Young, urban women showed no reduction in their use of contraceptives, nor any other changes in their sexual behavior when provided with easier access to the so-called "morning after pill," also known as emergency contraception (EC), according to UCSF researchers.
Rates of pregnancy and sexually transmitted infections (STIs) were the same at the end of the six-month study regardless of whether women had increased access to EC.
In the study, published in the January 5 issue of the Journal of the American Medical Association,
2,117 women age 15-24 in two San Francisco Bay Area cities were randomly assigned to one of three groups, each providing a different degree of accessibility to EC. The women either were instructed to get emergency contraception directly from pharmacists (without a prescription), were provided with three doses of emergency contraception in advance, or were assigned to get the drug by going through a clinic (the study's "control" group).
Six states, including California, allow emergency contraception to be dispensed at pharmacies without a prescription in cases where pharmacists have been specially trained and have a collaborative agreement with physicians that allows them to dispense EC. Clinic or health care provider access is the standard of care in the United States.
The participants, who received the emergency contraception at no cost, received some basic education about the use and limitations of EC, which does not protect against STIs.
Although the study was limited to women who stated their intention to avoid pregnancy for the duration of the trial, eight percent of women in each group became pregnant. About 40 percent of women in each group self-reported having unprotected sex at least once over the study period. Women's number of sexual partners and frequency of condom use were similar across all three groups.
Those who could get emergency contraception directly from pharmacies were no more likely to use it than women who were assigned to the clinic-access group. And although women in the advance provision group were almost twice as likely to use emergency contraception as the others, only slightly more than half actually used emergency contraception over the study period, perhaps explaining a pregnancy rate statistically similar to the other two groups.
"While many policymakers and even some health care providers are worried that young women will abuse emergency contraception if they have easy access, our study shows they actually don't use it as much as we would hope," said Tina Raine, MD, MPH, lead author of the paper and UCSF associate professor of obstetrics, gynecology and reproductive sciences.
"Sadly, these data show us we are still not influencing young women to take fewer risks in their sexual behavior," said Raine. "Given that only a fraction of the women having unprotected sex used emergency contraception, it seems we need to spend our energy trying to make it easier for these women to get contraception, not harder."
While California allows emergency contraception to be dispensed at pharmacies without a prescription, not all pharmacies provide it, said Raine. Individual pharmacists, who would be required to complete specialized training to dispense the drug, also may decline to participate, she said.
Regardless, said Raine, "while direct pharmacy access may offer some advantages over clinics, it is not a panacea to the problem of unintended pregnancies." Over-the-counter access to EC could eliminate many of the barriers associated with pharmacy or clinic access, she said.
Each year 3.5 million unintended pregnancies occur in the United States and some researchers speculate that as many as half of those could be averted if EC were easily accessible and used.
Raine said although the FDA's 2004 decision to reject over-the-counter sale of emergency contraception was based on concerns that increased access to emergency contraception could lead to misuse by young women, this study -- like all the published literature -- indicates that is not the case.
The study was conducted from July 2001 to June 2003 at four clinics in San Francisco and Daly City, California. The study enrolled women who spoke either English or Spanish and reported sexual intercourse during the prior six months. The EC used in all cases was Levonorgestrel.
Upon enrollment, participants were interviewed about sexual behavior and tested for both pregnancy and herpes simplex 2 and Chlamydia infections. Six months later, research assistants conducted follow-up visits and again tested for pregnancy and STIs. They found that about 12 percent of the participants in each group had acquired an STI during the course of the study.
Half of the participants were adolescents, and, as a whole, the participants were characterized by Raine as being at "moderately high risk" for unintended pregnancies. "This is representative of a major population for whom this contraceptive method was developed," said Raine.
Raine is the medical director of the New Generation Health Center, a clinic operated by UCSF which provided reproductive health care services to 2,300 young women in 2003. The Women's Capital Corporation, former distributor of "Plan B" (Levonorgestrel) donated the emergency contraception used in the study.
Co-authors of the study were Cynthia Harper, PhD, assistant research demographer in the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences; Corinne H. Rocca, MPH, UCSF research associate in the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences; Richard Fischer, MD, Planned Parenthood Mar Monte, California; Nancy Padian, PhD, UCSF professor of obstetrics, gynecology and reproductive sciences; Jeffrey D Klausner, MD, MPH, San Francisco Department of Public Health,; and Philip D. Darney, MD, MSc, UCSF professor and chief of obstetrics, gynecology and reproductive sciences, San Francisco General Hospital.
Source: Carol Hyman