New data emerge on emergency contraception
Family planning clinicians have new research information to add to their emergency contraception (EC) knowledge bank as they incorporate use of two new branded products into their practice.
There is now a generic over-the-counter emergency contraceptive pill (ECP) for over-the-counter use in women ages 17 and above. The Food and Drug Administration (FDA) in August 2009 approved Watson Laboratories' Abbreviated New Drug Application for Next Choice, the generic equivalent to Duramed Pharmaceutical's Plan B ECP. Next Choice originally received FDA approval in June 2009 for prescription use only of Next Choice. The drug is now labeled for prescription and over-the-counter use. Women who are 16 years and younger must have a prescription for Next Choice use.
Each package of Next Choice contains two doses of 0.75 mg of levonorgestrel. Package instructions call for one pill to be taken within 72 hours after unprotected sex, followed by the second dose 12 hours later.
The second ECP is a one-dose product, Plan B One-Step, from Duramed. It received FDA approval in July 2009 for over-the-counter for consumers ages 17 and older. Women who are 16 years and younger must have a prescription for Plan B One-Step. (Editor's note: To help clinicians understand the use of the available branded EC products, the Washington, DC-based Reproductive Health Technologies Project has put together an informative chart. This chart is available with the online issue of Contraceptive Technology Update.)
Are adolescents and young adult women who use ECPs at higher risk than nonusers for sex at risk for pregnancy, unintended pregnancy, and sexually transmitted infection (STIs)? No, suggest the results of a new study of women ages 14-24.1
The study, a secondary analysis of 718 young women who participated in a trial of advanced provision of emergency contraception, failed to show evidence that ECP users were at higher risk for pregnancy and sexually transmitted infections after using ECPs than women who did not use ECPs, says Petra Sander, MSPH, PhD, lead author of the paper and doctoral candidate in the Department of Epidemiology of the Gillings School of Global Public Health at the University of North Carolina, Chapel Hill.
The analysis found no association between use of emergency contraception and either pregnancy or infection. Recent use predicted decreased occurrence of subsequent sex at risk for pregnancy among women with a history of STIs [relative risk (RR), 0.39; 95% confidence interval (CI), 0.15-0.97]. Ever having used predicted increased occurrence among women who were highly effective method users (RR, 1.45; 95% CI, 1.05-2.01) or had no history of sexually transmitted infection (RR, 1.31; 95% CI, 1.04-1.65).
Investigators undertook the study to provide a better understanding of whether ECP use is an indicator of increased risk for later adverse behaviors and events in an effort to inform the development of customized preventive counseling guidelines and interventions. Research and clinical efforts should focus on improved risk communication, explicit instruction on effective contraceptive use, and improved identification of high-risk adolescents prior to the initiation of sexual activity, the researchers conclude.
As it now stands, over-the-counter access to emergency contraception in the United States is not available to young women ages 16 and younger. Can female adolescents ages 12-17 comprehend over-the-counter emergency contraception labeling? Yes, indicate findings from a new study.2
To perform the study, surveys were administered to female adolescents in New York City in public venues such as malls, movie theaters, and parks. Participants were asked to read the emergency contraception label before answering survey questions. A total of 1,085 girls between ages 12 and 17 participated in the study.
Overall, teens demonstrated high comprehension of the following key points of emergency contraception, investigators report:
- that it is a method of preventing pregnancy, 92% [confidence interval (CI) 91-94%];
- that it has to be taken within the first 72 hours after unprotected intercourse, 83% (CI 83-87%);
- that if you are already pregnant, emergency contraception will not be effective, 87% (CI 85-89%);
- that emergency contraception will not protect against HIV/AIDS, 95% (CI 94-96%);
- that emergency contraception should not be used as a method of long-term birth control, 85% (CI 83-87%).2
After reading the label, the teenagers understood the information necessary to use emergency contraception safely and effectively as well as their adult counterparts, the researchers report.
"I think the decisions by the FDA have not been motivated by science; emergency contraception's safety and efficacy have been proven for a long time," says Miriam Cremer, MD, MPH, assistant professor of obstetrics and gynecology at Mount Sinai School of Medicine of New York University. Cremer served as lead author of the current paper. "For this age group, to have the highest efficacy possible and prevent unwanted, unplanned pregnancies, it is important for emergency contraception to become over the counter to all age groups," Cremer says.
References
- Sander PM, Raymond EG, Weaver MA. Emergency contraceptive use as a marker of future risky sex, pregnancy, and sexually transmitted infection. Am J Obstet Gynecol 2009; 201:146.e1-6.
- Cremer M, Holland E, Adams B, et al. Adolescent comprehension of emergency contraception in New York City. Obstet Gynecol 2009; 113:840-844.
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