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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 of "Emergency Contraception"

    1. 1. Emergency Contraception and Adolescents<br />
    2. 2. Objectives<br />By the end of this presentation, participants will be able to:<br />Discuss need for EC among adolescents<br />Describe clinical components of EC <br />Understand the challenges and opportunities for increasing EC use at the patient, provider, and health systems level<br />
    3. 3. What Is Emergency Contraception (EC)?<br />
    4. 4. Adolescents Need EC<br />The U.S. has one of the highest teen pregnancy rate in the industrialized world.<br />82% of teen pregnancies are unplanned<br />
    5. 5. Teen Pregnancy Rates Worldwide, 2000<br />Per 1000<br />
    6. 6. Unprotected Sex Happens<br />
    7. 7. Female Contraceptive Use at 1st Intercourse by Year of 1st Sex<br />2002 National Survey of Family Growth<br />
    8. 8. HS Students Contraceptive Use at Last Intercourse<br />YRBS 2007<br />*This data only reflects oral contraceptives and not rates of injectable contraceptives use<br />
    9. 9. Sexual Assault and EC<br />
    10. 10. Indications for EC<br />
    11. 11. Human Error<br />Inconsistent contraceptive use <br />Incorrect contraceptive use <br />Unplanned intercourse<br />
    12. 12. Method Failure: Patch<br />Patch off for 24 hours or more during patch-on weeks<br />More than two days late changing a patch<br />Late putting patch back on after patch-free week<br />
    13. 13. Method Failure: Ring<br />Taken out for more than 3 hours during ring-in weeks<br />Same ring left in more than 5 weeks in a row<br />Late putting ring back after ring-out week<br />
    14. 14. Method Failure: Others<br />Condom breaks or slips<br />2 or more missed active OCPs<br />DMPA shot 14 or more weeks ago<br />Expelled IUD<br />3 > = hours late taking a POP<br />Diaphragm or cervical cap dislodges<br />
    15. 15. Methods of EC<br />
    16. 16. Brand Name Levonorgestrel ECPs<br />Dedicated Product: Plan B One-Step<br />FDA approved July 2009<br />ingle tablet formulation 1.5mg of levonorgestrel<br />Original Plan B<br />Two tabs of 750 mcg levonorgestrel <br />Approved in 1999<br />Approved for OTC 18 and older in 2006<br />Both are now OTC for 17 and older<br />
    17. 17. GenericLevonorgestrel EC<br />Next ChoiceTM, a generic dedicated product approved June 2009<br />Two tabs of 750 mcg levonorgestrel <br />For prescription use by women 16 and younger<br />OTC for women 17 and older<br />17<br />
    18. 18. Summary: FDA Approved Dedicated EC Products<br />Plan B OneStep<br />Single dose<br />NextChoice <br />Generic<br />Original PlanB<br />Now discontinued<br />18<br />
    19. 19. Combined Oral Contraceptives as ECPs <br />Yuzpe method<br />Combined oral contraceptive pills (OCPs) containing combined ethinyl estradiol and either norgestrel or levonorgestrel<br />
    20. 20. The Copper-T Intrauterine Device<br />Insert within 5 days<br />Highly effective: Reduces risk of pregnancy by more than 99% <br />Rarely used for EC alone<br />Cannot use levonorgestrel IUD (Mirena) for EC<br />
    21. 21. Clinical Components of EC <br />Regimens<br />Efficacy<br />Mechanism of action<br />
    22. 22. Levonorgestrel-Only Regimen<br />
    23. 23. ECP Efficacy<br />
    24. 24. How Long After the Morning After?<br />2002 WHO Trial of Levonorgestrel-Only EC Regimen Taken in Single Dose<br />p=.16<br />Von Hertzen H, et al. Lancet 2002;360:1803-1810<br />
    25. 25. Mechanism of Action of Levonorgestrel-Only EC<br />Disrupts normal follicular development and maturation<br />Results in ovulation or delayed ovulation with deficient luteal function<br />May also interfere w/sperm migration and function at all levels of the genital tract<br />
    26. 26. Does ECPrevent Implantation? <br />
    27. 27. Does Levonorgestrel-Only EC Prevent Implantation? <br />Studies in animals: Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect<br />
    28. 28. Mechanism of Action: Combined ECPs <br />Can inhibit or delay ovulation<br />Older studies have shown histologic or biochemical alterations in the endometrium.<br />More recent studies have found no such effects on the endometrium.<br />
    29. 29. Mechanism of Action: Combined ECPs <br />*No clinical data exist regarding these mechanisms<br />
    30. 30. Side Effects & Complications:Levonorgestrel v. Yuzpe<br />Significant at p<0.01<br />
    31. 31. EC is Safe <br />
    32. 32. Few Contraindications<br />
    33. 33. Adolescent Access to EC:Challenges & Opportunities<br />
    34. 34. Challenges and Opportunities<br />To utilize EC, young women (under 18) must<br />Be aware of the option<br />Locate a provider<br />Obtain a prescription<br />Find the money to pay for the pills<br />Fill prescription at a pharmacy that has EC<br />Take pills at correct time<br />
    35. 35. Challenges and Opportunities<br />Patient Level<br />Provider Level<br />Health Systems and Public Policy Level<br />
    36. 36. Patient Level<br />
    37. 37. Few Young Women Are Aware of EC<br />
    38. 38. Patient Misconceptions Create Barriers to EC Use <br />Beliefs that EC functions as an abortifacient<br />Fear that the drug would harm fetus<br />Confusion over fertility cycle and timing<br />
    39. 39. Other Barriers<br />Perceived lack of confidentiality<br />Lack of money and/or insurance<br />Lack of transportation<br />Inability to locate a healthcare provider w/in the limited and effective timeframe <br />Belief that pelvic examination is mandatory<br />OTC exclusion of minors <br />
    40. 40. Provider Level<br />
