Emergency Contraception
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Emergency Contraception

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Emergency Contraception Emergency Contraception Presentation Transcript

  • Updates in Emergency Contraception
    • Penina Segall-Gutierrez, M.D.
    • Clinical Instructor
    • Fellow, Division of Family Planning
    • Department of Obstetrics and Gynecology
    • Keck School of Medicine
    • University of Southern California
  • What is Emergency Contraception?
    • Therapeutic option available for women to prevent pregnancy after a coital act not adequately protected by a regular method of contraception.
    Trussell et al. American Journal of Obstetrics and Gynecology. (2004) 190; S30-8
  • Emergency Contraception Could Help Prevent Unintended Pregnancies in the U.S. Henshaw. Perspectives on Sexual and Reproductive Health (2006) 38; 2: 90-6 Unintended 49%: Intended 51% Unintended births 44% (22% of total) Elective Abortions 42% ( 20% of total) 6.4 million pregnancies
  • Case Presentation #1: Cathy
  • Case Presentation #1: Cathy
    • You are on-call from home and the operator connects you with Cathy, a 21 y.o. G0P0 undergraduate student who is routinely seen by a colleague in your clinic. PMH & PSH (-).
    • Her last normal period was 9 days ago. She was last seen in the clinic for a well woman exam 8 months ago, at which time she received a refill on her birth control pills.
  • Case Presentation #1: Cathy
    • She is now on Spring Break in Hawaii with her boyfriend. She left her “pills” at home and hasn’t taken them for 4 days.
    • She says she also always uses condoms, but one broke 8 hours ago. Otherwise she has not had unprotected sex this cycle.
    • Can you help her?
  • Indications for the Use of EC
    • No contraceptive used when intercourse took place
    • ≥ 14 days late for DMPA shot or unknown last injection date
    • ≥ 2 days late inserting new ring or applying new patch
    • Missed ≥2 missing C-OCPs (*)
    • Missed ≥ 1 progestin-only pill or took it ≥ 3 hrs late
    • Male condom slipped, broke, or leaked or Female condom inserted/removed incorrectly or penis inserted between condom and vaginal wall resulting in intravaginal ejaculation (*)
    • Coupled erred in practicing periodic abstinence or coitus interuptus
    • IUD partially or totally expelled or has been removed ≤7 days after last act of sexual intercourse
    • Diaphragm or cervical cap inserted incorrectly, dislodged, removed too early, or found to be torn
    • Woman exposed to possible tetratogen or cytotoxic medication while not protected by effective contraception
    • Rape victims
    Hatcher, R. et al Contraceptive Technology 18th ed. Ardent Media, Inc. New York 2004
  • Indications for the Use of EC
    • Missed ≥2 missing C-OCPs (*)
    • Male condom slipped, broke, or leaked or Female condom inserted/removed incorrectly or penis inserted between condom and vaginal wall resulting in intravaginal ejaculation (*)
  • Contraceptive Use in the US: 2002 2002 National Survey of Family Growth, US Dept of Health and Human Services N=61,561 15-44 yrs
  • “ When Plan A fails, there’s Plan B”
    • Plan B ii tabs PO STAT
  • Plan B
    • Levonorgesterel 0.75mg = i tab Plan B
      • Progestin only
      • Equivalent to 20 tabs Overette (P-OCPs) -$
    • Equally effective dosing regiments:
      • ii PO x1
      • i PO q12 x 2 (FDA approved Rx)
        • less effective if second dose missed
    von Hertzen, H et al. Lancet 7 December 2002; 360: 1803-1810 Ngai SW, et al. Hum Reprod. Jan 2005;20(1):307-311
  • Effectiveness
    • Effective up to 120 hours after unprotected intercourse
      • FDA approved up to 72 hrs
    • Pregnancy Rate overall = 1.1%
      • 0.4% @ <24 hrs after unprotected sex
      • 2.7% @ 49-72 hrs after unprotected sex
    Task Force on Postovulatory Methods of Fertility Regulation. Lancet 8 August 1998; 352(9126); 428-433
  • Does this mean Plan B is 98.9% effective?
