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Original Investigation |

Promoting Safe Use of Isotretinoin by Increasing Contraceptive Knowledge FREE

Carly A. Werner, MD1,2; Melissa J. Papic, BS3; Laura K. Ferris, MD, PhD1,4; Eleanor B. Schwarz, MD, MS1,2,3,5,6
[+] Author Affiliations
1School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
2Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania
3Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
4Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania
5Graduate School of Public Health, Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania
6now with Division of General Internal Medicine, University of California, Davis, Sacramento
JAMA Dermatol. 2015;151(4):389-393. doi:10.1001/jamadermatol.2014.4171.
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Published online

Importance  Isotretinoin, a known teratogen, is strictly regulated through the iPLEDGE program. However, isotretinoin-exposed pregnancies continue to occur.

Objective  To evaluate an information sheet’s effect on women’s contraceptive knowledge.

Design, Setting, and Participants  Women aged 18 to 45 years visiting a dermatology practice completed anonymous surveys assessing their knowledge of the typical effectiveness of 8 contraceptive methods before and after reviewing an educational information sheet. Participants categorized each contraceptive as “most effective, >99% effective,” “medium effective, 92%-97% effective,” or “least effective, <89% effective” or indicated that they had “never heard of” it. All participants were recruited from a single dermatology clinic between April and May 2014. A total of 118 women were approached by consecutive sampling, and surveys were completed by 100 women.

Main Outcomes and Measures  Preintervention contraceptive effectiveness knowledge and change in contraceptive effectiveness knowledge after viewing the educational tool.

Results  Prior to viewing the contraceptive information sheet, more than half of women overestimated the typical effectiveness of condoms (75%), contraceptive injections (57%), and oral contraceptives (51%). Thirty-four percent had never heard of contraceptive implants, whereas 16% had never heard of an intrauterine contraceptive device (IUD). Participants correctly identified the typical effectiveness of only a mean (SD) of 3.8 (1.9) of the 8 contraceptives that they were asked about. Only 3% of participating women were able to correctly identify the typical effectiveness of all available contraceptives. On average, women spent less than 1 minute reviewing the contraceptive information sheet (mean [SD], 31 [27] seconds). After viewing the educational handout, the proportions of participants able to correctly identify the typical effectiveness of contraceptives increased for almost all methods (subdermal implant, 45% to 78% [P < .001]; IUD, 61% to 83% [P < .001]; injection, 28% to 44% [P = .02]; ring, 60% to 69% [P = .18]; patch, 50% to 71% [P = .002]; pills, 41% to 65% [P < .001]; condoms, 25% to 45% [P = .003]; withdrawal, 74% to 90% [P = .003]).

Conclusions and Relevance  A contraceptive information sheet can significantly improve patients’ contraceptive knowledge and may be a useful addition to efforts to prevent isotretinoin-induced birth defects.

Figures in this Article

Isotretinoin anisatil therapy produces significant clinical improvement for many patients with severe acne that has been refractory to other treatments.1 Because isotretinoin is a known teratogen, the US Food and Drug Administration strictly regulates the distribution of this medication to female patients of childbearing potential through the iPLEDGE program. The iPLEDGE program requires that women pledge to use 2 forms of contraception, in addition to completing monthly serum pregnancy tests and online tests of their comprehension of the teratogenic risks associated with isotretinoin use. Unfortunately, although the iPLEDGE program has unintentionally limited use of isotretinoin by young women with severe skin disease,2 it has only minimally increased contraceptive use,3 and there were still 122 pregnancies affected by isotretinoin reported in the first year of this program.4

Persistent reports of pregnancies affected by isotretinoin use5 are due in large part to the prevalence of use of contraceptives with relatively high rates of failure,4 such as condoms and oral contraceptives.6 When interviewed, women who have been treated with isotretinoin report clearly understanding isotretinoin’s teratogenic risks, but many indicate that they lacked information on how to effectively avoid unintended pregnancy.7 In particular, many women reported limited knowledge of the most effective contraceptives, such as the subdermal contraceptive implant and intrauterine contraceptives,7 and many reported little awareness of the fact that the effectiveness of available contraceptives can differ by an order of magnitude.8 Nonetheless, women indicated that a contraceptive’s effectiveness would be a key factor in their choice of a contraceptive method to use while being treated with isotretinoin.