    41. 41. Many Providers Do Not Discuss EC w/ Young Patients<br />
    42. 42. Providers Need More Training About EC<br />
    43. 43. Provider Misconceptions Can Discourage Use<br />
    44. 44. Providers Can Remove Clinical Barriers to EC<br />No pelvic examination or pregnancy test required by ACOG or FDA<br />Pregnancy test prior to EC treatment is recommended only if:<br />Other episodes of unprotected sex occurred that cycle<br />LMP (last menstrual period) was not normal in duration, timing, or flow<br />
    45. 45. Providers Can to Facilitate Use<br />
    46. 46. Providers Can Facilitate Use<br />Providers must take into account patient’s:<br />Knowledge of reproductive physiology<br />Ability to understand the regimen<br />Moral perceptions of contraception<br />Misconceptions about the drug’s mechanism of action <br />Barriers that may restrict access<br />
    47. 47. Providers Can Facilitate Use<br />
    48. 48. Counseling Key Points<br />
    49. 49. Facilitating Use in Practice<br />
    50. 50. Facilitating Use in Practice<br />Train office staff on EC<br />Importance of timely appointments<br />Lack of required exam for prescriptions<br />OTC for patients over 18<br />
    51. 51. Facilitating Use in Practice<br />List yourself as an EC provider on www.not-2-late.com<br />Compile list of pharmacists in area that dispense EC<br />Refer patients to <br />www.not-2-late.com<br />
    52. 52. Opportunities for Bridging Contraceptive Services<br />Cost of EC may prohibit multiple use w/in a cycle (~$25-$50)<br />During visit, discuss alternative and ongoing methods of contraception that are more effective and less expensive<br />
    53. 53. Counseling Teens About Contraception Method<br />
    54. 54. InitiatingContraception: Quickstart<br />Consider QuickStart initiation of an ongoing birth control method on day of EC administration<br />Patient should bleed in ~ 2 weeks<br />If administering DMPA:<br />Patient should return in 2 weeks for pregnancy test<br />
    55. 55. Provider Opportunities for Facilitating Use<br />
    56. 56. Provider Level: Ethical Obligations<br />If provider does not feel comfortable or competent counseling patient or writing prescription for EC:<br />S/he must make a referral to someone who can<br />Refer patient to www.not-2-late.com<br />
    57. 57. Health Systems and Public Policy Level<br />
    58. 58. Path to OTC Access: August 2006<br />
    59. 59. 2009 Court Decisions<br />March 2009<br />
    60. 60. Generic Dedicated EC Product Approved<br />June<br />2009<br />August<br />2009<br />
    61. 61. Single-Dose Dedicated EC Product Approved<br />July 2009<br />
    62. 62. What’s Next for EC?<br />Generics are free to enter the market<br />Until Aug 2012, Plan B has market exclusivity on single dose products<br />Per the March2009 rulings, the FDA is still under obligation to reconsider age restrictions on all EC products<br />Data still supports increased access for minors<br />62<br />
    63. 63. Advanced Provision & Pharmacy Access to Minors<br />Does NOT increase risk taking behavior<br />Does not decrease condom use<br />Does not decrease contraceptive use <br />Does not increase number of sexual partners Increase risk for STIs<br /> DOES increase use of EC<br />Risks are reduced from episodes of unprotected sex and/or contraceptive failure that occur<br />
    64. 64. Advanced Provision: No Increase in Risk Behavior<br />Advance Rx: ~2xs as much EC use as control (15% vs. 8%)<br />Receive EC in advance<br />No decrease in condom or contraceptive use<br />2004 study of young women randomized to:<br />No increase in unprotected sex<br />Receive instructions on how to get EC<br />Advance Rx: used EC sooner than control group (10 vs. 21 hrs<br />
    65. 65. Pharmacy Access Does Not Increase Risk Behavior<br />A 2005 study of 2117 young women <br />Improved access group no more likely to:<br />Miss a pill<br />Switch birth control methods<br />Forgo using a condom <br />Frequency of intercourse, amount of unprotected sex, & number of sexual partners similar among the study groups<br />
    66. 66. Addressing Concerns About STI Risk<br />
    67. 67. Conclusions<br />
    68. 68.
    69. 69. Provider Resources:<br />www.prch.org - Physicians for Reproductive Choice and Health<br />www.aap.org - The American Academy of Pediatrics<br />www.acog.org - The American College of Obstetricians and Gynecologists<br />www.adolescenthealth.org - The Society for Adolescent Medicine <br />http://www.aclu.org/reproductiverights/ - The Reproductive Freedom Project of the American Civil Liberties Union <br />www.advocatesforyouth.org – Advocates for Youth<br />www.guttmacher.org – Guttmacher Institute<br />www.cahl.org/ - Center for Adolescent Health and the Law <br />www.gynob.emory.edu - The Jane Fonda Center of Emory University<br />www.siecus.org - The Sexuality Information and Education Council of the United States<br />www.arhp.org - The Association of Reproductive Health Professionals<br />www.rhtp.org – Reproductive Health Technologies Project<br />
    70. 70. Provider Resources: Emergency Contraception<br />PRCH’s Emergency Contraception: A Practitioner’s Guide<br />ARHP Reproductive Health Model Curriculum<br />For information and a directory of EC providers, women can visit www.not-2-late.com<br />Managing Contraception: http://www.managingcontraception.com<br />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<br />Plan B Website: http://go2planb.com/ForConsumers/Index.aspx<br />National Sexual Assault Hotline 1-800-656-HOPE. Provides victims of sexual assault with free, confidential, around-the-clock services.<br />
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