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CALIFORNIA FAMILY HEALTH COUNCIL, INC.

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.

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  1. CALIFORNIA FAMILY HEALTH COUNCIL, INC. Emergency Contraception Initiative Anna García, Project Director

  2. 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

  3. Counter Misinformation • ACCURATE INFORMATION • MEDICAL EVIDENCE • PROMOTING BENEFITS

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Pregnancy Rates: Effect of Delayed Dosing Hours Delay 386 522 326 379 191 146Number of Women Piaggio, G. et al. Lancet 1998: 352; 721.

  13. 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:

  14. 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).

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. Adapted from the ACOG Practice Patterns, EC patient management algorithm, 1996 and Managing Contraception, Using ECPs, 2002-2003.

  23. Encourage Pharmacy Stocking • Link prescribing providers with pharmacies • Phone call from EC prescribing provider to ensure stocking

  24. 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

  25. 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

  26. 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)

  27. 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)

  28. 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

  29. A Win-Win Situation! EC in advance… • Eliminates the sense of urgency • Eliminates having to admit failure • Helps avoid pharmacy stocking challenges

  30. 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

  31. 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

  32. 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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