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Through the Back Door

While the FDA delays over-the-counter sales of emergency contraception, eight states are taking matters into their own hands.
 
 
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Her rapist could have impregnated her. But a new state protocol saved her from that fate.

In 1998, when Washington state started allowing pharmacists to dispense emergency contraception without a doctor's prescription, one of the first women to ask for this medication was a Tacoma-area teen who had been raped by her boyfriend.

"She was 15 years old and scared spitless," says Don Downing, a clinical associate professor of pharmacy at the University of Washington in Seattle. "She was too afraid to tell her parents about the rape and too afraid to go to the police or her regular doctor. But when her pharmacist gave her this medication, it prevented her from getting pregnant. And if more states pass these laws, thousands of other women will benefit in the same way."

In September, Massachusetts became the eighth state to legalize "collaborative practice agreements" for Preven and Plan B, hormonal drugs known as "emergency contraception" because they are 89 percent effective at preventing pregnancy if taken within 72 hours of unprotected sex.

Alaska, California, Hawaii, Maine, New Mexico, New Hampshire and Washington already have these agreements on their books.

In a collaborative practice agreement, a doctor agrees to oversee or sanction a pharmacist who dispenses emergency contraception without a prescription.

The doctor is off-site and anonymous. His or her name does not appear on any receipt or other sales record, so the woman buying emergency contraception may never know that a doctor is part of the process. To her, it's like buying any other medication that does not require a prescription.

A single doctor can work with several pharmacists under this type of agreement, which usually requires several days of training for the pharmacist so he or she can properly instruct the buyer.

"Since the Food and Drug Administration has spent two years stalling the approval of over-the-counter emergency contraception, collaborative agreements are vital," says Karen Pearl, interim president of the Washington-based Planned Parenthood Federation of America, Inc. "These laws allow women to get medication they need without scurrying to find a doctor, get a prescription and find a pharmacist to fill the prescription."

Renewed Pressure on FDA

This week, after a 60-day public comment period expired on a drug maker's most recent application for over-the-counter sale, four dozen medical and public health groups renewed pressure on the FDA. The groups urged the FDA to "heed the scientific consensus" about the safety of emergency contraception.

Signatories, which included the Washington-based American College of Obstetricians and Gynecologists, said that requiring a prescription creates a medically unjustified barrier to women who need these drugs.

Yesterday, a bipartisan group of congressional legislators turned up the heat by announcing new legislation to require the FDA to make a decision on emergency contraception. Within 30 days of this legislation's enactment, the FDA would have to approve or disapprove over-the-counter sale or publish a determination to do so.

Emergency contraception caused a 43 percent drop in abortion rates from 1994 to 2000 and could prevent 800,000 abortions annually if it were more widely available, according to the Washington-based Alan Guttmacher Institute.

In the past decade, collaborative practice agreements have become popular in the treatment of diabetes, a disease that causes blood sugar levels to spike and that a growing number of patients are now managing with direct help from their pharmacists.

In the case of emergency contraception, collaborative practice agreements can spare users from potentially harmful delays.

"Emergency contraception works best within the first 24 hours of unprotected sex," says Dr. Carole Ben-Maimon of Barr Pharmaceuticals, Inc., the Woodcliff Lake, N.J.-based maker of Plan B. "Its efficacy decreases by 50 percent with every 12 hours of delay. So it's helpful if women can bypass their doctors and get it directly from their pharmacists."

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