Emergency Contraception and Conception
Special Feature
Emergency Contraception and Conception
By Leon Speroff, MD
A few weeks ago, i received a letter from a gynecologist in Pennsylvania asking for my response to an article given to the gynecologist by a pharmacist. The article, entitled "For Some, Morning-After Regimen Is Tough Pill to Swallow," was written by Cynthia Cooper, RPh, and appeared in the September 1998 issue of Pharmacy Times. The article was obviously stimulated by the FDA approval of the emergency contraception kit (PREVEN from Gynetics, Inc.). (If you haven’t seen this kit, please try to do so. It is a handsome package that includes four tablets (each containing 50 g ethinyl estradiol and 250 g levonorgestrel) and a pregnancy test for self-administration.
The article in Pharmacy Times reviews the recommended doses and regimens of various oral contraceptives used for emergency contraception, as well as the efficacy and side effects. It states that the exact mechanism of action of emergency contraception with oral contraceptives is not known, and indicates that several mechanisms are possible, including prevention or delay of ovulation, inhibition of fertilization, and endometrial alteration preventing implantation. The article then devotes most of its space to what it calls "A Flurry of Controversy."
One of the inciting events was the refusal of a California pharmacist to dispense a prescription for emergency contraception, based upon his moral beliefs and the "conscience clause" adopted by the California Pharmacist’s Association. The chief executive of the California Pharmacist’s Association is quoted as saying that this is a delicate issue—one that is a private issue among the patient, the doctor, and the pharmacist. The chief executive recognized that it is inappropriate to tell a patient, "we don’t have it." The California pharmacist received a reprimand because refusing a patient’s right to medication is a form of discrimination.
In another episode, the employment of a pharmacist in Ohio was terminated for refusing to provide Micronor, in the belief (obviously erroneous) that it is an abortifacient. This particular pharmacist is a member of Pharmacists for Life, an organization working to introduce conscience-clause legislation in every state. The fundamental principle of this organization is that human life is sacred from conception to death.
The use of large doses of estrogen to prevent implantation was pioneered by Morris and van Wagenen at Yale in the 1960s. The initial work in monkeys led to the use of high doses of diethylstilbestrol (25-50 mg/d) and ethinyl estradiol in women.1 It was quickly appreciated that these extremely large doses of estrogen were associated with a high rate of gastrointestinal side effects. Yuzpe developed a method using a combination oral contraceptive, resulting in an important reduction in dosage.2 The following treatment regimens have been documented to be effective:
• Ovral: two tablets followed by two tablets 12 hours later.
• Alesse: five tablets followed by five tablets 12 hours later.
• Lo Ovral, Nordette, Levlen, Triphasil, Trilevlen: four tablets followed by four tablets 12 hours later.
Levonorgestrel in a dose of 0.75 mg given twice, 12 hours apart, is more successful and better tolerated than the combination oral contraceptive method, but this dose is equivalent to 10 pills of the levonorgestrel progestin-only minipill.3,4 In some countries, special packages of 0.75 mg levonorgestrel are available for emergency contraception. Greater efficacy and fewer side effects make low-dose levonorgestrel the treatment of choice.
This method has been more commonly called postcoital contraception, or the "morning after" treatment. Emergency contraception is a more accurate and appropriate name, indicating the intention to be one-time protection. It is an important option for patients and should be considered when condoms break, sexual assault occurs, if diaphragms or cervical caps dislodge, or with the lapsed use of any method. In studies at abortion units, 50-60% of the patients would have been suitable for emergency contraception and would have used it if readily available.5,6 In the United States, it is estimated that emergency contraception could annually prevent 1.7 million unintended pregnancies and the number of induced abortions would decrease by about 40%—to 800,000 per year.7 It would be a major contribution to our efforts to avoid unwanted pregnancies for all patients without contraindications to oral contraceptives to have emergency contraception available for use when needed. In my view, this would be much more effective in reducing the need for abortion than waiting for patients to call. In a study of such an approach, self-administration by appropriately screened and educated women was found to be effective and free of unwanted effects.8
The mechanism of action, as pointed out in the Pharmacy Times article, is not known with certainty, but it is believed with justification that this treatment combines delay of ovulation with interference of implantation and survival of the embryo.9,10 The efficacy has been confirmed in large clinical trials and summarized in complete reviews of the literature.11-13 Treatment with high doses of estrogen yields a failure rate of approximately 1%, and with the combination oral contraceptive, about 2%. In general clinical use, the method can reduce the risk of pregnancy by about 75%. This degree of reduction in probability of conception (given the relatively low chance, about 8%, for pregnancy associated with one act of coitus14) yields the 2% failure rate measured in clinical studies (in other words, 98% effective).15,16
The usual contraindications for oral contraception apply to this use. In view of the high dose of estrogen, emergency contraception with combined oral contraceptives should not be provided to women with either a personal or close family history of idiopathic thrombotic disease. For women with a contraindication to exogenous estrogen, the progestin-only minipill can be used for emergency contraception (e.g., administering 10 levonorgestrel tablets [75 g], for each of the two doses, or in some countries using the special commercial package).
I believe that most of us would agree that pharmacists should have the opportunity to remove themselves from an action they cannot morally support. But at the same time, the right of the patient to obtain legally approved medication must be protected. In March 1998, the American Pharmacy Association established by vote an official policy that recognizes the right of the individual pharmacist to exercise conscientious refusal but, at the same time, supported the establishment of systems to ensure patients’ access to legally prescribed therapy.
A major part of this disagreement and argument revolves around the question of when life begins. Is it at conception, at implantation, or at a certain stage of development? It seems to me that, at this point, this is very much an individual decision. I’m reminded of a story I heard at a conference last summer. A Muslim priest, a Catholic priest, and a rabbi were discussing when life begins. The Muslim priest said, "According to the Koran, life begins 40 days after conception." The Catholic priest said, "No, the pope tells us that life begins at conception." Finally, the rabbi said, "Both of you are wrong. Life begins when your children go away to college and the dog dies!"
References
1. Morris JM, van Wagenen G. Am J Obstet Gynecol 1966;96:804-815.
2. Yuzpe AA, Smith RP, Rademaker AW. Fertil Steril 1982;37:508.
3. Ho PC, Kwan MSW. Hum Reprod 1993;8:389-392.
4. Task Force on Postovulatory Methods of Fertility Regulation. Lancet 1998;352:428-433.
5. Burton R, Savage W, Reader F. Br J Fam Plann 1990;15:119.
6. Young L, et al. N Z Med J 1995;108:145.
7. Harper CC, Ellerton CE. Am J Obstet Gynecol 1995;173:1438.
8. Glasier A, Baird D. N Engl J Med 1998;339:1-4.
9. Young DC, et al. Obstet Gynecol 1994;84:266.
10. Swahn ML, et al. Acta Obstet Gynecol Scand 1996;75:738-744.
11. Fasoli M, et al. Contraception 1989;39:459-468.
12. Haspels AA. Contraception 1994;50:101.
13. Glasier A. N Engl J Med 1997;337:1058-1064.
14. Wilcox AJ, Weinberg CR, Baird DD. N Engl J Med 1995;333:1517-1521.
15. Trussell J, Ellertson C, Stewart F. Fam Plann Perspect 1996;28:58-64.
16. Trussell J, Rodriguez G, Ellertson C. Contraception 1998;57:363-369.
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