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Morning-after pill accessible
despite FDA delays

Posted November 30, 2005

Bailey Porter
Web Editor

While debate continues at the federal level over making the morning-after pill, or Plan B, available over-the-counter, confusion at home has left many California women confused about access to emergency contraceptives.

California is one of six states that offer emergency contraceptives over-the-counter (without a prescription). But many women and pharmacists for that matter are unaware of this.

What is Plan B?

Plan B is an emergency contraceptive originally put on the market in 1999 as a prescription drug. Its purpose: to prevent pregnancy after unprotected sex.

The pill, an increased dose of the hormones found in regular birth control pills, acts as a contraceptive bydelaying ovulation – or preventing fertilization or implantation. The morning-after pill is available by prescription only in most states. But California passed legislation in 2001 legalizing over-the-counter EC at certified pharmacies and clinics.

“When someone comes in, we have doctors who write prescriptions and dispense EC,” said Kavita, a spokeswoman for Planned Parenthood of Los Angeles. “But if it’s after hours, women can go to pharmacies that have taken the steps to become certified to dispense it.”

Several Web sites explain safe ways to obtain EC without a prescription. Also, the University of La Verne Student Health Center prescribes emergency contraceptives to its students.

Pill flames controversy

For the past year, the Food and Drug Administration has been under fire from many groups including the nonprofit Government Accountability Office and Senators Hilary Rodham Clinton (D-NY) and Edward Kennedy (D-Mass.) for delays in making Plan B available over the counter after the pill’s manufacturer Barr Laboratories, Inc., applied to the FDA over a year ago.

An over-the-counter emergency contraceptive is in women’s best interest, said University of La Verne Director of Student Health Services and Services for Students with Disabilities Cindy Denne.

Senior English major Erin Moya agrees.

“If it’s safe and healthy,” she said, “I think it should be over-the-counter.”

After initial reviews approved over-the-counter Plan B, the FDA declined the switch from prescription to over-the-counter. Such stalling by the FDA was found to be “not typical” of other prescription to over-the-counter switches by the FDA from 1994 to 2004, said the GAO report that reviewed the decision.   

The argument against over-the-counter Plan B – lead by FDA’s Center for Drug Evaluation and Research director Steve Galson, who vetoed recommendations from advisory committees and medical-review staff – cited the need for more evidence on its safety in women under 16.

But many believe the decision was based more on politics than health concerns.

“I think you have to separate the science from moral issues. Each individual should be allowed to make that choice,” Denne said.

“Planned Parenthood believes in access for everyone,” Kavita said. “We just have to wait and see what the FDA decides.”

So far the FDA has not revised its decision.

Meanwhile, some who oppose over-the-counter Plan B said that increasing access by making the drug over-the-counter would increase irresponsible sexual behavior, especially in minors, and the possibility of health problems due to the increased levels of hormones in morning-after pills.

At ULV, liberal studies major April Houts said her experience in student teaching affirms that morning-after pills should be prescription only: “With these kids’ naiveté, it would increase their sexual activity.”

“And what about STDs,” she asked. “You get rid of the possibility of pregnancy, but what else did they get?”

CAPA student Raphael Plunkett said that although she believes Plan B should be over the counter, it is a “Band Aid to the problem” of unprotected sex.

However, arguments for over-the-counter Plan B said it would not increase unprotected sex.

“You walk into the same section and there are condoms. We need to trust people to make their own decisions,” Moya said.

Proponents say over-the-counter emergency contraceptives would decrease abortions since access to the pill would be immediate instead of 24 to 72 hours later with a prescription.

In fact, Planned Parenthood’s data finds emergency contraception could prevent up to 1.7 million unintended pregnancies and 800,000 abortions each year in the United States.

ULV senior business administration major Harris Petropoulos and his friend, Dimitris Iliopoulos, a graduate student at the Claremont Colleges, agree that Plan B should be available over-the-counter to increase accessibility to the drug which offers an important “solution.” However, Iliopoulos said in the case of minors, a consultation with family or a physician should be implemented.

