Clinical Issues in Emergency Contraception: Clinical Issues in Emergency Contraception Association of Reproductive Health Professionals www.arhp.org


Learning Objectives: Learning Objectives Understand progestin-only emergency contraceptive pill (ECP) product regimen Identify mechanism of action of ECPs Understand link between EC and risk-taking behavior State the effectiveness of ECPs Understand how to begin contraception after ECPs Understand how to enhance the availability of EC ACOG. 2005. Stewart F, Trussell J, Van Look PFA. 2007.


Evidence-Based Plan B® Regimen: Evidence-Based Plan B® Regimen Both pills taken at the same time Effective up to 120 hours after intercourse Most effective when taken sooner Arowojolu AO, et al. Contraception. 2002. von Hertzen H, et al. Lancet. 2002. Ngai SW, et al. Hum Reprod. 2004. Plan B® = progestin-only ECP


How MIGHT EC Work?: How MIGHT EC Work? Inhibit ovulation Trap sperm in thickened cervical mucus Inhibit tubal transport of egg or sperm Interfere with fertilization, early cell division, or transport of embryo Prevent implantation by disrupting the uterine lining Trussell J, Jordan B. Contraception. 2006.


Mechanism of Action: LNg ECPs: Mechanism of Action: LNg ECPs Clinical evidence about the effect of LNg ECPs on: Ovulation Uterine lining characteristics Timing of the next menstrual period Sperm motility and function Kesseru et al. 1974; Durand et al. 2001; Croxatto et al. 2001. Hapangama et al. 2001; Marions et al. 2002; Croxatto et al. 2003. Marions et al. 2004; Croxotto et al. 2004; Durand et al. 2005.


Clinical Evidence: LNg ECPs: Clinical Evidence: LNg ECPs Can inhibit ovulation, though not always May be only mechanism of action Can immobilize sperm by altering uterine pH Can alter glycodelin in serum & endometrium Can shorten the luteal phase Kesseru et al. 1974; Durand et al. 2001; Croxatto et al. 2001. Hapangama et al. 2001; Marions et al. 2002; Croxatto et al. 2003. Marions et al. 2004; Croxotto et al. 2004; Durand et al. 2005.


Animal Evidence: Levonorgestrel: Animal Evidence: Levonorgestrel Müller AL, et al. Contraception. 2003. Ortiz ME, et al. Hum Reprod. 2004.


Mechanism of Action:Is there a Post-Fertilization Effect?: Mechanism of Action: Is there a Post-Fertilization Effect? About the same amount of evidence for: ECPs OCs, implants, patches, rings, injectables IUDs The contraceptive effect of breastfeeding ACOG. 1998. Díaz S, et al. Fertil Steril. 1992. …all MAY work by inhibiting implantation of a fertilized egg


What Should Women Be Told?: What Should Women Be Told? EC may prevent pregnancy by: Delaying or inhibiting ovulation Inhibiting fertilization Inhibiting implantation of a fertilized egg Davidoff & Trussell. J Am Med Assoc. 2006.


ECPs & Post-Fertilization Effects: ECPs & Post-Fertilization Effects Davidoff & Trussell. J Am Med Assoc. 2006. “Women should be informed that the best available evidence is consistent with the hypothesis that Plan B®’s ability to prevent pregnancy can be fully accounted for by mechanisms that do not involve interference with post-fertilization events.”


Do ECPs Increase Risk Taking?: Do ECPs Increase Risk Taking? Studies conducted with women around the world San Francisco Pittsburgh Hong Kong Scotland Glasier A, Baird D. 1998.; Raine T, et al. 2000.; Jackson RA, et al. 2003.; Gold MA, et al. 2004.; Lo SS, et al. 2004.; Raine TR, et al. 2005.; Hu X, et al. 2005.; Raymond EG, et al. 2006.; Belzer M, et al. 2005.; Trussell J, et al. 2006.; Walsh TL, Frezieres RG. 2006.


Studies of ECP Use & Risk Taking: Studies of ECP Use & Risk Taking San Francisco Pittsburgh Hong Kong Scotland Women randomized to receive either: Counseling and ECPs on demand OR ECPs in advance for later use Glasier A, Baird D. 1998.; Raine T, et al. 2000.; Jackson RA, et al. 2003.; Gold MA, et al. 2004.; Lo SS, et al. 2004.; Raine TR, et al. 2005.; Hu X, et al. 2005.; Raymond EG, et al. 2006.; Belzer M, et al. 2005.; Trussell J, et al. 2006.; Walsh TL, Frezieres RG. 2006.


