Emergency contraception: an important part of primary care

Julie Fagan, M.D.

23 February 2005

Learning Objectives

• Understand why emergency contraception is important in primary care

• List the types of and effectiveness rate for various types of EC

• Be able to prescribe EC and counsel women about risks, benefits, alternatives

• Discuss with patients and prescribe EC in advance, to enhance effectiveness

Conflicts

• This talk was not sponsored by any drug or device manufacturer.

Emergency contraception

• ½ of all pregnancies in the US are unintended About 3.2 million/year~25,000 of which result from sexual assault

• ½ of those end in abortion~ 1.5 million

• Conservatively, EC could prevent ½ of unintended pregnancies

~ 1.5 million

• Over 700,000 abortions could be avoided per year

What is emergency contraception?

• Emergency contraception is NOT medical abortion: it does not cause abortion/miscarriage

• Involves using a contraceptive after unprotected intercourse to PREVENT a pregnancy, in the same way oral contraceptives and breastfeeding do (by blocking fertilization or implantation)

• Poses no significant health risk to an existing pregnancy or pregnant woman

• Hormonal and intrusion methods available

NARAL Pro-Choice Wisconsin Foundation Provider EC Education Project (PEEP)

• Educate primary care providers about EC

• Encourage advance prescription of EC by PCPs to minimize use of the ER

• Address perceived barriers to using EC among providers

• Increase EC access to reduce unintended pregnancy

Types of EC commonly used

• Combination estrogen and progestin (Yuzpe method)

• Progestin only

• IUD

Yuzpe method

• Can use regular OCPs or prepackaged Preven (now off the market).

• Most effective within 72 hours after unprotected intercourse

• Two doses of pills, 12 hours apart• Most common side effects are nausea (30-

50%) and vomiting (15-20%)• Should also prescribe an antiemetic

Antiemetic regimens commonly used

• Meclizine– 25-50 mg 1 hour before 1st dose

• Promethazine – 25 mg po or pr 30-60 minutes before each dose

and prn q6-8h

• Trimethobenzamide – 250 mg 1 hour before each dose

Progestin-only

• Usually equals a dose of 0.75mg of Levonorgestrel

• Packaged as “Plan B”• Can also use Ovrette ocps

– Take 20 pills at once

• As effective as Yuzpe method but much lower risk of nausea and vomiting – 23% and 5% respectively

“Plan B”

• Originally prescribed as two doses, 12 hours apart

• 2002 study found that a single dose of 1.5 mg of Levonorgestrel (twice the original dose) is as effective as dividing the dose

• New recommendation: take 2 pills at once

• Lancet 2002;360:1803-10

Side Effects: ECPs

WHO Task Force. Lancet 1998;352:428

Nausea Vomiting

Progestin Only 23% 6%

Combination (Yuzpe) 50% 19%

RR .46 .28

ARHP

0%

10%

20%

30%

40%

50%

60%

Nausea Vomiting Dizziness Fatigue

Levonorgestrel vs. Yuzpe: Side Effects

LevonorgestrelYuzpe

* Significant at p<0.01

23%

Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433.

51%*

6%

19%*

11%

17%*

29%*

17%

Contraception online

0%

10%

20%

30%

40%

Nausea Vomiting Diarrhea Fatigue BreastTenderness

Bleeding MensesDelay >7

Days

Single- vs. Two-Dose Levonorgestrel: Side Effects

Single-Dose Levonorgestrel

Two-Dose Levonorgestrel

14%

von Hertzen H, et al. Lancet. 2002;360:1803-1810.

15%

1% 1%4% 3%

14%

18%

8% 8%

31% 31%

5%

0%

Contraception online

Effectiveness

• Decreases pregnancy rate by 75% if taken within 72 hours of unprotected intercourse– If 100 women have unprotected intercourse

during the middle of their cycles, you expect 8 to get pregnant. If all of the women use EC, only 2 will get pregnant.