    • Chance of Pregnancy in Normal Fertile Women =
      • 20%/cycle
      • Average single act of unprotected intercourse = 3.1%
      • Single act on cycle day #12 or 13 = 9.3-9.4%
    • Overall Effectiveness
      • For single act overall = 64.5%
      • For single act on day #12 or 13, EC taken @ < 12 hrs = 95.7%
      • Proportion of Pregnancies Prevented in WHO Trial = 85%
    Figure from Wilcox, A. et al. Likelihood of Conception with a Single Act of Intercourse: Providing Benchmark Rates for Assessment of Post-Coital Contraceptives. Contraception 2001; 63: 211-15 No!
  • Clinical Pearl – Give EC !
    • Despite that at any given time an individual’s risk at may be low for pregnancy, EC should not be withheld in a patient asking for it.
  • Cathy’s Questions…
    • She is concerned because she has heard that “the morning after pill” contains the same medication as “the abortion pill” and causes birth defects. What do you tell her?
  • EC Mechanism
    • Multiple studies of endometrial samples in women who had taken EC at the time of expected time of implantation showed no significant change in morphometric analysis, biochemical markers, steroid receptors, and histology.
    Croxatto, H et al. Steroids November 2003; 68: 1095-1098
  • Mechanism of Emergency Contraception
    • LNG delays or inhibits ovulation, but does not interfere w/ implantation after fertilization in monkeys
    • Pregnancy not prevented in women after ovulation had occurred
      • (evident by follicular diameter >18mm)
    Ortiz, M et al. Human Reproduction 2004; 19(6): 1352-1356 Croxatto, H et al. Contraception 2002; 65: 121-128
  • EC Mechanism
    • Early concerns re: progesterone-only hormonal contraception interfering w/ implantation DISPROVEN
      • Works via ovulation delay / inhibition
    • There have been no report of birth defects in live births after administration of EC.
    De Santis M, et al. Fertil Steril. Aug 2005;84(2):296-299.
  • EC Knowledge
    • Multiple studies show pharmacists surveyed don’t know how EC works
    • Pharmacists In South Dakota re: Plan B
      • 43% certain + 31% not sure if it caused birth defects if taken while pregnant
      • 21% believed health risks from repeated use
      • 37% of were wrong re: mechanism of action
      • 5% answered all 3 questions regarding scientific knowledge re: EC correctly
    Riper, K et al. Perspectives on sexual and reproductive health 2005; 37(1):19 -24
  • Cathy’s Question
    • She says she has enough condoms to last her through the rest of this trip. She wants to know if she should wait until she gets home to resume taking her birth control pills?
  • Start or Restart Method Right Away
    • No lasting effect with Plan B
    • Multiple use in a single month decreases effectiveness
    • Also Rx regular OCPs to start day after EC
      • If @ home, could resume OCPs where left off
    • Use a back-up method for ≥7 days for patch, ring, DMPA, or OCPs
  • Other Contraceptive Choices
    • Also OK to start DMPA, Cu-IUD, or barrier methods now
    • For Mirena (LNG- IUS), use another method x 2 weeks.
      • If (-) urine HCG, insert within 5 days of next menses
    • For Fertility Awareness Method, use abstinence or barrier method until next normal menses.
    Hatcher, R. et al Contraceptive Technology 18th ed. Ardent Media, Inc. New York 2004
  • Other Concerns for Cathy
    • No increase risk for ectopic
    • No affect on future fertility
    • Bleeding Profile:
      • May have spotting after taking EC
      • Menses may be few days early or late
    • Office Visits:
      • Pregnancy test or physical exam not required prior to administering Plan B
      • May come in any time for STI testing
      • If no menses in 3 weeks, come in for HCG √
  • Case Presentation #2: Doris
  • Case Presentation #2: Doris
    • You are in practice in rural Alaska. Doris, a 35 y.o. G6P5SAB1, comes in to your office. She has Qmonthly menses with an LMP 18 days ago.
    • The only pharmacist in a 200 mile radius refused to fill the prescription for Plan B that you wrote 3 days ago, as he was misinformed about its mechanism of action (too bad he didn’t come to grand rounds!).
  • Case Presentation #2: Doris
    • It has now been 6 days since she had unprotected sex, but she was unable to come in sooner because of a snow storm.
    • She and her husband have never used birth control, but lately they’ve been talking about getting one of them “fixed” because they really don’t want to have any more children.
