Emergency contraception changes may benefit teens
By Anita Brakman, MS
Assistant Director of Education & Research
Physicians for Reproductive Choice and Health
New York City
and Melanie Gold, DO, FAAP, FACOP
Clinical Professor of Pediatrics
University of Pittsburgh School of Medicine
Staff Physician
University of Pittsburgh Student Health Service
An important change might be on the horizon for adolescents seeking emergency contraception (EC). On Nov. 16, 2010, the Center for Reproductive Rights filed a motion charging the United States Food and Drug Administration (FDA) of being in contempt for ignoring a March 2009 court order to end age restrictions of the EC product, Plan B.
Women ages 16 years of age and younger are required to get a prescription, while older women can access this medication over the counter (OTC) in pharmacies. The court recognized that there are no medical contraindications to EC use in female adolescents.1 Additionally, recent studies agree that females under age 17 are clearly able to comprehend EC labeling in order to use the medication appropriately and effectively.2,3 Finally, the decision reflects professional consensus among organizations including the American Congress of Obstetricians and Gynecologists, American Academy of Pediatrics, and Society for Adolescent Health and Medicine, which have all recommended OTC access regardless of age.4-6
This potential change in EC access is one of many changes that have occurred in relation to this important medication for pregnancy prevention after unprotected sex or contraceptive failure. First, the very product that this lawsuit centers on has undergone a change in name and formulation. When Plan B was first marketed in the United States, it consisted of two tablets each containing 0.75mg of levonorgestrel. After research showed that taking the two tablets at one time was just as safe and effective as the FDA-approved regimen of taking the two tablets 12 hours apart,7 it became common practice for clinicians to recommend a single-dose regimen.
In July 2009, the FDA approved Plan B One-Step, a single tablet EC containing 1.5mg of levonorgestrel that has now replaced the original Plan B on the market. In June 2009, the first generic EC was approved by the FDA. NextChoice is a generic version of the original Plan B including two tablets, each containing 0.75mg levonorgestrel. Similar to all Plan B branded products, NextChoice is available OTC for women ages 17 years and older, but younger adolescents still require a prescription.
While safety and efficacy profiles are the same between the two products, the generic might be more desirable for adolescents who are paying for the medications out of pocket or using insurance, which often provides better coverage for generic medications. Plan B One-Step ranges in price from $35-60, while NextChoice is generally priced about 10% less.8
Yet another change is the entrance of a new form of EC on the market, ella. Ella consists of one 30mg tablet of ulipristal acetate, a progesterone receptor modulator that works primarily by inhibiting or delaying ovulation. Ella is available by prescription only to all women regardless of age, and it costs about $55.8 While increased cost might be a barrier for women, especially teens, the fact that it maintains consistent efficacy for 120 hours, rather than declining over this time period compared to levonorgestrel, offers women a longer window with which to access highly effective EC.7,9,10
Continue advance Rxs
The prescription requirements for all of the EC products described above make it essential that clinicians continue to provide advance prescriptions for EC products to patients, especially those ages 16 years and younger. Contrary to critics' claims that advance provision will lead to increased risk taking, research has shown advance provision among adolescents increases use and decreases delays in taking the medication, but not does increase the likelihood they will engage in unprotected sex.11
To reduce the lengthy process that prescription requirements create, ella has integrated an online prescription service into its web site that allows users to submit medical information to physicians electronically and receive the medication overnight by mail. Unfortunately, many adolescents will not have access to a credit card necessary to use the online service. Also, service and shipping costs for online ordering bring the cost up to $77.8
Clinicians can stay updated on prescription requirements and age restrictions for EC by visiting the Emergency Contraception Website, not-2-late.com. Patients also can visit the site to get more information on the whole range of EC products, as well as referrals to local clinicians who can provide EC.
References
- World Health Organization. Medical eligibility criteria for contraceptive use. Third ed. Geneva: WHO; 2004.
- Raymond E, Engle K, Tolley E, et al. Comprehension of a prototype emergency contraception package label by female adolescents. Contraception 2009;79:199-205.
- Cremer M, Holland E, Adams B, et al. Adolescent comprehension of emergency contraception in New York City. Obstet Gynecol April 2009;113:840-844.
- Statement of The American College of Obstetricians and Gynecologists on the FDA's approval of OTC status for Plan B. Press release. Accessed at http://www.acog.org/from_home/publications/press_releases/nr08-24-06.cfm.
- American Academy of Pediatrics Committee on Adolescence. Emergency contraception. Pediatrics 2005;116: 26-35.
- Gold MA, Sucato GS, Conard LE, et al. Provision of emergency contraception to adolescents: Position paper of the Society For Adolescent Medicine. J Adolesc Health 2004;5:67-70.
- Von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet 2002; 360:1803-1810.
- How to get emergency contraception: How much do emergency contraceptive pills cost? Accessed at http://ec.princeton.edu.
- Creinin MD, Schlaff W, Archer DF, et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol 2006;108:1089-1097.
- Fine P, Mathé H, Ginde S, et al. Ulipristal acetate taken 48–120 hours after intercourse for emergency contraception. Obstet Gynecol 2010;115(2, Part 1):257-263.
- Polis CB, Schaffer K, Blanchard K, et al. Advance provision of emergency contraception for pregnancy prevention: a meta-analysis. Obstet Gynecol 2007;110:1379.
Source
To access ella's integrated online prescription service, go to www.ella-rx.com. Click on "Where do I get ella," then "Need a prescription for ella?"
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