Plan B One-Step is an emergency “morning after” contraceptive that prevents a pregnancy if taken within 72 hours of having unprotected intercourse. On December 19, a report was published that noted that teen access to the morning after pill was further impacted by the fact that some teens who qualify for over-the-counter purchase of the pill being were being denied the purchase by the pharmacists. Thus, Los Angeles teens who reside in the city’s less affluent neighborhoods may have difficulty in obtaining the medication.
The study, which was published online on December 19 in the Journal of the American Medical Association reported that women who live in low-income neighborhoods are more likely than their wealthier counterparts to get misinformation about emergency contraception from their local pharmacies. The study reported that young women in areas where teen pregnancy rates are highest may struggle most in trying to get the morning-after pill, which can prevent a pregnancy after unprotected intercourse.
The drug’s manufacturer, Teva Pharmaceuticals had petitioned the Food and Drug Administration (FDA) to allow merchandisers to place the morning after pill on shelves with other family-planning products–– and to sell it to anyone who wanted it. The manufacturer claimed that it had conducted a study, which revealed that girls as young as 12 could understand how to safely use the product.
The FDA agreed; in a statement released December 7, FDA Commissioner Margaret Hamburg, MD, said "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of childbearing potential." However, in a surprising move, Health and Human Services (HHS) Commissioner Kathleen Sebelius, Dr. Hamburg's boss, overruled the FDA.
On December 8, President Obama endorsed the decision of Health and Human Service Secretary to prohibit the sales of the morning after pill, Plan B One-Step, to girls under 18 without a prescription. He said, “I did not get involved in the process.” When asked if he fully supported her decision, he said, “I do.” Obama explained, “I will say this, as the father of two daughters: I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine… “And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able—alongside bubble gum or batteries—be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way.
Currently, the pill is available over-the-counter at pharmacies to individuals 17 and older; because of Secretary Sebelius’ ruling, younger teens are required to furnish a prescription. "The sooner Plan B is taken, the better it works," said Amy Niemann, vice president of Teva Women's Health. She added, "That is the entire rationale for having widespread availability for this product." Nancy L. Stanwood, MD, MPH, section chief of family planning at Yale School of Medicine, noted that full over-the-counter (OTC) status would have made emergency contraception available to many more people who need it. She noted, “The irony of Plan B not being OTC for women of all ages is that it has not been available for the women who need it the most… "Teens may be sexually active for a while before they see a doctor to get a prescription for contraceptives. ... [With emergency contraceptives] they don't just have to hope the condom doesn't break. There is something they can do. "Emergency contraception pills become less effective as time passes after unprotected sex, so time is of the essence for women hoping to prevent a pregnancy.
Quick access to the morning after pill is essential; however, Tracey Wilkinson, MD, a general pediatric fellow at Boston Medical Center and the Boston University School of Medicine, had been hearing "weird things" about teens' attempts to obtain the pill; "things like prescriptions not showing up if they'd been sent electronically, or if they were an adolescent, they would have difficulty getting their prescriptions filled," said Dr. Wilkinson.
The rumors prompted Dr. Wilkinson to investigate the accessibility of the morning after pill to teens. From September through December 2010, she and her colleagues requested female research assistants to call every pharmacy in Nashville, TN, Philadelphia, PA, Cleveland, OH, Austin, TX, and Portland, OR. In each call, the research assistant would first ask whether the pharmacy stocked morning after pills. Approximately 80% percent of the 943 pharmacies did; this percentage was constant regardless of the income level of the neighborhood.
Next, the caller would ask, "If I'm 17, is that okay?" Since the morning-after pill is available to 17-year-olds over the counter, the answer should have been yes. However, 19% of calls, the pharmacy staff said no, that a 17-year-old could not get emergency contraception under any circumstances. The proportion of erroneous "no" answers was higher in low-income neighborhoods: 23.7% of low-income area pharmacies gave false information, compared with 14.6% of pharmacies in more affluent areas.
Finally, the caller asked at what age it was possible to get emergency contraception over the counter. In about half of the calls, they got the wrong answer. And all but 11 of those wrong answers put the age too high, potentially restricting access. Again, the misinformation problem was worse in low-income neighborhoods. Half of pharmacies in affluent areas gave incorrect information, compared with 62.8% in poorer neighborhoods.
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