1. Adolescent Reproductive & Sexual Health Education Project Adolescent Reproductive & Sexual Health Education Project Emergency Contraception and Adolescents

2. Emergency Contraception PRCH 2012  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. Objectives

3. Emergency Contraception PRCH 2012  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. What Is Emergency Contraception (EC)?

4. Emergency Contraception PRCH 2012  The U.S. has one of the highest teen pregnancy rates in the industrialized world.  82% of teen pregnancies are unplanned. Adolescents Need EC

5. Emergency Contraception PRCH 2012 Teen Pregnancy Rates Worldwide Teen Pregnancies per 1000 Population

6. Emergency Contraception PRCH 2012  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 Unprotected Sex Happens

7. Emergency Contraception PRCH 2012 2006–2008 National Survey of Family Growth Female Contraceptive Use at First Intercourse by Year of First Intercourse

8. Emergency Contraception PRCH 2012 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. Emergency Contraception PRCH 2012  >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. Sexual Assault and EC

10. Emergency Contraception PRCH 2012 Indications for EC

11. Emergency Contraception PRCH 2012  Inconsistent contraceptive use  Incorrect contraceptive use  Unplanned intercourse Human Error

12. Emergency Contraception PRCH 2012  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 Method Failure: Patch

13. Emergency Contraception PRCH 2012  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 Method Failure: Ring

14. Emergency Contraception PRCH 2012  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 Method Failure: Others

15. Emergency Contraception PRCH 2012 Methods of EC

16. Emergency Contraception PRCH 2012  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 Brand Name Levonorgestrel ECPs

17. Emergency Contraception PRCH 2012  Next Choice TM, 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 Generic Levonorgestrel EC

18. Emergency Contraception PRCH 2012  ella ®  FDA approved in August 2010  Single tablet of 30 mg ulipristal acetate  Only available by prescription Brand Name Ulipristal Acetate EC

19. Emergency Contraception PRCH 2012  Original PlanB ®  Now discontinued  Two doses  ella ®  Single dose Summary: FDA Approved Dedicated EC Products

20. Emergency Contraception PRCH 2012  Plan B OneStep ®  Single dose  NextChoice TM  Generic  Two doses Summary: FDA Approved Dedicated EC Products

21. Emergency Contraception PRCH 2012  Yuzpe method  Combined oral contraceptive pills (OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel Combined Oral Contraceptives as ECPs

22. Emergency Contraception PRCH 2012  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 The Copper-T Intrauterine Device

23. Emergency Contraception PRCH 2012  Regimens  Efficacy Clinical Components of EC

24. Emergency Contraception PRCH 2012  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 Levonorgestrel-Only Regimen

25. Emergency Contraception PRCH 2012  Each packet includes  A single course of treatment Ulipristal Acetate Regimen

26. Emergency Contraception PRCH 2012  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 Levonorgestrel Efficacy

27. Emergency Contraception PRCH 2012 Levonorgestrel: How Long After the Morning After? p=.16 Von Hertzen H, et al. Lancet 2002;360:1803–1810 2002 WHO Trial of Levonorgestrel-Only EC Regimen Taken in Single Dose

28. Emergency Contraception PRCH 2012  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 Ulipristal Acetate Efficacy

29. Emergency Contraception PRCH 2012  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 Mechanism of Action of Levonorgestrel-Only EC

30. Emergency Contraception PRCH 2012  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 Mechanism of Action of Ulipristal Acetate EC

31. Emergency Contraception PRCH 2012  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 Does EC Prevent Implantation?

32. Emergency Contraception PRCH 2012  Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect Does Levonorgestrel-Only EC Prevent Implantation?

33. Emergency Contraception PRCH 2012  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 Mechanism of Action: Combined ECPs

34. Emergency Contraception PRCH 2012  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* Mechanism of Action: Combined ECPs *No clinical data exist regarding these mechanisms

35. Emergency Contraception PRCH 2012 Side Effects & Complications: Comparing Hormonal Methods Significant at p<0.01

36. Emergency Contraception PRCH 2012  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 EC Is Safe

37. Emergency Contraception PRCH 2012  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 Levonorgestrel EC Contraindications

38. Emergency Contraception PRCH 2012  Known or suspected pregnancy  Limited data suggests that ulipristal acetate will not affect an existing pregnancy  More research needs to be done to confirm Ulipristal Acetate EC Contraindications

39. Emergency Contraception PRCH 2012 Adolescent Access to EC: Challenges & Opportunities

40. Emergency Contraception PRCH 2012  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. Challenges and Opportunities

41. Emergency Contraception PRCH 2012  Patient Level  Provider Level  Health Systems and Public Policy Level Challenges and Opportunities

