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Emergency Contraception
Emergency Contraception
Emergency Contraception
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Emergency Contraception
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Emergency Contraception

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  • 1. Emergency Contraception Bliss Kaneshiro September 17, 2003
  • 2. Emergency Contraception: Outline
    • Background and History
    • Methods
      • Combined method (Yuzpe)
      • Progestin only method (Plan B)
      • High dose estrogen
      • Copper IUD
    • Contraindications
    • Utilizing Emergency Contraception
    • Washington Experience
    • Plans for Hawaii
  • 3. What is Emergency Contraception (EC) ?
    • Medication administered within a few days of unprotected intercourse to prevent pregnancy
    • “Morning after pill”
    • Post coital contraception
  • 4. Who can use EC?
    • Every woman of reproductive age who wishes to prevent unintended pregnancy
      • Failure of a regular method
        • Missed a pill
        • Condom broke
      • Failure to use contraception
      • Sexual assault
        • 22,000 pregnancies resulting from rape could be prevented annually in the United States
    Am J Prev Med 2000;19:228-229
  • 5. When do women actually use EC? Obstet Gynec 2003;101:1160-1167
  • 6. Why is EC needed?
    • 48% of all pregnancies in the US are unintended
      • 3.0 million unintended pregnancies each year
    • 47% of these pregnancies result in elective abortion in the US
      • 1.4 million abortions annually
    J Am Med Women’s Assoc 1998;53:215-216 Fam Plann Persp 1998;30:24-29
  • 7. The History of EC
    • 1960’s : first documented use, oral contraceptive pills used off label
    • 1997 : FDA announces that oral contraceptives are safe to use off label as EC
    • 1998 : The first product dedicated to EC is marketed (Preven)
    • 1999 : Plan B is approved by the FDA
  • 8. EC is Not a New Idea….
    • “ Traditional” methods for post coital contraception have been used for decades
      • High doses of vitamin C, aspirin or chloroquine
      • Douches of coca cola, tequila, baking soda, urine
      • Family Planning Perspectives.1996;22:52-66
  • 9. Methods
    • Combined method of emergency contraception (Yuzpe)
    • Progestin only method (Plan B)
    • High dose estrogen
    • Copper IUD
  • 10. Combined method of emergency contraception
    • Yuzpe Regimen
    • Ethinyl estradiol 100 mcg + levonorgestrel 0.5 mg taken twice, 12 hours apart
    • Administered within 72 hours of unprotected intercourse
    • Marketed as Preven
      • 4 combination pills (each containing ethinyl estradiol 50 mcg and levonorgestrel 0.25 mg)
      • Pregnancy test to use prior to taking medication
    • Various oral contraceptives can be substituted for Preven
    Fertil Steril 1997;28:932-936
  • 11. Combined method: How does it work?
    • A single mechanism of action has not been established
    • Hypothesis:
      • Primary mechanism: Delays or inhibits ovulation
      • Secondary mechanisms:
        • Causes histologic changes in the endometrium so the fertilized egg cannot implant
        • Alters tubal motility
    • Does not cause abortions
      • Medication acts before implantation
      • ineffective if implantation has already occurred
  • 12. Combined method: Efficacy
    • Reduces the number of unintended pregnancies by 75%
      • If 100 women have unprotected intercourse at the time of ovulation, 8 will become pregnant, The combined method would reduce this number to 2
    Fam Plann Perspect 1996;28:58-64
  • 13. Combined Method: Efficacy
    • There is a linear relationship between efficacy and time from intercourse to treatment
    • Piaggio et al
      • pregnancy rates increased from 0.5% to 4% when treatment was administered within 12 hours versus 61-72 hours
      • Conclusion: The sooner EC is taken, the more effective it is
    • ACOG Guidelines : If possible, EC should be used within the first 24 hours of unprotected intercourse because efficacy may be greatest if used within this time frame.
    Lancet 1999:353;721
  • 14. Is EC effective after 72 hrs?
