Updates in Emergency Contraception Penina SegallGutierrez M D

Updates in Emergency Contraception Penina Segall-Gutierrez, M. D. Assistant Professor of Clinical Obstetrics and Gynecology Keck School of Medicine University of Southern California

Objectives n Upon completion of this presentation, the learner should be able to: – 1. List all methods of Emergency Contraception in order of effectiveness – 2. Understand the mechanism of Levonorgesterel EC – 3. Understand when and to whom one should talk about EC

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; S 30 -8

Emergency Contraception Could Help Prevent Unintended Pregnancies in the U. S. Intended 51% Unintended 49%: Unintended births 44% (22% of total) 6. 4 million pregnancies Elective Abortions 42% ( 20% of total) Henshaw. Perspectives on Sexual and Reproductive Health (2006) 38; 2: 90 -6

Case Presentation #1: Cathy

Case Presentation #1: Cathy You are at home Friday night when you get a frantic call from your med student Cathy. She forgot to take her OCP Wed AM, when you were on call. She was so tired postcall that she slept all day and forgot her pills. She was nervous about the final exam this AM and she forgot her pills again!!

Case Presentation #1: Cathy She flew up to visit her boyfriend in S. F. right after exams, and forgot to bring her pills with her. She says she always uses condoms for STI prophylaxis, but one just broke ! Her last normal period was 11 days ago, and she did not miss any other pills this cycle. She gives you the phone number of a pharmacy that accepts her student health insurance. Can you help her?

Indications for the Use of EC n n n 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 18 th ed. Ardent Media, Inc. New York 2004

Indications for EC for Cathy n Missed n Male ≥ 2 missing C-OCPs (*) 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 N=61, 561 15 -44 yrs 2002 National Survey of Family Growth, US Dept of Health and Human Services

“When Plan A fails, there’s Plan B” Plan B ii tabs PO STAT

Plan B n Levonorgesterel 0. 75 mg = i tab Plan B – Progestin only – Equivalent to 20 tabs Overette (P-OCPs) -$ n Equally effective dosing regiments: – ii PO x 1 – i PO q 12 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 n Effective up to 120 hours after unprotected intercourse – FDA approved up to 72 hrs n 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? No! n 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% n 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

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?

Mechanism of Emergency Contraception n LNG delays or inhibits ovulation, but does not interfere w/ implantation after fertilization in monkeys n Pregnancy not prevented in women after ovulation had occurred – evident by follicular diameter >18 mm – evident by hormone markers Ortiz, M et al. Human Reproduction 2004; 19(6): 1352 -1356 Croxatto, H et al. Contraception 2002; 65: 121 -128 Nokivia, N et al. Conmtraception 2007; 75: 112 -118

EC Does Not… n …Affect sperm transport or function n …Interfere w/ endometrial receptivity to implantation n …Cause Abortion Lalitkumar, P et a. l Human Reproduction 2007; 1 -7 Do Nascimento J et al. Human Reproduction 2007; 22(8): 2190 -95 Croxatto, H et al. Steroids November 2003; 68: 1095 -1098

EC and Pregnancy n Early concerns re: progesterone-only hormonal contraception interfering w/ implantation DISPROVEN – Works via ovulation delay / inhibition n No increase in congenital malformations or pregnancy complications in live births after EC administration. De Santis M, et al. Fertil Steril. Aug 2005; 84(2): 296 -299.

EC Knowledge n Multiple studies show pharmacists surveyed don’t know how EC works n 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 n No lasting effect with Plan B n Multiple use in a single month decreases effectiveness n Also Rx regular OCPs to start day after EC – If @ home, could resume OCPs where left off n Use a back-up method for ≥ 7 days for patch, ring, DMPA, or OCPs

Other Contraceptive Choices n Also OK to start DMPA, Cu-IUD, or barrier methods now n For LNG- IUS or Contraceptive Implant, use another method x 2 weeks. – If (-) urine HCG, insert within 5 days of next menses n For Fertility Awareness Method, use abstinence or barrier method until next normal menses. Hatcher, R. et al Contraceptive Technology 18 th ed. Ardent Media, Inc. New York 2004

Other Concerns for Cathy n No increase risk for ectopic n No affect on future fertility n Bleeding Profile: – May have spotting after taking EC – Menses may be few days early or late n 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. G 6 P 5 SAB 1, comes in to your office. She has Qmonthly menses with an LMP 18 days ago. When she called your office 5 days ago, you informed her she could get Plan B OTC. The only pharmacist in a 200 mile radius does not stock Plan B as he is 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 n After Copper IUD for Emergency Contraception Pregnancy Rate 0. 0 -0. 2% n 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; S 30 -8

Copper T 380 A n Same precautions for Cu-IUD for emergency contraception as for long term contraception (no current acute pelvic infection, no Wilson’s Disease, etc. ) n On return visit – If Hc. G (-), leave in up to 10 years – If Hc. G (+), IUD must be removed for termination or continuation of pregnancy

