The recent United States Food and Drug Administration approval of a commercial kit containing the Yuzpe regimen for emergency contraception is a welcome event. Unlike emergency contraceptive pills sold in other countries, however, the United States product has a pregnancy test bundled with the pills. The test could identify existing pregnancies and avoid unnecessary use of the pills, although any protection against lawsuits alleging injury to an embryo is speculative. Conversely, no major medical organization recommends routine pregnancy testing before using emergency contraceptive pills. The test might stigmatize the Yuzpe regimen as being dangerous to an embryo. Difficulty in understanding the pregnancy test instructions could, paradoxically, deter some women from using the pills after having bought them. The bulky size of the pregnancy test reagent stick makes the package indiscreet, and the test adds unnecessary cost to emergency contraception. The greatest usefulness of the test could be to confirm or exclude a pregnancy several weeks after taking the pills, rather than before. If bundling an unnecessary test with emergency contraception is the only way to bring this useful product to the United States market, then the public health benefits could outweigh the disadvantages. However, this approach sets a worrisome precedent and further isolates the United States from the international medical community.
The recent approval by the United States Food and Drug Administration of a commercial kit (Preven; Gynétics, Inc., Somerville, NJ) expressly for emergency contraception is a welcome event. For several decades, United States clinicians have had to prescribe a traditional birth control pill pack and instruct women on how to use part of it for emergency contraception or dispense the pills themselves. Having a Food and Drug Administration-approved product for emergency contraception (the Yuzpe regimen of levonorgestrel plus ethinyl estradiol) should remove reservations about this off-label use of oral contraceptives.
However, many clinicians and women will be surprised to find a urine pregnancy test in addition to the four emergency contraceptive pills. The product pamphlet instructs women to use this test before taking the pills. Several major organizations, including ACOG,1 International Planned Parenthood Federation,2 and the World Health Organization,3 have guidelines for emergency contraception. None recommends a pregnancy test before using emergency contraception. Indeed, the World Health Organization3 argues against imposing unnecessary medical barriers to contraception. Why the surprise in the box? As with many issues concerning contraception in the United States, the answer is complex.
Performing a urine pregnancy test before using the Yuzpe regimen has several potential benefits. The test included with the new kit has high sensitivity (20–25 mIU/mL) (Gynétics, Inc.; www.preven.com.product/). The incremental cost of the test is probably small in comparison to purchasing a similar test in a pharmacy. The Preven package costs about $20.00, whereas the over-the-counter tests alone cost from $9.00 to $18.00. Prompt detection of a pregnancy could lead to earlier prenatal care or induced abortion than would have occurred otherwise.
Recognition of an early (but otherwise unsuspected) pregnancy avoids the unnecessary taking of the emergency contraceptive pills. Although this will not save a woman money (she will have already bought the kit), she can avoid the nausea, vomiting, and breast tenderness that sometimes accompany this regimen.
Another reason for inclusion of a pregnancy test in the kit is to relieve anxiety. It will exclude the presence of a pregnancy fertilized more than 10 days earlier. However, it cannot detect pregnancies conceived more recently, including the unprotected coitus leading to the request for emergency contraception. The included pregnancy test might make physicians more comfortable prescribing the pills to women over the telephone without an office visit or in advance of need, which could increase access to this contraceptive method.
Testing for pregnancy before emergency contraception might protect a clinician from medicolegal liability in case of birth defect. Approximately 2% of women who use the Yuzpe regimen will be pregnant at the end of the month in which it is used, so predictable numbers of embryos could be exposed. An unknown proportion of exposed pregnancies will terminate through spontaneous and induced abortion. Of those that proceed to delivery, about 2–3% will have a recognizable birth defect (the background rate). Although the Yuzpe regimen does not increase the rate of birth defects,4,5 post hoc ergo propter hoc reasoning might lead to litigation. (The birth defect occurred after exposure to the Yuzpe regimen, therefore it was caused by the pills.) This common error in logic has led to successful lawsuits, sometimes with outrageous awards against manufacturers, as occurred with a spermicide (Wells v. Ortho Pharmaceutical Corp. [615 F. Supp 262] [N.D. Ga. 1985]).6 In this case, a judge ruled that a spermicide containing octoxynol-9 caused limb defects in a child and initially awarded the plaintiff $5.1 million. A prior pregnancy test might not eliminate such lawsuits, but the clinician could at least claim that he or she had done everything possible to avoid unintentional exposure to the steroids. Of importance, the test would not detect pregnancies resulting from fertilization in the previous 10 days.
