EMERGENCY CONTRACEPTION

1. EMERGENCY CONTRACEPTION “Beyond Coca-Cola” - ECPs & IUDs Barb Orcutt, CNM 2/2004

2. In the US, EC could potentially prevent up to 1.7 million unintended pregnancies and 800,000 abortions each year

3. A PILOT PROJECT - • in the state of Washington • a pilot project for 16 months • allowed easier access to EC by providing it directly through 130 participating pharmacies • prevented an estimated 700 unintended pregnancies and 350 abortions

4. DID YOU KNOW - • 3.04 million unintended pregnancies in 1994 • 48% of all pregnancies were unintended • 47% of unintended pregnancies ended in abortion, 40% in birth, 13% in miscarriage

5. 53% of the women with unplanned pregnancies were using contraception • 48% of women aged 15-44 have had an unplanned pregnancy • 60% of women aged 35-39 have had an unplanned pregnancy

6. ANYONE CAN FORGET HER OCPS!

7. HISTORY of EC - • "First immediately after ejaculation let the two come apart and let the woman arise roughly, squeeze and blow her nose seven times and call out in a loud voice. She should jump violently backwards seven to nine times." • Abu Bakr Muhammad ibin Zakariya' al-Razi (865 AD-925 AD)

8. HISTORY of EC - • Hormonal methods originated in mid-1920s with discovery that estrogenic ovarian extracts have anti-fertility effect • High-dose estrogen (DES or EE) post-coitally as a treatment for rape survivors in the 1960s

9. HISTORY of EC - • How about a post-coital Coca-Cola douche! • (The New England Journal of Medicine published a study on that one as late as the 1980s.)

10. CURRENT EC - • Yuzpe’s original article – 1974 • Dosage was two doses of two Ovral tablets, 12 hours apart • within 72 hours of unprotected intercourse • Effectiveness believed to be about 95% • Problems = nausea, time frame

11. Other Regimens – 2 doses, 12 hrs apart • Ogestrel – 2 white pills per dose • Levora – 4 white pills per dose • LoOvral – 4 white pills per dose • Levlen – 4 light orange pills per dose • TriLevlen – 4 yellow pills per dose

12. Copper IUDs also are EC- first reported in 1976 • Advantages: • Decreases risk of pregnancy by 99% if used within 5 days of unprotected intercourse • Can be left in place for ongoing effective contraception for up to 10 years • Disadvantage • Not a good option for women who are at risk for STDs – pre-RX?

13. ANTIPROGESTINS • Different action from its use in medical abortion, same dose • A single 600mg dose of Mifepristone (RU-486) within 72 hrs after unprotected intercourse is highly effective • Fewer side-effects than Yuzpe • 10mg dose may be equally effective

14. PLAN B® - • Levonorgestrel 0.75mg per dose (1 pill), x 2 doses, packaged as EC • Approved by FDA in 1999, Rx only • More effective than Yuzpe regimen of combination OCs • Less nausea, fewer side-effects • As of April 2003, more than 3 million doses sold

15. PLAN B® • OTC “behind the counter” in 5 states – WA, CA, AK, HI, NM • Dec. 2003 – FDA advisory committee endorsed OTC sale • Feb. 2004 – strong political pressure to reject OTC sales • FDA decision pended until May

16. How do ECPs work? • Emergency contraceptives work before implantation and not after a woman is already pregnant

17. EC Does Not Cause Abortion - • “Pregnancy” is medically defined as the implantation of a fertilized egg in the lining of a woman's uterus

18. PLAN B® –MECHANISM OF ACTION • The exact mechanism of action may vary from woman to woman and may depend on the day of the menstrual cycle on which treatment is started • (DO NOT try to calculate by her menstrual cycle how likely it is or isn’t that she might get pregnant – just get it to her as soon as possible no matter where she is in her cycle)

19. Levonorgestrel, the active ingredient in Plan B®, is believed to act principally by interfering with the process of ovulation • It may inhibit tubal transport of the egg or sperm • It may also interfere with fertilization or implantation

20. IF YOU CARE ABOUT DISRUPTING A FERTILIZED EGG -- • the sooner ECPs are taken, the more likely they are to alter ovulation, and less likely to inhibit implantation after fertilization • PROVIDE ECP IN ADVANCE!

