Plan B doesn't change much

If a medication doesn't offer a significant improvement in health risks, why risk the complications of changing laws, much less side effects of medication?

Plan B is supposed to decrease pregnancies due to unprotected intercourse. Easy access to Plan B is supposed to work better to decrease pregnancy.

But, it doesn't work that way.

You may have heard the statement that easier access to Plan B does not increase risky sexual practices and that it does not affect the use of other forms of contraception. How often do you hear that the same study proved that there is no difference in the number of pregnancies either? In spite of the extra education given to all participants, there was no difference in the groups who had to obtain EC from clinics or pharmacies when they needed it, and in those who had the medication in advance.

Here is an excerpt from the January 5, 2005 issue of the Journal of the American Medical Association (subscription only):

Direct Access to Emergency Contraception Through Pharmacies and Effect on Unintended Pregnancy and STIs

A Randomized Controlled Trial

Tina R. Raine, MD, MPH; Cynthia C. Harper, PhD; Corinne H. Rocca, MPH; Richard Fischer, MD; Nancy Padian, PhD; Jeffrey D. Klausner, MD, MPH; Philip D. Darney, MD, MSc

JAMA. 2005;293:54-62.

ABSTRACT


Context It is estimated that half of unintended pregnancies could be averted if emergency contraception (EC) were easily accessible and used.

Objective To evaluate the effect of direct access to EC through pharmacies and advance provision on reproductive health outcomes.

Design, Setting, and Participants A randomized, single-blind, controlled trial (July 2001-June 2003) of 2117 women, ages 15 to 24 years, attending 4 California clinics providing family planning services, who were not desiring pregnancy, using long-term hormonal contraception or requesting EC.

Intervention Participants were assigned to 1 of the following groups: (1) pharmacy access to EC; (2) advance provision of 3 packs of levonorgestrel EC; or (3) clinic access (control).

Main Outcome Measures Primary outcomes were use of EC, pregnancies, and sexually transmitted infections (STIs) assessed at 6 months; secondary outcomes were changes in contraceptive and condom use and sexual behavior.

Results Women in the pharmacy access group were no more likely to use EC (24.2%) than controls (21.0%) (P = .25). Women in the advance provision group (37.4%) were almost twice as likely to use EC than controls (21.0%) (P<.001) even though the frequency of unprotected intercourse was similar (39.8% vs 41.0%, respectively, P = .46). Only half (46.7%) of study participants who had unprotected intercourse used EC over the study period. Eight percent of participants became pregnant and 12% acquired an STI; compared with controls, women in the pharmacy access and advance provision groups did not experience a significant reduction in pregnancy rate (pharmacy access group: adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.58-1.64; P = .93; advance provision group: OR, 1.10; 95% CI, 0.66-1.84, P = .71) or increase in STIs (pharmacy access group: adjusted OR, 1.08, 95% CI, 0.71-1.63, P = .73; advance provision group: OR, 0.94, 95% CI, 0.62-1.44, P = .79). There were no differences in patterns of contraceptive or condom use or sexual behaviors by study group.

Conclusions While removing the requirement to go through pharmacists or clinics to obtain EC increases use, the public health impact may be negligible because of high rates of unprotected intercourse and relative underutilization of the method. Given that there is clear evidence that neither pharmacy access nor advance provision compromises contraceptive or sexual behavior, it seems unreasonable to restrict access to EC to clinics.

* * * *

We did not observe a difference in pregnancy rates in women with either pharmacy access or advance provision; the adjusted risk of pregnancy for both treatment groups was not significantly less than 1. Previous studies also failed to show significant differences in pregnancy or abortion rates among women with advance provisions of EC.6-7,19 It is possible that the effect of increased access on pregnancy rates is truly negligible because EC is not as effective as found in the single-use clinical trials, or because women at highest risk do not use EC frequently enough or at all. Indeed, almost half of women in the advance provision group who reported having unprotected sex did not use EC. Thus, it is not surprising that the vast majority of pregnancies (73%) occurred in the women who reported having unprotected intercourse rather than in women experiencing method failures. We would not expect the pregnancy rate to be lower in the pharmacy access group given the similar EC use rate as the control group; however, EC use was increased in the advance provision group. An alternative explanation for the lack of observed difference in pregnancy rates is that women in the advance provision group used EC more because they were using it "unnecessarily," ie, as a backup to a regular method. We think this is unlikely since the proportion of women reporting using EC because of condom mishaps or using no birth control method the last time they used EC was similar for women in the advance provision group and the control group (94.9% vs 96.9%, P = .74).

Our sample size calculations were based on equally sized groups; however, with our unequal group sizes, we had an 80% power to detect a 50% difference in pregnancy rates. It is possible that with a larger sample or widespread increased public access that a smaller, yet meaningful reduction in pregnancy rates would be observed. While we set out to demonstrate a large reduction in pregnancy rates, even a 10% or 20% reduction in unintended pregnancy rates would be a significant and desirable public health achievement. Access to EC did not have a detrimental effect on contraceptive use or sexual behavior. While women who used condoms or other less effective forms of contraception were more likely to become pregnant than women who used hormonal contraception, women with advance provision or pharmacy access were not more likely to abandon contraception or switch to less effective methods. Given this finding, it is unlikely that increased access to EC would lead to higher pregnancy rates, even though our risk estimates indicate that the true effect may also be greater than 1.

Our study supports the hypothesis that behavior is not influenced by access to EC and that women who have increased access to EC do not have more unprotected intercourse. There were no significant differences in self-reported frequency of unprotected intercourse. One might argue that self-report is not an accurate measure of actual behavior, ie, there is underreporting.

Pregnancy is an outcome that is less susceptible to recall bias and was assessed by several measures in our study, including biological markers. We demonstrate that baseline self-report of unprotected intercourse, as well as contraceptive method, correlated directly with pregnancy rates at follow-up, adding validity to our self-report measures.

Across all measures, we also found similar rates of sexual risk behaviors in all study groups. The finding of similar STI acquisition rates among study groups seems plausible given the lack of difference in self-reported measures of risk. Using the combined STI variable including test results, self-report, and medical chart review, we had 90% power to detect an increase in STIs from 12% to 18%. It is possible that we failed to detect a smaller yet clinically meaningful increase in STIs; however, given our increased power to detect small differences in self-reported measures of risk, like number of sex partners, this seems less plausible. The FDA’s decision to reject over-the-counter sale of EC was based on concerns that increased access to EC could lead to unsafe sexual practices and the spread of STIs and HIV/AIDS, a notion that is contrary to the findings of our current study and the published literature.4-7,13, 20-22

Our study has limitations. There was cross over of treatment groups as participants could obtain EC through any of the 3 methods. The majority of participants (67%) reported obtaining EC at last use consistent with the study group to which they were assigned. Thirty percent of women in the pharmacy access group and 26% of women in the advance provision group reported obtaining EC through clinics and 12% of women in the clinic access group reported obtaining EC directly from pharmacies without speaking with a provider. This cross over may have diminished our ability to demonstrate a difference in reproductive health outcomes in treatment groups.