In an effort to improve the contraceptive knowledge of women treated with highly teratogenic medications such as isotretinoin, we developed a contraceptive information sheet that displays the relative effectiveness of available methods of contraception with typical use. We assessed changes in women’s contraceptive knowledge before and after they reviewed this contraceptive information sheet while waiting to see a dermatologist.

This study was approved by the institutional review board of the University of Pittsburgh. Between April and May 2014, we approached a consecutive sample of 118 English-speaking women, aged 18 to 45 years, in the waiting room of an urban dermatology practice. Verbal consent was obtained from each partcipant of this anonymous survey. Participants were asked to categorize each contraceptive method as being either “most effective, >99% effective,” “medium effective, 92%-97% effective,” or “least effective, <89% effective” or to indicate that they had “never heard of” the method. Participants were then provided with a contraceptive information sheet that we developed using materials developed by the World Health Organization,9 as well as interviews that we had conducted with women who had previously participated in the iPledge program.7 This information sheet (Figure) outlines each contraceptive’s duration of efficacy, risks, and benefits, while highlighting the relative effectiveness of these methods with typical use. The research assistant (C.A.W.) instructed all participants to review the handout as if a clinician had provided it to them and to give the handout back when they were finished. The research assistant made note of how long each participant spent reviewing the handout and then asked her to complete a posttest in which she identified the typical-use effectiveness of available contraceptive methods using the same 4 response categories. In addition, we collected information regarding respondents’ demographic characteristics (including race, ethnicity, age, highest level of education) and health care use (seen a physician in the previous year [yes/no], seen a physician for skin problems such as acne [yes/no], and currently or previously being prescribed isotretinoin [yes/no]).

Place holder to copy figure label and caption
Figure.
Contraceptive Information Sheet

Contraceptive information sheet shown to participants.

Graphic Jump Location

We used descriptive statistics to present the sociodemographic characteristics of participants and used χ2 tests to compare differences in contraceptive knowledge on pretests and posttests. We used paired t tests to compare the mean number of correct answers provided on pretests and posttests. Finally, we used multivariable logistic regression analysis to evaluate whether the amount that participants learned from the contraceptive information sheet varied by age, race, educational level, or their having seen a physician in the past year. All analyses were performed using Stata, version 13.0 (StataCorp).

Of the 118 women approached, 18 did not have time to complete the survey before being called to see a clinician. Participants in this study had a mean (SD) age of 27.5 (6.0) years. The majority of participants were white (66%) and had at least a college education (64%). Most (91%) had seen a physician in the past year, and 55% had been treated for acne or other skin problems in the past year. Eleven participants had been, or were currently being, treated with isotretinoin (Table 1).

Table Graphic Jump LocationTable 1.  Participant Characteristics

Prior to viewing the contraceptive information sheet, participants correctly identified the typical effectiveness of only approximately half (mean [SD], 3.8 [1.9]) of the contraceptives that they were asked about. Seventy-five percent of women overestimated the effectiveness of condoms, and 51% overestimated the typical effectiveness of oral contraceptives (Table 2). Only 3% of participating women were able to correctly identify the typical effectiveness of all available contraceptives. Approximately one-third of participants (34%) indicated that they had “never heard of” the implant, whereas 16% had never heard of an IUD (intrauterine contraceptive device).

Table Graphic Jump LocationTable 2.  Baseline Knowledge of the Typical Effectiveness of Available Contraceptives

Women spent a mean (SD) of 31 (27) seconds reviewing the contraceptive information sheet. Nonetheless, significant improvements were noted in participants’ abilities to correctly identify the typical effectiveness of available contraceptives. After viewing the contraceptive information sheet, the proportions of participants able to correctly identify the typical effectiveness of most contraceptives increased (Table 3). However, even after reviewing the contraceptive information sheet, 55% of participants still overestimated the typical effectiveness of condoms on their posttest. Among women who reported inaccurate perceptions of the typical effectiveness of available contraceptives on the pretest, the largest improvements in knowledge were seen regarding the typical effectiveness of withdrawal (69%), the IUD (67%), implant (64%), and patch (62%). Learning from the contraceptive information sheet did not vary by participants’ age, race, educational level, or contact with a physician in the past year (data not shown).

