Transcript Emergency Contraception Plan B

Legislative Advocacy Noon Conference
Melissa Woods PGY-2

Each year, almost 750,000 women aged 15-19 yrs
become pregnant
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Two thirds of this occurs among 18 – 19 yr olds
This rate has declined 40% from 1990 – 2005
Historic low in 2005 70.6 per 1,000 women 15 – 19 yrs
Increased 3.5% from 2005 - 2006
Eighty-two percent of teen pregnancies are
unplanned; they account for about 20% of all
unintended pregnancies annually
Of teenage pregnancies: 57% end in live births, 29%
end in induced abortion, and 14% end in miscarriage
or stillbirth
Teen pregnancy rates are much higher in the US than
in many other developed countries
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US rates are twice that of Canada and England, eight
times as high as Japan, and ten times higher than France
and Sweden
 Each
year, almost 30,000 New York City teens
become pregnant each year
 In New York City, rates for teenage pregnancy
far exceed the national averages
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99.4 per 1000 females aged 15 – 19 yrs
29% higher than the US rate
 Highest
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reported rates in the Bronx
137.2 per 1000 females aged 15 – 19 yrs
 Forty
percent of all pregnant teens in NYC
had been pregnant before
 Of NYC teen pregnancies:
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41% live birth, 56% abortion, 3 % miscarriage
 The
use of hormonal medications after
sexual intercourse to prevent pregnancy
 Indications:
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Unprotected sexual intercourse
Underprotected sexual intercourse
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Condom breaks or slips / diaphragm or cap dislodged
Two or more OCPs are missed
One or more progestin-only pills is missed
A depo-provera shot is 2 or more weeks late
The transdermal patch is detached for 24 hrs or longer
The vaginal ring is removed for 3 hrs or longer
Vaginal spermicide is used alone
 Progestin
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Preven, many combination OCPs
 Progestin
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+ Estrogen
Only
Plan B, Plan B One Step, Next Choice
 Antiprogestins
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Mifepristone, Ulipristal
 Preven
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approved by the FDA in 1998
removed in 2004 due to studies revealing that
progestin-only pills were more effective and had
a better side effect profile
 Many
brands of daily birth control can be
used for emergency contraception and are
approved for off-label use by the FDA
 Effectiveness: 56 – 89%
Brand
Company
Plan B
Teva
One-Step
Next Choice Watson
Pills per Dose
Ethinyl Estradiol
per Dose (μg)
Progestin-only pills: take one dose
1 white pill
0
2 peach pills
0
Levonorgestrel
per Dose (mg)
1.5
1.5
Combined progestin and estrogen pills: take two doses 12 hours apart
Alesse
Wyeth
5 pink pills
100
0.50
Aviane
Teva
5 orange pills
100
0.50
Cryselle
Teva
4 white pills
120
0.60
Enpresse
Teva
4 orange pills
120
0.50
Jolessa
Teva
4 pink pills
120
0.60
Lessina
Teva
5 pink pills
100
0.50
Levlen
Berlex
4 light-orange pills
120
0.60
Levlite
Berlex
5 pink pills
100
0.50
Levora
Watson
4 white pills
120
0.60
Lo/Ovral
Wyeth
4 white pills
120
0.60
LoSeasonique Teva
5 orange pills
100
0.50
Low-Ogestrel Watson
4 white pills
120
0.60
Lutera
Watson
5 white pills
100
0.50
Lybrel
Wyeth
6 yellow pills
120
0.54
Nordette
Wyeth
4 light-orange pills
120
0.60
Ogestrel
Watson
2 white pills
100
0.50
Ovral
Wyeth
2 white pills
100
0.50
Portia
Teva
4 pink pills
120
0.60
Quasense
Watson
4 white pills
120
0.60
Seasonale
Teva
4 pink pills
120
0.60
Seasonique Teva
4 light-blue-green pills
120
0.60
Sronyx
Watson
5 white pills
100
0.50
Tri-Levlen
Berlex
4 yellow pills
120
0.50
Triphasil
Wyeth
4 yellow pills
120
0.50
Trivora
Watson
4 pink pills
120
0.50
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The only pills available specifically for emergency
contraception in the United States
Plan B (1999)
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Plan B One Step (2009)
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Directions on package insert: one 1.5 mg tablet as soon
as possible within 72 hrs after unprotected intercourse
Next Choice (2009)
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Directions on package insert: one 0.75 mg dose within 72
hrs after unprotected intercourse and a second 0.75 mg
dose 12 hrs later
2002 WHO study found that progestin only ECs can be
taken in one dose of 1.5 mg and that they can be taken
up to 120 hrs after intercourse
There is a statistical decline in effectiveness with
delayed use
Directions on package insert: same as Plan B above
Estimates of effectiveness 59 – 94%
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Antiprogestins
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Progesterone receptor modulators
First generation
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Mifepristone – aka. RU-486
 FDA Approved for use for early first trimester medical
abortions (2000)
In other countries, used as emergency contraception in
much lower doses than those used for abortion (10 vs.
