By Molly M. Ginty
Friday, November 4, 2005
Congress renewed pressure this week on the FDA to allow over-the-counter sales of emergency contraception. Eight states already make that possible.
(WOMENSENEWS)--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. "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."
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, 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."
In six states, collaborative practice agreements allow pharmacists to distribute emergency contraception when acting under the guidance of a physician. In two other states, pharmacists can distribute the drugs in accordance with separate state-approved protocols.
"We are working with advocacy groups and lobbying state legislatures in the hope of passing more laws," says Ben-Maimon.
In August, the FDA said it was considering the over-the-counter sale of Plan B to women over 17. Then, in what critics say is a response to pressure from the Bush administration, the agency said it would launch a period of "public comment" on the drug that could delay its approval indefinitely.
The announcement infuriated activists such as Cynthia Pearson, executive director of the Washington-based National Women's Health Network, who called it "denial couched in the bureaucratic language of delay."
Before making the announcement, FDA officials alleged that girls under 16 would engage in riskier sex if they could get the drug. Studies, however, show no increase in pregnancy or sexually transmitted diseases when women have access to emergency contraception.
A similar struggle surrounds a newly-developed vaccine for cervical cancer. Pharmaceutical company Merck, based in Whitehouse Station, N.J., plans to ask the FDA to approve the vaccine for sale before the end of the year, according to the Washington Post.
But some conservative groups argue its release will condone premarital sex. In a retort to them, Congresswoman Lois Capps, D-Calif., circulated a letter to her colleagues this week urging them to overlook "ideological agendas" while reviewing public input about the vaccine.
The battle for access to Plan B goes beyond state laws and the FDA and extends to policymaking by pharmacies and hospitals.
Wal-Mart, the largest retailer in the U.S., does not carry emergency contraception in any state, even those with collaborative practice agreements. Chains including Rite-Aid and Winn-Dixie allow their pharmacists to refuse to fill prescriptions for emergency contraception.
Arkansas, Georgia, Mississippi and South Dakota recently enacted "conscience clause" laws that allow pharmacists to refuse to dispense emergency contraception to women who have prescriptions.
In the past year, 14 other states have considered similar legislation.
Hospitals can also raise barriers to emergency contraception.
Eight states--California, Illinois, Massachusetts, New Mexico, New York, New Jersey, South Carolina and Washington--require hospital emergency rooms to offer emergency contraception to women who have been sexually assaulted.
But due to a recent spate of Catholic hospital mergers, a growing number of private hospitals are now following Catholic doctrine and refusing to dispense this medication to rape survivors as well as other patients.
For women in the 42 states without collaborative practice agreements, such obstacles can mean emergency contraception isn't available when contraception fails or when they are sexually assaulted.
As a prophylactic measure, the American Medical Women's Association, based in Alexandria, Va., and the American College of Obstetricians and Gynecologists are encouraging women to get advanced prescriptions for Plan B or Preven.
Health advocates also encourage women to lobby their state representatives to pass collaborative practice agreements. Sixty-six percent of U.S. women support pharmacy access to emergency contraception, according to the Pharmacy Access Partnership in Oakland, Calif.
But the main target of activists remains the FDA.
"Collaborative practice agreements are an important step," says Kirsten Moore, president of the Washington-based Reproductive Health Technologies Project. "But ultimately, this drug should be available over the counter and nationwide."
Molly M. Ginty is a freelance writer based in New York City.
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Plan B Activists Prepare for Next Battle at FDA:
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By Molly M. Ginty