42. Emergency Contraception PRCH 2012 Patient Level

43. Emergency Contraception PRCH 2012  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 Few Young Women Are Aware of EC

44. Emergency Contraception PRCH 2012  Beliefs that EC functions as an abortifacient  Fear that the drug would harm fetus  Confusion over fertility cycle and timing Patient Misconceptions Create Barriers to EC Use

45. Emergency Contraception PRCH 2012  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 Other Barriers

46. Emergency Contraception PRCH 2012 Provider Level

47. Emergency Contraception PRCH 2012  Of pediatricians with adolescent patients:  20% report prescribing EC  24% report counseling adolescents about EC Many Providers Do Not Discuss EC with Young Patients

48. Emergency Contraception PRCH 2012  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 Providers Need More Training About EC

49. Emergency Contraception PRCH 2012  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 Provider Misconceptions Can Discourage Use

50. Emergency Contraception PRCH 2012  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 Providers Can Remove Clinical Barriers to EC

51. Emergency Contraception PRCH 2012  Discuss EC with ALL patients  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 To Facilitate Use, Providers Can

52. Emergency Contraception PRCH 2012  Providers must take into account patient’s:  Knowledge of reproductive physiology  Ability to understand the regimen  Moral perceptions of contraception  Misconceptions about the drug’s mechanism of action  Barriers that may restrict access Providers Can Facilitate Use

53. Emergency Contraception PRCH 2012  Instruct patient on use:  More effective the sooner it is taken  Taking two pills at once (when applicable) increases compliance and no increase in side effects  Call provider if there is no menstrual period within three weeks after taking EC Providers Can Facilitate Use

54. Emergency Contraception PRCH 2012  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. Counseling Key Points

55. Emergency Contraception PRCH 2012 Facilitating Use in Practice  Write: advanced prescription with multiple refills (12 recommended)  Discuss: condoms and assess for STI risk  Explain: EC is not an abortifacient, nor is it teratogenic

56. Emergency Contraception PRCH 2012  Train office staff on EC  Importance of timely appointments  Lack of required exam for prescriptions  LNG EC is OTC for patients 17 and older Facilitating Use in Practice

57. Emergency Contraception PRCH 2012 Facilitating Use in Practice  List yourself as an EC provider on www.not-2-late.com  Compile list of pharmacists in area that dispense EC  Refer patients to www.not-2-late.com

58. Emergency Contraception PRCH 2012  Cost of EC may prohibit multiple use within a cycle (~$25–$50)  Cost of ella ® expected to be higher  During visit, discuss alternative and ongoing methods of contraception that are more effective and less expensive Opportunities for Bridging Contraceptive Services

59. Emergency Contraception PRCH 2012  Have you tried anything to prevent pregnancy in past?  Any problems with a previous method?  Trouble remembering to take the pill?  Concerns over privacy with the pill/patch?  Difficulty using condoms consistently?  Cost barriers? Counseling Teens About Contraception Method

60. Emergency Contraception PRCH 2012  Consider QuickStart initiation of an ongoing birth control method on day of EC administration  Use backup method with ella ® until next menstrual period  Patient should bleed in ~two weeks  If administering DMPA:  Patient should return in two weeks for pregnancy test Initiating Contraception: Quickstart

61. Emergency Contraception PRCH 2012  Display posters and materials about EC  Work with teen patients to establish a “plan” in the event of contraceptive failure, including identifying:  A pharmacy that will fill prescription  A method of transportation to pharmacy  A means of locating or borrowing funds for pills Provider Opportunities for Facilitating Use

62. Emergency Contraception PRCH 2012  If provider does not feel comfortable or competent counseling patient or writing prescription for EC:  S/he must make a referral to someone who can  Refer patient to www.not-2-late.com Provider Level: Ethical Obligations

63. Emergency Contraception PRCH 2012 Health Systems and Public Policy Level

64. Emergency Contraception PRCH 2012 Path to OTC Access: August 2006 FDA announced that Plan B ® will be available OTC to women 18 and older Minors still need to obtain a prescription (in states without pharmacy access) No medical or public health reason for limiting adolescents’ access to LNG EC

65. Emergency Contraception PRCH 2012 2009 Court Decisions 65 US District Court rules: FDA must make Plan B available to women 17 and older within 30 days and reconsider the scientific evidence supporting any age limit on access to EC Women 16 and younger still need a prescription to access EC March 2009

66. Emergency Contraception PRCH 2012 Generic Dedicated EC Product Approved Generic dedicated LNG EC product, NextChoice TM approved by the FDA to be available by prescription only NextChoice TM approved for OTC sales to women 17 and older June 2009 August 2009

67. Emergency Contraception PRCH 2012 Single-Dose Dedicated EC Product Approved 67 FDA approves Plan B OneStep ® with a dual label Women 16 and younger still need a prescription to access EC July 2009 OneStep ® begins to replace original Plan B in pharmacies

68. Emergency Contraception PRCH 2012 Single-Dose Dedicated EC Product Approved 68 FDA approves ella ® ella ® is a prescription-only product August 2010 Upon approval, new drugs are limited to prescription-only status for at least two years

69. Emergency Contraception PRCH 2012  Generics free to enter the market  Until Aug 2012, Plan B ® has market exclusivity on single dose LNG products  FDA still under obligation to reconsider age restrictions  Data still supports increased access for minors  Marketing and distribution of ella ® What’s Next for EC?