100 mg)
Has the potential to disrupt a pregnancy after
implantation within the uterine lining
Second generation
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Ulipristal - aka. ellaOne (Oct 2009)
Only available in Europe
Labeled use: one 30 mg pill taken within 5 days of
unprotected intercourse
Recent study comparing levonorgestrel with ulipristal
suggests that ulipristal is at least as efficacious as
levonorgestrel
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Primarily inhibits ovulation, disrupts follicular
development, and/or interferes with the maturation of the
corpus luteum
Plan B taken prior to the day before a woman’s LH surge
suppresses the surge completely  no ovulation
 When Plan B is taken closer to or during the LH surge, it blunts
or delays the surge and renders the ova resistant to
fertilization
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Early suggested histological/biochemical alterations of the
endometrium, thereby impairing receptivity to
implantation
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Other suggested mechanisms include alteration of sperm
or egg transport, interference with fertilization, and/or
cervical mucus changes
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More recent studies have demonstrated little to no effect on
the endometrium
Have not been verified by clinical data
ECPs do not interrupt an established pregnancy that has
already implanted in the uterine lining!
1974 – Albert Yuzpe described the regimen of
using ethinyl estradiol and norgestrel for
emergency contraception
 February 14, 1996 – Reproductive Health
Technologies Project established a 24 hr
emergency contraception hotline number
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In the first 5 months of operation, over 25,000 calls
were made
February 1997 – FDA publishes notice that
certain combined oral contraceptives are
approved for off label use as emergency
contraceptives
All containing ethinyl estradiol + norgestrel or
levonorgestrel
 Ovral , lo/ovral, nordette, levlen, triphasil, tri-levlen
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February 1998 – women in Washington state can
receive EC from participating pharmacies
without a doctors prescription
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September 1998 – FDA approves, Preven, the first
dedicated emergency contraception product
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Eight states have followed: alaska, california, hawaii,
maine, massachusetts, new hampshire, new mexico
and vermont
Removed from the market in 2004
July 1999 – FDA approves Plan B, the first
progestin-only emergency contraception product
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After 1998 WHO study demonstrated that progestin
only products are more efficacious and have less side
effects
 February
14, 2001 – The Center for
Reproductive Rights files a citizens petition
with the FDA on behalf of over 70 other
medical and public health organizations to
make Plan B available OTC
 June 2001 – NY Assembly passes legislation
requiring hospital ERs to inform rape
survivors of EC
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Includes catholic institutions
In the following year: Washington state law
required hospitals to offer rape victims EC
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Many states followed – currently 13 states. NY passed
legislation in April 2003
April 2003 – Women’s Capitol Corporation
submits its application to the FDA for Plan B OTC
status
 December 2003- FDA advisory committee voted
23 – 4 that plan B be switched to OTC
 May 2004 – FDA rejected the OTC switch
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Cited concerns about the effects of OTC availability
on the sexual behavior of young teenagers
 Data at that point had already demonstrated that
ready access to Plan B by adolescents as young as 15
did not increase irresponsible sexual behavior
 Additional studies more recently consistently
demonstrate that women given ready access do not
routinely use less effective regular contraception, do
not engage more often in high risk sexual behavior, do
not become more promiscuous, and do not have
increased rates of pregnancy or STDs.