    • Yuzpe chose to study the 72 window based on normal clinic hours
    • Several observational studies have shown that pregnancy rates are similar when women take EC <72 hours after unprotected intercourse vs 72-120 hrs
      • Ellerton et al: Extending the Time Limit for Starting the Yuzpe Regimen of Emergency Contraception to 120 hours; Obstetrics and Gynecology 2003
      • Rodrigues et al: Effectiveness of emergency contraceptive pills between 72-120 hours after unprotected intercourse; American Journal of Obstetrics and Gynecology 2001
  • 15. Efficacy after 72 hours
    • ACOG guideline : Women requesting EC 72-120 after unprotected intercourse (who decline IUD insertion) should still be given EC but they should be informed that efficacy will probably be reduced
  • 16. Combined Method: side effects
    • Nausea (50%) and vomiting (20%)
      • Vomiting can theoretically reduce efficacy if it occurs less than 2 hours after taking pills
        • No studies show decreased efficacy with vomiting
        • ACOG guidelines : There is no need for repeat dosing if emesis occurs
    ACOG Practice Bulletin 2001;25
  • 17. Combined Method: Side Effects (cont’d)
      • Treatment of nausea
        • Meclizine
        • Metoclopramide
        • ACOG Guidelines : To minimize nausea and vomiting with combined method, an antiemetic should be prescribed and taken 1 hr before first contraceptive dose
      • Taking EC with food has not been shown to decrease nausea
    Obstet Gynecol 2000;95:271 Am J Obstet Gynecol 2003;88:389
  • 18. Combined Method: side effects (cont’d)
    • Breast tenderness
    • Abdominal pain
    • Headaches
    • Dizziness
    • Effect on menses
      • 50% of patients will have menses at the expected time
      • 90% will have normal duration and flow of menses
      • 98% will menstruate with 21 days of taking EC
      • ACOG Guidelines : Women who do not begin to menstruate 21 days after taking EC should be evaluated for pregnancy
    Fertil Steril 1982;37:508-513
  • 19. Modifying the Yuzpe Method
    • Can progestins other than Levonorgestrel be used?
      • Half life of levonorgestrel is 15 hrs
      • Half life of norethindrone is 7 hrs
  • 20. Modifying the Combined Method (cont’d)
    • Ellerton et al
    • Randomized, controlled trial
    • Inclusion criteria: women presenting for EC within 72 hours of unprotected intercourse
    • Sites: 5 clinics in Iowa, 5 clinics in the UK
    • 2041 participants received one of the following:
      • Standard levonorgestrel-ethinyl estradiol regimen
      • Norethindrone-ethinyl estradiol regimen
    Obstet Gynecol 2003;101:1160-1167
  • 21. Modifying the Combined Method (cont’d)
    • Results: Pregnancy rates were similar
      • Levonorgestrel-ethinyl estradiol: 2.0%
      • Norethindrone-ethinyl estradiol: 2.7%
      • Difference was not statistically significant (p=0.44)
    • Conclusion: Oral contraceptive formulations containing norethindrone can be used for EC
    • ACOG Guidelines do not address using formulations other than the levonorgestrel-ethinyl estradiol regimen for combination EC
    Obstet Gynecol 2003;101:1160-1167
  • 22. Progestin Only method: Plan B
    • Levonorgestrel 0.75 mg taken twice, 12 hours apart
  • 23. Progestin Only Method: How does it work?
    • Hypothesis: Delays or inhibits ovulation
    • Durand et al
      • Participants:
        • 45 healthy women age 29-35 yrs
        • Surgically sterilized by bilateral tubal ligation
        • No hormonal medications in the prior 6 months
        • Regular menstrual cycles
    Contraception 2001;64:227-234
  • 24. Progestin Only Method: How does it work? (cont’d)
    • Methods:
      • Women were followed through 2 consecutive cycles
        • first cycle = control arm
        • Second cycle = treatment arm
      • Randomly divided into 3 groups
        • All received levonorgestrel 0.75 mg 12 hrs apart during the second cycle
        • Group A: received medication on day 10 of their menstrual cycle (prior to ovulation)
        • Group B: received medication at time of LH surge
        • Group C: received medication 48 hrs after LH surge
    Contraception 2001;64:227-234
  • 25. Progestin Only Method: How does it work? (cont’d)
    • Methods:
      • Measurements during both cycles:
        • Urinary LH every morning from day 11 of the menstrual cycle (LH surge)
        • When LH was detected in the urine transvaginal US was performed daily until follicle rupture was observed (ovulation)
        • Endometrial biopsies were taken 9 days after urinary LH was detected (implantation window)
    Contraception 2001;64:227-234
  • 26. Progestin Only Method: How does it work? (cont’d)
    • Results: Group A (levonorgestrel given before ovulation)
      • 12/15 participants did not ovulate during the treatment arm
        • Absence of LH surge
        • No ultrasonographic evidence of follicle rupture
      • 3/15 participants had delayed ovulation during the treatment arm
        • Delayed LH surge
        • Delayed follicle rupture on ultrasound
    Contraception 2001;64:227-234
  • 27. Progestin Only Method: How does it work? (cont’d)
    • Results for group B and group C were similar:
      • All participants ovulated at the expected time
    • Results: endometrial biopsies
      • No differences in histology between group A, B and C. No difference in control and treatment arms
    Contraception 2001;64:227-234
  • 28. Progestin Only Method: How does it work? (cont’d)
    • Conclusion:
      • Plan B delays or inhibits ovulation when taken in the preovulatory period
      • This study does not support the anti-implantation contraceptive effect of Plan B
    Contraception 2001;64:227-234
  • 29. Progestin Only Method: Efficacy
    • More effective than combined method
      • Reduces pregnancy by 85% (compared with 75%)
    • Incidence of nausea and vomiting lower than with combined method
      • 23% will have nausea, 6% will have vomiting (compared with 50% and 20% with combined method)
    • ACOG Guidelines : Because the progestin only method produces less nausea and may be more effective than the combined method, this regimen should be strongly considered
    Lancet 1998;352:428-432
  • 30. Modifying the Progestin Only Method
    • Can Plan B be taken as a single dose?