Use of ECPs: Advance v. On Demand: Use of ECPs: Advance v. On Demand Glasier A, Baird D. 1998.; Raine T, et al. 2000.; Jackson RA, et al. 2003.; Gold MA, et al. 2004.; Lo SS, et al. 2004.; Raine TR, et al. 2005.; Hu X, et al. 2005.; Raymond EG, et al. 2006.; Belzer M, et al. 2005.; Trussell J, et al. 2006.; Walsh TL, Frezieres RG. 2006.


Findings from ECP Use Studies: Findings from ECP Use Studies Women who received ECPs in advance were not more likely to: Use ECPs repeatedly Have unprotected sex Change to less effective contraception Use contraception less consistently Acquire an STI Glasier A, Baird D. 1998.; Raine T, et al. 2000.; Jackson RA, et al. 2003.; Gold MA, et al. 2004.; Lo SS, et al. 2004.; Raine TR, et al. 2005.; Hu X, et al. 2005.; Raymond EG, et al. 2006.; Belzer M, et al. 2005.; Trussell J, et al. 2006.; Walsh TL, Frezieres RG. 2006. more…


Findings from ECP Use Studies (continued): Findings from ECP Use Studies (continued) Women who received ECPs in advance: Took ECPs sooner after sex Used other methods of contraception equally well Women who received ECPs in advance were NOT less likely to become pregnant. Glasier A, Baird D. 1998.; Raine T, et al. 2000.; Jackson RA, et al. 2003.; Gold MA, et al. 2004.; Lo SS, et al. 2004.; Raine TR, et al. 2005.; Hu X, et al. 2005.; Raymond EG, et al. 2006.; Belzer M, et al. 2005.; Trussell J, et al. 2006.; Walsh TL, Frezieres RG. 2006.


Impact of Advanced Provision of ECPs: Impact of Advanced Provision of ECPs Raymond EG, Trussell J, Polis C. Obstet Gynecol; 2007. Having ECPs in advance increases use but… has not been shown to reduce rates of unintended pregnancy.


Why No Reduction in Pregnancies?: Why No Reduction in Pregnancies? Lo, SS, et al. Hum Reprod. 2004.; Raine TR, et al. JAMA. 2005. Hu X, et al. Contraception. 2005. Raymond EG, et al. Contraception. 2006. Among women who received ECPs in advance more…


Why No Reduction in Pregnancies? (continued): Why No Reduction in Pregnancies? (continued) Glasier A, et al. Contraception. 2004. Community intervention in Scotland Women ages 16-29 received ECPs in advance ~50% used ECPs at least once Results: No effect on abortion rate observed 78% of women with advanced supplies who got pregnant did not use ECPs Women most at risk probably did not get ECPs


Excellent Evidence that LNg ECPs Work: Excellent Evidence that LNg ECPs Work Raymond et al. Contraception. 2004.


Lessons Learned about ECPs: Lessons Learned about ECPs Women underestimate their risk of pregnancy More education is needed OTC switch is necessary – but not sufficient – for solving this problem Major public health impact is unlikely Raymond EG, Trussell J, Polis C. Obstet Gynecol; 2007.


Beginning Contraception after ECPs: Beginning Contraception after ECPs OCs, patch, vaginal ring & injectable Regular start Use backup until next period Start contraceptive method according to regular patient instructions Jump/Quick start Take ECPs Start contraceptive method the same day (use backup for first seven days) more…


Jump-Start Recommended after ECPs: Jump-Start Recommended after ECPs


Initiating Ongoing Contraception after EC: Initiating Ongoing Contraception after EC


Bleeding Patterns After ECPs: Bleeding Patterns After ECPs Raymond EG, et al. Contraception. 2006. Gainer E, et al. Contraception. 2006. Two studies assessed the effects of ECPs on bleeding patterns 1.5 mg levonorgestrel Single dose


Study 1: Results: Study 1: Results Raymond EG, et al. Contraception. 2006.


Study 2: Results: Study 2: Results Compared baseline cycle with treatment and post-treatment cycles Gainer E, et al. Contraception. 2006.


EC Hotline and Website: EC Hotline and Website www.not-2-late.com 888-NOT-2-LATE


Providers on the Hotline and Website: Providers on the Hotline and Website www.not-2-late.com


ECPs Available Over-the-Counter in US: ECPs Available Over-the-Counter in US FDA approved Plan B® for over-the-counter sales to US women and men age 18 and older in 2006 Government-issued ID required for proof of age Loss of insurance coverage for Plan B® OTC Women age 17 and younger still need prescription except in states with pharmacy access US Food and Drug Administration. 2006. Pharmacy Access Partnership. 2007.


