Emergency Contraception and Adolescents

1. Emergency Contraception and Adolescents

2. 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.

3. 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. • Some methods very effective up to 120 hours after unprotected intercourse.

4. Adolescents Need EC • The U.S. has one of the highest teen pregnancy rates in the industrialized world. • 82% of teen pregnancies are unplanned.

5. Teen Pregnancy Rates Worldwide Teen Pregnancies per 1000 Population

6. Unprotected Sex Happens • Sexually active females ages 15–19 report: • 21% used no method at first intercourse • 16% used no method at most recent intercourse • 13% of adolescents experience a contraceptive method failure during their first year of use

7. Female Contraceptive Use at First Intercourse by Year of First Intercourse 2006–2008 National Survey of Family Growth

8. Contraceptive Use, YRBS 2009 Percent of US High School Students Reporting Use of a Contraceptive Method at Last Intercourse 8.9% of students reported using both a condom and either birth control pills or injectable contraception

9. Sexual Assault and EC • >50% of all rapes occur in young women under 18 years old. • For teens, 5.3% of rapes lead to a pregnancy. • Emergency contraception should be offered to all survivors of sexual assault.

10. Indications for EC

11. Human Error • Inconsistent contraceptive use • Incorrect contraceptive use • Unplanned intercourse

12. 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

13. 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

14. Method Failure: Others • Condom breaks or slips • Two or more missed active OCPs • DMPA shot 14 or more weeks ago • Expelled IUD • Three or more hours late taking a POP • Diaphragm or cervical cap dislodges

15. Methods of EC

16. Brand Name Levonorgestrel ECPs • Dedicated Product: Plan B One-Step® • FDA approved July 2009 • Single tablet formulation 1.5 mg of levonorgestrel • Original Plan B® • Two tabs of 750 mcg levonorgestrel • Approved in 1999 • Approved for OTC 18 and older in 2006 • Both are now OTC for 17 and older

17. GenericLevonorgestrel EC • Next ChoiceTM, a generic dedicated product approved June 2009 • Two tabs of .75 mg levonorgestrel • For prescription use by women 16 and younger • OTC for women 17 and older

18. Brand NameUlipristal Acetate EC • ella® • FDA approved in August 2010 • Single tablet of 30 mg ulipristal acetate • Only available by prescription

19. Summary: FDA Approved Dedicated EC Products • Original PlanB® • Now discontinued • Two doses • ella® • Single dose

20. Summary: FDA Approved Dedicated EC Products • Plan B OneStep® • Single dose • NextChoiceTM • Generic • Two doses

21. Combined Oral Contraceptives as ECPs • Yuzpe method • Combined oral contraceptive pills (OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel

22. The Copper-T Intrauterine Device • 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

23. Clinical Components of EC • Regimens • Efficacy

24. Levonorgestrel-Only Regimen • Each packet includes: • A single course of treatment • For two dose regimens: • Both tablets may be taken at the same time (to increase compliance) with • No reduction in effectiveness • No increase in side effects

25. Ulipristal Acetate Regimen • Each packet includes • A single course of treatment

26. LevonorgestrelEfficacy • Exact efficacy rates are difficult to determine • Minimum efficacy for levonorgestrel regimen is 49% • Can substantially reduce the chance of pregnancy after an episode of unprotected sex • Most effective the sooner it is taken

27. Levonorgestrel: 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

28. Ulipristal AcetateEfficacy • Two randomized clinical trials determined that the failure rate was around 2% • Up to 120 hours after unprotected intercourse • Unlike levonorgestrel, it does not decrease in efficacy between 72 and 120 hours

29. Mechanism of Action of Levonorgestrel-Only EC • Disrupts normal follicular development and maturation • Results in ovulation or delayed ovulation with deficient luteal function • May also interfere with sperm migration and function at all levels of the genital tract

30. Mechanism of Action of Ulipristal Acetate EC • Precise mechanism of action unknown • Thought to delay mid-cycle LH surge and thereby delay ovulation • May also interfere with sperm’s ability to reach and fertilize an egg, should ovulation occur

31. Does ECPrevent Implantation? • LNG EC • 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 • Ulipristal acetate • May depress endometrial enrichment, thereby discouraging implantation • More research needed to confirm • No evidence of interrupting cells after implantation

32. Does Levonorgestrel-Only EC Prevent Implantation? • Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect

33. Mechanism of Action: Combined ECPs • Can inhibit or delay ovulation • Older studies have shown histologic or biochemical alterations in the endometrium • Recent studies found no such effects on the endometrium

34. Mechanism of Action: Combined ECPs • Additional possible mechanisms: • 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 these mechanisms

35. Side Effects & Complications:Comparing Hormonal Methods Significant at p<0.01

36. EC Is Safe • 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 EC outweigh benefits

37. Levonorgestrel ECContraindications • 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

38. Ulipristal Acetate ECContraindications • Known or suspected pregnancy • Limited data suggests that ulipristal acetate will not affect an existing pregnancy • More research needs to be done to confirm

39. Adolescent Access to EC: Challenges & Opportunities

40. Challenges and Opportunities • To utilize EC, young women (under 17) 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.

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

42. Patient Level

43. Few Young Women Are Aware of EC • 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 • Since ella® has recently been approved, awareness of this drug is expected to be much lower

44. Patient 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

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

46. Provider Level

47. Many Providers Do Not Discuss EC with Young Patients • Of pediatricians with adolescent patients: • 20% report prescribing EC • 24% report counseling adolescents about EC

48. Providers Need More Training About EC • As ella® becomes more widely available, physicians will need to learn about this option • A 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

49. Provider Misconceptions 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

50. Providers Can Remove Clinical Barriers to EC • 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