    • She wants the most effective method of emergency contraception. Can you help her?
  • Most Effective Form of Emergency Contraception
    • After Copper IUD for Emergency Contraception Pregnancy Rate 0.0-0.2%
    • Insertion of Copper IUD
      • up to 5 days after unprotected sex or
      • up to 5-7 days after suspected ovulation
    Trussell et al. American Journal of Obstetrics and Gynecology. (2004) 190; S30-8
  • Copper T380A
    • Same precautions for Cu-IUD for emergency contraception as for long term contraception (no current acute pelvic infection, no Wilson’s Disease, etc.)
    • On return visit
      • If HcG (-), leave in up to 10 years
      • If HcG (+), IUD must be removed for termination or continuation of pregnancy
  • Ethical Considerations
    • EC is effective way of preventing unwanted pregnancies & abortions
    • Interference w/ EC access interferes w/ principles of
      • non-malfeasance
      • autonomy
      • beneficence
    Faundes, A et al. International Journal of Gynecology and Obstetrics 2003; 82: 297-305
  • Ethical Considerations
    • Respect individual rights of pharmacists, but ensure patients have timely access to timely medications
      • Resolution passed at the AAFP Congress of Delegates in 2005 to address this issue
      • Stock Plan B in your office
      • Use pharmacies that will supply EC
      • Education is Key!
  • Which pharmacies have a policy to “ensure patients’ access to their Rxs in-store, without discrimination or delay”?
    • Aurora Pharmacies, Inc.
    • Brooks Pharmacy/ Eckerd Corporation
    • CVS Pharmacy
    • Fagen’s Pharmacy
    • Kmart Pharmacy
    • Medicine Shoppe
    • Rite-Aid Corporation
    • Walgreens
    • Wal-Mart Stores, Inc.
    http://www.saveroe.com/campaigns/fillmypillsnow/scored 6/28/07
  • Case Presentation #3: Margie
  • Case Presentation #3: Margie
    • Margie is a 16 y.o. G1P1 here for her 6 week post-partum visit. This pregnancy was unplanned, as a result of forgetting to return for her Depo shot and lack of knowledge about Emergency Contraception.
    • Despite your best efforts to encourage her, she has already stopped breastfeeding. Her PMH and Family Hx is (-) for DVT, early MI or stroke, or other medical problems. Her best friend is on “the patch” and she wants to get on it too.
  • Case Presentation #3: Margie
    • She wants to know what she should do if she forgets to put the patch on or it falls off, because she is very concerned with getting pregnant again.
    • What do you tell her?
  • Contraceptive Options
    • Discuss abstinence and contraceptive options (including IUD) as pregnancy resulted from missed DMPA
    • If Ortho Evra Patch chosen, needs 2 additional Rxs
      • Ortho Evra apply to skin w/in 24 hours of patch falling off
      • Plan B use as directed WITH REFILLS
  • Advance EC Provision
    • Giving advanced Rx does not tempt contraceptors to abandon ongoing method
    • Randomized comparison of condom users, advanced EC provision vs. information only
      • No significant difference in unprotected sex rates
      • Advanced Provision group used EC 2x more often
      • All in advanced provision group found it useful
      • All in info-only group expressed desire for advanced provision ≥1 x in 12 month study
    Ellertson, C. et al. Obstetrics and Gynecology October 2001; 98(4): 570-5
  • Can’t Margie get EC OTC?
    • OTC Plan B available behind counter starting Nov. 2006 if ≥ 18 years old
    • Patients < 18 years old can get EC with Rx
      • safety data for teens
    • Insurance Coverage vs. expense of OTC
    American Academy of Pediatrics Committee on Adolescence. Pediatrics. 116(4):1026-35, 2005 Oct
  • Margie’s Myths
    • She tells you her friend told her that if you use emergency contraception you have to take a lot of pills and you will get really sick.
    • What is Margie’s friend talking about?
