancy rate among isotretinoin users is no lower than it was under the prior program, SMART (System to Manage Accutane-Related Teratogenicity); it is estimated that 2.7 isotretinoin-exposed pregnancies occur per 1000 treatment courses.1 Our country can do better, and we propose overhauling iPLEDGE in 2 areas: (1) by emphasizing the relative effectiveness of contraceptive measures for the target audience, women of child-bearing potential, and (2) removing other requirements that do not contribute to the mission of the program.
People respond to the notion of what works best. Unfortunately, despite scaring patients about the risks of medication-induced birth defects, iPLEDGE’s information on pregnancy prevention is not organized in a what-works-best fashion. Because 72% of women who became pregnant while using isotretinoin used condoms and oral contraceptives, which typically have failure rates of 15% and 8%, respectively, during their first year of use,2,3 we cannot condone continued pursuit of the current strategy.
Instead, iPLEDGE materials must be revised to provide clear information on how women can avoid isotretinoin-associated birth defects, emphasizing contraceptive options that are over 20 times more effective than oral contraceptives: subdermal implants and intrauterine contraceptives.3,4 A previous study found that many women enrolled in iPLEDGE had misconceptions about these highly effective reversible contraceptives and that many were dismayed that their superior effectiveness had not been highlighted before they began using isotretinoin.5 A user-friendly contraceptive information document, highlighting subdermal implants and intrauterine contraceptives at the top of a column labeled “How well it works,” depicts the more than 99% effectiveness of these options, followed by less successful methods in descending order.4 Wider distribution of this simple summary of the relative effectiveness of available contraceptives could improve on the status quo when it comes to isotretinoin-exposed pregnancies. Also, those patients who do opt to use an intrauterine or subdermal contraceptive should be permitted to use this 1 highly effective method in place of 2 less effective forms.
In addition, given teenagers’ high risk for unintended pregnancy, plans to abstain from sexual intercourse with male partners during isotretinoin therapy should always be questioned. In 1 study of adherence to pregnancy prevention measures during isotretinoin therapy, 19% of women who committed to abstinence while receiving isotretinoin later admitted to having intercourse, all of whom had previously been sexually active.6 This is not to say that women who identify as homosexual should be required to use contraception in order to be treated with isotretinoin but rather that we must be realistic about the typical failure rates of the “abstinence” method of pregnancy prevention among teens.
We also believe that strong consideration should be given to removing the requirement of acknowledging potential mood changes prior to starting isotretinoin therapy because this verbiage likely has the unintended consequences of obfuscating and detracting from the program’s primary intent of reducing the incidence of fetal exposures to isotretinoin. Whereas we should always maintain awareness of our patients’ psychological well-being, even more so in the vulnerable population of patients with severe acne,7 currently, this issue that is unrelated to pregnancy makes up more than 50% of the universal consent form. Information overload distracts from actionable information.4
Finally, we suggest that the iPLEDGE program remove the requirement for monthly confirmations of patients (male or female) who are not of child-bearing potential. Although education and registration of these patients prior to treatment is warranted, subsequent formal monthly confirmations regarding both not sharing isotretinoin and avoidance of blood donations during therapy and 1 month after discontinuation are not needed. There is no evidence to suggest that repeating such mandatory monthly electronic verifications is effective. Rather, the time, energy, and resources currently diverted to these individuals who are not of child-bearing potential may be better spent on maintaining and heightening the focus on the primary target audience for iPLEDGE, women of childbearing potential.
While we respect the good intentions of those who designed the iPLEDGE program, we believe that sufficient time has elapsed to concede that this program has not achieved the desired goals. Streamlining the iPLEDGE program and prioritizing its most important goal will benefit many patients and clinicians who are currently diverting considerable effort to nonproductive iPLEDGE activities. Please join us in asking the Food and Drug Administration to replace the current iPLEDGE program with an evidence-based “version 2.0” by signing our 1-click online petition at http://www.ipetitions.com/petition/we-pledge-to-change-ipledge.
Pierson JC, Ferris LK*, Schwarz EB**
Corresponding Author: Joseph C. Pierson, MD, University of Vermont Medical Center, 111 Colchester Ave, Burlington, VT 05401 ([email protected]).
*Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
**Division of General Internal Medicine, University of California, Davis Medical Center, Sacramento
Conflict of Interest Disclosures: None reported.
REFERENCES
2.Food and Drug Administration. Briefing document for iPLEDGE year one update:http://www.fda.gov/ohrms/dockets/ac/07/briefing/20.... updated February 28, 2007. Accessed February 17, 2015.
3.Winner B, Peipert JF, Zhao Q, et al. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.
4. Werner CA, Papic MJ, Ferris LK, Schwarz EB. Promoting Safe Use of Isotretinoin by Increasing Contraceptive Knowledge. JAMA Dermatol. 2015 Feb 4 [Epub ahead of print]
5. Werner CA, Papic MJ, Ferris LK, et al. Women's experiences with isotretinoin risk reduction counseling. JAMA Dermatol. 2014;150(4):366-71.
6.Collins MK, Moreau JF, Opel D, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55-9.7.Borovaya A, Olisova O, Ruzicka T, Sárdy M. Does isotretinoin therapy of acne cure or cause depression? Int J Dermatol. 2013;52(9):1040-52.
Updates
Reached 250 supporters
August 21, 2015
Reached 100 supporters
April 10, 2015
63 Comments
I agree most closely with the sentiment to completely eliminate iPledge. Other medications cause birth defects. Why do we not trust people (women) to make decisions for themselves? Unfair to create additional barriers for women in particular to receive medical care.
the 7 day window for females to fill prescription is too short. because of scheduling conflicts, many patients miss window and need unnecessary repeat urine tests.. The website is poorly designed: print is too small and hard to read.
We need to absolutely change this ineffective system. Another reason: it makes it impossible to use isotretinoin for men and post-menopausal women for off-label indications. This is a HUGE loss for many afflicted patients.
iPLEDGE has not decreased the number of pregnancies. It has caused more work for the doctors, staff, pharmacy and patients. I think that instead or protecting patients, it has made it less available to those in need of it.
iPledge has created countless wasted manhours and wasted resources in my practice. It is an unnecessary headache. Isotretinoin is a great medication when used appropriately. Just as we routinely prescribe other medications that have many potential side effects, we should be able to prescribe Isotretinoin without all of the bureaucracy. As physicians, we are more than capable of educating our patients.
Imagine being post-menopausal for five years and still being required to submit to monthly CBC labs to prove I am not pregnant. Isotretinoin is the only medication that has ever cleared my skin. However, it is a hardship to have these unnecessary blood tests as they take too much out of my work schedule.
The iPledge program is long overdue for a major overhaul. The program is meant to prevent fetal exposure, but what is really does is prevent patient access.
I'd like to see iPledge abolished completely and any similar programs be placed on moratorium for it's clearly thinly-veiled patriarchy.
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I agree most closely with the sentiment to completely eliminate iPledge. Other medications cause birth defects. Why do we not trust people (women) to make decisions for themselves? Unfair to create additional barriers for women in particular to receive medical care.