      • Levonorgestrel 1.5 mg po x 1
    • WHO multicenter trial by von Hertzen et al
      • Randomized, double blind trial
      • 15 family planning clinics in 10 countries
      • Included 4136 healthy women with regular menstrual cycles who requested EC within 120 hours of unprotected intercourse
    Lancet 2002;360:1803-10
  • 31. Modifying the Progestin Only Method (Cont’d)
      • Compared Levonorgestrel as a single dose to 2 divided doses given 12 hours apart
      • Results: No difference in efficacy
        • Pregnancy rates with single dose vs divided doses (1.5% vs 1.8%, p=0.83)
      • Conclusion: Progestin only method can be given as a single dose
      • ACOG Guidelines : Do not address prescribing the progestin only method as a single dose
    Lancet 2002;260:1803-10
  • 32. High Dose Estrogen
    • “ five by five regimen”
      • 5 tablets of 1 mg ethinyl estradiol given daily for 5 days
    • Standard regimen in the 1960’s and 1970’s
    • Efficacy similar to the Yuzpe Regimen
    • Theoretically higher risk of thromboembolism
    • Higher incidence of nausea and vomiting
  • 33. Copper IUD
    • Placed within 120 hours of unprotected intercourse
    • Mechanism: Prevents implantation
    • Failure rate of <1%
    • Appropriate for women who wish to use a long term method of contraception
    • Contraindicated in women at risk for STDs
    • Side effects and complications are the same whether placing IUD for EC or long term contraception
  • 34.
    • CONTRAINDICATIONS
  • 35. Contraindications to EC
    • World Health Organization: “There are no contraindications to the Yuzpe method except known pregnancy”
    • Hypersensitivity to any component of the product
    • Undiagnosed abnormal vaginal bleeding
  • 36. Contraindications (continued)
    • Does EC cause birth defects?
      • No case reports of birth defects due to EC in the literature
      • EC is taken before organogenesis
      • There is no increased risk of birth defects in women who inadvertently continue to take oral contraceptives without knowing they are pregnant
  • 37. Contraindications (continued)
    • Can women who can’t take oral contraceptives take EC?
      • Theoretical risk of thromboembolism with estrogen containing ECs
      • Combined method contains a higher daily dose of estrogen than standard oral contraceptives
      • Contraindications to standard oral contraceptives are based on long term use and do not to pertain to the short duration required for EC
    Fertil Control Rev 1995;4:16-18
  • 38. Contraindications (cont’d)
    • ACOG Guidelines: There is no data to specifically examine the risk of EC among women with contraindications to the use of conventional oral contraceptives. EC may be offered to such women, however, the progestin only regimen may be preferred
  • 39. Contraindications (cont’d)
    • What if the patient is taking other medications?
      • Theoretical decrease in efficacy if the patient is taking hepatic enzyme inducing drugs
      • However, no study has demonstrated a decrease in efficacy under these circumstances
      • ACOG guidelines : standard dosing for EC in women on additional medications
  • 40. Utilizing EC
  • 41. Utilizing EC
    • How can EC be successful in decreasing unintended pregnancies?
      • Women must perceive that her risk of pregnancy is real and must be motivated to prevent it
      • Women must be aware that EC exists
      • Women must have specific knowledge about how to obtain it and time its administration
      • Women must have access to EC
  • 42. Do patients know about EC?
    • 1997 Henry J Kaiser Foundation Survey of women 18-44 yrs of age
      • 66% report having heard of EC
      • 16% of women know about the 72 hour window
      • 1-2% report having ever used EC
  • 43. Do health care providers discuss EC with their patients?
