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Behind-the-Counter BC

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by Suzanne Schreiner & r & & lt;span class= & quot;dropcap & quot; & M & lt;/span & ore than three years ago, Barr Pharmaceutical applied to the FDA for permission to sell its "morning after" contraceptive, Plan B, over the counter. Two weeks ago, the FDA finally gave its approval, with these caveats: Plan B will be kept behind the counter and will only be available without prescription to women older than 18. Despite the conditions and the 40-month delay, Jet Tilley of Planned Parenthood of the Inland Northwest says, "It's a great day for access and a great day for women's health."


But she expressed dismay at the exclusion of girls younger than 18, citing figures from Advocates for Youth, based in Washington, D.C., showing that teen pregnancy rates in the United States are four to nine times greater than in western Europe, where comprehensive sex education and contraception are widely available.


"There is no science to indicate that making contraception readily available to teens means that they are going to act any differently," Tilley adds.


Plan B (levonorgestrel) was approved as a prescription emergency contraception drug by the FDA in 1999. The agency defines it this way: "Emergency contraception is a method of preventing pregnancy to be used after a contraceptive fails or after unprotected sex." Taken within 72 hours, Plan B can lower the risk of pregnancy by nearly 89 percent.


Abortion opponents object to Plan B on the grounds that it causes abortions, but the FDA says it does not: "Plan B works like other birth control pills to prevent pregnancy." Essentially, Plan B interferes with ovulation, fertilization or implantation, depending on where a woman is in her monthly cycle. If a fertilized egg is implanted in the womb before a woman takes the drug, the FDA says, "Plan B will not work."


Manufacturer Barr Pharmaceuticals initially asked the FDA to make Plan B available over the counter, rather than by prescription. The agency said no, claiming it was not persuaded that young adolescent women could safely use Plan B "without the professional supervision of a licensed practitioner." Many took that as official-speak for apprehensions that Plan B might lead to promiscuous behavior among teenage girls. Susan Wood, the FDA official in charge of women's health issues, resigned in protest a year ago because she said the FDA's own scientific and clinical evidence had been ignored for political reasons.





A Public Health Matter


Unintended pregnancy leads to higher rates of poverty, drug abuse, job loss and failure to finish school, says Dr. Kim Marie Thorburn of the Spokane Regional Health District, particularly for mothers and families who are low-income or where there is substance abuse. "Easy access to safe, available, emergency contraception is a really key piece" to avoiding those outcomes, she says, because such drugs allow a woman "to get control of her reproduction through contraception." For teenage girls, unintended pregnancy poses a threat to their education, which may seriously impact future employability.


Though rates of teen pregnancy have been declining nationally, Thorburn says access to contraception, including Plan B, "is a huge public health issue," adding that teens have the highest rates of unintended pregnancy. She cites Washington state data for 1995-2000 showing that 75 percent of pregnancies among teenage girls 15 to 19 years old were unintended; rates of unintended pregnancy decline significantly for women in their 20s. Nationwide, about 820,000 teenagers get pregnant every year. Across all age groups, about half of all pregnancies -- some 3 million -- are unplanned.


If she had her way, Thorburn says, "I would make access to Plan B [for teens] no different than for the rest of the population." She would also like to see access linked to a plan of referrals and information for girls, who could make informed decisions on the risks of sexual activity. Unfortunately, programs for teens are poorly funded across the board, whether they are social services, mental health or public health. Rather than being refused or ostracized, says Thorburn, the ideal would be for teens to use Plan B as a point of entry for health services and counseling.


"No door is the wrong door," says Thorburn, if it brings a teenage girl in for needed health services.





At the Pharmacy


As a clinical pharmacist at Group Health Cooperative, Jim Ruster is responsible for giving accurate drug information to the co-op's doctors. Past president of the Spokane Pharmacy Association and a veteran of 14 years in the field, Ruster personally believed Plan B should be sold over the counter to patients, just like Tylenol PM. "I think any barrier is going to increase unwanted pregnancies," he says. "[Other] people believe if you restrict access, that's going to decrease promiscuity, but I don't think that's the case at all. People are still going to have sex and get pregnant whether [Plan B is] available or not."


When it comes to teens, Group Health's privacy policy on reproductive health issues allows girls and boys as young as 13 to receive information and treatment independent of their parents. If a girl younger than 18 came in requesting Plan B, she would be counseled by consulting nurses, who would have a doctor sign off on the prescription. "In general," says Ruster, "we support [policies] that promote access to care."


"Women need timely access to backup birth control," says Planned Parenthood's Tilley. "Last year alone, PPINW provided more than 13,000 women with emergency contraception in order to help them have a second chance to prevent an unintended pregnancy." Tilley thinks that should include access for teens. "The U.S. has one of the highest rates of teen pregnancy in the western world -- anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy."

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