Clinician kits help put emergency contraception into practice
Groups band together to get out the message: Prescribing ECPs is OK
Get ready to take advantage of a nationally distributed provider kit to help you incorporate emergency contraceptive pills (ECPs) and other forms of emergency contraception into your practice.
Previews of the kits, titled "Emergency Contraception: Resources for Providers," are scheduled to be displayed at the April annual meeting of the Washington, DC-based American College of Obstetricians and Gynecologists (ACOG), says Elisa Wells, MPH, senior program officer at Program for Appropriate Technology in Health (PATH) of Seattle. PATH, a nonprofit international health organization, has taken on the responsibility of preparing the informational material included in the U.S. provider kit, incorporating information on all methods of emergency contraception, including ECPs, mini-pills, and IUDs.
"The centerpiece of the packet will be a resource book for providers, with current information about prescribing practices for emergency contraceptive pills, mini-pills, and IUDs; counseling issues; and service delivery considerations, including pharmacist/prescriber collaborative agreements for ECPs," notes Wells. "The resource book also will contain sample use instructions in English and Spanish, prescription blanks, informed consent forms, and screening protocols that can be adapted or photocopied for general use."
Other items in the packet include a small poster, client brochures for adults and young adults, a fact sheet about emergency contraception, and an enrollment form for the national Emergency Contraceptive Hotline and Web site. (For contact information, see Resources, p. 56.) PATH and an advisory committee drew from material developed by the Welcome, MD-based Consortium for Emergency Contraception, a group of seven organizations involved in family planning and women’s health initiatives, to produce the provider information kit. Full packets will be out this month, says Wells.
Work was well under way on the provider kit distribution project at Contraceptive Technology Update’s press time, according to Felicia Stewart, MD, director of reproductive health programs at the Menlo Park, CA-based Henry J. Kaiser Family Foundation. The project is sponsored by the Foundation and co-sponsored by ACOG.
A number of organizations have agreed to participate in the distribution program, including ACOG; the American Medical Association in Chicago; the Planned Parenthood Federation of America in New York City; and the National Family Planning and Reproductive Health Association, the Association of Reproductive Health Professionals, and the National Association of Nurse Practitioners in Reproductive Health, all based in Washington, DC.
Federal Register notice removes barrier
The final barrier fell for ECPs when the Washington, DC-based U.S. Food and Drug Administration (FDA) affirmed the safety and efficacy of the ECP method in its Feb. 25, 1997, notice in the Federal Register.
The FDA also included the ECP regimen in its notice, specifying dosages of six brands of oral contraceptives: Ovral, Lo/Ovral, Nordette, and Triphasil, manufactured by Wyeth-Ayerst Laboratories of Philadelphia, PA, and Levlen and Tri-Levlen, produced by Berlex Laboratories of Wayne, NJ. All six brands contain the proper amount of ethinyl estradiol and either norgestrel or levonorgestrel required for effective post-coital emergency contraception.
Both Wyeth-Ayerst and Berlex have been reluctant to repackage their products for emergency contraception due to apprehension over possible litigation and political concerns. Now that the FDA has brought the information straight to clinicians and patients in the Federal Register notice, there’s no reason clinicians should not move forward with prescribing ECPs, says Janet Benshoof, JD, president of the Center for Reproductive Law and Policy in New York City.
"I think that doctors should prescribe this prophylactically and that everybody going in for a doctor’s visit who’s sexually active should come out with a package of pills," Benshoof asserts. "And I think it should be over-the-counter in short order."
The FDA’s call for new drug applications for ECPs will allow companies to package pills just as they are routinely marketed overseas. A company must meet two requirements: first, show it can produce a drug equivalent to any of the six named in the Federal Register, and second, provide proper labeling.
Since the patents for all six formulas have expired, they are now released for remanufacture, says James Trussell, PhD, director of the Office of Population Research at Princeton (NJ) University. And since the FDA attached sample labeling to the Federal Register notice, much of the groundwork for the second requirement already has been completed.
"I think part of the problem was that some people were hesitant to use [ECPs] because it hadn’t been approved as safe and effective previously," notes FDA spokeswoman Susan Cruzan. "Now, FDA has reviewed all the information, and in fact, we’re calling for applications, because we say the manufacturers can cite the available data as part of their application."
A new company, Gynétics of Somerville, NJ, is moving forward in gaining FDA approval for ECP distribution. It plans to partner with a private manufacturing firm to market and distribute ECPs sometime in 1998, says Richard Abel, director of sales and marketing.
Although the company may be new, Gynétics’ staff is no stranger to advancing products in female health care. Its founder is Roderick Mackenzie, former chairman of the board of GynoPharma, the company that brought the Copper T-380A IUD to the United States. The firm already markets the GynoSampler endometrial curette, a disposable endometrial sampler.
Look at the statistics
Emergency contraceptive pills could prevent up to 2.3 million unplanned pregnancies a year, nearly one million of which now end in abortion, says Trussell, who presented this estimate at the June 1996 FDA advisory committee hearing. For every 100 women who have unprotected sex once during the second or third week of their menstrual cycle, eight would normally become pregnant, but only two would if the women took emergency contraceptive pills, he notes.
ECPs are a cost-effective approach to preventing unintended pregnancy, Trussell explained at the recent Contraceptive Technology conference. To illustrate that point, he presented figures on the cost of a single use of ECPs: $59 in a managed care setting vs. $8,619 for a live birth and $4,994 for an ectopic pregnancy. (See charts, at left.)
Ten percent of all the women who are unprotected by contraception account for half of unintended pregnancies, says Michael Burnhill, MD, vice president for medical affairs for Planned Parenthood Federation of America. By dropping that figure just 2% with ECP use, unintended pregnancies would fall by 10%. If clinicians could encourage ECP use to lower the number to 5% (reducing by half the number of women who don’t use contraception), unintended pregnancies would plummet 25% a "huge impact," Burnhill contends.
Be assertive in making ECPs available
Planned Parenthood affiliates are simplifying their protocols to make ECPs more available to both existing patients and to nonpatients who come into their centers, says Burnhill.
"If you’re not a Planned Parenthood patient, you still have to come in, but you don’t have to go through a complete history and physical in order to get it prescribed," he says. "If you’re an ongoing patient, you can get the prescription over the telephone."
Ninety-eight percent of the problems with delivery of ECPs in this country are logistical, ot clinical, says Trussell. He suggests clinicians implement the following to achieve effective ECP practices:
• Make continuous monitoring a top priority.
Track how many ECP packs are distributed at your facility. Understand what leads to their use, whether it is a contraceptive method failure or lack of using any method of birth control.
• Don’t make your patients dig for ECP information.
The people who answer your telephone lines both the receptionist and your after-hours answering service need to know that your facility offers ECPs. Make sure on the very first call that patients know ECPs are available.
(Editor’s note: A pilot project at a Southern California health maintenance organization and an established New Mexico university health center are both at work dispensing ECPs to patients. Get tips on how they operate their programs, below.)
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