    • 2001 Henry J Kaiser Foundation survey
      • 25% of gynecologists routinely discuss EC as part of routine contraceptive counseling
      • 16% of gynecologists never discuss EC
        • Reasons:
          • lack of patient demand (73%)
          • personal opposition (41%)
          • concerns about EC safety and efficacy (20%)
          • lack of knowledge (10%)
  • 44. Should women be given an advance supply of EC?
    • Glasier et al
      • Methods: 1000 women were randomized to receive either a home supply of EC or education only
      • Results:
        • 47% of women who received a home supply used EC (treatment group)
        • 27% of women given education only used EC (control group)
        • Unintended pregnancies were less frequent in the treatment group (18 vs 25)
    N Engl J Med 1998;229:1-4
  • 45. Should women be given an advance supply of EC (cont’d)?
    • Jackson et al
      • Evaluated advance provision of EC in a postpartum population (n=370)
      • All women received routine contraceptive counseling, treatment group also received advance supply of EC
      • Participants were followed for one year
    Obstetrics and Gynecology 2003;102
  • 46. Should women be given an advance supply of EC (cont’d)?
      • Jackson et al: Results
        • Half of all women reported at least one episode of unprotected intercourse
        • Treatment group was 4 times as likely to use EC as the control group (17% vs 4%, RR 4, 95% CI 1.8,9.0)
        • Treatment group was no more likely to change to a less effective method of contraception (18 vs 25%,RR 0.74, CI 0.45, 1.2)
        • Women in treatment group were no more likely to use EC repeatedly (3 vs 2 individuals)
        • 16 unplanned pregnancy in control group (none used EC), 11 in treatment group (4 used EC)
  • 47. Can the public understand how to take EC without seeing an MD?
    • Raymond et al
      • 663 women ages 12-50 were interviewed in malls and family planning clinics in 8 US cities
      • Participants were given an OTC label for EC and a reading comprehension test
    • Results:
      • 97% understood that the pill should be taken within 72 hours of unprotected intercourse
      • 93% understood that EC is indicated for the prevention of pregnancy but does not prevent against STDs
      • Population:
        • 20% had an eighth grade reading level or lower
        • 20% were 17 yrs of age or lower
    Obstet Gynecol 2002;100:342-9
  • 48. Can the public understand how to take EC without seeing an MD?
    • Raymond et al
      • Women who requested EC at family planning clinics and pharmacies were given Plan B and instructions
      • Women were not was provided
      • Study subjects paid for the product
      • Staff contacted study subjects 1 and 3 wks later
    Obstet Gynecol 2003;102:17-23
  • 49. Can the public understand how to take EC without seeing an MD (cont’d)?
    • Results: Raymond et al
      • 1.3% of patients used EC when it was contraindicated
      • 6.6% of patients took EC incorrectly
    Obstet Gynecol 2003;102:17-23
  • 50. ACOG Guidelines
    • During a routine gynecologic visit, physicians who wish to increase the availability and use of EC may offer patients an advance prescription
  • 51. The Washington Experience
  • 52. The Washington Experience
    • Washington State Emergency Contraception Collaborative Agreement Pilot Project 1997-1999
      • Pharmacists trained in dispensing EC were authorized to provide EC in accordance with standardized protocols
      • Patients did not have to see a doctor
    • Goal: provide women with more convenient and timely access to EC
  • 53. The Washington Experience (continued)
    • Trained 800 pharmacists and conducted a public awareness media campaign
    • Prior to dispensing EC the following questions were asked
      • Have you had unprotected intercourse in the last 120 hours?
      • Have you had a normal menstrual period in the last 4 weeks
    • Victims of rape or abuse were referred to appropriate community services
    • No pregnancy tests were given
    • Patients were given referrals to physicians if they did not have one already
  • 54. The Washington Experience (continued)
    • Results:
      • In the first 16 months, 12,000 EC prescriptions were provided (60 fold increase)
      • Pharmacists are now the largest provider of EC in Washington
      • 70% of patients sought EC at pharmacies less than 24 hours after unprotected intercourse
      • 42% of visits were during evenings, weekends, and holidays
      • Medicaid costs were decreased by an estimated 22 million dollars
      • Abortion rate in Washington has fallen 30%
    PATH: Executive Summary of Findings
  • 55. EC in the United States
    • The following states provide EC without a prescription
      • Washington
        • Collaborative agreement
      • Alaska
        • Collaborative agreement
      • California
        • Collaborative agreement
      • New Mexico
        • State wide protocol authorizes all pharmacists to provide EC
  • 56. What about Hawaii?
  • 57. What about Hawaii?