Inclusion of a pregnancy test with emergency contraceptive pills has important disadvantages as well. First, long experience with oral contraceptives indicates that the Yuzpe regimen has no teratogenic or abortifacient effects on an established pregnancy.4,5,7 Because no harm will result to an embryo or fetus if a woman with an unrecognized pregnancy takes the pills, the test is simply unnecessary from a medical point of view. Unnecessary testing, with the attendant risks of false-negative and false-positive results, carries emotional and economic costs.
Furthermore, inclusion of the pregnancy test with the emergency contraception might imply to some women that emergency contraception is dangerous to an embryo. To our knowledge, no other prescription drug sold in the United States is bundled with a pregnancy test. Package labeling for isotretinoin and thalidomide, two highly teratogenic drugs, includes forceful warnings8 to physicians and women to rule out pregnancy before beginning these drugs. However, they are not sold with a pregnancy test. This discrepancy could puzzle women and some providers.
Inclusion of the pregnancy test with the emergency contraception regimen might paradoxically deter some women from using the pills. This could happen in several ways. For example, women with limited literacy might be so confused by the instructions that they become discouraged and quit before taking the pills. The average reading level in the United States is at or below the eighth-grade level.9 Forty-four million adults in the United States cannot read or write well enough to meet the needs of everyday life, and another 50 million are only marginally literate. Thus, many health education messages are incomprehensible to many people.10 The reading level of the patient information book is appropriately low, but it does contain several challenging words, such as “chorionic” and “gonadotropin.” The detailed patient labeling has words such as “monoclonal” and “desiccant,” which will not be understood by many women. A recent metaanalysis of performance of home pregnancy testing by lay persons had a worrisome conclusion: “Clinicians should be concerned about the diagnostic efficiency of HPT [home pregnancy test] kits, given the relatively low effectiveness score when used by actual patients.”11 Whether this warning applies to the test included with the Yuzpe regimen is unknown.
Alternatively, despite the instructions, a woman might have a negative pregnancy test result and incorrectly infer that her recent act of unprotected intercourse did not result in a pregnancy. She might then conclude that the emergency contraceptive pills are unnecessary and thus not take them.
The addition of a pregnancy test makes the packaging bulky. In some European countries where the Yuzpe regimen has been marketed for years, the package consists of four pills in a blister pack, which is small enough to fit discreetly in a purse. In contrast, the 14-cm-long Preven urine test stick requires a box that is too large to fit in some women's purses. The box measures approximately 22 × 6.5 × 2 cm.
Finally, no health care policy can be viewed in a vacuum. One must ask what benefits would have accrued had the same amount of money been spent on alternative programs. For example, suppose the cost of thousands of pregnancy tests before emergency contraception were spent instead on cervical cytology screening, ongoing oral contraception, or mammography for women 50 to 70 years old. If the latter programs have greater benefit, then the pregnancy test has a net negative effect on women's health. The fact that the incremental cost of the included pregnancy tests is small limits but does not remove this concern.
As noted by the United States Preventive Services Task Force, “Documented effectiveness is—or generally should be—the most basic requirement for providing a health care service.”12 This criterion has not been met for the pregnancy test bundled with the Yuzpe regimen. We are unaware of any published studies that have examined its effect on acceptability or efficacy. Thus, level III evidence (studies of effectiveness have not been conducted) supports a level C recommendation (insufficient evidence to recommend for or against the pregnancy test).12 Given the lack of evidence, a pregnancy test before using emergency contraceptive pills should not become standard practice.
Why then the pregnancy test? It might have been included because of consumer-generated demand, political worries, or legal fears. The test clearly does not reflect a medical need.1–3 We recommend that women not follow the Preven instructions. The best use of the pregnancy test will likely be after, and not before, taking the pills. Women should save the pregnancy test. If menstruation does not resume within three weeks after taking the pills, they can then use the test to confirm a pregnancy.
If bundling an unnecessary medical test with emergency contraception is the only way to bring a useful product to the United States market, then the public health benefits may indeed outweigh the disadvantages. However, this test poses yet another unnecessary impediment to contraception and further isolates the United States from the international medical community3
Family Health International, Research Triangle Park, North Carolina.
Address reprint requests to: David A. Grimes, MD, Family Health International, PO Box 13950, Research Triangle Park, NC 27709. E-mail: firstname.lastname@example.org
Support for this article was provided by Family Health International (FHI) with funds from the U.S. Agency for International Development (USAID), Cooperative Agreement Number AID/CCP-A-00-95-00022-02. The views expressed in this article do not necessarily reflect those of FHI or USAID.
Received November 30, 1998. Received in revised form February 27, 2999. Accepted February 24, 2999.