– New study shows that may be effective for up to 5 days

0%

20%

40%

60%

80%

100%

Levonorgestrel Yuzpe

Proportion of Pregnancies Prevented by Levonorgestrel vs. Yuzpe Regimen*

Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433.

85%85%

71%71%

57%57%

39%39%

93%93%

74%74%

* 95% CI

Contraception online

0%

20%

40%

60%

80%

100%

<24 25-48 49-62

Proportion of Pregnancies Prevented by Levonorgestrel vs. Yuzpe, by Timing of Treatment

Task Force on Postovulatory Methods of Fertility Regulation. Lancet. 1998;352:428-433.

Levonorgestrel Yuzpe

Timing of Treatment (hours)

58%

31%36%

85%95%

77%

Contraception online

Effectiveness

• Levonorgestrel alone was slightly more effective than estrogen/progestin method

• Single dose Plan B is now the first line method of EC to be used

– Cheng L, et al. Interventions for emergency contraception (Cochrane Review). In: The Cochrane Library, Issue 2 2003. Oxford: Update Software.

Emergency Contraceptive Effectiveness

# of Pregnancies % Reduction

No treatment 80

Combined ECPs 20 75%

Progestin-Only ECPs 10 88%

IUD Insertion 1 99%

If 1000 women have unprotected sex once in the second or third week of their cycle

ARHP data

Contraindications

• Pre-existing pregnancy is the only contraindication, due to the ineffectiveness of the method

• May not be appropriate in a woman with an active migraine with neurologic symptoms

Conflicting Contraindications: Combined ECPs

• World Health Organization– Confirmed pregnancy

• Faculty of FP and RH Care (United Kingdom)– Confirmed pregnancy– Migraine at presentation (if Hx of focal migraine)– Past Hx of thromboembolism (relative contraindication)

• Planned Parenthood Federation of America– Suspicion or evidence of established pregnancy

WHO Emergency Contraception: A Guide for Service Delivery 1998Kubba. Emergency Contraception Guidelines for Doctors 1995

PPFA Manual of Medical Standards and Guidelines 1998ARHP data

How do the pills work?

• If taken before ovulation, may disrupt follicular development and maturation, causing either delayed ovulation or anovulation and/or an impaired luteal phase.

• May also decrease endometrial receptivity to implantation and impair corpus luteum function

Other possible mechanisms of action (cont.)

• Cause thick cervical mucus

• Alter tubal transport

• Inhibit fertilization

IUD as EC

• IUD insertion within 5 days of unprotected intercourse is almost 100% effective in preventing a pregnancy.

• Probably interferes with implantation

• May need to use prophylactic antibiotics because same women may be at high risk for sexually transmitted infections

Access to EC in WI—why advance prescription is important

• Only 50% of Wisconsin ERs prescribe EC

• Only 43% of hospitals dispense EC

• 28% of WI hospitals will not prescribe EC to victims of sexual assault

• In hospitals that do not prescribe EC, only 47% will provide a referral

• NARAL, 2002 Wisconsin Reproductive Access Project findings

Advance Prescription: issues

• Does it promote sexual risk taking behavior?

• Does it encourage women to use reliable contraception less?

• Do women use EC as a birth control method?

Results in ScotlandWomen who received ECPs in advance

• Were more likely to use ECPs: – 47% vs. 27% of women who received only counseling

(p<.001)

• Were not more likely to use ECPs repeatedly

• Used other methods of contraception equally well

• Had fewer unintended pregnancies– 3.3% vs 4.8 % for women who received only counseling

(p=0.14)

Glasier and Baird, N Engl J Med 1998;339:1ARHP

Results in San Francisco: Women who received ECPs in advance

• Were more likely to use ECPs– 22% vs 7% of women who received only counseling (p=.006)

• Were not more likely to have unprotected sex

• Were not less likely to use condoms consistently

• Were less likely to use oral contraceptives consistently– 32% vs. 58% of women who received only counseling (p=.03)

Raine et al. Obstet Gynecol 2000;96:1ARHP

Randomized trial of advance supply of EC

• Women with advance Rx were 4 times as likely to use EC in the following year (17% vs. 4%)

• No difference in use of effective birth control or consistency of use

• Same incidence of unprotected intercourse: women with Rx were 6 times as likely to use EC

Jackson, et al. Obstetrics and Gynecology 2003;102:8-16.

