Emergency Contraception

2. Emergency Contraception

3. Objectives • By the end of this presentation, participants will be able to • Discuss need for EC among adolescents • Describe clinical components of EC • Understand the challenges and opportunities for increasing EC use at the patient, provider, and health systems level

4. What Is Emergency Contraception (EC)? • A safe and effective way of preventing pregnancy in cases of • Contraceptive failure • No contraceptive use • Unplanned or forced intercourse • Reasonable effectiveness up to 120 hours after unprotected intercourse

5. The Need for EC in the Adolescent Population • The U.S. has one of the highest teen pregnancy rate in the industrialized world • 82% of teen pregnancies are unplanned (Henshaw, 2006)

6. Japan Teen Pregnancy Rates Worldwide, 2000(per 1000) United States

7. Unprotected Sex Happens to Even the Most Responsible Teens • 21% of females whose first sex was between 1999-2002 used no method of contraception • 16% of adolescents experience a contraceptive method failure during their first year of use

8. Female Contraceptive Use at First Intercourse by Year of First Premarital IntercourseNSFG, 2002

9. Contraceptive Use at Last Intercourse, High SchoolYRBS 2005

10. Sex is not always a choice. • >50% of all rapes occur in young women under 18 years old • For teens, 5.3% of rapes lead to a pregnancy

11. Indications for EC

12. To Err Is Human • Incorrect contraceptive use • Poor planning • Inconsistent contraceptive use

13. Method Failure: Patch • Patch off for 24 hours or more during patch-on weeks • More than two days late changing a patch • Late putting patch back on after patch-free week

14. Method Failure: Ring • Taken out for more than three hours during ring-in weeks • Same ring left in more than five weeks in a row • Late putting ring back after ring-out week

15. Method Failure: Other • Condom breaks or slips • Miss two or more active OCPs • DMPA shot 14 or more weeks ago • IUD expelling/expelled • three or more hours late taking a progestin-only pill • Diaphragm or cervical cap dislodges

16. Methods of EC

17. Plan B: Only Dedicated Product • Levonorgestrel-Only Pills (Plan B) • Two tabs of 750 mcg levonorgestrel • Approved in 1999 • OTC for 18 and older in 2006

18. Methods of Emergency Contraception: Additional Options • Birth control pills containing combined(Yuzpe method)ethinyl estradiol and either norgestrel or levonorgestrel

19. Regimen for OCs for Use as ECPs

20. The Copper-T Intrauterine Device (IUD) as EC • Insert within five days • Highly effective: Reduces risk of pregnancy by more than 99% • Rarely used for EC alone • Cannot use levonorgestrel IUD (Mirena) for EC

21. Regimens, Efficacy, and Mechanism of Action of Emergency Contraception Pills

22. Levonorgestrel-Only (Plan B): Regimen • Each packet includes • A single course of treatment • Both tablets may be taken at the same time (to increase compliance) with • No reduction in effectiveness • No increase in side effects Sources: von Hertzen et al. 2002; Arowojolu et al. 2002

23. When taken < 24 hours: Levonorgestrel: may prevent 95% of expected pregnancies Yuzpe: may prevent 77% of expected pregnancies When first dose is taken < 72 hours and second dose < 24 hours later: Levonorgestrel: may prevent 89% of expected pregnancies Yuzpe: may prevent 76% of expected pregnancies Levonorgestrel vs. Yuzpe (Combined) Method: Efficacy • Grimes D, et al. Lancet 1998.

24. How Long After the Morning After?2002 WHO Trial of Levonorgestrel-Only EC Regimen Taken in Single Dose p=.16 Von Hertzen H, et al. Lancet 2002;360:1803-1810

25. Primary Mechanism(s) of Action of Levonorgestrel-Only EC • Disrupts normal follicular development and maturation • Results in an ovulation or delayed ovulation w/a deficient luteal function • May also interfere w/sperm migration and function at all levels of the genital tract

26. Does Levonorgestrel-Only ECPrevent Implantation? • Two studies: No effect on the endometrium • One study: Taken before LH surge, altered luteal phase secretory pattern of glycodelin in serum and the endometrium Durand M, et al. Contraception 2001; Marions L, Obstet Gyn 2002 Durand M, et al. Contraception 2005

27. Does Levonorgestrel-Only ECPrevent Implantation? Probably Not • Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect Croxatto HB, et al. Steroids 2003; Mueller Al, et al. Contraception 2003; Ortiz ME, et al. Cebua apella. HumReprod 2004

