Movement growing to expand access to ECPs

Prescribing emergency contraceptive pills (ECPs) before they are needed can facilitate their use and may reduce the rate of unwanted pregnancies, findings from a new study show.1

A total of 553 women were given a pre-supply of ECPs to keep at home, while a control group of 530 women had to obtain ECPs through a physician office visit. Both the treatment and the control groups were followed for one year, with frequency of use, use of other contraceptives, and incidence of unwanted pregnancies charted.

While women in the treatment group were more likely to use ECPs at least once, they were no more likely to use them on a repeated basis. Women in the treatment group also were less likely to have an unintended pregnancy, but due to the size of the sample, the difference cannot be considered statistically signifcant.

The study, conducted by Anna Glasier, MD, director of Family Planning and Well Woman Services at the Edinburgh (Scotland) Healthcare NHS Trust, and David Baird, MD, professor of reproductive endocrinology at the Centre for Reproductive Medicine in the department of obstetrics and gynaecology at the University of Edinburgh, supports the expansion of access for ECPs, contends Phillip Stubblefield, MD. Stubblefield, who serves as professor and chairman of OB/GYN at Boston University School of Medicine and director of OB/GYN at Boston Medical Center, says he would like to see the study expanded to fully confirm that enhanced access to ECPs does result in unintended pregnancy.

Until ECPs are available over the counter, providers should prescribe a pre-supply for women to keep at home, he says. Expanded access should be considered preventive care, he says in his accompanying editorial to the published study.2 To prove effective, ECPs must be available around the clock. "If a woman has unprotected intercourse on Friday night, anything that gets in the way of her getting it before Monday night is bad," he says. "If you call my office and want to see me on Monday, you have a problem. If you can get to me on the telephone, I will prescribe it over the phone, but many doctors will not. The more obstacles there are in the way, the more likely the woman is to say, 'I probably don't need it, anyway.'"

His belief is borne out in results of an initial survey from the Washington State collaborative provider/pharmacist project. Almost half of women who have received ECPs through the project said they would have taken no action and waited to see if they were pregnant if such immediate access were not available. (For details, see Contraceptive Technol ogy Update, June 1998, pp. 79-80, and March 1998, pp. 34 and 39.)

The success of the Washington State project may be replicated in the United Kingdom following movement in Parliament to expand access to ECPs. Members of a government committee will be examining the Washington project in designing a British group protocol to allow pharmacists to dispense ECPs through a collaborative provider agreement, says David Nolan, spokesman for the Birth Control Trust in London, a nonprofit reproductive health information group.

An important turn in considering such access comes with Berlin, Germany, drug manufacturer Schering AG's decision to discuss extending the availability of its PC4 ECP product in the UK through such a collaborative agreement. PC4, a four-pill strip with each pill containing 50 µg ethinyl estradiol and 0.50 mg norgestrel, was pulled from the market in New Zealand after regulatory authorities there switched its status from prescription to over-the-counter.

To expand ECP access, protocols will have to be drafted and approved, which could take six to nine months, Nolan estimates. An amendment to the legislation regulating UK drug supplies also may be needed, but it should move through fairly quickly due to support for the project. If no obstacles are presented, expanded ECP access may be available in 1999, the Birth Control Trust projects.

ECPs and manufacturers

The Food and Drug Administration (FDA) has approved 11 brands of oral contraceptives for use as ECPs, says James Trussell, PhD, associate dean of the Woodrow Wilson School of Public and International Affairs at Princeton (NJ) University. (The Emergency Contraception Web site lists all 11 brands and approved dosages. See box, below.)

While there may be more approved pills, manufacturers still are not doing their part to ease access to ECPs for women, contends Janet Benshoof, JD, president of the Center for Reproductive Law and Policy in New York City. No current OC manufacturer is stepping forward to package OCs for ECPs, she says. In fact, they are failing to meet FDA regulations by not including ECP information on their package information inserts, she says. She has written the companies to notify them of their noncompliance to the law. "I think the next step is that manufacturers, in their package inserts, ought to talk about the fact that this is a method. Since they have to list all methods that exist under the regulations, the next step is to get them to obey the present law."

References

1. Glasier A, Baird D. The effects of self-administering emergency contraception. N Engl J Med 1998; 339:1-4.

2. Stubblefield P. Self-administered emergency contraception - a second chance. N Engl J Med 1998; 339:41-42.