Easy EC access doesn’t increase risky behavior

If it were easier for women to obtain emergency contraception (EC), would it result in an increase in unprotected intercourse, cause women to forego their current method of contraception, or increase the risk of sexually transmitted diseases (STDs)? Apparently not, according to the findings of a just-published study.1

Women enrolled at four California women’s health clinics were randomly assigned to one of three EC sources: the clinic, nearby pharmacies without a prescription, or an advance supply of pills. Researchers found about the same percentage of women in each group had unprotected sex over a six-month period, incidents of sexually transmitted disease were equal, and about the same percentage in each group became pregnant. About 37% of women in the group with advance EC used it at least once during the six months, compared with 21% in the clinic access group and 24% in the pharmacy access group.

The results counter concerns voiced by opponents to expanded EC access, who have claimed that easier access will lead to increases in sexual promiscuity and STDs. Such concerns may have lead the Food and Drug Administration to issue an initial rejection to Pomona, NY-based Barr Pharmaceuticals’ application to move its levonorgestrel-only EC pill Plan B to over-the-counter (OTC) status.

One of the concerns voiced by policy-makers, some providers, and even some women, is that women will "misuse" EC, says the study’s lead author, Tina Raine, MD, MPH, an associate professor in obstetrics, gynecology, and reproductive sciences at the University of California-San Francisco. Such concern would be warranted if women used EC instead of regular contraception, if they adopted unsafe sexual behaviors (abandoning condom use or having multiple sexual partners), or if women used EC repeatedly, she points out.

"I don’t think that anyone would consider using EC once or even twice over a six-month period as excessive or in any way dangerous, and we demonstrated no differences in use of regular contraception, condoms, or sexual practices [promiscuity] among women with increased access," comments Raine. "So our study is important in that we demonstrate that women with increased access to EC do not misuse’ EC in this way."

The Washington, DC-based American College of Obstetricians and Gynecologists (ACOG) has issued a statement on the new research and calls on the FDA to approve expanded access to EC.

"These new data clearly add to the existing body of evidence previously reviewed by two FDA expert advisory panels," the ACOG statement reads. "They overwhelmingly had recommended OTC approval of Plan B by a 23-4 vote, after reviewing more than 15,000 pages of clinical data from approximately 40 studies submitted with the OTC application."2

Review the research

To study expanded access, researchers designed a randomized controlled trial, enrolling 2,117 women ages 15-24 at four San Francisco area women’s health care clinics (New Generation Health Center/University of California-San Francisco, Planned Parenthood — San Francisco, City College of San Francisco Student Health Center, and Planned Parenthood — Daly City). Women were assigned to one of three groups: pharmacy access to EC, advance provision of three packs of Plan B EC, or clinic access (control).

Researchers found that the percentage of women in the pharmacy group (24.2%) and in the clinic group (21%) using EC essentially were the same. Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21%) even though their reported frequency of unprotected intercourse was similar (39.8% vs. 41%, respectively). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of the women in the trial became pregnant, and 12% acquired an STD; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate or increase in STDs. There were no differences in patterns of contraceptive or condom use or sexual behaviors by women in the study group.

The FDA continues to review Plan B’s OTC application. Barr Laboratories resubmitted its application in July 2004 with "bifurcated labeling," seeking OTC access for women ages 16 and older, with prescription-only status for those below the age limit, says company spokeswoman Carol Cox. The regulatory agency extended its review past the scheduled Jan. 21, 2005, deadline.

References

1. Raine TR, Harper CC, Rocca CH, et al. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: A randomized controlled trial. JAMA 2005; 293:54-62.

2. American College of Obstetricians and Gynecologists. Statement of Vivian M. Dickerson, MD, President. The American College of Obstetricians and Gynecologists on JAMA Emergency Contraception Study. Washington, DC; Jan. 5, 2005.