OTC Status Increased Use of "Morning After" Pill

Plan B’s Rx-to-OTC switch more than doubled sales of the emergency contraceptive, but use remains relatively low.

Since its switch from prescription-only to OTC status in 2006, use of the emergency contraceptive Plan B has more than doubled among women aged 15 to 44 years, researchers reported online in April in the journal Fertility and Sterility. The findings were drawn from an analysis of government data collected from the 2006 to 2008 National Survey of Family Growth.

Among the 6329 sexually active women who responded to the survey, 9.7% said they had ever used emergency contraception—twice the rate of 4.2% that was recorded in 2002, before patients could purchase Plan B in pharmacies without a prescription. According to the latest figures, 68% of those who had used emergency contraception purchased it without a prescription, and 61% had used it only once.

Study author Megan L. Kavanaugh, DrPH, MPH, a senior research associate at New York’s Guttmacher Institute, told Reuters that although many more women have used emergency contraception than in the past, “its use still seems relatively low, given that it’s easy to access.” She added that “there’s room for improvement.”

One area in which Kavanaugh and her colleagues see an unmet need is counseling, which can heavily influence whether or not a woman uses emergency contraception. Despite the expanded availability of the drugs, “counseling about emergency contraception remains disappointingly low,” the authors wrote.

According to the study, women’s understanding of where to get it, how to use it, and other basic facts about its safety and efficacy is severely limited due to lack of counseling by health care professionals. In her interview with Reuters, Kavanaugh urged women to speak with their health care providers to learn more about emergency contraception as part of a larger discussion about birth control.

Plan B's thorny path

Although the study did not offer a hypothesis as to why providers tend not to discuss emergency contraception, Plan B’s rocky regulatory history provides some clues.

The medication has been available in the US since 1999, when it was approved by the FDA as a prescription-only drug indicated for the prevention of pregnancy following unprotected sex or contraceptive failure. After a series of delays and rejections, Barr Laboratories, now a subsidiary of Teva Pharmaceuticals, was given the nod to sell the product over the counter to patients 18 and older. The minimum age to purchase was lowered to 17 in 2009, after a federal judge ordered the FDA to do so within 30 days.

Also in 2009, Barr introduced Plan B One-Step, a one-pill formulation that contains 1.5 mg of levonorgestrel. A generic version of Plan B, Next Choice, is available from generic drug maker Watson. Both drugs must be taken within 72 hours of unprotected sex to effectively prevent pregnancy. Watson also markets ella, a prescription-only pill containing 30 mg of the progesterone receptor modulator ulipristal acetate that is effective for up to 5 days, or 120 hours, after unprotected sex. This chart from Teva explains some of the additional differences between the 3 medications.

Broader access to the drugs has been met with considerable debate and disagreement. Just last month, 2 Illinois pharmacists fought for the right not to dispense the pills, citing religious objections. They won when a judge determined that the pharmacists were protected under the Illinois Health Care Right of Conscience Act, which prevents the government from compelling individuals or entities to provide health care services that violate their religious beliefs.

The political tug-of-war over emergency contraception is not likely to end anytime soon, however. According to a USA Today report on the trial, “the state attorney general’s office will appeal the decision,” due to “a compelling need for emergency contraceptives to be available at all licensed pharmacies in the state of Illinois.”

WEIGH IN.

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For other articles in this issue, see:

• Infants at Risk for Opioid Dosing Errors
• Preventing Drug Interactions Starts With Prescribers