70. Emergency Contraception PRCH 2012  In the early stages of its approval, providers and patients may not know about this EC option  Until use becomes common, may not be regularly stocked in pharmacies  Cost expected to be higher than that of levonorgestrel methods  Confusion over when to prescribe ella ® versus when to recommend levonorgestrel ella ® Expected Challenges

71. Emergency Contraception PRCH 2012  Does NOT increase risk taking behavior  Does not decrease condom use  Does not decrease contraceptive use  Does not increase number of sexual partners or increase risk for STIs  DOES increase use of EC  Risks are reduced from episodes of unprotected sex and/or contraceptive failure that occur Advanced Provision & Pharmacy Access to Minors

72. Emergency Contraception PRCH 2012 Advanced Provision: No Increase in Risk Behavior 2004 study of young women randomized to: Receive EC in advance Receive instructions on how to get EC Advance Rx: ~twice as much EC use as control (15% vs. 8%) No decrease in condom or contraceptive use No increase in unprotected sex Advance Rx: used EC sooner than control group (10 vs. 21 hrs)

73. Emergency Contraception PRCH 2012  A 2005 study of 2117 young women  Improved access group no more likely to:  Miss a pill  Switch birth control methods  Forgo using a condom  Frequency of intercourse, amount of unprotected sex, and number of sexual partners similar among the study groups Pharmacy Access Does Not Increase Risk Behavior

74. Emergency Contraception PRCH 2012  While EC does NOT protect against STIs or HIV:  2005 study: Young women obtaining EC from pharmacist were no more likely to get an STI  Product’s label clearly states that regimen does not protect against STIs or HIV Addressing Concerns About STI Risk

75. Emergency Contraception PRCH 2012  EC: safe and effective method of preventing pregnancy  Can prevent pregnancies when taken within indicated window  Should be readily available to all women, especially adolescents  Advanced provision and pharmacy access will not increase health risks for young women Conclusions

76. Emergency Contraception PRCH 2012 Please Complete Your Evaluations Now

77. Emergency Contraception PRCH 2012  Resources:  www.prch.org—Physicians for Reproductive Choice and Health www.prch.org  www.aap.org—The American Academy of Pediatrics www.aap.org  www.acog.org—The American College of Obstetricians and Gynecologists www.acog.org  www.adolescenthealth.org—The Society for Adolescent Health and Medicine www.adolescenthealth.org  http://www.aclu.org/reproductiverights—The Reproductive Freedom Project of the American Civil Liberties Union http://www.aclu.org/reproductiverights  www.advocatesforyouth.org—Advocates for Youth www.advocatesforyouth.org  www.guttmacher.org—Guttmacher Institute www.guttmacher.org  www.cahl.org—Center for Adolescent Health and the Law www.cahl.org  www.gynob.emory.edu/centers/jfc.html—The Jane Fonda Center of Emory University www.gynob.emory.edu/centers/jfc.html  www.siecus.org—The Sexuality Information and Education Council of the United States www.siecus.org  www.arhp.org—The Association of Reproductive Health Professionals www.arhp.org  www.rhtp.org—Reproductive Health Technologies Project www.rhtp.org Provider Resources

78. Emergency Contraception PRCH 2012  PRCH’s Emergency Contraception: A Practitioner’s Guide  For information and a directory of EC providers, women can visit www.not-2-late.com www.not-2-late.com  Managing Contraception: www.managingcontraception.com www.managingcontraception.com  Reproductive Health Technology Project EC Resources: www.rhtp.org/contraception/emergency/default.asp www.rhtp.org/contraception/emergency/default.asp  Back Up Your Birth Control: Building Emergency Contraception Awareness Among Adolescents, A Tool Kit, Academy for Educational Development, www.aed.org/Publications/upload/ECtoolkit3283.pdf www.aed.org/Publications/upload/ECtoolkit3283.pdf  National Sexual Assault Hotline 1-800-656-HOPE Provides victims of sexual assault with free, confidential, around-the-clock services Provider Resources: Emergency Contraception