Pharmacy Access to ECPs: Pharmacy Access to ECPs Alaska California Hawaii Maine Massachusetts Montana New Hampshire New Mexico Vermont Washington Canada France United Kingdom Australia South Africa 33 other countries + 4 OTC ECPs are available directly from pharmacists without having first to get a prescription in: www.not-2-late.com


Pharmacy Access to ECPs in the US: Pharmacy Access to ECPs in the US www.not-2-late.com


Appendix: Appendix Results: Studies of ECP Use and Risk Taking


Advanced Provision of ECPs:Results from Scotland: Advanced Provision of ECPs: Results from Scotland Women 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 A, Baird D. N Engl J Med. 1998.


Advanced Provision of ECPs:Results from San Francisco (Study 1): Advanced Provision of ECPs: Results from San Francisco (Study 1) 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 T, et al. Obstet Gynecol. 2000.


Advanced Provision of ECPs:Results from San Francisco (Study 2): Advanced Provision of ECPs: Results from San Francisco (Study 2) Women who received ECPs in advance Were more likely to use ECPs: 17% vs 4% of women who received only counseling (p=.006) Were not more likely to change to a less effective method of contraception Were not more likely to have unprotected sex Were not more likely to use contraception less consistently Had fewer unintended pregnancies: 7% vs 10% for women who received only counseling (p=0.16) Jackson RA, et al. Obstet Gynecol. 2003.


Advanced Provision of ECPs:Results from San Francisco (Study 3-A) : Advanced Provision of ECPs: Results from San Francisco (Study 3-A) Women who received ECPs in advance Were more likely to use ECPs: 37% vs 21% of women who received only counseling (p<.001)) Were not more likely to have unprotected sex Were not less likely to use condoms or pills consistently Were not more likely to acquire an STI Were not less likely to become pregnant Raine T, et al. JAMA. 2005.


Advanced Provision of ECPs:Results from San Francisco (Study 3-B): Advanced Provision of ECPs: Results from San Francisco (Study 3-B) Women who received ECPs from a pharmacist Were no more likely to use ECPs: 24% vs 21% of women who received only counseling (p=.25) Were not more likely to have unprotected sex Were not less likely to use condoms or pills consistently Were not more likely to acquire an STI Were not less likely to become pregnant Raine T, et al. JAMA. 2005.


Advanced Provision of ECPs:Results from Pittsburgh : Advanced Provision of ECPs: Results from Pittsburgh Women who received ECPs in advance Were more likely to use ECPs: 15% vs 8% of women who received only counseling (p=.05) Took ECPs sooner after sex (11 vs 22 hours) Were more likely to use condoms Were not less likely to use hormonal contraception Gold MA, et al. J Pediatr Adolesc Gynecol. 2004.


Advanced Provision of ECPs:Results from Hong Kong : Advanced Provision of ECPs: Results from Hong Kong Women who received ECPs in advance Were more likely to use ECPs: 30% vs 13% of women who received only counseling (p<.001) Were not less likely to use contraception consistently Were not less likely to use condoms Took ECPs sooner after sex (14 vs 29 hours) Were not less likely to become pregnant Lo SS, et al. Hum Reprod. 2004.


Advanced Provision of ECPs:Results from China : Advanced Provision of ECPs: Results from China Women who received ECPs in advance Were twice as likely to use ECPs Were not less likely to use contraception Were not less likely to use condoms Were not less likely to become pregnant Hu X, et al. Contraception. 2005.


Advanced Provision of ECPs:Results from Los Angeles (Study 1): Advanced Provision of ECPs: Results from Los Angeles (Study 1) Women who received ECPs in advance Were more likely to use ECPs: 83% vs 11% of women at 6 months and 64% vs 17% of women at 12 months who received only counseling (p<.01) Were not more likely to have unprotected sex Were not less likely to use condoms Were not less likely to become pregnant Belzer M, et al. J Pediatr Adolesc Gynecol. 2005 Trussell J, Raymond E, Stewart FH. J Pediatr Adolesc Gynecol. 2006.


Advanced Provision of ECPs:Results from Los Angeles (Study 2) : Advanced Provision of ECPs: Results from Los Angeles (Study 2) Women who received ECPs in advance Were more likely to use ECPs: 19% vs 12% of women who received only counseling (p<0.05) Were not more likely to have unprotected sex Were not less likely to use barrier methods or pills Were not less likely to become pregnant Walsh TL, Frezieres RG. Contraception. 2006.


Advanced Provision of ECPs:Results from Nevada & North Carolina : Advanced Provision of ECPs: Results from Nevada & North Carolina Women who received ECPs in advance Were more likely to use ECPs: 71% vs 32% of women who received only counseling (p<0.001) Were not more likely to have unprotected sex Were not less likely to use condoms or pills Were not more likely to acquire an STI Were not less likely to become pregnant Raymond EG, et al. Obstet Gynecol. 2006.