Advance Provision of EC: Teens* Prospective randomized trial at urban, hospital-based adolescent clinic

• 301 minority, low-income women age 15-20 years

• Advance provision/Rx vs. instructions on how to get EC

• At 1 month, advance Rx group reported nearly twice as much use as control group

– 15% vs. 8%, p=0.05

• Advance EC group began EC significantly sooner

– 11.4 h vs. 21.8 h, p=0.005

• No detrimental effects on condom or hormonal contraceptive use

• No increase in unprotected intercourseGold MA, et al. J Pediatr Adolesc Gynecol. 2004;17:87-96. Contraception online

Advance Rx vs. Patient request

Women do not know to ask for Advance Rx:

– While 76% of women have heard of ECPs or morning-after pills

– Only 16% of women know 72-hour time frame– Only 2% of women have ever used ECPs

ARHP data

Emergency Contraception OTC• ECPs are available directly from pharmacists

without a prescription in:

–California–Washington State–Hawaii–Maine–New Mexico–Legislation pending in 8 other states

–British Columbia

–France

–United Kingdom

–South Africa

–Portugal

–Belgium

–Albania

–Denmark

–SwedenARHP data

Response to Pharmacy Availability: Washington State

• 10,000 patient visits per year

• 42% of visits were during evenings, weekends, or holidays

• 95% of women had sufficient opportunity to ask questions

• 85% of women were satisfied with the on-going contraceptive counseling provided by pharmacists

• Medicaid projects savings of up to $10 million/year

ARHP data

Emergency Contraception: Rx by Telephone

• 3 questions to ask:

– Have you had unprotected sex or a problem with your birth control (such as condom breakage) during the last 3 days (rule out sexual assault)?

– Did your last menstrual period begin less than 4 weeks ago?

– Was the timing and duration of your last menstrual period normal?

• If the patient responds “yes” to all 3 questions, a clinician may prescribe emergency contraception over the telephone

Adapted from ACOG, Emergency Contraception: A Resource Manual for Providers, 1998. Contraception online

Patient Counseling for EC• Use of antiemetic (Rx or OTC) 1 hour prior to first dose of Yuzpe

• Expected side effects (nausea/vomiting/cramping)

• When to expect menses (up to 98% bleed within 21 days of EC)

• If no menses after 3 weeks, rule out pregnancy

• May discuss future contraceptive needs, STD risk

• How to take medication (give written instructions when possible)

• Assess for sexual assault

LaValleur J. Obstet Gynecol Clin North Am. 2000;27(4): 817-839.ACOG Practice Bulletin. Int J Gynecol Obstet. 2002;78:191-198.

Contraception online

Strategies to compensate for conflicting views among partners

• One back up partner on call for EC requests

• Provide advance prescriptions to minimize use of on-call system

• Open communication among call group

Resources: Emergency Contraception

• Hotlines– 1-888-NOT-2-Late or 800-584-9911

• Web Sites– http://www.NOT-2-Late.org

http://www.ec.princeton.edu/– http://www.PREVEN.com– http://kaisernetwork.org– http://cecinfo/html/updates.htm (emergency contraception

newsletters)– http://www.acog.org– http://www.go2ec.org/– http://www.prch.org

Contraception online

Summary:

• EC is a safe, easy-to-use method of preventing pregnancy after unprotected intercourse or sexual assault

• Advance Rx of EC should be a regular part of primary care for women

• Increased advance Rx will significantly reduce unintended pregnancies and abortion

• Advance Rx of EC does not negatively impact use of other birth control or increase unprotected intercourse

• PCPs should lead in making EC more accessible to women through regular and routine advance Rx