Study supports over the counter access to morning after pill

Robin Wulffson MD's picture
morning after pill, Plan B One-Step, emergency conraception, OTC
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The emergency contraceptive, Plan B One-Step, is an effective method of preventing an unwanted pregnancy. Whether the medication should be available to young girls has sparked heated debate. A new study published in the April 2012 issue of Obstetrics & Gynecology evaluated whether girls aged 11 through 17 should have over the counter (OTC) access to the morning after pill.

Last December, the Food and Drug Administration (FDA) Commissioner Margaret Hamburg, MD agreed with the drug’s manufacturer, Teva Pharmaceuticals, that Plan B One-Step should be made available to anyone who wanted it without prescription. Teva claimed that it had conducted a study, which revealed that girls as young as 12 could understand how to safely use the product. 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.

Commissioner Sebelius claimed that only about 10% of girls are able to get pregnant at age 11. In a statement, Commissioner Sebelius said her action "reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger without talking to a healthcare professional." Following that statement, advocates of the morning after pill fought back. Now, they have support of scientific research that Plan B One-Step should have OTC availability.

Between October 22, 2008, and November 26, 2010, the researchers conducted an OTC simulation study in females requesting emergency contraception at teen reproductive health clinics in five metropolitan areas in the United States (San Francisco, Minneapolis, Atlanta, Pittsburgh, and Philadelphia). The goal of the study was to evaluate the use of Plan
B On-Step and to assess repeat use, pregnancy, and adverse events.

The study group was comprised of 345 females aged 11–17; 279 were younger than age 17 years. The subjects were required to read the study product label and to determine whether and how to use the product without interacting with providers. The medication was dispensed to girls who appropriately selected to use it. They were then contacted one, four, and eight weeks later to assess use, pregnancy, and adverse events. Of the 345 subjects, 340 were included in the final analysis; 274 (92.9%) correctly used it as labeled. Selection and correct use were not related with age. Of the 274 females, 57 (18.8%) used additional emergency contraception over the study period and seven (2.3%) participants who used Plan B One-Step pregnant; no unusual adverse events occurred among the study participants.

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The authors concluded that restricting young females' use of a single-tablet emergency contraceptive by prescription only is not warranted; they explained that females younger than 17 years can use it in a manner consistent with OTC access.

The researchers were affiliated with: Women's Health Research Institute, Division of Research, Kaiser Permanente Northern California, Oakland, California; Teva Women's Health Research, Division of Teva Branded Pharmaceutical Products R&D Inc, North Wales, Pennsylvania; and the Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, California.

Plan B One-Step facts:

Plan B should be taken within 72 hours (three days) of unprotected intercourse. When taken within 72 hours, it decreases the chance of getting pregnant by 89% (from 8% without Plan B to 1% with Plan B).
Plan B is even more effective when taken within 24 hours. Effectiveness decreases the longer a woman waits to take it.
Plan B is not an abortion pill. It contains levonorgestrel, a synthetic version of the hormone progestin. The abortion pill RU-486 contains a completely different drug.
Plan B works mainly by preventing release of eggs from a woman's ovary, although it may also prevent sperm from fertilizing the egg. However, if a fertilized egg already has been implanted, the pregnancy continues normally even if a woman takes Plan B.
Plan B may cause side effects. The most common side effect is nausea, which occurs in about 25% of women after taking Plan B. Other side effects may include abdominal pain, fatigue, headache, and heavy menstrual bleeding.

Reference: Obstetrics & Gynecology

See Also:
Morning after pill advocates fight back
Morning after pill controversy heats up
Commissioner Sebelius nixes sale of morning after pill without ID

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