1. Emergency contraception: an important part of primary care Julie Fagan, M.D. 23 February 2005

2. Learning Objectives Understand why emergency contraception is important in primary care List the types of and effectiveness rate for various types of EC Be able to prescribe EC and counsel women about risks, benefits, alternatives Discuss with patients and prescribe EC in advance, to enhance effectiveness

3. Conflicts This talk was not sponsored by any drug or device manufacturer.

4. Emergency contraception ½ of all pregnancies in the US are unintended About 3.2 million/year ~25,000 of which result from sexual assault ½ of those end in abortion ~ 1.5 million Conservatively, EC could prevent ½ of unintended pregnancies ~ 1.5 million Over 700,000 abortions could be avoided per year

5. What is emergency contraception? Emergency contraception is NOT medical abortion: it does not cause abortion/miscarriage Involves using a contraceptive after unprotected intercourse to PREVENT a pregnancy, in the same way oral contraceptives and breastfeeding do (by blocking fertilization or implantation) Poses no significant health risk to an existing pregnancy or pregnant woman Hormonal and intrusion methods available

6. NARAL Pro-Choice Wisconsin Foundation Provider EC Education Project (PEEP) Educate primary care providers about EC Encourage advance prescription of EC by PCPs to minimize use of the ER Address perceived barriers to using EC among providers Increase EC access to reduce unintended pregnancy

7. Types of EC commonly used Combination estrogen and progestin (Yuzpe method) Progestin only IUD

8. Yuzpe method Can use regular OCPs or prepackaged Preven (now off the market). Most effective within 72 hours after unprotected intercourse Two doses of pills, 12 hours apart Most common side effects are nausea (30- 50%) and vomiting (15-20%) Should also prescribe an antiemetic

9. Antiemetic regimens commonly used Meclizine –25-50 mg 1 hour before 1 st dose Promethazine –25 mg po or pr 30-60 minutes before each dose and prn q6-8h Trimethobenzamide –250 mg 1 hour before each dose

10. Progestin-only Usually equals a dose of 0.75mg of Levonorgestrel Packaged as “Plan B” Can also use Ovrette ocps –Take 20 pills at once As effective as Yuzpe method but much lower risk of nausea and vomiting –23% and 5% respectively

11. “Plan B” Originally prescribed as two doses, 12 hours apart 2002 study found that a single dose of 1.5 mg of Levonorgestrel (twice the original dose) is as effective as dividing the dose New recommendation: take 2 pills at once Lancet 2002;360:1803-10

12. Side Effects: ECPs WHO Task Force. Lancet 1998;352:428 NauseaVomiting Progestin Only23%6% Combination (Yuzpe)50%19% RR.46.28 ARHP

13. Levonorgestrel vs. Yuzpe: Side Effects Levonorgestrel Yuzpe * Significant at p<0.01 23% Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433. 51%* 6% 19%* 11% 17%* 29%* 17% Contraception online

14. Single- vs. Two-Dose Levonorgestrel: Side Effects Single-Dose Levonorgestrel Two-Dose Levonorgestrel 14% von Hertzen H, et al. Lancet. 2002;360:1803-1810. 15% 1% 4%3% 14% 18% 8% 31% 5% 0% Contraception online

15. Effectiveness Decreases pregnancy rate by 75% if taken within 72 hours of unprotected intercourse –If 100 women have unprotected intercourse during the middle of their cycles, you expect 8 to get pregnant. If all of the women use EC, only 2 will get pregnant. –New study shows that may be effective for up to 5 days

16. Proportion of Pregnancies Prevented by Levonorgestrel vs. Yuzpe Regimen* Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433. 85% 71% 57% 39% 93% 74% * 95% CI Contraception online

17. Proportion of Pregnancies Prevented by Levonorgestrel vs. Yuzpe, by Timing of Treatment Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433. Levonorgestrel Yuzpe Timing of Treatment (hours) 58% 31% 36% 85% 95% 77% Contraception online

19. Effectiveness Levonorgestrel alone was slightly more effective than estrogen/progestin method Single dose Plan B is now the first line method of EC to be used –Cheng L, et al. Interventions for emergency contraception (Cochrane Review). In: The Cochrane Library, Issue 2 2003. Oxford: Update Software.

20. Emergency Contraceptive Effectiveness # of Pregnancies% Reduction No treatment80 Combined ECPs2075% Progestin-Only ECPs 1088% IUD Insertion199% If 1000 women have unprotected sex once in the second or third week of their cycle ARHP data

21. Contraindications Pre-existing pregnancy is the only contraindication, due to the ineffectiveness of the method May not be appropriate in a woman with an active migraine with neurologic symptoms

22. Conflicting Contraindications: Combined ECPs World Health Organization –Confirmed pregnancy Faculty of FP and RH Care (United Kingdom) –Confirmed pregnancy –Migraine at presentation (if Hx of focal migraine) –Past Hx of thromboembolism (relative contraindication) Planned Parenthood Federation of America –Suspicion or evidence of established pregnancy WHO Emergency Contraception: A Guide for Service Delivery 1998 Kubba. Emergency Contraception Guidelines for Doctors 1995 PPFA Manual of Medical Standards and Guidelines 1998 ARHP data

23. How do the pills work? If taken before ovulation, may disrupt follicular development and maturation, causing either delayed ovulation or anovulation and/or an impaired luteal phase. May also decrease endometrial receptivity to implantation and impair corpus luteum function

24. Other possible mechanisms of action (cont.) Cause thick cervical mucus Alter tubal transport Inhibit fertilization

25. IUD as EC IUD insertion within 5 days of unprotected intercourse is almost 100% effective in preventing a pregnancy. Probably interferes with implantation May need to use prophylactic antibiotics because same women may be at high risk for sexually transmitted infections

26. Access to EC in WI—why advance prescription is important Only 50% of Wisconsin ERs prescribe EC Only 43% of hospitals dispense EC 28% of WI hospitals will not prescribe EC to victims of sexual assault In hospitals that do not prescribe EC, only 47% will provide a referral NARAL, 2002 Wisconsin Reproductive Access Project findings

27. Advance Prescription: issues Does it promote sexual risk taking behavior? Does it encourage women to use reliable contraception less? Do women use EC as a birth control method?

