EMERGENCY CONTRACEPTION
Still the Nation’s Best-Kept Secret
James Trussell, PhD
Office of Population Research
Princeton University
What if ?
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 . . .
Emergency Contraceptives
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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
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.”
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
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%)
Emergency Contraceptive Pills:
Progestin-only
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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
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
History of EC Methods
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mid-1960s: high dose estrogens
early 1970s: combined OCs (Yuzpe regimen)
late 1970s: copper IUD
mid-1990s: levonorgestrel-only pills
mid-1990s: antiprogestins
Effectiveness
If 1000 women have unprotected sex once in the
second or third week of their cycle
# of Pregnancies
% Reduction
No treatment
80
Combined ECPs
20
75%
Progestin-Only
ECPs
10
88%
1
99%
IUD Insertion
How Long After the Morning After?
Meta-Analysis of 9 Trials (Combined)
2.5%
p=.25
Pregnancy Rate
2.0%
1.5%
1.0%
0.5%
0.0%
Day 1
Day 2
Day 3
How Long After the Morning After?
WHO (Combined and LNg)
5.0%
Pregnancy Rate
4.0%
p<.01
3.0%
2.0%
1.0%
0.0%
0-12
13-24
25-36
37-48
49-60
61-72
How Long After the Morning After?
Quebec (Combined)
1.2%
Pregnancy Rate
1.0%
p=.75
87
92
Days 1-3
Days 4-5
0.8%
0.6%
0.4%
0.2%
0.0%
How Long After the Morning After?
Population Council (Combined)
Pregnancy Rate
4.0%
3.5%
111
3.0%
2.5%
2.0%
1.5%
675
589
104
1.0%
0.5%
0.0%
Days 1-3
p=.52 and .99
Days 4-5
Typical
Perfect
How Long After the Morning After?
Latest WHO Trial (LNg)
2.5%
p=.16
Pregnancy Rate
2.0%
314
1.5%
1.0%
2381
0.5%
0.0%
Days 1-3
Days 4-5
How Long After the Morning After?
Chinese Trial (LNg)
3.0%
p=.26
Pregnancy Rate
2.5%
139
2.0%
1.5%
1932
1.0%
0.5%
0.0%
Days 1-3
Days 4-5
The Setting
• 3.1 million unintended pregnancies each
year in the United States: half (49%) 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 costeffective
Potential Impact
Reduce unintended
pregnancies by half
1.5 million fewer
Reduce abortions
needed by half
0.7 million fewer
Reduce pregnancies
after rape by 88%
22 thousand fewer
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
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
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)
MARKETING
Preven
Gynétics 1998-2004
The Value of a Dedicated Product
Ovral
Preven
Alesse
Plan B
WCC 1999
The Value of a Dedicated Product
Plan B
Ovrette
EC in Europe
PC4
Schering
Postinor-2
Gedeon Richter
NorLevo
HRA Pharma
• OTC in Norway (2000), Sweden (2001),
Netherlands (2004), India (2005), US (2006)
• Dispensed by school nurses in every junior
and senior high school in France
• And dispensed at no cost to minors by
pharmacists
PROVIDER PRACTICE
Providing EC is Now the MedicoLegal 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 20) 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
Provider Practice: Good News
100%
OB/GYNs
80%
80%
FPPs
60%
40%
36%
20%
0%
Prescribed ECPs Last Year
Provider Practice: Bad News
50%
40%
39%
OB/GYNs
30%
20%
25%
17%
FPPs
14%
10%
0%
Prescribed More Than Five Times
Among Those Who Prescribed
Rountinely Discuss EC
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
INCREASING ACCESS
EC Hotline and Website
• Emergency Contraception Hotline
– 1-888-NOT-2-LATE
– 630k calls since 1996
• Emergency Contraception Website
– http://not-2-late.com
– 3.2m visits since 1994
Providers on the Hotline and Website
State Websites: Prescriptions Called In
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Georgia: www.ecconnection.org
Illinois: www.plannedparenthoodchicago.com
Indiana: www.ppin.org/ecaccess/ecinfo.html
Maine: www.ppnne.org
Massachusetts: www.pplm.org
North Carolina: http://www.pphsinc.org/ec/
Oregon: www.ppcw.org
South Carolina: http://www.pphsinc.org/ec/
Vermont: www.ppnne.org
Washington: www.ppcw.org
West Virginia: http://www.pphsinc.org/ec/
Statewide Hotlines: Prescriptions Called In
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Connecticut: 800-230-PLAN
Georgia: 877-ECPills
Illinois : 866-222-EC4U or 217-544-2744
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: 585-271-9055
North Carolina: 866-942-7762
South Carolina: 800-230-PLAN
West Virginia: 800-230-PLAN
Wisconsin: 877-975-9858
States with Call-in Prescriptions
39% of women aged 15-44
Emergency Contraception BTC
ECPs are available directly from pharmacists
without having first to get a prescription in:
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Alaska
California
Hawaii
Maine
Massachusetts
Montana
New Hampshire
New Mexico
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Vermont
Washington
Canada
France
United Kingdom
Australia
South Africa
33 other countries+5 OTC
Pharmacists Providing ECPs
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
Evidence-Based Decision?
