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CALIFORNIA FAMILY HEALTH COUNCIL, INC. Emergency Contraception Initiative Anna García, Project Director Emergency Contraception Initiative Increase the network of EC providers FREE EC Provider kit and technical assistance Offer EC resources and policy updates

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california family health council inc
CALIFORNIA FAMILY HEALTH COUNCIL, INC.

Emergency Contraception Initiative

Anna García, Project Director

slide2
Emergency Contraception Initiative
  • Increase the network of EC providers
    • FREE EC Provider kit and technical assistance
    • Offer EC resources and policy updates
  • Increase patient awareness of EC
    • Client education brochures
    • Outreach materials and promotion
counter misinformation
Counter Misinformation
  • ACCURATE INFORMATION
  • MEDICAL EVIDENCE
  • PROMOTING BENEFITS
comparison of ec pills
Plan B

No estrogen

Less nausea & vomiting

89% effective

Single dose or two doses

Consists of two .75mg Levonorgestrel tablets

Combined Hormones

Estrogen & progestin

50% nausea/20% vomiting

75% effective

Two doses 12 hours apart

Varied number of tablets for proper EC dosing by brand

Comparison of EC pills
emergency contraception also known as the morning after pill
Emergency Contraceptionalso known as the Morning After Pill
  • Does not cause abortion
  • Will not interrupt or harm an established pregnancy
  • Does not protect against sexually transmitted infections (STIs)
  • Is not the same as mifepristone (RU486)
definition of pregnancy
Definition of Pregnancy
  • NIH/FDA
    • “Pregnancy encompasses the period of time from confirmation of implantation until expulsion or extraction of the fetus.”
  • ACOG
    • “Pregnancy is the state of a female after conception and until termination of the gestation.”
    • “Conception is the implantation of the blastocyst. It is not synonymous with fertilization; synonym: implantation.”

US Government 1983

Hughes ACOG 1972

ARHP

mechanism of action
Mechanism of Action
  • EC primarily works to delay or inhibit ovulation.
  • EC MAY keep the sperm from meeting the egg.
  • EC MAY keep the fertilized egg from implanting.
  • Other methods that MAY keep the fertilized egg from implanting.
    • OCs, Norplant, Vaginal ring, Patch & Depo-Provera
    • IUDs (Mirena and ParaGard)
    • The contraceptive effect of breastfeeding

Source: ACOG 1998

ARHP

mode of action evidence levonorgestrel
Mode of Action Evidence: Levonorgestrel
  • Studies in the rat and in the new-world monkey Cebus apella
  • Levonorgestrel administered in doses that inhibit ovulation has no post-fertilization effect that impairs fertility
  • Emergency doses of Levonorgestrel interfered with ovulation 82% of the time in women

Müller et al. 2003; Ortiz et al. 2004; Croxatto et al. 2005

slide10
Professional Liability Issues
  • EC is the only treatment available to prevent unintended pregnancy after unprotected intercourse.
  • Emergency Contraception is the accepted standard of care. (ACOG Practice Pattern 1996, 2001)
  • Consider liability for failure to provide EC.

ACOG 1996, CRLP 1999

ultimate ec impact
Ultimate EC Impact
  • 54% having abortions used contraception during the month they became pregnant
  • Of those using EC:
    • 35% had no method of contraception
    • 65% used EC for backup
  • Up to 51,000 abortions were prevented by EC use in 2000

Source: Alan Guttmacher Institute

research highlights
Research Highlights
  • EC is most effective the sooner it’s taken
  • EC works up to 5 days after sex
  • Plan B can be taken as a Single dose with no increase in side effects
  • EC use has no adverse effects to pregnancy
  • There are no known medical restrictions to the number of times EC can safely be taken
pregnancy rates effect of delayed dosing
Pregnancy Rates: Effect of Delayed Dosing

Hours Delay

386 522 326 379 191 146Number of Women

Piaggio, G. et al. Lancet 1998: 352; 721.

benefits of ec in advance
For patients:

EC on hand to take right after sex when it’s most effective

Avoid barriers to access (transportation, work, school, childcare)

Eliminates potential embarrassment or shame

For providers:

Cuts down walk-in EC patients

Reduces the urgent need for EC

Advance prescription is good for one year

Benefits of EC in Advance:
ec works up to 5 days after
EC Works up to 5 Days After
  • Studies show EC effectiveness up to 120 hours (Ellertson, et al. 2003).
  • Canadian researchers found an effectiveness

rate up to 87% for EC taken 3 to 5 days after unprotected sex (Rodrigues, et al. 2001).

  • Low conception rates up to 120 hours after exposure (ACOG, 1996 & 2001).
single vs two dose levonorgestrel side effects
Single vs. Two-Dose Levonorgestrel: Side Effects

Single-Dose Levonorgestrel

Two-Dose Levonorgestrel

31%

31%

18%

15%

14%

14%

8%

8%

5%

4%

3%

1%

1%

0%

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

fetus unharmed by failed ec
Fetus Unharmed by Failed EC
  • No adverse effects of hormonal EC
  • No increased risk to mother or child
  • No need to consider voluntary abortion

SOURCE: De Santis, M. Fertility and Sterility, August 2005.

research highlights18
Research Highlights
  • EC is most effective the sooner it’s taken
  • EC works up to 5 days after sex.
  • Plan B can be taken as a Single dose with no increase in side effects
  • EC use has no adverse effects to pregnancy
  • There are no known medical restrictions to the number of times EC can safely be taken
repeated ec use
Repeated EC Use
  • No known “medical” restrictions to repeat EC use
  • EC is safe and effective
  • EC can be taken as often as needed

“Repeated use poses no health risks and should not be cited as a reason for denying EC treatment.”