  • “ The Yuzpe Method”
    • Yuzpe originally described 100mcg ethinyl estradiol + 1mg dL-norgesterel
    • “ Modified Yuzpe”
      • Preven no longer marketed
      • C-OCPs = 0.5mg levonorgestrel + 100mcg ethinyl estradiol PO Q12hrs X2
      • Can use 2mg norethindrone as progestin
    Yuzpe, A. J Reprod Med. 1974 Aug;13(2):53-8. Ellertson, C. et al. Obstetrics and Gynecology 2003; 101(6); 1160-7
  • Combined Oral Contraceptives as EC Trivora (pink) Low-Ogestrel (white) Triphasil (yellow) Seasonale (pink) Nordette (light orange) Aviane (orange) Levora (light orange) Levlite (pink) Lo-Ovral (white) Ogestrel (white) Alesse (pink) Tri-Leven (yellow) Ovral (white) 5+5 4+4 2+2
  • The Yuzpe Method
    • C-OCP regimen = Estrogenic Effect
      • Rates of Nausea and Vomiting = >2x Plan B!
        • Nausea 50% vs. 23%
        • Vomiting 19% vs. 6%
      • Significant increase in Dizziness & Fatigue
    • Rx with an anti-emetic
      • Administer 1 hour after PO anti-emetic
      • Repeated if vomiting occurs w/in 1 hour of administration
      • Meclizine 25mg i-ii tabs PO
        • lasts 24 hrs & decreases dizziness
    Raymond EG, et al. Obstet Gynecol. Feb 2000;95(2):271-277
  • The Yuzpe Method
    • Pregnancy Rate after Yuzpe administration:
      • 2% @ <24 hrs after unprotected sex
      • 4.7% @ 49-72 hrs after unprotected sex
    • Not as effective as Plan B
      • 57% Pregnancies Prevented in 1998 WHO Trial
    Task Force on Postovulatory Methods of Fertility Regulation. Lancet 8 August 1998; 352(9126); 428-433
  • Observed vs. Expected Number of Pregnancies
    • Levonorgesterel
    • Yuzpe
  • Yuzpe vs. Plan B NO YES Contra-indications to repeated use 6% 19% Vomiting 23% 50% Nausea 85% 57% Effectiveness Plan B Yuzpe
  • Other Oral Methods
    • Mifepristone (Mifeprex or RU-486)
      • Antiprogesterone
      • As effective as Plan B
      • One time dose of 10mg (available in U.S. as 200mg tablets)
      • Not FDA approved for EC
      • Causes more delayed menstruation than other methods
      • $$$
    von Hertzen, H et al. Lancet 7 December 2002; 360: 1803-1810
  • Case Presentation#4 : Jenny
  • Case Presentation#4 : Jenny
    • Jenny is a 35y.o. G2P2 who presents to the emergency room stating that she was just raped by a stranger. Her LMP was 11 days ago. She is not on any long acting hormonal method of birth control, as she and her husband always use condoms.
  • Case Presentation#4 : Jenny
    • You do a complete H&P (including documenting all injuries and collecting specimens as outlined by your ER’s protocol). You also contact a counselor and police.
    • In addition to offering her STI prophylaxis and treatment, you also offer her what medication?
  • Offer EC to Rape Victims
    • EC!!!! (as recommended by ACOG and American College of Emergency Physicians).
    • Hx of Emergency Contraception
      • 1960s- High dose estrogen first used to prevent pregnancy in rape victims
    • EC helps prevent pregnancy, not prevent STIs
    ACOG Technical Bulletin “Sexual Assault” November 1997
  • Conclusions
    • “ Any women who has been exposed to an unprotected vaginal coitus and does not want to have a child can use the emergency contraception pill”
      • Faundes, 2003
  • Conclusions
    • No Physical Exam or Pregnancy Test Needed Prior to Plan B Administration
    • (OK to call in Rx)
    • No Absolute Contraindications to Plan B
    • Give Advance Rx for Plan B with refills
      • Along with long term method of contraception
  • Conclusions
    • EC can be given up to 120 hours after unprotected sex, but taking EC sooner increases effectiveness
    • Plan B (EC) is not an abortifacent & does not interfere with an existing pregnancy
    • Offer EC to Rape Victims
  • Conclusions
    • Most effective method of emergency contraception is Copper IUD
      • Leave in for long term contraception
    • Yuzpe is acceptable method is if:
      • Plan B is unavailable, but C-OCPs are
      • Patient without contraindications
  • Emergency Contraception Resources
    • For providers:
      • www.managingcontraception.com
    • For patients and providers:
      • http://www.rhedi.org/contraception/emergency_contra.php
      • http://familydoctor.org/805.xml
      • 1-888-NOT-2-LATE
  •  
  • Yes, you can!
