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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
    17
  • 18. Summary: FDA Approved Dedicated EC Products
    Plan B OneStep
    Single dose
    NextChoice
    Generic
    Original PlanB
    Now discontinued
    18
  • 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
    Regimens
    Efficacy
    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
    p=.16
    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 www.not-2-late.com
    Compile list of pharmacists in area that dispense EC
    Refer patients to
    www.not-2-late.com
  • 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 www.not-2-late.com
  • 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
    June
    2009
    August
    2009
  • 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
    62
  • 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:
    www.prch.org - Physicians for Reproductive Choice and Health
    www.aap.org - The American Academy of Pediatrics
    www.acog.org - The American College of Obstetricians and Gynecologists
    www.adolescenthealth.org - The Society for Adolescent Medicine
    http://www.aclu.org/reproductiverights/ - The Reproductive Freedom Project of the American Civil Liberties Union
    www.advocatesforyouth.org – Advocates for Youth
    www.guttmacher.org – Guttmacher Institute
    www.cahl.org/ - Center for Adolescent Health and the Law
    www.gynob.emory.edu - The Jane Fonda Center of Emory University
    www.siecus.org - The Sexuality Information and Education Council of the United States
    www.arhp.org - The Association of Reproductive Health Professionals
    www.rhtp.org – 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 www.not-2-late.com
    Managing Contraception: http://www.managingcontraception.com
    Back Up Your Birth Control: Building Emergency Contraception Awareness Among Adolescents, A Tool Kit, Academy for Educational Development, http://www.aed.org/Publications/upload/ECtoolkit3283.pdf
    Plan B Website: http://go2planb.com/ForConsumers/Index.aspx
    National Sexual Assault Hotline 1-800-656-HOPE. Provides victims of sexual assault with free, confidential, around-the-clock services.