• In 10 studies, women were randomly
assigned to get ECPs in advance or in the
regular way
• 1 study among teens, 1 among mothers 1320, 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
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
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
Plan B OTC
• On August 26, 2005, FDA announced that
Plan B was safe for OTC use by women ≥17
• But FDA announced an indefinite delay in
reaching a decision, citing three concerns:
– Can Plan B be both Rx and OTC depending on
age?
– Can Rx and OTC versions of the same drug be
marketed in the same package
– Can an age restriction be enforced?
• 60-day public comment period on first two
Plan B OTC
• Three days later, Susan Wood resigned her
position as the Assistant Commissioner for
Women's Health and Director of the FDA Office
of Women's Health, stating that:
“I have spent the last 15 years working to
ensure that science informs good health policy
decisions. I can no longer serve as staff when
scientific and clinical evidence, fully evaluated
and recommended for approval by the
professional staff here, has been overruled.”
Plan B OTC
• On July 31, 2006, the day before his
confirmation hearing, acting FDA
Commissioner Andrew von Eschenbach
publicly invited Barr Labs to resubmit its
application by changing the OTC age
restriction to 18 and over.
• On August 18, 2006, Barr Labs resubmitted
its application.
• On August 24, 2006, the FDA approved.
Department of Justice
• National Protocol for Sexual Assault, 9/04
• Extensive 4-page discussion of STI
counseling, testing, and prophylaxis
• Short ½-page discussion of pregnancy risk
evaluation and care
• No mention of emergency contraception
Department of Defense
• Basic Core Formulary (BCF) is a list of
medications that are required to be on all
Military Treatment Facility formularies
• The Pharmacy & Therapeutics Committee
(P&TC) is responsible for changes to the BCF
• Plan B added to the BCF on April 3 2002 but
removed on May 8 after intervention by the
Assistant Secretary of Defense for Health
Affairs
Are ECPs Effective?
• Eight of the ten studies conducted to test
whether easy assess to ECPs increased risk
taking also measured pregnancies
• In none of the eight did advance provision of
ECPs reduce pregnancy rates
• Only three studies powered to detect a
decrease in pregnancy rates
Why No Reduction in Pregnancies?
• In San Francisco almost half of the women in
the advance provision group who had
unprotected intercourse did not use ECPs
• In China, 30 of the 38 pregnancies in the
advance provision group occurred to women
who did not use ECPs in that cycle
• In Nevada/NC, 57 of the 74 pregnancies in the
advance provision group occurred to women
who did not use ECPs in that cycle
• Lesson: ECPs are not used frequently enough!
Source: Raine et al. 2005; Hu et al. 2005; Raymond et al. 2006
Advance Provision of ECPs Did Not
Reduce Abortions Rates in Lothian
• Community intervention study in Scotland
• About 1 in 5 women aged 16-29 got ECPs in
advance to take home
• About half of these used ECPs at least once
• No effect on abortion rates was observed
• Women most at risk probably did not get ECPs
• 78% of women with advance supplies who got
pregnant did not use ECPs.
Source: Glasier et al. 2004
Excellent Evidence that Plan B Works
• Two trials in which women were randomly
assigned to Plan B or Yuzpe regimen.
• Pregnancy rate in Plan B arm was 51% of
the rate in the Yuzpe arm.
• Plan B is 49% effective if Yuzpe regimen is
completely ineffective.
• If, for example, Yuzpe regimen is 60%
effective, then Plan B is 79% effective.
Source: Raymond et al. 2004
Lesson Learned
• ECPs are not used nearly frequently enough!
• Women underestimate their risk of
pregnancy
• More education is needed
• OTC switch is necessary―but not
sufficient―for solving this problem
EDUCATION
Public Education Campaign Messages
• There is something that can be done after
unprotected sex to prevent pregnancy
• To find out more, call 1-888-NOT-2-LATE
• There is a 72-hour time limit