Doctors assess impact of morning-after pill going OTC

Reproductive rights advocates, many physicians and several medical groups are celebrating the fact that Plan B, also known as emergency contraception or the morning-after pill, soon might be available without a prescription.

"Let's face facts: Accidents happen," said Vivian M. Dickerson, MD, president-elect of the American College of Obstetricians and Gynecologists, explaining that the change would help reduce unwanted pregnancies and abortions in this country.

The concept, of course, is not new. Since the 1960s, concentrated doses of birth control pills have been prescribed off label for use after unprotected intercourse, primarily for sexual assault victims. But the Food and Drug Administration officially approved use on a prescription basis with Preven (a levonorgestrel and estradiol compound distributed by Gynetics Inc.) in September 1998, and with Plan B in July 1999.

Last month, two Food and Drug Administration advisory panels endorsed switching Plan B to over-the-counter status. The FDA is not required to follow this advice, though it is expected to do so.

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive distributed by the Women's Capital Corp., headquartered in Washington, D.C.

The American Medical Association, the American Academy of Family Physicians, ACOG and the American Academy of Pediatrics support OTC availability as a way for women to access the medication within the 72-hour time window required for it to be effective. ACOG even took the interim step in 2001 of recommending that women be offered advance prescriptions.

"People need to be able to use it as intended, which means as soon as possible," said Wendy Chavkin, MD, MPH, professor of public health and obstetrics-gynecology at Columbia College of Physicians and Surgeons and the Columbia School of Public Health in New York City. "Removing steps that would slow down the process is very desirable."

This approach, however, is not without adversaries -- most of whom view Plan B through the lens of abortion-related issues or other women's health concerns.

Expanding access called a positive step

Proponents say having emergency contraception available without a prescription will allow greater access. They note that a woman rarely needs it in the middle of a weekday when a doctor is easily reachable.

"Doctors are not always available to their patients when they most need Plan B," said Gina Sucato, MD, MPH, assistant professor in pediatrics and adolescent medicine at the University of Pittsburgh. "Our role as physicians should really be to try to help make our patients aware of it, to prescribe it in advance and to encourage them to recognize the appropriate time to take it."

If Plan B were made available without a prescription, women who are uninsured or without a medical home also would have a better chance of obtaining it within the time frame.

Advocates argue that the drug is simple enough for women to use, and misuse carries few consequences. The accompanying nausea that so many women experience makes regular use unlikely and unappealing. Five states already allow pharmacists to dispense the drug directly, and few problems have been noted.

Those in this camp also dismiss Plan B's association with abortion. They use the widely accepted medical idea that conception occurs when the fertilized egg implants to argue that the drug prevents unwanted pregnancies. As a result, then, it also prevents abortions.

According to research from the Alan Guttmacher Institute, a New York-based reproductive health research think tank, emergency contraception, even with its limited availability, prevents about 50,000 abortions annually and could prevent many more if access were easier.

"This is a real win-win situation," said Paul Blumenthal, MD, MPH, associate professor in obstetrics and gynecology at Johns Hopkins University in Baltimore. "This is prevention of unintended pregnancy, not interruption of unintended pregnancy."

Advocates are also hoping that over-the-counter status will increase the number of stores willing to carry it, another factor hampering access. Currently, most surveys have found that only about a third to half of pharmacists are able to provide the medication within 24 hours.

Advocates also hope that Barr Laboratories Inc., the Woodcliff Lake, N.J., pharmaceutical company that has agreed to acquire the product from Women's Capital Corp., will launch a promotional campaign that will raise awareness.

"This would be the best possible use that I could possibly think of for drug company direct-to-consumer advertising," said Julie Komarow, MD, a family physician based in Covington, Wash.

Despite periodic publicity, awareness is still low, and many women still confuse Plan B with RU-486, mifepristone, a medical abortion available in the very early stages of pregnancy.

Support not unanimous

While much of the medical establishment backs the status change, some believe making Plan B available OTC would be a very bad idea.

Some physician groups perceive it to be a form of abortion and a risk to women's health. Critics also note that birth control pills are not available without a prescription. So, since Plan B is a formulation of birth control pills, it should require a prescription, too.

There is also concern about the possible impact the hormones could have over the long term, particularly on adolescents. Additionally, some opponents worry that wider availability of Plan B might lead to more unprotected sex and, thereby, more sexually transmitted diseases.

"It's totally irresponsible medicine," said Joe DeCook, MD, vice president of the American Assn. of Pro Life Obstetricians and Gynecologists.

Some physicians who prescribe emergency contraception also have expressed concern. While most advocates argue that women know when the drug is needed, these doctors say not all women understand when it's not indicated.

"They're very presumptive of people's ability to utilize medications," said Delmar Tonge, MD, an ob-gyn based in Modesto, Calif., who prescribes the medication regularly. "Women deserve to be evaluated before they take this."

Doctors in states where emergency contraception already is available directly from pharmacists, however, say they are in the loop -- just not in the middle of the night.

"The safety and effectiveness have been shown," said Roger Rowles, MD, an ob-gyn and president of the Washington State Obstetric Assn. "I have no hesitation about bypassing the physician or the pharmacist, and we should do everything to prevent unplanned pregnancies."