EMERGENCY CONTRACEPTION Still the Nation’s Best-Kept Secret

1. EMERGENCY CONTRACEPTIONStill the Nation’s Best-Kept Secret James Trussell, PhD Office of Population Research Princeton University

2. A condom broke or slipped off, you had sex when you did not expect to, you did not use any birth control that weekend, you missed several pills, you were forced to have sex . . . What if ? ?

3. Emergency Contraceptives • Regular contraceptives used in a different way • Prevent pregnancy after intercourse • Inhibit ovulation, fertilization, or implantation • Do not cause an abortion • Will not interrupt an established pregnancy • Are not the same as mifepristone • Do not protect against STIs

4. 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.”

5. Options in the United States Emergency use of oral contraceptive pills containing estrogen and progestin Emergency use of oral contraceptive pills containing only progestin Emergency Copper-T IUD insertion

6. Emergency Contraceptive Pills: Combined • Ordinary birth control pills • Contain estrogen and progestin • 2 doses of 2, 4, or 5 pills, depending on brand • First dose within 120 hours after intercourse • Second dose 12 hours later • Side effects: nausea (50%) and vomiting (20%)

7. Emergency Contraceptive Pills: Progestin-only • Birth control pills containing only progestin • 2 doses of 1 Plan B pill or 20 Ovrette pills • First dose within 120 hours after intercourse • Second dose 12 hours later • Both doses can be taken at the same time • More effective than combined ECPs • Less nausea and vomiting than combined ECPs

8. Copper IUD Insertion • Copper-T IUD (ParaGard) • Insertion within 5 days after ovulation (but most protocols state within 5 days after unprotected intercourse) • 10 more years of highly effective contraception • Much more effective than ECPs

9. History of EC Methods • mid-1960s: high dose estrogens • early 1970s: combined OCs (Yuzpe regimen) • late 1970s: copper IUD • mid-1990s: levonorgestrel-only pills • mid-1990s: antiprogestins

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

11. How Long After the Morning After?Meta-Analysis of 9 Trials (Combined) p=.25

12. How Long After the Morning After?WHO (Combined and LNg) p<.01

13. How Long After the Morning After?Quebec (Combined) p=.75 87 92

14. How Long After the Morning After?Population Council (Combined) 111 675 Pregnancy Rate 589 104 p=.52 and .99

15. How Long After the Morning After?Latest WHO Trial (LNg) p=.16 314 2381

16. How Long After the Morning After?Chinese Trial (LNg) p=.26 139 1932

17. The Setting • 3.0 million unintended pregnancies each year in the United States: half (48%) of all pregnancies • Half (48%) of women aged 15-44 have ever had an unintended pregnancy • Emergency contraception has the potential to reduce unintended pregnancy significantly • Emergency contraception is highly cost-effective

18. Potential Impact

19. Potential Unrealized • 75 million cycles per year in which unprotected intercourse occurs among women at risk of an unintended pregnancy • Only 6% of women have ever used ECPs

20. The Problem • Companies did not market pills or IUDs for emergency contraception in the United States • Clinicians do not routinely counsel women (or men) about emergency contraception • Women (and men) do not know about emergency contraception • Pharmacies do not routinely carry ECPs

21. The Solution • Market EC • Change provider practices • Enhance availability • Establish call-in prescription services • Enhance pharmacy access • Change from Rx to OTC • Educate women (and men)

22. MARKETING

23. Preven Gynétics 1998-2004

24. The Value of a Dedicated Product Ovral Preven Alesse

25. Plan B WCC 1999

26. The Value of a Dedicated Product Plan B Ovrette

27. EC in Europe PC4 Schering Postinor-2 Gedeon Richter

31. NorLevo HRA Pharma • OTC in Norway (2000), Sweden (2001), Netherlands (2004), India (2005) • Dispensed by school nurses in every junior and senior high school in France • And dispensed at no cost to minors by pharmacists

32. PROVIDER PRACTICE

33. Providing EC is Now the Medico-Legal Standard of Care • ACOG Practice Pattern on ECPs (12/96) established the professional standard of care • FDA notice in Federal Register on ECPs (2/97) declared 6 (now 19) brands of regular OCs to be safe and effective for use for emergency contraception • FDA explicitly approved Preven and Plan B as dedicated products, but FDA still recognizes 19 brands of regular combined OCs to be safe and effective for use for EC

34. Provider Practice: Good News

35. Provider Practice: Bad News

36. The Clinical Bottleneck • Clinicians overwhelmingly think ECPs are safe and effective, and the majority have prescribed in the last year • And clinicians are waiting for women to ask for EC • But women do not know to ask • while 68% of women have heard of ECPs/MAPs • only 6% of women have ever used ECPs

37. INCREASING ACCESS

38. EC Hotline and Website • Emergency Contraception Hotline • 1-888-NOT-2-LATE • 500k calls since 1996 • Emergency Contraception Website • http://not-2-late.com • 2.5m visits since 1994

39. Providers on the Hotline and Website

40. State Websites Prescriptions are called in to the client’s pharmacy of choice • Georgia: www.ecconnection.org • Illinois: www.plannedparenthoodchicago.com • Indiana: www.ppin.org/ecaccess/ecinfo.html • Massachusetts: www.pplm.org • Oregon: www.ppcw.org • Washington: www.ppcw.org

41. Statewide Hotlines • Connecticut: 800-230-PLAN • Georgia: 877-ECPills • Illinois : 866-222-EC4U or 217-544-2744 • Maine: 800-887-4029 • Maryland: 877-99-GO-4-EC • Massachusetts: 800-682-9218, 642-5665, 539-2378 • Michigan: 734-973-0710 • Minnesota: 612-625-4607 • Montana: 800-584-9911 • New Mexico: 505-272-9304 • New York: 917 641-5084 • North Carolina: 866-942-7762 • Wisconsin: 877-975-9858

43. States with Call-in Prescriptions 37% of women aged 15-44

44. Alaska California Hawaii Maine Massachusetts New Hampshire New Mexico Washington Canada France United Kingdom Australia South Africa New Zealand Israel 27 other countries Emergency Contraception BTC ECPs are available directly from pharmacists without having first to get a prescription in:

45. Pharmacists Providing ECPs

46. Plan B OTC • Application to switch from Rx to OTC submitted April 20, 2003. FDA decision due by February 20, 2004 • FDA convened advisory committee on December 16, 2003. Committee voted 23-4 in favor • FDA announced on February 13, 2004 that it would delay the decision by up to 90 days • FDA rejected application on May 6, 2004, citing lack of data on females <16

48. Evidence-Based Decision? • In 7 studies, women were randomly assigned to get ECPs in advance or in the regular way • 1 study among teens, 2 among women 15-24 • Not one study found an increase in risk taking, or a reduction in condom use, or abandonment of regular contraceptive use • FDA has never previously required data on persons <16

49. GAO Report: Decision Very Unusual • Report requested by Congress in June 2004 and released in October 2005 • Report concludes that the decision was highly unusual, was made with atypical involvement from top agency officials, and may well have been made months before it was formally announced

50. Plan B OTC • Barr Laboratories submitted amended application on July 22, 2004, to make Plan B an Rx drug for females <16 and OTC otherwise • FDA had until January 21, 2005 to respond • On July 15, 2005, HHS Secretary Leavitt promised that FDA would act on Barr's application by September 1 to ensure a vote on Senate confirmation of Lester Crawford as FDA Commissioner