Table Graphic Jump LocationTable 3.  Change in Contraceptive Knowledge Following Review of Information Sheet

This study found that women who spent less than a minute reviewing a contraceptive information sheet while waiting to see a dermatologist demonstrated significant improvement in their knowledge of the full range of available contraceptives. Because women treated with isotretinoin as part of the iPLEDGE program often report needing more information regarding available contraceptives,7 we recommend that dermatologists make this contraceptive information sheet available to all women whom they are considering treating with isotretinoin. Alternatively, updating the materials distributed by the iPLEDGE program to include this contraceptive information would be useful.

Our finding that most women seeking care from a dermatologist are not able to accurately identify the typical effectiveness of available contraceptives is concerning because it likely contributes to suboptimal contraceptive use, which is particularly problematic when women are treated with teratogenic medications such as isotretinoin. The majority of women whom we studied overestimated the effectiveness of condoms, which typically fail 1 of every 6 women within their first year of use.10 Women also frequently overestimated the effectiveness of oral contraceptives, which typically fail 9% of women within their first year of use,10 20 times the rate of failure seen with either the subdermal contraceptive implant or intrauterine contraceptives.8 Yet, more than one-third of the women whom we studied reported that they had never heard of these most effective contraceptive methods, which are most commonly chosen by family planning clinicians for their own personal use.11 Thus, it may be helpful for clinicians to counsel women that many people overestimate the effectiveness of both condoms and oral contraceptives. Although currently few dermatologists offer to place subdermal contraceptives, clinicians who are committed to helping women effectively avoid pregnancy while being treated with isotretinoin could offer women this service after completing a few hours of training.12 Of note, these subdermal contraceptives, like all oral contraceptives and other medications that suppress ovulation, improve acne for the majority of women.13 Clinicians who do not feel comfortable directly providing such contraceptive services should maintain close communication with their local providers of family planning services regarding the best ways to facilitate prompt referrals. Importantly, we found that this contraceptive information sheet improved the contraceptive knowledge of women irrespective of the participants’ age, race, educational level, or contact with a physician in the past year. Future studies should investigate retention of this contraceptive knowledge. Although our study population included women from a range of racial and educational backgrounds, all participants were recruited from a single, urban hospital-based clinic, and thus our results may not be fully generalizable. Because adolescents face the highest risk of undesired pregnancy,14 future work is needed to confirm our findings among women younger than 18 years. In addition, although prior studies have closely linked women’s contraceptive knowledge with their contraceptive use,1518 efforts are needed to confirm that providing this contraceptive information sheet to women considering treatment with isotretinoin increases use of highly effective contraception and decreases risk of medication-induced birth defects.

We have developed a 1-page contraceptive information sheet that increases women’s knowledge of the typical effectiveness of available contraceptives and can be easily integrated into existing dermatology practice. Addition of this information sheet to the materials distributed by the iPLEDGE program may help decrease the number of isotretinoin-exposed pregnancies.

Accepted for Publication: October 7, 2014.

Corresponding Author: Eleanor B. Schwarz, MD, MS, University of California, Davis, 4150 V Street, PSSB 2400, Sacramento, CA 95817 (ebschwarz@ucdavis.edu).

Published Online: February 4, 2015. doi:10.1001/jamadermatol.2014.4171.

Author Contributions: Drs Werner and Schwarz had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Ferris, Schwarz.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Werner, Papic, Schwarz.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Werner, Papic, Schwarz.

Obtained funding: Schwarz.

Administrative, technical, or material support: Werner, Papic, Ferris.

Study supervision: Ferris, Schwarz.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was funded in part by Food and Drug Administration grant U01FD004253-01 to Dr Schwarz.

Role of the Funder/Sponsor: The Food and Drug Administration 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.

Disclaimer: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Food and Drug Administration.