  • Don’t be emBEARassed to ask questions!
  • References
    • ACOG Committee Opinion “Sexually Transmitted Diseases in Adolescence” October 2004
    • ACOG Practice Bulletin “Emergency Contraception”, December 2005
    • ACOG Technical Bulletin “Sexual Assault” November 1997
    • Cheng, L et al. “Interventions for Emergency Contraception”. The Cochrane Database of Systemic Review .24 August 2005
    • Croxatto, H et al. Effects of Yuzpe regimen, given during follucular phase, upon ovarian function. Contraception 2002; 65: 121-128
    • Croxatto, H et al. Mechanisms of Action of Emergency Contraception. Steroids November 2003; 68: 1095-1098
    • Croxatto, H et al. Pituitary-ovarian function following standard levonorgesrel emergency contraceptive dose or a single 0.75-mg dose given the day preceding ovulation. Contraception 2004;1-9
    • Ellertson, C. et al. Emergency Contraception: Randomized Comparison of Advanced Provision and Information Only. Obstetrics and Gynecology October 2001; 98(4): 570-5
    • Ellertson, C. et al. Modifying the Yuzpe Regimen of Emergency Contraception: A Multicenter Randomized Control Trial. Obstetrics and Gynecology 2003; 101(6); 1160-7
    • Guttmacker Institute. The Effect of Emergency Contraception on Unintended Pregnancies. Nov 15, 2006
    • Faundes, A et al. Emergency Contraception- clinical and ethical aspects. International Journal of Gynecology and Obstetrics 2003; 82: 297-305
    • Hatcher, R. et al. Chapter 24: Emergency Contraception in A Pocket Guide to Managing Contraception (pgs 77-87). Tiger, GA: Bridging the gap Foundation, 2005
    • Hatcher, R. et al Contraceptive Technology 18 th ed. Ardent Media, Inc. New York 2004
    • Henshaw. Perspectives on Sexual and Reproductive Health (2006) 38; 2: 90-6
    • Jones,R et al.Patterns in the socioeconomic characteristics of women obtaining abortions in 2000–2001, Perspectives on Sexual and Reproductive Health , 2002, 34(5):226–235
    • Ortiz, M et al. Post-coital Administration of Levonorgesterel Does Not Interfere with Post-Fertilization Events in the New-World Monkey Cebus Apella. Human Reproduction 2004; 19(6): 1352-1356
    • Raymond, E. et al. Minimum Effectiveness of the Levonorgesterel Regimen of Emergency Contraceptive pills. Contraception Jan 2004; 69(1):79-81
    • Riper, K et al. Emergency contraceptive pills: dispensing practices, knowledge and attitudes of South Dakota pharmacists. Perspectives on sexual and reproductive health 2005; 37(1):19 -24
    • Task Force on Postovulatory Methods of Fertility Regulation. Randomized control trial of levonorgesterel versus the Yuzpe regimen of Combined oral Contraceptives for emergency contraception. Lancet 8 August 1998; 352(9126); 428-433
    • Trussel, J. et al. Estimating the effectiveness of Emergency Contraceptive pills. Contraception April 2003; 67(4):259-65
    • Trussell, J. et al. Preventing Unintended Pregnancy: the Cost-Effectiveness of Three Methods of Emergency Contraception. American Journal of Public Health June 1997;87(6): 932-7
    • Trussell, J et al. Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception 1999; 59 (3): 147-51
    • Trussell et al. The role of emergency contraception American Journal of Obstetrics and Gynecology. (2004) 190; S30-8
    • Vasilakis, C et al. The Risk of Venous Thromboembolism in Users of Postcoital Contraceptive Pills. Contraception 1999; 59: 79-83
    • von Hertzen, H et al. Low dose mifepristone and two regimens of levnorgesterel for emergency contraception: a WHO multicentere randomized trial. Lancet 7 December 2002; 360: 1803-1810
    • Wilcox, A. et al. Likelyhood of Conception with a Single Act of Intercourse: Providing Benchmark Rates for Assessment of Post-Coital Contraceptives. Contraception 2001; 63: 211-15
    • Thank you!
    • Questions?