1. Emergency Contraception for Clinical Providers in Washington State 1

2. The New Yorker, July 23, 1999 2 “Don’t get me wrong. I think the morning after pill is great. It’s just that right now my problem is lining up something for the night before.”

3. Learning Objectives w Understand the history and expanding role of emergency contraception (EC) in pregnancy prevention w Understand the differences between EC regimens and their effectiveness w Identify mechanisms for raising awareness of EC within the client population w Increase awareness of EC resources w Facilitate integration of EC into routine family planning, reproductive health, and primary care activities activities 3

4. w Around 10 million couples have sexual intercourse every night in America w Approximately 27,000 condoms break or slip w Even perfect contraceptors can and do experience contraceptive failure 4 Why Is Emergency Contraception Needed? Source: Trussell & Kowal, 1998.

5. Current Proportion of Unintended Pregnancies United States: 49% Washington State: 55% Source: Henshaw, 1998; Schrager, 1997. 5

6. Definition of Unintended Pregnancy 6 wPregnancy that is unwanted or mistimed at conception wDoes not mean unwanted births/unloved children wDoes mean less opportunity to prepare :  Prepregnancy risk identification  Management of preexisting conditions  Changes in diet and vitamins  Avoidance of alcohol, toxic exposure, and smoking

7. The Institute of Medicine Recommends That the Nation Adopt a New Social Norm All pregnancies should be intended– that is, they should be consciously and clearly desired at the time of conception. Source: Institute of Medicine, 1995. 7

8. Emergency contraception prevents pregnancy AFTER sex 8

9. Awareness of Emergency Contraception is Limited w Public uninformed about the method u 11% of women know the basic facts about EC u 1% have used it w These data are supported by PATH’s local assessment, which found that most clients have not heard about EC Source: Kaiser Family Foundation, 1997 9

10. Kaiser Family Foundation Survey: Client Education Adapted from ARHP, 1999. Source: Kaiser Family Foundation, 1997. 10

11. History of EC w mid-1960s: High-dose estrogens in use w early 1970s: Combined OCs (Yuzpe regimen) w 1997:FDA announces that combined oral contraceptives are safe and effective for use as postcoital emergency contraception w 1998:First dedicated product, Preven™, approved by FDA w 1999:Progestin-only dedicated product, Plan B™, approved by FDA Adapted from ARHP, 1999. Source: Federal Register, 1997. 11

12. What Is Emergency Contraception? w Emergency Contraceptive Pills (ECPs) u Often referred to as “the morning-after pill” u Birth control pill hormones taken in high dose within 3 days (72 hours) of unprotected sex w IUD Insertion u Within 5 days (120 hours) of unprotected sex u Can also be a long-term contraceptive method 12

13. IUDs as Emergency Contraception w 99% effective in preventing pregnancies w Can be retained for up to 10 years w Screening should follow regular IUD screening criteria plus ascertain unprotected intercourse within 5 days of seeking treatment Source: Trussell & Ellertson, 1995. 13

14. Two Types of ECPs Progestin-only w Reduces the risk of pregnancy by 89% w Side effects u Nausea (23%) u Vomiting (6%) Estrogen and Progestin w Reduces the risk of pregnancy by 75% w Side effects u Nausea (50%) u Vomiting (20%) Source: Task Force on Postovulatory Methods of Fertility Regulation, 1998. Both Methods: First dose within 72 hours after intercourse First dose within 72 hours after intercourse Second dose 12 hours later Second dose 12 hours later 14

15. w Plan B™ w Women’s Capital Corporation w FDA approved July 1999 Dedicated Progestin-Only Product 15

16. Effectiveness: Single-Use Progestin Only 100 women have unprotected sex in the 2nd or 3rd week of their cycle 8 will become pregnant without emergency contraception 1 will become pregnant using progestin-only ECPs (89% reduction) (89% reduction) Adapted from ARHP, 1999. Source: Task Force on Postovulatory Methods of Fertility Regulation, 1998. 16

17. Dedicated Estrogen and Progestin (Combined) Product w Preven™ w Gynétics w FDA approved March 1998 17

18. Effectiveness: Single-Use Combination Pill 100 women have unprotected sex in the 2nd or 3rd week of their cycle 8 will become pregnant without emergency contraception 2 will become pregnant using combined ECPs (75% reduction) (75% reduction) Adapted from ARHP, 1999. Source: Trussell, Rodriguez, and Ellertson, 1998. 18

19. Regular Oral Contraceptives Used for Emergency Contraception w In addition to dedicated ECP products, regular birth control pills can be prescribed in special doses for emergency contraception (See table in your packet) 19

20. Treatment Is More Effective the Sooner It Begins Source: Lancet, 1998 20

21. ECP Mechanism of Action w Clinical studies have shown that ECPs can inhibit or delay ovulation w Evidence regarding endometrial alterations equivocal u Not clear that changes observed would inhibit implantation w Biologic plausibility regarding inhibition of fertilization u Thickening of cervical mucous u Alterations in tubal transport of sperm or egg 21 Source: Swahn et al., 1996; Ling et al., 1979; Rowlands et al., 1986; Ling et al., 1983; Kubba et al., 1986; Taskin et al., 1994.