28. Results in Scotland Women who received ECPs in advance Were more likely to use ECPs: –47% vs. 27% of women who received only counseling (p<.001) Were not more likely to use ECPs repeatedly Used other methods of contraception equally well Had fewer unintended pregnancies –3.3% vs 4.8 % for women who received only counseling (p=0.14) Glasier and Baird, N Engl J Med 1998;339:1 ARHP

29. Results in San Francisco: Women who received ECPs in advance Were more likely to use ECPs –22% vs 7% of women who received only counseling (p=.006) Were not more likely to have unprotected sex Were not less likely to use condoms consistently Were less likely to use oral contraceptives consistently –32% vs. 58% of women who received only counseling (p=.03) Raine et al. Obstet Gynecol 2000;96:1 ARHP

30. Randomized trial of advance supply of EC Women with advance Rx were 4 times as likely to use EC in the following year (17% vs. 4%) No difference in use of effective birth control or consistency of use Same incidence of unprotected intercourse: women with Rx were 6 times as likely to use EC Jackson, et al. Obstetrics and Gynecology 2003;102:8-16.

31. Advance Provision of EC: Teens * Prospective randomized trial at urban, hospital-based adolescent clinic 301 minority, low-income women age 15-20 years Advance provision/Rx vs. instructions on how to get EC At 1 month, advance Rx group reported nearly twice as much use as control group –15% vs. 8%, p=0.05 Advance EC group began EC significantly sooner –11.4 h vs. 21.8 h, p=0.005 No detrimental effects on condom or hormonal contraceptive use No increase in unprotected intercourse Gold MA, et al. J Pediatr Adolesc Gynecol. 2004;17:87-96. Contraception online

32. Advance Rx vs. Patient request Women do not know to ask for Advance Rx: –While 76% of women have heard of ECPs or morning-after pills –Only 16% of women know 72-hour time frame –Only 2% of women have ever used ECPs ARHP data

33. Emergency Contraception OTC ECPs are available directly from pharmacists without a prescription in: –California –Washington State –Hawaii –Maine –New Mexico –Legislation pending in 8 other states –British Columbia –France –United Kingdom –South Africa –Portugal –Belgium –Albania –Denmark –Sweden ARHP data

34. Response to Pharmacy Availability: Washington State 10,000 patient visits per year 42% of visits were during evenings, weekends, or holidays 95% of women had sufficient opportunity to ask questions 85% of women were satisfied with the on-going contraceptive counseling provided by pharmacists Medicaid projects savings of up to $10 million/year ARHP data

35. Emergency Contraception: Rx by Telephone 3 questions to ask: –Have you had unprotected sex or a problem with your birth control (such as condom breakage) during the last 3 days (rule out sexual assault)? –Did your last menstrual period begin less than 4 weeks ago? –Was the timing and duration of your last menstrual period normal? If the patient responds “yes” to all 3 questions, a clinician may prescribe emergency contraception over the telephone Adapted from ACOG, Emergency Contraception: A Resource Manual for Providers, 1998. Contraception online

36. Patient Counseling for EC Use of antiemetic (Rx or OTC) 1 hour prior to first dose of Yuzpe Expected side effects (nausea/vomiting/cramping) When to expect menses (up to 98% bleed within 21 days of EC) If no menses after 3 weeks, rule out pregnancy May discuss future contraceptive needs, STD risk How to take medication (give written instructions when possible) Assess for sexual assault LaValleur J. Obstet Gynecol Clin North Am. 2000;27(4): 817-839. ACOG Practice Bulletin. Int J Gynecol Obstet. 2002;78:191-198. Contraception online

37. Strategies to compensate for conflicting views among partners One back up partner on call for EC requests Provide advance prescriptions to minimize use of on-call system Open communication among call group

38. Resources: Emergency Contraception Hotlines –1-888-NOT-2-Late or 800-584-9911 Web Sites –http://www.NOT-2-Late.orghttp://www.NOT-2-Late.org http://www.ec.princeton.edu/ –http://www.PREVEN.comhttp://www.PREVEN.com –http://kaisernetwork.orghttp://kaisernetwork.org –http://cecinfo/html/updates.htm (emergency contraception newsletters)http://cecinfo/html/updates.htm –http://www.acog.orghttp://www.acog.org –http://www.go2ec.org/http://www.go2ec.org/ –http://www.prch.org Contraception online

39. Summary: EC is a safe, easy-to-use method of preventing pregnancy after unprotected intercourse or sexual assault Advance Rx of EC should be a regular part of primary care for women Increased advance Rx will significantly reduce unintended pregnancies and abortion Advance Rx of EC does not negatively impact use of other birth control or increase unprotected intercourse PCPs should lead in making EC more accessible to women through regular and routine advance Rx