Emergency Contraception
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Transcript of Emergency Contraception
Emergency Contraception
Bliss Kaneshiro September 17, 2003
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
What is Emergency What is Emergency Contraception (EC) ?Contraception (EC) ? Medication administered within a
few days of unprotected intercourse to prevent pregnancy
“Morning after pill” Post coital contraception
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
When do women actually use EC?
4%4%
25%
67%
Didn't plan to have sex
Other
Withdrawal accident
Condom broke
Obstet Gynec 2003;101:1160-1167
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;53:215-216Fam Plann Persp 1998;30:24-29
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
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
Methods
1. Combined method of emergency contraception (Yuzpe)
2. Progestin only method (Plan B)3. High dose estrogen4. Copper IUD
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
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
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
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
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
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
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
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;95:271Am J Obstet Gynecol 2003;88:389
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
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
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
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
Progestin Only method: Plan B Levonorgestrel 0.75 mg taken twice,
12 hours apart
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
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
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
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
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
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
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
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
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
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
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
CONTRAINDICATIONS
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
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
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
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
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
Utilizing EC
Utilizing EC
How can EC be successful in decreasing unintended pregnancies?
1. Women must perceive that her risk of pregnancy is real and must be motivated to prevent it
2. Women must be aware that EC exists3. Women must have specific knowledge about
how to obtain it and time its administration4. Women must have access to EC
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
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%)
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
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
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)
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
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
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
ACOG Guidelines
During a routine gynecologic visit, physicians who wish to increase the availability and use of EC may offer patients an advance prescription
The Washington Experience
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
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
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
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
What about Hawaii?
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
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
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
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
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)
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
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
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
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
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
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
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
Thanks to
Tod AebyThomas KosasaKari Wheeling and Nancy Partika from Healthy
Mothers Healthy BabiesFrances Chung from Pharmacy Access Partnership,
California