22. ECP Mechanism of Action w Timing impacts how ECPs work: u Cycle day on which intercourse occurred u Cycle day on which treatment is used w Statistical evidence suggests there must be an additional mechanism beyond delaying or preventing ovulation 22 Source: Von Hertzen & Van Look, 1996; Trussel & Raymond,1999.

23. Medical Definition of Pregnancy w NIH, FDA, and ACOG all define pregnancy as beginning with implantation w Takes about 6 days for a fertilized egg to begin to implant w Intervention within 72 hours cannot result in abortion w ECPs are not effective if a woman is already pregnant Source: Code of Federal Regulations, 1998; Hughes, 1972. 23

24. Providing EC Information w For some women, clearly understanding the mechanism of action will be critical to making an informed choice about ECP use. 24

25. Key Points on Mechanism of Action w ECPs work through various mechanisms w ECPs will not interrupt or harm an established pregnancy w ECPs are not the same as mifepristone (RU486), which is used after pregnancy is already established 25

26. ECP Safety: Women’s Health w According to the World Health Organization, there are no absolute contraindications for ECPs. w ECPs are believed to have no clinically significant impact on conditions such as cardiovascular disease, angina, acute focal migraine, or severe liver disease. w However, ECPs do not protect against STDs. Source: WHO, 1996. 26

27. ECP Safety: Health of Fetus w ECPs do not interfere with an established pregnancy. w No evidence that ECP hormones have an adverse effect on fetal development. Source: FDA, 1997. 27

28. What are the key messages to communicate to your clients? 28

29. Key Messages for Clients: w 72-hour time frame for ECPs (b ut sooner is better) w Safe and effective w Mechanism of action (informed choice) w Do not cause abortion w Side effects: nausea and vomiting w Not as effective as other contraceptives for regular use w Do not protect against STDs 29

30. What other issues might be of importance to clients? 30

31. Key Topics of Importance to Clients w No future impact on childbearing w No threat to potential pregnancy w Not abortion w Religion (individual’s religious background not always predictive of EC interest) w Expense of ECPs (covered by Medicaid) w Confidentiality u Adolescents u Diverse communities u Interpreters 31

32. Physician/Clinic Referral or Follow-up w No menses within 3 weeks after treatment 98% of women have menses within 21 days98% of women have menses within 21 days w If client has concerns or problems w For initiation of routine birth control method w For information or screening for STDs 32

33. Initiating Regular Contraceptive Use w Condomimmediately w Diaphragmimmediately w Oral contraceptivesimmediately or after next menses* w Injectable within 7 days after or implantnext menses* w IUDafter next menses (for long-term use)* (* use back-up method until menses) 33

34. Advance Distribution or Advance-of-Need Prescribing of ECPs w ECPs are more effective when taken sooner w Advance prescription reduces access barrier w Women are not more likely to use ECPs repeatedly w Advance prescription does not decrease the use of other birth control methods Source: Glasier and Baird, 1998. 34

35. Expanded Access Through Pharmacies in Washington State w Collaborative drug therapy agreement between pharmacist and independent prescriber w Trained pharmacists participating in a collaborative agreement can provide ECPs directly to women who request them w Currently over 145 pharmacies participating w In the first 16 months of project pharmacists wrote and filled almost 12,000 prescriptions for ECPs 35

36. Medicaid Coverage of ECPs w Medicaid covers ECP prescriptions u Covers Preven™ and Plan B™ u Covers regular birth control pills prescribed in special doses for emergency contraception w Medicaid covers pharmacist counseling time u For women who receive ECPs directly from pharmacist, the pharmacist’s counseling time and the ECP prescription are covered. 36

37. Cost of ECPs w For prescriptions written by medical providers (MDs, ARNPs, PAs): u If covered by insurance:$5-10 co-pay u If no insurance coverage: Plan B™:$18-35Plan B™:$18-35 Preven™:$20-35Preven™:$20-35 –Note: client also must pay for office visit to get prescription w For prescription and consultation at pharmacy: u Pills and counseling:$35-45 u As dedicated products become more widely used, cost may rise slightly:$40-45 37

38. Tools Included in Provider Packet w Q & A for medical providers w Key messages to convey to clients w Telephone screening protocol w EC referral card w Emergency Contraception: Client Materials for Diverse Audiences booklet w List of pharmacies that provide ECPs in Washington State w EC reference list 38

39. EC Materials for Diverse Audiences 39 w Provides EC information in 13 languages: u Amharic u Arabic u Cambodian u Chinese u English u Haitian-Creole u Korean u Laotian u Portuguese u Russian u Somali u Spanish u Vietnamese

40. Clinics and Pharmacies that Provide ECPs in Your Area w EC Hotline u 1-888-NOT-2-LATE (1-888-668-2528) w EC website u http://not-2-late.com w Planned Parenthood website u http://plannedparenthood.org w Washington State Family Planning Hotline u 1-800-770-4334 40

41. How will you emphasize ECPs in your practice? 41

42. Tell Your Clients About ECPs by: w Routinely advising about ECPs w Making ECP materials available in clinic settings w Encouraging advance-of-need prescribing w Signing up to be listed as an EC provider on the national hotline by calling 1-888-NOT-2-LATE (1-888-668-2528) 42

43. JWVP15045 (8/24/00)