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Thursday, April 29, 2004

'Morning after' pill may not need Rx


Over-the-counter ruling likely in May

By Matt Leingang
The Cincinnati Enquirer

Women might soon be able to buy the so-called "morning-after pill" without a doctor's prescription, a move that angers anti-abortion groups and puts added pressure on neighborhood pharmacists.

The U.S. Food and Drug Administration, after delaying a decision earlier this year, is expected to rule by May 21 whether Barr Laboratories' version of emergency contraception, called Plan B, can be sold over the counter, next to aspirin and cough medicine, the company says.

POLICIES
The FDA might decide next month to make morning-after birth control available without a doctor's prescription.
But there's no guarantee that drugstores will sell it over the counter. Here's what some of the major chains are saying:
Kroger
• Current policy: Carries emergency contraception and fills prescriptions for it at almost all of its 100 pharmacies in Greater Cincinnati. A few stores don't because of a lack of demand in those areas, spokesman Gary Rhodes said. He did not identify those stores.
• Sell it over the counter? Kroger is undecided.
Wal-Mart
• Current policy: The discount giant does not stock emergency contraception. "It is a business decision, not a moral decision," spokeswoman Danette Thompson said.
• Sell it over the counter? Wal-Mart does not anticipate doing so, Thompson said.
Walgreens
• Current policy: Carries the medication and fills prescriptions.
• Sell it over the counter? "We have not announced what we will do regarding that," spokeswoman Carol Hively said.
Meijer
• Could not be reached for comment.
CVS
•  Current policy: Carries the medication and fills prescriptions.
• Sell it over the counter? "We won't speculate on future over-the-counter sales," spokesman Todd Andrews said.
The FDA's scientific panel already has endorsed the idea. The agency doesn't have to follow the panel's advice, but it usually does.

Such a move could inflame abortion politics, and many conservatives argue that the medical and social consequences for adolescents in particular haven't been studied sufficiently.

Pharmacies, wary of negative publicity and protests, are approaching the issue cautiously.

Kroger, which currently fills prescriptions for emergency contraception, hasn't decided what to do about over-the-counter sales of Plan B in the event of FDA approval, company spokesman Gary Rhodes said.

The FDA says emergency contraception is safe. It is currently available in 101 countries, 33 of which do not require a prescription.

Supporters of selling Plan B in the U.S. without a prescription say the move will allow greater access - doctors aren't always available to write or call in a prescription, and not all pharmacies carry it.

Widespread access to Plan B could prevent 1.5 million of the estimated 3 million unintended pregnancies that occur each year in the U.S., advocates say.

The pill, basically a higher dose of regular birth-control pills, is designed to be taken within 72 hours of unprotected sex, whether as a result of rape, contraceptive failure or failure to use contraception.

But opponents argue that wider availability of Plan B might lead to more unprotected sex and, as a consequence, more sexually transmitted diseases. Some even see the pill as an abortive agent.

Plan B works in one of three ways: by preventing ovulation, interfering with fertilization or interfering with the implantation of the fertilized egg in the uterine wall, the medical definition of pregnancy.

"This is a very strong chemical that destroys the newly created human being," said Robert C. Cetrulo, a lawyer in Covington and president of Kentucky Right to Life.

Making Plan B available to anyone who walks into a drugstore would not be well received in Greater Cincinnati, which has a conservative base and a high population of Catholics, Cetrulo said. He declined to speculate about campaigns against drugstores that might carry it.

Right to Life of Greater Cincinnati is also waiting for the FDA to make its move before deciding how to respond, executive director Paula Westwood said.

Access varies

Plan B, along with another brand of emergency contraception called Preven, has been sold by prescription in the United States since the late 1990s. Preven is made by Gynetics Inc., based in New Jersey.

Five states - Washington, California, Arkansas, New Mexico and Hawaii - already have pushed for greater accessibility. They allow women to obtain the pills directly from a pharmacist without a prescription.Plan B generally costs $20 to $25, generating sales of $12 million to $15 million a year, according to Barr Laboratories.

"It's safe and effective, and the FDA is really going to help women if they allow for over-the-counter sales. Doctors and pharmacists don't need to be the gatekeeper of this," said Debi Jackson, president of Cincinnati Women's Services in Walnut Hills.

Jackson said her clinic, which has a pharmacy license, dispenses the medication 10 to 15 times a month.

Elsewhere in Greater Cincinnati:

• The University of Cincinnati's student health center wrote 55 prescriptions last year, medical director Dr. John Andrews said.

• Planned Parenthood's eight local health centers gave out 9,000 emergency contraceptive kits in 2003, executive director Sue Momeyer said.

Not all of those kits were for emergency situations - Planned Parenthood offers them to patients after regular visits.

But for some women, getting a prescription filled within the 72-hour window can be hit or miss, Momeyer said.

For example, Wal-Mart does not stock emergency contraception at its U.S. pharmacies. Nor is it available at the six health clinics run by the Cincinnati Health Department, which serve as the primary source of health care for 45,000 low-income people.

"It would erode our community support," Health Commissioner Malcolm Adcock said, conceding that some people see Plan B as a form of abortion.

Wal-Mart's position is a "business decision, not a moral decision," spokeswoman Danette Thompson said.

Refusing to dispense

Some pharmacists who liken emergency contraception to abortion have even refused to dispense the medication as a matter of conscience.

In 1996, pharmacist Karen Brauer refused to fill a prescription for a type of morning-after pill at a since-closed Kmart store in Delhi Township.

Kmart eventually fired her. Brauer, who describes herself as a pro-life Catholic, sued the company in 1999 for wrongful termination. The case is pending in federal court.

"It would be criminal for the FDA to bring this over the counter," said Brauer, a resident of Lawrenceburg, who now works at another Greater Cincinnati pharmacy that she declined to identify.

Brauer said her current employer allows her to opt out of filling prescriptions for emergency contraception.

Most major chains, including Kroger, allow their pharmacists to do the same - as long as they refer the patient to a colleague who will provide the pills.

Ernest Boyd, executive director of the Ohio Pharmacists Association, disagrees with the notion that women who want emergency contraception have been inconvenienced by these policies.

"Another pharmacy or a clinic can always take care of it," Boyd said.

Supporters of widespread access to emergency contraception disagree.

"There is so much intimidation around this issue that some women, even if they get a prescription, feel afraid to ask their pharmacists to fill it," said Dr. Paula J. Adams Hillard, a professor of obstetrics and gynecology at the University of Cincinnati College of Medicine.

Hillard has much of the U.S. medical establishment on her side, including the American Medical Association, which backs granting Plan B over-the-counter status.

But some doctors still say making Plan B available without a prescription is a bad idea.

Dr. Walter Bowers, an obstetrician/gynecologist in Mount Auburn, said he prescribes the medication, but he has concerns about the long-term effect of these pills, particularly on adolescents.

"This medication is not without complications, and I would much rather know if one of my patients is taking it so that I'm aware of any complication," Bowers said. "I think this is something that should be left in the hands of physicians."

E-mail mleingang@enquirer.com




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