Virtually all major medical and health care organizations, including the American College of Obstetricians and Gynecologists and the original teams at the FDA approved the safety of the over-the-counter pill. After the FDA advisory panel approval of Plan B was rejected, the FDA women’s health director Susan F. Wood resigned in protest.

Since the FDA originally approved the drug, it should be out there, Denne said.

ULV’s response

Even without federal legislation to support a national practice, women in California can still receive EC over-the-counter. And the quick response from clinics like the Health Center effectively does the same, even though it is a prescription.

“(The FDA decision) doesn’t affect what we do here, because we don’t use Plan B,” Denne said.

The ULV clinic offers an equivalent to Plan B.

Since EC effectiveness rests within the first 72 hours after unprotected sex, the Center’s EC works even if the woman must wait from Friday after-hours to Monday morning.

However, since EC are most effective in the first hours after unprotected sex, an over-the-counter drug available at 24-hour pharmacies would be best for women, Denne said.

A woman seeking EC at ULV is first given literature to read and staff makes sure she understands EC. She then takes a pregnancy test, which Denne said is the clinic’s way of maintaining a good practice.

The woman is then given two doses of regular birth control regulated for emergency contraception; one right away and another 12 hours later. The woman is then given an anti-nausea pill to combat nausea, a common side effect of EC because of its high hormone levels. She is asked to return to the clinic in three weeks for another pregnancy test. Most women are good at following through with this second visit, Denne said.

Whereas Plan B costs upward of $30, EC is free at the Center. Planned Parenthood is also cheaper than pharmacies because it works off a sliding scale, Kavita said.

Leapfrogging the doctor’s visit

Pharmacies that participate in a continuing education program are authorized to dispense Plan B and other EC. The EC would not be on the store shelves, but women can go straight to a qualified pharmacist, who is trained as an educator according to statewide protocol by the State Board of Pharmacy and the State Medical Boards to help women understand EC and dispense it to them, Denne said.

“The issue is that it’s going to cost,” Denne said, adding that the cost might act as another deterrent for unprotected sex, like the risk of sexually transmitted diseases.

If a pharmacy chooses not to carry it, they can refer you to one that does.

Myth increases controversy

The morning-after pill is most effective within the first 24 hours after unprotected sex but works up to 72 hours later. It is not an abortion pill, a common misconception linking Plan B with RU-486. The morning-after pill cannot terminate an established pregnancy.

“I think that there is still a misconception that people need to understand. Emergency contraceptives are clearly not abortion pills,” Denne said. “The ECP does not interrupt pregnancy.”

The misconception linking RU-486 to emergency contraceptives is probably a big reason there is such a controversy over Plan B, Denne said.

Freshman psychology major Alyse Beni said over-the-counter EC could help end the abortion controversy.

“With more access to the pill, it would prevent you from having an abortion,” she said.

Safety

Morning-after pills were first prescribed in the 1960s predominantly for rape cases. Since then, EC is used for accidents like condom breaks.

However, emergency contraceptives do not prevent STDs.

Despite the increased progestin or estrogen hormones in EC, it is considered very safe.

“Even the increased amount of hormones is still not enough to be a risk,” Denne said.

The principle risk of emergency contraceptives is any allergic reaction the woman might have to ingredients in the medication, Denne said. But people with medical concerns tend to be savvy about what could trigger medical problems, she added.

Freshman Kellie Salmeron said her friend got really sick after taking a morning-after pill, which made Salmeron decide EC should be available with a prescription.

“I don’t think it should be as readily available as Tylenol,” she said.

ULV doing more

“During office hours, there isn’t any reason a young student couldn’t be seen as soon as possible,” Denne said.

In fact, in recent months the clinic has taken further steps to make EC more readily available to students. Under leadership from University Physician Victoria Shook, the Health Center became authorized to dispense EC without Shook or a physician’s assistant present (whose hours at the clinic are limited).

“We can give you the education you need and follow all the protocol like taking vital signs to provide proper medical care,” said Denne, a registered nurse.

“We want to do the right thing in a timely fashion,” she said. “We’re not supporting that our students become sexually active. We just want you all to have a choice and to support that choice.”

Bailey Porter can be reached at porterb@ulv.edu.