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Access barriers to the dedicated emergency contraceptive pill (ECP) Plan B are set to be lifted. A federal judge has instructed the Food and Drug Administration (FDA) to make Plan B available to 17-year-olds and ordered the agency to review whether to make the ECP available to females 17 and under without prescription.
In 2006, Duramed Pharmaceuticals began distributing the dual-label version of Plan B, which allowed the drug to be sold "behind the counter," but without a prescription, to women 18 years of age and older, with prescription-only availability for females 17 and younger. In handing down its decision on March 23, 2009, the U.S. District Court for the Eastern District of New York ordered the FDA to make Plan B available over the counter to women ages 17 and older within 30 days. U.S. District Judge Edward Korman also instructed the FDA to reconsider whether minors under age 17 should be permitted to obtain emergency contraception over the counter (OTC). The ruling was spurred by a lawsuit filed in 2005 by the Center for Reproductive Rights on behalf of the Association of Reproductive Health Professionals (ARHP) and a number of other women's health organizations.
As the FDA reconsiders whether to allow OTC access for women of all ages, health care providers around the country should encourage the agency to make a decision free from political and ideological influence, said Beth Jordan, MD, ARHP medical director. Safety and efficacy are the only legitimate criteria the FDA should use in its review process, and Plan B passes those tests, she said in a press statement issued following the court ruling. It is safe and easy for a reproductive-age woman to self-diagnose her own need for Plan B and then to use it, Jordan said. The FDA's own panel of independent medical experts advised them on this fact prior to the FDA's politically motivated decision, she maintained.
ECPs work to prevent pregnancy fairly well for a single act of intercourse; however, several global studies have shown that after a protracted period of time, ECPs do not lower rates of pregnancy in populations of women, says Robert Hatcher, MD, MPH, professor of obstetrics and gynecology at Emory University in Atlanta. "On the other hand, the emergency contraceptive insertion of a copper T-380A intrauterine device is more effective than Plan B in preventing pregnancy from a single act of intercourse and, if tolerated by a woman, leaves her extremely well protected against pregnancy for a number of years," he explains.
Access limits in EDs?
Hospital emergency departments (EDs) might represent one barrier when it comes to ECP access. Recent research indicates that many physicians may not offer ECPs to adolescents who might benefit from them during ED visits.1
Researchers affiliated with The Children's Hospital of Philadelphia performed a cross- sectional, anonymous, Internet-based survey of members of the American Academy of Pediatrics' Section of Emergency Medicine. They found that while 85% of physicians had prescribed ECPs, more than 80% of those doctors had done so fewer than five times in a year. Physician knowledge about the drug and its use may be an important factor: 43% of physicians incorrectly answered half of the questions in the web-based survey.
Monika Goyal, MD, lead author of the study and an emergency medicine physician at Children's Hospital, says, "It is extremely important for emergency department physicians to be knowledgeable about emergency contraception — a safe and effective method of pregnancy prevention — because unintended teenage pregnancy is a major public health issue, and adolescents frequently utilize the emergency department. Moreover, adolescents may feel embarrassed or may not know about emergency contraception, so it is even more important for physicians caring for teens in the ED setting to be cognizant of the indications for EC and to consider it when they evaluate patients."
As emergency contraception becomes increasingly available without prescription, it is important that women in need be provided accurate information about its use. Researchers at Los Angeles Biomedical Research Institute at Harbor — UCLA Medical Center in Torrance performed a telephone survey of all retail pharmacies in Los Angeles County to assess the accuracy of the information a vulnerable young woman would be given about Plan B.2 The survey was conducted four years after it became available without a prescription through the California State Pharmacy Access Project and 12-18 months after Plan B became available on a dual-label status basis.
There were 1,460 pharmacies called between October 2007 and April 2008. Sixty-nine percent had the ECP available on site, and 19% referred the caller elsewhere. While most pharmacies provided information about Plan B that was consistent with labeling, barriers still exist to accurate information and timely access to the drug, researchers note. While most pharmacies that volunteered details over the telephone provided accurate information, some offered misinformation, such as recommendations for medications that are not Food and Drug Administration-approved for emergency contraception, including "a cream that kills sperm," "herbs to cleanse the ovaries," and douching.2
New EC on the way?
Will the United States see a second dedicated ECP? CDB-2914, a second-generation emergency contraceptive pill, is in a U.S. Phase III clinical trial conducted in 14 states in 17 clinics affiliated with the Planned Parenthood Federation of America. The manufacturer of the prospective drug, HRA Pharma of Paris, estimates study completion in 2009, according to Christina Aplington, company spokeswoman. The company has not yet applied for FDA approval, but it plans to do so, she says.
CDB-2914 is a second-generation progesterone receptor modulator that is akin to mifepristone, a first-generation progesterone receptor modulator. Previous research indicates CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile.3 The drug is under evaluation by the European Medicines Agency, the European marketing authorization body based in London, says Aplington. The agency's final decision is expected later in 2009, she states.