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 • Increase patient awareness of EC • Client education brochures • Outreach materials and promotion
Counter Misinformation • ACCURATE INFORMATION • MEDICAL EVIDENCE • PROMOTING BENEFITS
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 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 • 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 • 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 • 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
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 • 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 • 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 Hours Delay 386 522 326 379 191 146Number of Women Piaggio, G. et al. Lancet 1998: 352; 721.
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 • 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-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 • 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 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 • 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 • 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
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
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
Adapted from the ACOG Practice Patterns, EC patient management algorithm, 1996 and Managing Contraception, Using ECPs, 2002-2003.
Encourage Pharmacy Stocking • Link prescribing providers with pharmacies • Phone call from EC prescribing provider to ensure stocking
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? • 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 • 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 • 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: • 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! EC in advance… • Eliminates the sense of urgency • Eliminates having to admit failure • Helps avoid pharmacy stocking challenges
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 • 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: • 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