Advocates Push for OTC Access To Emergency Contraceptive Pills.
While a quiet debate has persisted for decades as to whether oral contraceptives should be made available without a prescription, safety concerns have made such a move unlikely But safety issues associated with long-term use of hormonal preparations do not exist with the two currently available emergency contraceptive products Preven (levonorgestrel and ethinyl estradiol) and Plan B (levonorgestrel), Dr. Carolyn Westhoff said at a press briefing on emergency contraception sponsored by the Kaiser Family Foundation.
Preven, which first came on the market in 1998, is a combined estrogen-progestin pill, while Plan B, available since 1999, is a progestin-only "minipill." With both products, one pill must be taken within 72 hours of unprotected intercourse and a second pill, 12 hours later.
In answer to a question about possible untoward medical effects occurring with "a huge blast of hormones" contained in emergency contraceptive pills (ECPs), Dr. Westhoff explained that a single 2-pill emergency contraception dose is equivalent to only 3 days' worth of low-dose contraceptives and to only one pill of the first-generation higher-dose contraceptives used by millions in the 1960s and 1970s.
Emergency contraception is "safe, safe, safe," said Dr. Westhoff, professor of obstetrics, gynecology and public health at Columbia University in New York.
While the window of opportunity for beginning ECP use is within 72 hours, optimal efficacy is seen when the first pill is taken within 12 hours of unprotected sex, and several women's health advocacy groups are questioning why these drugs should not be accorded OTC status.
Indeed, the American Medical Association's House of Delegates recently passed a resolution stating that the organization would support over-the-counter access to ECPs if the Food and Drug Administration determined they were safe for use without a prescription. (See related story on p. 3.)
Access and speed are important if ECPs are to be effective: "The pregnancy rate in the last 12 hours of the 72-hour window is eight times as high as during the first 12 hours," said James Trussell, Ph.D., professor of economics and public affairs, Office of Population Research, Princeton (N.J.) University.
And during that time, the woman has to contact her physician and find a pharmacy that's open, Dr. Westhoff said. If it's the evening or the weekend, this may prove difficult. And if she has recently changed jobs, she may end up flipping through an unfamiliar HMO directory and making multiple phone calls trying to find a nearby physician whose practice isn't closed.
It will ultimately be necessary for ECPs to become available over the counter if they are ever to "make a significant inroad into the abysmal rate of unintended pregnancy and abortion in the United States," Roderick L. Mackenzie, chairman of Gynetics Inc., the New Jersey-based company that distributes Preven, said at the briefing. There are considerable barriers to such a move, however, Mr. Mackenzie said, noting that it would require 2 years of work and an expenditure of $3 million to $6 million by his small company. "That's not in the cards," he said.
It's also unlikely that the Seattle-based Women's Capital Corp., the manufacturer of Plan B, will mount an effort to take its drug OTC because of the expense and uncertainty about the outcome. What is more likely is that an as-yet-unnamed women's advocacy group will submit a "citizen's petition" to the FDA, requesting a change to OTC status, Dr. Trussell said, Such a group could also undertake the studies needed to prove to the FDA that ECPs could be used safely without a prescription, sparing manufacturers the cost of performing such research. There already is movement in this area, he added, declining to provide specifics.
Mr. Mackenzie said he doubted that serious political controversy would ensue if the FDA were to agree to consider an OTC switch for these drugs because the pills are not abortifacients. If a pregnancy has already begun, ECPs will have no effect on either the mother or the fetus, Dr. Westhoff said.
Nevertheless, some abortion opponents have objected to ECPs, which they view as abortifacients because they may prevent implantation of a fertilized egg after conception.
One of the main objections to ECPs being made available without a prescription is that women will abandon their long-term contraceptive methods and rely too strongly on after-the-fact contraception, which certainly is not infallible. "If the typical woman uses only Preven for a year, her risk of pregnancy is going to be about 35%, and if she used Plan B only, the risk is about 20%," Dr. Trussell said. "And that's if she uses [them] perfectly."
But Dr. Westhoff believes women are much too highly motivated to control their fertility to ever rely on such a risky approach to contraception.
Awareness about ECPs is lacking, the speakers agreed. According to a new survey by the Kaiser Family Foundation, only 20% of ob.gyns. and 23% of family physicians routinely counsel their patients about backup ECPs. And, according to the foundation's "Third National Survey of Women's Health Care Providers on Reproductive Health," which was a national random sample survey of 767 physicians, 24% of ob.gyns. and 28% of family physicians said they never discuss this option with their patients.
Progress in ECP awareness has been made in recent years, said Tina Hoff, the foundation's director of public health information and communications in Menlo Park, Calif.
In 1997, when the foundation's previous survey was done, only 10% of ob.gyns. and 11% of family physicians were discussing emergency contraception "most" or "all" of the time.