EC provision doesn’t boost unprotected sex in teens

Does advance access to emergency contraception (EC) in adolescents lead to an increase in unprotected sex? Not according to findings from a newly published study, which indicate advance EC provision does not cause teens to have more unprotected intercourse or practice less consistent contraceptive use.1 In addition, researchers found that teens who were provided EC in advance were more likely to use the pills in the first 12 hours after unprotected intercourse, when the drug is most effective.

Teens who were provided advance EC were not likely to discontinue ongoing contraception and were more likely to report condom use at the six-month follow-up, reports Melanie Gold, DO, associate professor of pediatrics at the University of Pittsburgh School of Medicine and lead author of the paper.

"We hypothesized that might be because girls who have EC in advance have their action plan," Gold observes. "They are in a preventive health mode, and so in addition to having their backup for unprotected sex, they are now more careful overall and work harder to make sure that their Plan A’ is working."

The Food and Drug Administration (FDA) is reviewing these data, along with other information, in considering a move to over-the-counter status (OTC) for the levonorgestrel emergency contraceptive pill Plan B (Barr Laboratories, Pomona, NY). The agency announced in February 2004 it was extending its review of the company’s request to analyze additional data on adolescent use submitted by Barr Labs and Plan B’s former owner, Women’s Capital Corp. of Washington, DC.

Science given short shrift?

Advocates of EC OTC provision are concerned that the scientific evidence may not be given full weight in the decision on drug access. The editor of the New England Journal of Medicine and two members of the FDA advisory panel point to "political considerations" affecting the review extension in an April 2004 editorial published in the scientific journal.2

"Although the FDA is frequently criticized by politicians and others for being either too lenient or too tough . . . the integrity of the process has seldom been questioned," the editorial states. "To squander that trust by allowing political pressure to delay a decision to make safe and effective emergency contraception available over the counter seems to us a serious error."

To perform the adolescent study, researchers enrolled 301 female adolescents ages 15 to 20 between 1997 and 2001. Participants were provided education about emergency contraceptive pills (ECPs) and received monthly follow-up telephone calls to assess sexual activity and usage of various contraceptive methods.

Participants were followed for a period of six months and were randomized to receive emergency contraceptive education along with a package of ECPs or education only, with instruction on how to get the pills if they were needed. All participants were sexually active, with a mean age at first intercourse between 14 and 15 years.

At one-month interviews, teens who already had ECP packages were nearly twice as likely to use them, with 15% of the advance group reporting ECP use and 8% of the education-only control group reporting ECP use. By the final follow-up at six months, the differences between the groups had almost disappeared, with 8% of the advance group reporting ECP use, compared to 6% of the control group.1

EC safe for teen use

Is EC safe for use in adolescents? According to a small study in young teens, the drug is safe and well tolerated.3

Researchers found that teens were able to use the method correctly and that they experienced the same minor and transient side effects that adults experience, says Cynthia Harper, PhD, an assistant professor of obstetrics and gynecology at the University of California at San Francisco. The effect on the menstrual cycle for teens also was similar to that on adults, she states.

Until a decision is reached on OTC access for emergency contraception, providers should continue to offer advance EC to adolescent patients, says Gold. Discuss the expiration date for the drug, counsel teens to call for a prescription or another sample if they need it, and make sure teens understand that while EC may prevent unintended pregnancy, it does not provide protection against sexually transmitted diseases, she says.

"Until we have methods which are 100% effective, I think we have to have back-ups," states Gold. "I always do advance [EC] provision."

References

1. Gold MA, Wolford JE, Smith KA, et al. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. Pediatr Adolesc Gynecol 2004; 17:87-96.

2. Drazen JM, Greene MF, Wood AJ. The FDA, politics, and Plan B. N Engl J Med 2004; 350:1,561-1,562.

3. Harper CC, Sambol N, Rocca C, et al. Safety and pharmacokinetics of emergency contraception in a pediatric population (aged 12-16). Presented at the 131st annual meeting of the American Public Health Association. San Francisco; November 2003.