Source: Wells, E., Crook, B., Muller, N. Emergency Contraception: Resources for Providers. PATH, Seattle, WA, 1997.

Safety

No published studies using evidence-based criteria have reported contraindications to use of ECPs. None of these studies followed subjects beyond resumption of menses or onset of pregnancy, however, and no studies have specifically investigated outcomes among patients with contraindications to combined oral contraceptive use.(3) The total hormone dosage in ECPs is not large when compared with the total amount of hormones taken by women using combined oral contraceptives for routine contraception. ECPs, which are used for a short time period, do not affect clotting factors; therefore an increased risk of vascular problems (abnormal blood clotting, stroke, or heart attack) is unlikely. (18) No serious or long-term complications have been definitively linked to the Yuzpe regimen in Europe, where ECPs are widely used.

Birth defects: While no studies have assessed the teratogenic effects associated specifically with ECPs, there are no bio-medical reasons to expect an increased risk of birth defects if ECPs fail. Because combined oral contraceptives have been so widely used, considerable research on exposure during early pregnancy has been reported; there is no evidence that inadvertent combined oral contraceptive use, even of high-dose combined oral contraceptives (150 mcg per day ethinyl estradiol), has any teratogenic effects. (19,20) According to the FDA, "there is, therefore, no evidence that these drugs, taken in smaller total doses for a short period of time for emergency contraception, will have an adverse effect on an established pregnancy." (6)

Ectopic pregnancy: Research on ECP effectiveness has not suggested any increase in the risk of ectopic pregnancy.

Lactation: The effect of one-time ECP use on milk production in lactating women has not been studied. As an alternative to combined ECPs, the progestin-only ECP regimen can be used. Because some women may wish to avoid exposing their infants to artificial hormones through breast milk, some providers recommend manually expressing the milk and bottle feeding for 24 hours after treatment. (21)

Liability issues

While the threat of malpractice litigation can never be ruled out entirely with respect to any medical treatment, it is unlikely that litigation with respect to emergency contraception will be successful if providers have followed the appropriate guidelines with respect to screening, prescribing, dispensing, and counseling.

Providers should be aware, however, that failure to inform patients of the availability of emergency contraceptive services when medically indicated may leave them open to allegations of malpractice because emergency contraception is the only treatment available to prevent an unintended pregnancy after unprotected intercourse.

Providers should be familiar with the ACOG Practice Pattern on ECPs and the FDA endorsement of certain combined oral contraceptives for use in emergency regimens, which further support the use of ECPs for prevention of unintended pregnancy after unprotected intercourse.

In one known case prior to the FDA notice, a California court ruled that a hospital could be held liable for failing to provide a rape victim with information about and access to emergency contraception.(32) The hospital, which had a religious affiliation, had contended that it was immune from prosecution under the state Therapeutic Abortion Act, which provided that no health care facility with a religious affiliation could be liable for refusing to perform or permit an abortion. The Brownfield court concluded that the immunity did not apply to emergency contraception, which is a "pregnancy prevention" treatment.

A publication is available from the Center for Reproductive Rights that specifically addresses the legal issues surrounding emergency contraception services. To request a copy, contact:

Center for Reproductive Rights
120 Wall Street
New York, NY 10005
Phone: (917) 637-3600 Fax: (917) 637-3666
/

References

1. Trussell J, Stewart F, Guest F, Hatcher R. Emergency contraceptive pills: a simple proposal to reduce unintended pregnancies. Family Planning Perspectives 24(2):269-273, November/December 1992.

2. Trussell J, Koenig J, Ellertson C, Stewart F. Emergency contraception: a cost-effective approach to preventing unintended pregnancy. American Journal of Public Health 87(6), June 1997 (in press).

3. American College of Obstetricians and Gynecologists. Emergency Oral Contraception, ACOG Practice Pattern 3. Washington, DC, December 1996.

4. Planned Parenthood Federation of America (PPFA). Manual of Medical Standards and Guidelines (Draft). March 1997.

5. International Planned Parenthood Federation (IPPF). Medical and Service Delivery Guidelines for Family Planning. London, 1997 (in press).

6. Food and Drug Administration (FDA). Prescription drug products; Certain combined oral contraceptives for use as postcoital emergency contraception; Notice. Federal Register 62:8610-8612, February 25, 1997.

7. Hatcher RA, Trussell J, Stewart F, Stewart GK, Kowal D, Guest F, Cates W. Contraceptive Technology, Seventeenth Revised Edition. New York: Irvington Publishers, 1998 (in press).

8. Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI. Post coital contraception: a pilot study. Journal of Reproductive Medicine 13:53-58, 1974. Ê

9. Yuzpe AA, Lancee WJ. Ethinylestradiol and dl-norgestrel as a postcoital contraceptive. Fertility and Sterility 28(9):932-936, 1977.

10. Ho PC, Kwan MSW. A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception. Human Reproduction 8:389-392, 1993.

11. Swahn ML, Westlund P, Johannisson E, Bygdeman M. Effect of post-coital contraceptive methods on the endometrium and the menstrual cycle. Acta Obstetricia et Gynecologica Scandinavica 75:738-744, 1996.

12. Ling WY, Robichaud A, Zayid I, Wrixon W, MacLeod SC. Mode of action of DL-norgestrel and ethinylestradiol combination in postcoital contraception. Fertility and Sterility 32:297-302, 1979.

13. Rowlands S, Kubba AA, Guillebaud J, Bounds W. A possible mechanism of action of danazol and an ethinylestradiol/norgestrel combination used as postcoital contraceptive agents. Contraception 33:539-545, 1986.

14. Ling WY, Wrixon W, Acorn T, Wilson E, Collins J. Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception. III. Effect of preovulatory administration following the luteinizing hormone surge on ovarian steroidogenesis. Fertility and Sterility 40:631-636, 1983.

15. Kubba AA, White JO, Guillebaud J, Elder MG. The biochemistry of human endometrium after two regimens of postcoital contraception: a dl-norgestrel/ethinylestradiol combination or danazol. Fertility and Sterility 45:512-516, 1986.

16. Taskin O, Brown RW, Young DC, Poindexter AN, Wiehle RD. High doses of oral contraceptives do not alter endometrial a 1 and anb 3 integrins in the late implantation window. Fertility and Sterility 61:850-855, 1994.

17. Trussell J, Ellertson C, Stewart F. The effectiveness of the Yuzpe regimen of postcoital contraception. Family Planning Perspectives 28(2):58-64, 87, 1996.

18. Webb A, Taberner D. Clotting factors after emergency contraception. Advances in Contraception 9:75-82, 1993.

19. Bracken MB. Oral contraceptives and congenital malformations in offspring: a review and meta-analysis of the prospective studies. Obstetrics and Gynecology 76:552-557, 1990.

20. Cardy GC. Outcome of pregnancies after failed hormonal postcoital contraception: an interim report. British Journal of Family Planning

21:112115, 1995. 21. Guillebaud J. Contraception: Your Questions Answered. Second edition. Singapore, 1993.

22. Bagshaw SN, Edwards D, Tucker AK. Ethinyl oestradiol and D-norgestrel is an effective emergency postcoital contraceptive: a report of its use in 1,200 patients in a family planning clinic. Australian and New Zealand Journal of Obstetrics and Gynaecology 28:137-140, 1988.

23. Percival-Smith RK, Abercrombie B. Postcoital contraception with dl-norgestrel/ethinyl estradiol combination: six years experience in a student medical clinic. Contraception 36:287-293, 1987.

24. Grou F, Rodrigues I. The morning-after pill: how long after? American Journal of Obstetrics and Gynecology 171(6):1529-1534, 1994.

25. Trussell J, Ellertson C, Rodriguez G. The Yuzpe regimen of emergency contraception: how long after the morning after? Obstetrics and Gynecology 88(1):150Ð154, July 1996.

26. von Hertzen H and VanLook P. Research on new methods of emergency contraception. Family Planning Perspectives 28(2):52-57, 88, 1996.

27. Trussell J, Ellertson C. Efficacy of emergency contraception. Fertility Control Reviews 4(2):8-11, 1995.

28. Farley TMM, Rosenberg MJ, Rowe PJ, Chen J-H, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 339(8796): 785-788, March 28, 1992.

29. Food and Drug Administration (FDA). Use of approved drugs for unlabeled indications. FDA Drug Bulletin 12:1, 1982.

30. 21 CFR. § 202.1(e)(4)(iii) (1996).

31. Rarick L. Personal communication. March 27, 1997. 32. Brownfield v. Daniel Freeman Marina Hospital. No. B032109. Court of Appeals of California, Second Appellate District, Division Four. 208 Cal. App. 3d 405; 1989 Cal App. LEXIS 157;256 Cal. Rptr. 240. March 2, 1989.