Layton  AM, Dréno  B, Gollnick  H, Mobaken  H, Shear  N.  Isotretinoin therapy and the incidence of acne relapse: a nested case-control study. Br J Dermatol. 2009;160(1):217-218.
PubMed   |  Link to Article
Fleischer  AB  Jr, Simpson  JK, McMichael  A, Feldman  SR.  Are there racial and sex differences in the use of oral isotretinoin for acne management in the United States? J Am Acad Dermatol. 2003;49(4):662-666.
PubMed   |  Link to Article
Pinheiro  SP, Kang  EM, Kim  CY, Governale  LA, Zhou  EH, Hammad  TA.  Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States. Pharmacoepidemiol Drug Saf. 2013;22(12):1251-1257.
PubMed   |  Link to Article
Food and Drug Administration. Briefing Document for iPLEDGE Year One Update. 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-0+ipledge.pdf. Accessed April 28, 2014.
Shin  J, Cheetham  TC, Wong  L,  et al.  The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. J Am Acad Dermatol. 2011;65(6):1117-1125.
PubMed   |  Link to Article
Collins  MK, Moreau  JF, Opel  D,  et al.  Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55-59.
PubMed   |  Link to Article
Werner  CA, Papic  MJ, Ferris  LK,  et al.  Women’s experiences with isotretinoin risk reduction counseling. JAMA Dermatol. 2014;150(4):366-371.
PubMed   |  Link to Article
Winner  B, Peipert  JF, Zhao  Q,  et al.  Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.
PubMed   |  Link to Article
Steiner  MJ, Trussell  J, Johnson  S.  Communicating contraceptive effectiveness: an updated counseling chart. Am J Obstet Gynecol. 2007;197(1):118.
PubMed   |  Link to Article
Kost  K, Singh  S, Vaughan  B, Trussell  J, Bankole  A.  Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception. 2008;77(1):10-21.
PubMed   |  Link to Article
Stern  L, Debevec  E, Devaskar  S, Morfesis  J, Patel  A.  Differences in contraceptive use between family planning providers and the general population. Obstet Gynecol. 2014;123(suppl 1):14S-15S.
PubMed   |  Link to Article
Merck. Clinician Nexplanon Training Request 2014. http://www.nexplanon-usa.com/en/hcp/services-and-support/request-training/request-form/index.asp. Accessed May 1, 2014.
Funk  S, Miller  MM, Mishell  DR  Jr,  et al; Implanon US Study Group.  Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71(5):319-326.
PubMed   |  Link to Article
Ventura  SJ, Curtin  SC, Abma  JC, Henshaw  SK.  Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990-2008. Natl Vital Stat Rep. 2012;60(7):1-21.
PubMed
Upson  K, Reed  SD, Prager  SW, Schiff  MA.  Factors associated with contraceptive nonuse among US women ages 35-44 years at risk of unwanted pregnancy. Contraception. 2010;81(5):427-434.
PubMed   |  Link to Article
Harper  CC, Brown  BA, Foster-Rosales  A, Raine  TR.  Hormonal contraceptive method choice among young, low-income women: how important is the provider? Patient Educ Couns. 2010;81(3):349-354.
PubMed   |  Link to Article
Dehlendorf  C, Tharayil  M, Anderson  N, Gbenedio  K, Wittman  A, Steinauer  J.  Counseling about IUDs: a mixed-methods analysis. Perspect Sex Reprod Health. 2014;46(3):133-140.
PubMed   |  Link to Article
Lee  JK, Parisi  SM, Akers  AY, Borrero  S, Schwarz  EB.  The impact of contraceptive counseling in primary care on contraceptive use [published correction appears in J Gen Intern Med. 2011;26(7):822]. J Gen Intern Med. 2011;26(7):731-736.
PubMed   |  Link to Article

Figures

Place holder to copy figure label and caption
Figure.
Contraceptive Information Sheet

Contraceptive information sheet shown to participants.

