Published online April 3, 2006
PEDIATRICS Vol. 117 No. 4 April 2006, pp. 1448-1450 (doi:10.1542/peds.2005-2811)
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Emergency Contraception: To the Editor.—

Melanie A. Gold, DO
Adolescent Health Services
Children's Hospital of Pittsburgh
University of Pittsburgh School of Medicine
Pittsburgh, PA 15213

To the Editor.—

I was delighted to see the American Academy of Pediatrics policy statement on emergency contraception (EC) in the October issue of Pediatrics.1 I also applaud the publication of the fact sheet for parents and adolescents and the speaking points for pediatricians in the members-only section of the www.aap.org Web site. The policy statement joins those of other professional organizations dedicated to the reproductive health of adolescents such as the American College of Obstetrics and Gynecology and the Society for Adolescent Medicine, who likewise support adolescents' over-the-counter access to EC. This policy statement provides important information about EC to our membership and, in doing so, legitimizes and standardizes the expectation that pediatricians routinely counsel about and prescribe EC to adolescents.

I would like to commend the Committee on Adolescence for highlighting the following in their policy statement:

  1. Although approved by the Food and Drug Administration (FDA) for use within 72 hours of unprotected intercourse, EC is effective up to 120 hours (or 5 days) after unprotected intercourse.
  2. Pills with norethindrone (not just those with norgestrel and levonorgestrel) can be used for EC.
  3. Plan B is the EC regimen of choice because of its higher efficacy and less adverse effects compared with combination methods of EC.
  4. Plan B should be prescribed as 2 tablets in a single dose instead of splitting the dose 12 hours apart without compromising efficacy or inducing more adverse effects.
  5. The policy statement includes the indications for using EC when newer contraceptive methods such as the birth control patch and vaginal ring fail to provide adequate protection.
  6. The statement emphasizes that a urine pregnancy test is not required to prescribe EC and that timing of unprotected intercourse during the menstrual cycle should not determine if EC is prescribed.
  7. The statement recommends prescribing EC over the telephone, even to new patients, so as not to delay access.
  8. The summary statement for the policy statement recommends educating and counseling about EC at annual visits for all teens and young adult patients when sexuality issues are addressed, which would include male adolescents and those who have not yet become sexually active.

I would also like to comment on a few inaccuracies that I found in the policy statement, fact sheet, and speaking points that are primary a result of the policy already being out of date.

  1. All 3 resources (the policy statement, fact sheet, and speaking points) discuss Preven (a combination oral contraceptive pill) as a recommended EC product. It should be noted that Preven was bought by the makers of Plan B and subsequently taken off the market in 2004, because the company felt that Plan B was a superior product in terms of its efficacy and adverse-effect profile. Currently, there are very few pharmacies that have any remaining Preven in stock. Once the residual stock is gone, Preven will no longer be available. A prescription for Preven might prove very difficult to fill and will thus create an additional barrier to EC access. I worry that pediatricians may not be aware that Preven is no longer being produced. It should be emphasized that pediatricians should avoid writing prescriptions for Preven and rather should always provide prescriptions for Plan B.
  2. The policy statement appropriately emphasizes that Plan B is the preferred regimen for EC. However, neither the speaking points nor the fact sheet for parents and adolescents have the same emphasis. Plan B is the regimen of choice for all prescriptions for EC, and the instructions should read as follows: "Take 2 tablets as soon as possible after unprotected intercourse up to 120 hours from unprotected sex. Follow-up in 10 to 14 days."
  3. The fact sheet and the speaking points do not emphasize that EC can be prescribed up to 120 hours after unprotected intercourse (as the policy statement uniformly emphasizes). Pediatricians should be aware that restricting EC to 72 hours after unprotected intercourse limits access to EC. However, the message that the sooner EC is taken, the more likely it is to be effective should not be lost.
  4. In Table 2 of the policy statement, Women's Capitol Corporation is shown as the owner of Plan B, but it is now owned by Barr Laboratories.
  5. The policy statement comments on the FDA activities related to changing Plan B to over-the-counter status but neglects to provide the following most recent news: Barr Laboratories submitted an application to the FDA on July 22, 2004, for a unique and unprecedented dual prescribing status for Plan B in which they requested that the product be sold over-the-counter for women aged ≥16 years and remain a prescription-only product for women ≤15 years. The response to the application on August 26, 2005, from the FDA concluded that the available scientific data were sufficient to support the safe use of Plan B as an over-the-counter product, but only for women who are ≥17 years of age. However, they were unable to make a decision because the FDA has never determined whether a drug may be both prescription and over-the-counter on the basis of the age of the individual using the drug. A related concern is how an age-based distinction could be enforced. Public comments on questions related to the marketing of prescription and over-the-counter versions of the same active ingredient in a single package and enforcement of the age limitation were taken for 60 days; that period ended on November 1, 2005.
  6. The Society for Adolescent Medicine published a position paper that was not cited in this policy statement that affirms that EC should be available over-the-counter without an age restriction.2
  7. A relevant study that was published recently about advance access to EC was not cited in the position statement. Raine et al3 assessed the sexual and contraceptive behaviors of young women aged 15 to 24 years who were randomly assigned to 1 of 3 EC-access groups: advance provision (with 3 packs of EC), pharmacy access, or clinic access (control group). Those in the advance-provision group were almost twice as likely to use EC as those in the clinic-access group at the 6-month follow-up. The advance-provision group did not have significantly higher frequency of unprotected intercourse compared with the clinic-access group. No other differences in contraceptive or condom use or other sexual behaviors by group were found. At the 6-month follow-up, 8% of the young women in the study had become pregnant, and 12% had acquired a sexually transmitted infection. There were no reductions in pregnancies or increases in sexually transmitted infections by group (advance provision, pharmacy access, or clinic access).

It is my understanding that the American Academy of Pediatrics will soon be publishing a pamphlet on EC for adolescents. This is a sorely needed resource for the pediatrician in practice, and I look forward to its availability.

REFERENCES

  1. American Academy of Pediatrics, Committee on Adolescence. Emergency contraception. Pediatrics. 2005;116 :1026 –1035[Abstract/Free Full Text]
  2. Gold MA, Sucato GS, Conard LA, Hillard PJ; Society for Adolescent Medicine. Provision of emergency contraception to adolescents: position paper of the Society for Adolescent Medicine. J Adolesc Health. 2004;35 :67 –70[Medline]
  3. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on contraception and STIs: a randomized controlled trial. JAMA. 2005;293 :54 –62[Abstract/Free Full Text]

PEDIATRICS (ISSN 1098-4275). ©2006 by the American Academy of Pediatrics

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