21. EFFECTIVENESS • Recent studies indicate that BOTH types of pills (combination OCPs as well as Plan B) are effective when the first dose is started up to 5 days (120 hours) after unprotected intercourse

22. EFFECTIVENESS • However, a recent large study by the World Health Organization found effectiveness declined significantly with increasing delay between unprotected intercourse and the initiation of treatment

23. EFFECTIVENESS – PLAN B® INFORMATION • Early treatment is significantly more effective. For emergency contraception generally, each 12 hours of delay in the start of treatment reduces efficacy by 50%

24. EFFECTIVENESS –PLAN B® INFORMATION • Plan B® prevents 95% of expected pregnancies when taken in the first 24 hours after a single act of unprotected intercourse, reducing the crude pregnancy rate from about 8% with no treatment, down to 0.4%

25. EFFECTIVENESS –PLAN B® INFORMATION • If treatment is delayed 25-48 hours, efficacy declines to 85%, and if treatment is delayed beyond 48 hours, efficacy declines to 61%

26. But - one observational study cited by ACOG found that differences in success rates for women taking EC within either 72 hours or 120 hours of intercourse were not statistically significant

27. EFFECTIVENESS?? • Clinical trials demonstrated a higher pregnancy rate in Chinese populations with both Plan B® and the combination Yuzpe regimen • It is unknown as to exactly what the effectiveness may be in our patient populations

28. Dosage Adjustments • Recent studies indicate that BOTH doses of PLAN B can be taken at the same time with no decrease in efficacy • At least consider the timing of the second dose – earlier than 12 hours is OK

29. Dosage Adjustments • Efficacy of emergency contraceptive pills may be reduced in women also taking Dilantin or other enzyme inducers • No official recommendations exist for this situation • Informal - patients should double the amount of hormone in the first of the two ECP doses

30. Dosage Adjustments • If taking St. John's Wort – • ECPs may not work quite as well as they would otherwise • - but might still work well enough • Some advise to increase the number of pills in each dose by 50%

31. Dosage Adjustments • If doubling or increasing doses, consider ordering Meclizine • 25-50 mg before the first dose of ECPs

32. CONTRAINDICATIONS • The only absolute contraindication is PREGNANCY • Plan B® will have no effect • No evidence that there is any harm to a fetus

33. CONTRAINDICATIONS • Women with undiagnosed abnormal genital bleeding probably should not use emergency contraception

34. CONTRAINDICATIONS • Women should not use Plan B® if they might be hypersensitive to any component of the product • Women who should not use OCPs as a regular method are generally safe using occasional EC

35. Will women stop using other forms of contraception if EC becomes too easily available?

36. Studies have shown that women given ECPs in advance do not abandon other more reliable BCMs

37. Why don’t they? • ANY other BCM is more effective than ECPs! • ECPs are more expensive than most other BCMs! • ECPs contain a higher dose of hormones than ongoing BCPs • Nausea & cycle irregularity might deter routine use

38. OFFER ANOTHER METHOD! • Given that EC is less effective than ANY other ongoing contraception, offer another method while you’re counseling your patient • Condoms and other barrier methods can be provided immediately

39. OFFER ANOTHER METHOD! • Oral contraceptives and IUDs may be initiated immediately following Plan B® treatment or after the next menses • If waiting until the next menses, impress upon the woman that she should have no unprotected intercourse while waiting!

40. OFFER ANOTHER METHOD! • If oral contraceptives are initiated before the next menses, a follow-up pregnancy test is recommended, since the OCPs will change the bleeding pattern and make it difficult to tell if a woman is pregnant or not

41. PLAN B® • About 58 percent of users will have their next menses on time or a few days early or late • If no menses by 3 weeks, should get a pregnancy test

42. Will men be less likely to use condoms? • ECPs don’t protect against STDs • Condom use is critical for those at risk of STD • Men & women may feel more comfortable using condoms if they know EC is available if a condom slips or breaks • PLAN B has a note in the instructions about STD screening

43. What we know - • A Kaiser study found that 100% of obstetrician/gynecologists believe that ECPs are safe and effective

44. What we do - • - only 10% of OB/Gyns routinely discuss EC with patients • - only 24% prescribe ECPs more than 5 x a year

45. ACOG – Feb. 2002 • “Clinicians should proactively talk to their patients of reproductive age about ECPs and offer advance prescriptions for ECPs during routine gynecologic office visits….” • Remind women to check expiration dates if bought ahead

46. RESOURCES & FAQs • www.uptodateonline.com • http://www.plannedparenthood.org/library/BIRTHCONTROL • www.NOT-2-LATE.com • www.backupyourbirthcontrol.org • 1-888-NOT2LATE

47. Thanks for your attention – HAPPY TRAILS!