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


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)


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


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


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


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


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


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


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


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

Emergency Contraception

Health & Medicine

Transcript of Emergency Contraception