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Objective: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception., Methods: We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum beta-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity., Results: Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2-1.6%) and 13 (1.7%, 95% confidence interval 0.8-2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths., Conclusion: CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile., Level of Evidence: I.

The debate over emergency contraceptive pill access in the United States revolves around speculations about Americans' sexual lives. The recently released internal U.S. Food and Drug Administration (FDA) memo that expresses fears that adolescents will form "sex-based cults" around emergency contraceptive pills echoes arguments made against the nonprescription switch at the 2003 FDA hearings. In these hearings, opponents argued that nonprescription access would lead to adolescent promiscuity and disease transmission and that adult predators would use the drug to facilitate the sexual abuse of young women. In contrast, proponents of expanded access to emergency contraceptive pills overwhelmingly portrayed their model user as a responsible adult who experiences a torn condom during consensual sex. These imaginations of American sexuality are tied to competing models of the role of medical providers in women's sexual decision making. Opponents of the nonprescription switch argued that women need a learned intermediary, not only to determine their need for emergency contraception, but also to educate them about proper sexual behavior and protect them from abuse. Proponents advocated putting more responsibility for sexual health decision making in the hands of women, not doctors, and complained about the moralizing scrutiny of medical providers. In the absence of nonprescription access to emergency contraception, advance prescription of emergency contraceptive pills can ensure that contraceptive education is not tied to a specific sexual act and therefore not perceived as a judgment about women's sexual decisions. However, advance prescription does not help women who lack access to health care or women who make sexual and contraceptive decisions without consulting physicians.

Objective: To assess how a strategy to maximize access to emergency contraceptive pills would affect rates of pregnancy and sexually transmitted infections., Methods: Sexually active women, 14-24 years old, were randomly assigned to two methods of access to emergency contraceptive pills: increased access (two packages of pills dispensed in advance with unlimited resupply at no charge) or standard access (pills dispensed when needed at usual charges). Participants were followed for 1 year to assess incidence of pregnancy, gonorrhea, chlamydia, and trichomonas., Results: The numbers of women enrolled in the increased and standard access groups were 746 and 744, respectively. More than 93% of participants completed a full year of follow-up. The incidence of pregnancy was similar in both groups (increased access group: 9.9/100 woman years, 95% confidence interval [CI] 7.7-12.6; standard access group: 10.5/100 woman years, 95% CI 8.2-13.2). Aggregate rates of gonorrhea, chlamydia, and trichomonas were also similar in the two groups (increased access group: 6.9/100 woman years, 95% CI 5.1-9.1; standard access group: 7.6/100 woman years, 95% CI 5.7-9.9). The increased access group used emergency contraceptive pills substantially more often and sooner after coitus than the standard access group. No other differences were noted between groups in self-reported measures of sexual behavior and contraceptive use., Conclusion: This intensive strategy to enhance access to emergency contraceptive pills substantially increased use of the method and had no adverse impact on risk of sexually transmitted infections. However, it did not show benefit in decreasing pregnancy rates., Level of Evidence: II-1.

Pharmacists' refusals to fill prescriptions for emergency contraceptives for reasons of conscience have contributed to a national debate regarding the permissibility of such actions. Some in the medical community assert that pharmacists ought not to refuse to dispense emergency contraceptives on this basis. Three lines of argument have become prominent in defense of that position: 1) the professional status of pharmacists does not allow for refusal to dispense legitimately written prescriptions, 2) the medical facts regarding the mechanism of action of emergency contraception are often misunderstood, misrepresented, or both, and 3) refusals by pharmacists to fill legitimate prescriptions undermine patient care. In this commentary, these arguments are rejected as missing the central point of the issue, which is that pharmacists are autonomous, moral agents who are accountable for their choices and entitled-within limits-to decide in which activities they will participate. Pharmacists' professionalism is defended, their responsibilities in the provision of drug therapy are set forth in the context of pharmaceutical care, and these lead to the conclusion that pharmacists' refusals may be ethically justified. There are important limits on how pharmacists may respond when they are being asked to participate in actions they find morally objectionable. Notably, they must ensure that these prescriptions are filled by someone else in a timely manner and must refrain from any abusive or demeaning treatment of patients, as summed up in our Principle of Conscientious Refusal to Dispense.

Objective: To evaluate access to emergency contraception among women seeking help from clinicians who registered to be listed on the Emergency Contraception Hotline (1-888-NOT-2-LATE, ie, 1-888-668-2528) and the Emergency Contraception Website (not-2-late.com)., Methods: Two college-educated investigators posing as women who had a condom break the previous night called 200 providers to seek help., Results: Only 76% of attempts resulted in an appointment or telephone prescription from a hotline provider within 72 hours, 14% were failures, and 11% resulted in referrals to other providers not listed on the hotline or website., Conclusion: Even under ideal conditions, access to emergency contraception is currently constrained. Although emergency contraception could reduce significantly the incidence of unintended pregnancy and the consequent need for abortion, its potential will not be realized unless women have better access to clinicians who can prescribe emergency contraceptive pills.