Ethical Considerations EC is effective way of preventing unwanted pregnancies & abortions n Interference w/ EC access interferes w/ principles of n – non-malfeasance – autonomy (those capable of deliberation about personal choices should be treated w/ respect for capacity of self determination) – beneficence (ethical principle to minimize harms & wrongs & maximize benefits). Faundes, A et al. International Journal of Gynecology and Obstetrics 2003; 82: 297 -305

Ethical Considerations n 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 prescriptions in-store, without discrimination or delay”? n n n n n 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 8/08/07

Case Presentation #3: Margie

Case Presentation #3: Margie is a 16 y. o. G 1 P 1 here for her 6 week postpartum 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 n Discuss abstinence and contraceptive options (including IUD) as pregnancy resulted from missed DMPA n 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 n First RTC of condom users in high risk population (Urban Family Planning Clinic), advanced EC provision vs. information only – – No significant difference in unprotected sex rates Advanced Provision group used EC 2 x 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

Advanced Provision n Advanced Rx in teens and adult women: – does not tempt contraceptors to abandon ongoing method – does not affect rates of STI – shortens time from unprotected intercourse to EC administration and increases administration – but…. IT WON’T WORK FROM THE MEDICINE CABINET, YOU MUST ACTUALLY TAKE THE PILLS!!!!!!!!!!!!!! Polis, C. et al. Cochrane Database of Systematic Reviews 2007

Can’t Margie get EC OTC? n OTC Plan B available behind counter starting Nov. 2006 if ≥ 18 years old n Patients < 18 years old can get EC with Rx – safety data for teens n Insurance Coverage vs. expense of OTC – Medi. Cal and FPACT 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” n Yuzpe originally described 100 mcg ethinyl estradiol + 1 mg d. L-norgesterel n “Modified Yuzpe” – Preven no longer marketed – C-OCPs = 0. 5 mg levonorgestrel + 100 mcg ethinyl estradiol PO Q 12 hrs X 2 – Can use 2 mg 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 2+2 Ovral (white) 4+4 Tri-Leven (yellow) 5+5 Alesse (pink) Ogestrel (white) Lo-Ovral (white) Levlite (pink) Levora (light orange) Aviane (orange) Nordette (light orange) Triphasil (yellow) Low-Ogestrel (white) Trivora (pink) Table modified from www. managingcontraception. com Seasonale (pink)

The Yuzpe Method n C-OCP regimen = Estrogenic Effect – Rates of Nausea and Vomiting = >2 x Plan B! § Nausea 50% vs. 23% § Vomiting 19% vs. 6% – Significant increase in Dizziness & Fatigue n Rx with an anti-emetic – Administer 1 hour after PO anti-emetic – Repeated if vomiting occurs w/in 1 hour of administration – Meclizine 25 mg i-ii tabs PO § lasts 24 hrs & decreases dizziness Raymond EG, et al. Obstet Gynecol. Feb 2000; 95(2): 271 -277

The Yuzpe Method n Pregnancy Rate after Yuzpe administration: – 2% @ <24 hrs after unprotected sex – 4. 7% @ 49 -72 hrs after unprotected sex n 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 n Levonorgesterel n Yuzpe Figure From: Task Force on Postovulatory Methods of Fertility Regulation. Lancet 8 August 1998; 352(9126); 428 -433

Yuzpe vs. Plan B Yuzpe Plan B Effectiveness 57% 85% Nausea 50% 23% Vomiting 19% 6% Contraindications to Repeated Use YES NO

Other Oral Methods Mifepristone (Mifeprex or RU-486) – Antiprogesterone – As effective as Plan B – One time dose of 10 mg (available in U. S. as 200 mg 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 is a 35 y. o. G 2 P 2 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 n EC!!!! (as recommended by ACOG and American College of Emergency Physicians). n Hx of Emergency Contraception – 1960 s- High dose estrogen first used to prevent pregnancy in rape victims n 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 n No Physical Exam or Pregnancy Test Needed Prior to Plan B Administration (OK to call in Rx) n No Absolute Contraindications to Plan B n Give Advance Rx for Plan B with refills – Along with long term method of contraception

Conclusions n EC can be given up to 120 hours after unprotected sex, but taking EC sooner increases effectiveness n Plan B (EC) is not an abortifacent and does not interfere with an existing pregnancy n Offer EC to Rape Victims

Conclusions n Most effective method of emergency contraception is Copper IUD – Leave in for long term contraception n Yuzpe is acceptable method is if: – Plan B is unavailable, but C-OCPs are – Patient without contraindications

Emergency Contraception Resources n For providers: – www. managingcontraception. com n For patients and providers: – http: //www. rhedi. org – http: //familydoctor. org – http: //www. pharmacyaccess. org – 1 -888 -NOT-2 -LATE