Graphic Jump Location

Tables

Table Graphic Jump LocationTable 1.  Participant Characteristics
Table Graphic Jump LocationTable 2.  Baseline Knowledge of the Typical Effectiveness of Available Contraceptives
Table Graphic Jump LocationTable 3.  Change in Contraceptive Knowledge Following Review of Information Sheet

References

Layton  AM, Dréno  B, Gollnick  H, Mobaken  H, Shear  N.  Isotretinoin therapy and the incidence of acne relapse: a nested case-control study. Br J Dermatol. 2009;160(1):217-218.
PubMed   |  Link to Article
Fleischer  AB  Jr, Simpson  JK, McMichael  A, Feldman  SR.  Are there racial and sex differences in the use of oral isotretinoin for acne management in the United States? J Am Acad Dermatol. 2003;49(4):662-666.
PubMed   |  Link to Article
Pinheiro  SP, Kang  EM, Kim  CY, Governale  LA, Zhou  EH, Hammad  TA.  Concomitant use of isotretinoin and contraceptives before and after iPledge in the United States. Pharmacoepidemiol Drug Saf. 2013;22(12):1251-1257.
PubMed   |  Link to Article
Food and Drug Administration. Briefing Document for iPLEDGE Year One Update. 2007. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4311b1-0+ipledge.pdf. Accessed April 28, 2014.
Shin  J, Cheetham  TC, Wong  L,  et al.  The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system. J Am Acad Dermatol. 2011;65(6):1117-1125.
PubMed   |  Link to Article
Collins  MK, Moreau  JF, Opel  D,  et al.  Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55-59.
PubMed   |  Link to Article
Werner  CA, Papic  MJ, Ferris  LK,  et al.  Women’s experiences with isotretinoin risk reduction counseling. JAMA Dermatol. 2014;150(4):366-371.
PubMed   |  Link to Article
Winner  B, Peipert  JF, Zhao  Q,  et al.  Effectiveness of long-acting reversible contraception. N Engl J Med. 2012;366(21):1998-2007.
PubMed   |  Link to Article
Steiner  MJ, Trussell  J, Johnson  S.  Communicating contraceptive effectiveness: an updated counseling chart. Am J Obstet Gynecol. 2007;197(1):118.
PubMed   |  Link to Article
Kost  K, Singh  S, Vaughan  B, Trussell  J, Bankole  A.  Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception. 2008;77(1):10-21.
PubMed   |  Link to Article
Stern  L, Debevec  E, Devaskar  S, Morfesis  J, Patel  A.  Differences in contraceptive use between family planning providers and the general population. Obstet Gynecol. 2014;123(suppl 1):14S-15S.
PubMed   |  Link to Article
Merck. Clinician Nexplanon Training Request 2014. http://www.nexplanon-usa.com/en/hcp/services-and-support/request-training/request-form/index.asp. Accessed May 1, 2014.
Funk  S, Miller  MM, Mishell  DR  Jr,  et al; Implanon US Study Group.  Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005;71(5):319-326.
PubMed   |  Link to Article
Ventura  SJ, Curtin  SC, Abma  JC, Henshaw  SK.  Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990-2008. Natl Vital Stat Rep. 2012;60(7):1-21.
PubMed
Upson  K, Reed  SD, Prager  SW, Schiff  MA.  Factors associated with contraceptive nonuse among US women ages 35-44 years at risk of unwanted pregnancy. Contraception. 2010;81(5):427-434.
PubMed   |  Link to Article
Harper  CC, Brown  BA, Foster-Rosales  A, Raine  TR.  Hormonal contraceptive method choice among young, low-income women: how important is the provider? Patient Educ Couns. 2010;81(3):349-354.
PubMed   |  Link to Article
Dehlendorf  C, Tharayil  M, Anderson  N, Gbenedio  K, Wittman  A, Steinauer  J.  Counseling about IUDs: a mixed-methods analysis. Perspect Sex Reprod Health. 2014;46(3):133-140.
PubMed   |  Link to Article
Lee  JK, Parisi  SM, Akers  AY, Borrero  S, Schwarz  EB.  The impact of contraceptive counseling in primary care on contraceptive use [published correction appears in J Gen Intern Med. 2011;26(7):822]. J Gen Intern Med. 2011;26(7):731-736.
PubMed   |  Link to Article

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