—World Health Organization

reduce repeated ec use
Reduce Repeated EC Use
  • Hormonal methods
    • Regular start: use condoms until next period, then begin hormonal method according to regular patient instructions
    • Jump start: take two EC doses. Start a new pack of OCs on the next day or insert ring or apply patch (use backup for first seven days)
  • Important:  Be sure to do a pregnancy test if no normal period after completing a cycle of using a hormonal method.

ARHP

slide21
Identify EC patients
  • “Have you had unprotected sex in the last 5 days?”
    • If yes, treatment options:
      • Emergency Contraception
      • STI screening
      • Needs reliable Birth Control and counseling
  • Identify EC patients from clinic population.
    • Pregnancy testing
    • STI screening
slide22
Education and Counseling
  • Informed Consent
    • Verbal consent, necessary
    • Written consent, as desired

or required by funding source

  • Instructions for Use
    • Facts about EC pills
    • How EC is taken
    • Side Effects
  • Follow up
    • Pregnancy Testing, if no menses in 3 weeks
    • Establish use of a reliable birth control method
    • Assess STI risk and need for testing
slide23
Adapted from the ACOG Practice Patterns, EC patient management algorithm, 1996 and Managing Contraception, Using ECPs, 2002-2003.
slide24
Encourage Pharmacy Stocking
  • Link prescribing providers with pharmacies
  • Phone call from EC prescribing provider to ensure stocking
ec pharmacy access
California Legislation

SB 1169 made EC “behind the counter”

SB 545 put a $10 cap on pharmacy consult

SB 490 creates a statewide EC protocol

SB 644 requires pharmacies to fill EC prescriptions or refer

EC Pharmacy Programs

www.ec-help.org

EC Policy

www.go2ec.org

EC On-line Training*

www.pharmacyaccess.org

EC Pharmacy Access

*1 hour CE or CME credit for Health Care Professionals

ec over the counter
EC Over-the-Counter?
  • On May 7, 2004 the FDA denied approval for the Plan B dedicated EC product
  • Current Plan B application would require a dual-label:
    • OTC for ages 17 & up
    • Rx for ages 16 & under
  • FDA decision delayed January 2005
  • August 28th 2005, FDA decision was delayed indefinitely
meets fda approval
Meets FDA Approval
  • No evidence-based contraindications
  • No risk of overdose, prepackaged
  • Not addictive
  • Same dose for every woman
    • Two doses (12 hours apart)
    • Single dose (off-label)
research supports ec over the counter
Research supports EC Over-the-Counter
  • Mounting empirical evidence shows that better access to EC does not increase risk taking.
    • A study with OTC-like conditions showed proper use of EC was the norm (only 1.3% improper use).
    • Women 15-20 with an advance supply of EC were no less likely to use routine contraceptives.
    • JAMA study shows making EC available in advance and in pharmacies does not increase sexual risk taking.

Raymond et. al., 2003 and Gold et. al., 2004; Raine et. al., 2005 (respectively)

improving ec access
Improving EC Access:
  • Routinely discuss EC with patients
  • Streamline EC delivery
    • Identify women seeking pregnancy or STI testing
    • Use EC as a transition to reliable birth control
  • Provide/Rx EC in advance of need
a win win situation
A Win-Win Situation!

EC in advance…

  • Eliminates the sense of urgency
  • Eliminates having to admit failure
  • Helps avoid pharmacy stocking challenges
other suggestions to improve ec access
Other Suggestions to Improve EC Access:
  • Consider men good candidates for an EC message to aid their partner
  • Eliminate embarrassment by routinely offering EC at annual, initial, or EC visits
  • Dispense EC as often as needed
role of the provider
Role of the Provider
  • Increase awareness of EC to help prevent unplanned pregnancy and abortion
  • Educate patients on the benefits of proper EC use
  • ProvideEC pills to women at risk of unplanned pregnancy
  • Remove barriers to EC access and offer in advance as often as needed
for more information
For More Information:
  • www.agi-usa.org – Reproductive health research resources
  • www.arhp.org – Downloadable EC slides: Train the trainer
  • www.cfhc.org – NEW EC videos for teens & other resources
  • www.ec-help.org – Find an EC pharmacy program
  • www.go2ec.org – Updates on EC policy & programs
  • www.not-2-late.com – National EC Hotline resources
  • www.pharmacyaccess.org – 1 hour online training with CEUs

for healthcare professional

  • www.teensource.org – Family planning resources for teens
  • www.who.int/reproductive-health/family_planning/ec - World Health Organization Fact sheet which recommends Plan B as a Single dose
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