    • Case Study: Hawaii Emergency Contraception Access Survey (2001-2002)
      • Healthy Mothers, Healthy Babies Coalition of Hawaii
      • Purpose: determine how accessible EC is in Hawaii
        • Accessibility was defined as the ability to obtain EC within 72 hours after unprotected intercourse
      • Methods:
        • 81 facilities were contacted statewide
        • Calls were made on weekends and weekdays
        • Caller posed as a 19 year old female who had unprotected intercourse the night before
  • 58. Hawaii Emergency Contraception Access Survey (2001-2002)
    • Family Planning providers
      • 20/45 (44%) indicated that EC was accessible within the 72 hour time frame
    • Clinics
      • 25/45 (56%) indicated that EC could be made accessible within the 72 hour time frame
    • Financial quotes for an uninsured patient ranged from $10-$80
  • 59. Hawaii Emergency Contraception Access Survey (2001-2002)
    • Emergency Rooms
      • 2/20 (10%) indicated that EC could be made accessible within the 72 hour time frame
      • Most referred callers to their private doctor
      • Some made referrals to clinics in the community
    • Pregnancy/Counseling Centers (listed in the Verizon 2001 phone directory under pregnancy counseling)
      • 0/14 (0%) were willing or able to provide EC access within 72 hours
      • Most stated that celibacy and abstinence was the only form of birth control they endorsed
  • 60. Hawaii Emergency Contraception Access Survey (2001-2002)
    • Sex Abuse Treatment Centers
      • 0/2 (0%) indicated that EC could be made accessible within the 72 hour time frame
    • Conclusion: There are significant barriers in Hawaii in accessing EC within the 72 hour time frame
  • 61. Do pharmacies in Hawaii currently stock EC?
    • Survey of Pharmacists on Emergency Contraceptive Access
    • Healthy Mothers, Healthy Babies
    • Methods:
      • 225 pharmacies and 300 pharmacists were sent surveys
      • 67 responded (13% response rate)
  • 62. Do pharmacies in Hawaii currently stock EC (cont’d)?
    • Results
      • 86% indicated they stocked at least one product FDA approved for EC
      • 44% rarely fill EC prescriptions
      • 14% fill more than 10 prescriptions per month
      • Average cost for EC without insurance was $27
      • 5 pharmacists stated that they did not intend to dispense EC because of personal beliefs or company policy
  • 63. Plans for Hawaii
    • HB 123
      • Introduced by Representative Marilyn Lee (D-Waipio, Crestview, Mililani)
      • Supported by the Hawaii Medical Association
      • Passed in the Legislature in April 2003
      • Signed into law June 2003 (ACT 2001)
    • Allows pharmacists to dispense EC without a prescription
      • Collaborative agreement between a physician and a trained pharmacist
  • 64. Plans for Hawaii
    • USC school of pharmacy trained 100 pharmacists on Maui and Oahu (August 2003)
    • Currently collaborative agreements are being drafted
      • Voluntary agreements between pharmacists and physicians
      • EC will be dispensed if certain criteria is met
        • LMP
        • Time from unprotected intercourse
        • Age
        • Sexual Assault
  • 65. Plans for Hawaii (cont’d)
    • Referrals to a local physician or an appropriate agency will be made under the following circumstances:
      • Established pregnancy cannot be ruled out
      • The 72 hour window has passed
      • Possible exposure to STDs
      • Client is without a regular contraceptive method (may provide EC before referral)
      • Client needs free or low cost family planning services
      • Sexual assault
        • If the client is a minor and sexual assault or abuse is suspected, CPS with be contacted
  • 66. Plans for Hawaii (cont’d)
    • EC product selection
      • Plan B (or a generic equivalent) will be the product of choice
      • However, the client may choose from a list of products and over the counter antiemetics
    • Goal: implementation by the end of 2003
  • 67. Conclusion
    • Combined method and Progestin only method are effective emergency contraceptives
      • Studies have shown that the Progestin only method has higher efficacy and a more tolerable side effect profile
      • The sooner these methods are taken, the more effective they are
    • Copper IUD can also be used as EC and is effective up to 120 hours after intercourse
  • 68. Conclusion (cont’d)
    • EC is a safe medication that most women can understand how to take without seeing a physician
    • Initiatives in Washington have increased EC utilization and decreased unintended pregnancy
    • Similar initiative was started in Hawaii in 2003 and may be implemented by the end of the year
  • 69. Thanks to
    • Tod Aeby
    • Thomas Kosasa
    • Kari Wheeling and Nancy Partika from Healthy Mothers Healthy Babies
    • Frances Chung from Pharmacy Access Partnership, California

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