Should Oral Contraceptives Be Available OTC

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Oral contraceptives should be available to women over the counter (OTC) because the benefit of reducing unwanted pregnancies outweighs the risks of dispensing the drugs without a prescription, the American Congress of Obstetricians and Gynecologists (ACOG) has announced.

The ACOG policy statement, which has received mixed reviews, was published online yesterday in the December issue of Obstetrics & Gynecology, the society's house journal.

ACOG said that removing the prescription barrier to oral contraceptives would be a reasonable way to reduce the "unacceptably high" rate of unintended pregnancies, which have accounted for half of all pregnancies over the last 20 years. Oral contraceptives are safe, the group said, and although they run an "extremely low" risk for blood clots, that risk is higher during pregnancy or the postpartum period. Other drugs sold OTC, such as aspirin and acetaminophen, have their own health risks. Several studies show that women can accurately screen themselves for contraindications, which for some oral contraceptives include renal impairment, adrenal insufficiency, and a high risk for arterial or venous thrombotic disease. At the same time, ACOG expects women will continue to see their physician for screenings, preventive services, and discussions about contraception.

ACOG acknowledged that making oral contraceptives available OTC could result in the loss of insurance coverage, which could pose a financial hardship to some women. Any decision to make the pills OTC must address this cost issue, the group said.

The ACOG recommendation drew praise from Wayne Shields, the president and chief executive officer of the Association of Reproductive Health Professionals.

"We fully support it," said Shields, whose group includes physicians, nurse practitioners, physician assistants, midwives, and pharmacists. "We support full access to as many contraceptive methods as possible.

"And the timing is right. [This idea] has been debated in the field for a long time."

Shields said he believes that women are capable of screening themselves for contraindications to taking oral contraceptives. Even so, "there would need to be a careful introduction, and good public education," he said.

Advertising Could Replace a Physician's Advice, Critic Says

The ACOG recommendation has its critics. Diana Zuckerman, PhD, president of the nonpartisan National Research Center for Women and Families, called OTC oral contraceptives a "really risky idea." Some of these drugs pose greater risks than others, said Dr. Zuckerman, and without a physician's counsel, women might choose the riskier ones solely on the basis of advertising.

"Getting rid of the role of doctors will make advertising more influential, and it's already influential," said Dr. Zuckerman.

Some women, she added, decide to go on birth control pills not for the sake of preventing pregnancy but to regulate their menstrual cycle. A physician might advise them that the risk for blood clots outweighs this off-label benefit, but this message could go unheard if the drugs are available OTC.

Dr. Zuckerman said she also worries that women who obtain oral contraceptives without the need for periodic physician visits might not report, much less recognize, early signs of blood clots, potassium overdose, or other adverse events.

FDA Has Been Mulling Over OTC Idea

Converting a prescription drug to an OTC drug requires the approval of the US Food and Drug Administration (FDA). The decision-making process generally begins with a request by the drug's manufacturer to change the product's status, said FDA spokesperson Stephanie Yao in an email to Medscape Medical News. The FDA would then determine whether the prescription requirements are needed to protect public health. It may require studies about the drug's use and labeling to answer that question.

"Whether data would be needed for oral contraceptives to switch would require further review and discussion with sponsors," Yao said. The FDA, she said, is willing to meet with any drug manufacturer "who may want to propose switching their product to OTC status."

The agency has been mulling over the question of OTC availability of oral contraceptives for some time. In March, the FDA held public meetings with physicians, consumer advocates, and others to discuss the agency's proposal to make some commonly prescribed drugs available without a prescription. Several speakers advocated doing that with oral contraceptives. "The FDA is still considering the comments made during the meeting," Yao said.

Obstet Gynecol. 2012:120;1527-1531.


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