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Emergency Contraception


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  • Next Choice was first approved as a prescription-only product in June 2009, but by August 2009, the approval was given for OTC sales to women 17 and older (the same age structure used to sell Plan B and Plan B OneStep)
  • These are the products as they appear on the shelves of pharmacies.PlanBOneStep has replaced the original Plan B. While some pharmacies may be finishing up existing stock of Plan B, moving forward, only OneStep will be available.
  • PRCH will keep following this process as it unfolds and provide updates on our website when any new products are approved or age restrictions are changes or dropped.The Center for Reproductive Rights continues to pursue results from the March 2009 ruling to see what the FDA process will be for reconsidering restrictions on EC. More information is available at www.reprorights.orgThe evidence still shows that access to EC does not lead to increased risk taking or poor health outcomes for minors.
  • Transcript

    • 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)?
    • 4. Adolescents Need EC
      The U.S. has one of the highest teen pregnancy rate in the industrialized world.
      82% of teen pregnancies are unplanned
    • 5. Teen Pregnancy Rates Worldwide, 2000
      Per 1000
    • 6. Unprotected Sex Happens
    • 7. Female Contraceptive Use at 1st Intercourse by Year of 1st Sex
      2002 National Survey of Family Growth
    • 8. HS Students Contraceptive Use at Last Intercourse
      YRBS 2007
      *This data only reflects oral contraceptives and not rates of injectable contraceptives use
    • 9. Sexual Assault and EC
    • 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 3 hours during ring-in weeks
      Same ring left in more than 5 weeks in a row
      Late putting ring back after ring-out week
    • 14. Method Failure: Others
      Condom breaks or slips
      2 or more missed active OCPs
      DMPA shot 14 or more weeks ago
      Expelled IUD
      3 > = 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
      ingle tablet formulation 1.5mg 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 750 mcg levonorgestrel
      For prescription use by women 16 and younger
      OTC for women 17 and older
    • 18. Summary: FDA Approved Dedicated EC Products
      Plan B OneStep
      Single dose
      Original PlanB
      Now discontinued
    • 19. Combined Oral Contraceptives as ECPs
      Yuzpe method
      Combined oral contraceptive pills (OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel
    • 20. The Copper-T Intrauterine Device
      Insert within 5 days
      Highly effective: Reduces risk of pregnancy by more than 99%
      Rarely used for EC alone
      Cannot use levonorgestrel IUD (Mirena) for EC
    • 21. Clinical Components of EC
      Mechanism of action
    • 22. Levonorgestrel-Only Regimen
    • 23. ECP Efficacy
    • 24. How Long After the Morning After?
      2002 WHO Trial of Levonorgestrel-Only EC Regimen Taken in Single Dose
      Von Hertzen H, et al. Lancet 2002;360:1803-1810
    • 25. 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 w/sperm migration and function at all levels of the genital tract
    • 26. Does ECPrevent Implantation?
    • 27. Does Levonorgestrel-Only EC Prevent Implantation?
      Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect
    • 28. Mechanism of Action: Combined ECPs
      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
      *No clinical data exist regarding these mechanisms
    • 30. Side Effects & Complications:Levonorgestrel v. Yuzpe
      Significant at p<0.01
    • 31. EC is Safe
    • 32. Few Contraindications
    • 33. Adolescent Access to EC:Challenges & 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
    • 38. 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
    • 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 Discuss EC w/ Young Patients
    • 42. Providers Need More Training About EC
    • 43. Provider Misconceptions Can Discourage Use
    • 44. 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
    • 45. Providers Can to Facilitate Use
    • 46. Providers Can Facilitate Use
      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
    • 47. Providers Can Facilitate Use
    • 48. Counseling Key Points
    • 49. Facilitating Use in Practice
    • 50. Facilitating Use in Practice
      Train office staff on EC
      Importance of timely appointments
      Lack of required exam for prescriptions
      OTC for patients over 18
    • 51. Facilitating Use in Practice
      List yourself as an EC provider on
      Compile list of pharmacists in area that dispense EC
      Refer patients to
    • 52. Opportunities for Bridging Contraceptive Services
      Cost of EC may prohibit multiple use w/in a cycle (~$25-$50)
      During visit, discuss alternative and ongoing methods of contraception that are more effective and less expensive
    • 53. Counseling Teens About Contraception Method
    • 54. InitiatingContraception: Quickstart
      Consider QuickStart initiation of an ongoing birth control method on day of EC administration
      Patient should bleed in ~ 2 weeks
      If administering DMPA:
      Patient should return in 2 weeks for pregnancy test
    • 55. Provider Opportunities for Facilitating Use
    • 56. Provider Level: Ethical Obligations
      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
    • 57. Health Systems and Public Policy Level
    • 58. Path to OTC Access: August 2006
    • 59. 2009 Court Decisions
      March 2009
    • 60. Generic Dedicated EC Product Approved
    • 61. Single-Dose Dedicated EC Product Approved
      July 2009
    • 62. What’s Next for EC?
      Generics are free to enter the market
      Until Aug 2012, Plan B has market exclusivity on single dose products
      Per the March2009 rulings, the FDA is still under obligation to reconsider age restrictions on all EC products
      Data still supports increased access for minors
    • 63. Advanced Provision & Pharmacy Access to Minors
      Does NOT increase risk taking behavior
      Does not decrease condom use
      Does not decrease contraceptive use
      Does not increase number of sexual partners Increase risk for STIs
      DOES increase use of EC
      Risks are reduced from episodes of unprotected sex and/or contraceptive failure that occur
    • 64. Advanced Provision: No Increase in Risk Behavior
      Advance Rx: ~2xs as much EC use as control (15% vs. 8%)
      Receive EC in advance
      No decrease in condom or contraceptive use
      2004 study of young women randomized to:
      No increase in unprotected sex
      Receive instructions on how to get EC
      Advance Rx: used EC sooner than control group (10 vs. 21 hrs
    • 65. Pharmacy Access Does Not Increase Risk Behavior
      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, & number of sexual partners similar among the study groups
    • 66. Addressing Concerns About STI Risk
    • 67. Conclusions
    • 68.
    • 69. Provider Resources: - Physicians for Reproductive Choice and Health - The American Academy of Pediatrics - The American College of Obstetricians and Gynecologists - The Society for Adolescent Medicine - The Reproductive Freedom Project of the American Civil Liberties Union – Advocates for Youth – Guttmacher Institute - Center for Adolescent Health and the Law - The Jane Fonda Center of Emory University - The Sexuality Information and Education Council of the United States - The Association of Reproductive Health Professionals – Reproductive Health Technologies Project
    • 70. Provider Resources: Emergency Contraception
      PRCH’s Emergency Contraception: A Practitioner’s Guide
      ARHP Reproductive Health Model Curriculum
      For information and a directory of EC providers, women can visit
      Managing Contraception:
      Back Up Your Birth Control: Building Emergency Contraception Awareness Among Adolescents, A Tool Kit, Academy for Educational Development,
      Plan B Website:
      National Sexual Assault Hotline 1-800-656-HOPE. Provides victims of sexual assault with free, confidential, around-the-clock services.