28. Mechanism of Action: Combined ECPs (Yuzpe Method) • Can inhibit or delay ovulation • Older studies have shown histologic or biochemical alterations in the endometrium • More recent studies have found no such effects on the endometrium

29. Mechanism of Action: Combined ECPs (Yuzpe Method) • Additional possible mechanisms include • Dysfunctional ovulation • Interference w/corpus luteum function • Thickening of the cervical mucus • Alterations in tubal transport of sperm, egg, or embryo • Direct inhibition of fertilization • No clinical data exist regarding the last three of these

30. Side Effects and Complications:Levonorgestrel v. Yuzpe Method Significant at p<0.01

31. Safety • No deaths or serious complications have been causally linked to EC • No serious reactions have been reported • WHO Medical Eligibility Criteria • No situations in which risk of using Levonorgestrel-only or Yuzpe regimen EC outweigh benefits

32. Contraindications • Known or suspected pregnancy • Only because it is INEFFECTIVE, not because it is harmful • Will NOT increase the risk of miscarriage • Hypersensitivity to any component of the product • Undiagnosed abnormal genital bleeding PPFA, 2004

33. Adolescent Access to EC:Challenges and Opportunities

34. Challenges and Opportunities • To utilize EC, young women (under 18) must • Be aware of the option • Locate a provider • Obtain a prescription • Find the money to pay for the pills • Fill prescription at a pharmacy that has EC • Take pills at correct time

35. Challenges and Opportunities • Patient Level • Provider Level • Health Systems and Public Policy Level

36. Patient Level

37. Few Young Women Are Aware of EC as a Post-Coital Option • 28% of teen girls have heard of EC • 40% of teens who know about EC understand that the pills should be taken after, not before, sex

38. Misconceptions Create Barriers to EC Use • Beliefs that EC functions as an abortifacient • Fear that the drug would harm fetus • Confusion over fertility cycle and timing

39. Other Barriers • Perceived lack of confidentiality • Lack of money and/or insurance • Lack of transportation • Inability to locate a healthcare provider w/in the limited and effective timeframe • Belief that pelvic examination is mandatory • OTC exclusion of minors

40. Provider Level

41. Many Providers Do Not Routinely Discuss EC with Youth Patients • Of pediatricians with adolescent patients: • 20% report prescribing EC • 24% counsel teens about EC

42. Many Providers Are Uninformed About EC • 2001 survey of pediatricians found: • 72.9% were unable to identify any of the FDA-approved methods of EC • Only 27.9% correctly identified the timing for initiation • 31.6% felt comfortable prescribing EC

43. Provider Misconceptions and Bias Can Discourage Use • 2001 survey of pediatricians found • 22% believed that providing EC encourages adolescent risk-taking behavior • 52.4% would restrict the number of times they would dispense EC to a patient • 12% cited moral or religious reasons for not prescribing • 17% were concerned about teratogenic effects

44. Opportunities Facilitating Use • No pelvic examination or pregnancy test required by ACOG or FDA • Pregnancy test prior to EC treatment is recommended only if: • Other episodes of unprotected sex occurred that cycle • LMP (last menstrual period) was not normal in duration, timing, or flow

45. Counseling Patients to Facilitate Use • Discuss EC at all patient visits w/all patients, including males and non-sexually active teens • Assess patient’s previous knowledge of EC • Discuss patient’s definition of “unprotected sex” • When should patient fill/call in for prescription for EC • Frame scenarios according to patient’s current contraceptive plan, how it might fail, and how and when to use EC

46. Counseling Patients to Facilitate Use • Providers must take into account patient’s • Knowledge of reproductive physiology • Ability to understand the prescribed regimen • Moral perceptions of contraception • Misconceptions about the drug’s mechanism of action • Economic barriers that may restrict access

47. Facilitating Use • Write: advanced prescription w/ multiple refills (12 refills recommended) • Discuss: condoms and assess for STI risk • Explain: EC is not an abortifacient, nor is it teratogenic

48. Counseling Patients to Facilitate Use • Instruct patient on use • More effective the sooner it is taken • Taking two pills at once increases compliance • No increase in side effects • Check if they don’t have a menstrual period w/in three weeks after taking EC

49. Facilitating Use • List yourself as an EC provider on www.not-2-late.com • Compile list of pharmacists in area that prescribe EC • Refer patients to • www.not-2-late.com • 1-888- NOT-2-LATE

50. Counseling Key Points • Taking EC once during the cycle does not protect women from pregnancy for the entire cycle • Having unprotected sex after EC use can increase pregnancy risk • To be effective, EC must be used each and every time a woman has unprotected sexual intercourse