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July 2004 – Barr Laboratories submitted an
amended application with age restrictions: OTC
for 16 and younger
 January 2005 – The FDA fails to meet the
deadline
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The Center for Reproductive Rights filed a lawsuit
against the FDA
September 2005 – the FDA misses its second
deadline.
They announced that Plan B was safe for OTC use by
women 17 + yrs
 but also announced an indefinite delay in reaching a
decision.
 Requested a 60 day public comment period
 Three days later, Susan Wood, the Director of the FDA
Office of Women’s Health resigned
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“The recent decision announced by the commissioner about emergency
contraception, which continues to limit women’s access to a product that
would reduce unintended pregnancies and reduce abortions is contrary to my
core commitment to improving and advancing women’s health. I have spent
the last 15 year 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 by approval by the professional staff here,
has been overruled.” – Susan Wood
 August
2006 – FDA approves OTC sales of Plan
B for women/men ages 18 and older
 June 2009 – Next Choice, a generic version of
plan B, approved for OTC sales for ages 17
and older
 July 2009 – Plan B One step approved by the
FDA for OTC sales for ages 17 and older
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Pharmaceutical companies are not spending heavily on
direct-to-consumer advertising
Only 16 states have enacted legislation requiring hospitals
to provide info about and/or initiate emergency
contraception therapy to women who have been sexually
assaulted
The Department of Justice makes no mention of EC in the
National Protocol for Sexual Assault Medical Forensic
Examinations
 The Department of Defense Pharmacy & Therapeutics
Committee removed Plan B from the Basic Core Formulary in
May 2002
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Prescription requirement for teens 16 and younger
obstructs timely access
OTC availability still limited
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Limited by whether a pharmacist has EC or is willing to
dispense the EC
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2002 New York study demonstrated that ECs were only available in
50% of pharmacies
Lack of privacy for the patient who has to ask the pharmacist
for the drug
 Loss
of opportunities for physicians to
counsel patients
 Price increase
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Plan B
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Plan B One Step
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$35 - 60
$35 - 60
Next Choice
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~ $40
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EDUCATE your patients!
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A 2009 study in Obstetrics & Gynecology explored
Adolescent Comprehension in NYC
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A 2009 study in JOGNN explored female college students
knowledge of EC
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98% heard of EC, but 40% were unsure if EC was the same as RU486
95% knew EC was available in the US, but 33% believed a
prescription was required
Only 8% said they received info about EC from their health care
provider… 
EDUCATE yourself!
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A 2009 study in Pediatrics explored emergency
contraception knowledge among ER physicians
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67% of teens aged 12 – 17 yrs had heard of emergency
contraception
43% of the participants were unable to correctly answer 50% of
the knowledge based questions
Only 12% identified the correct time period for initiation of EC
Get involved!
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Von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bartfai G, Ng E, Gemzell K, Oyunbileg A, Wu S,
Cheng W, Ludicke F, Pretnar Am Kirkman R, Mittal S, Khomassuridze A, Apter D, Peregoudow A. Low
dose mifepristone and two regumens of levonorgestrel for emergency contraception: a WHO
multicentre randomised trial. Lancet 2002;360:1803-10.
Croxatto HB, Ortiz ME, Muller AL. Mechanisms of action of emergency contraception. Steroids
2003;68:1095-8.
Ellertson C, Webb A, Blanchard K, Bigrigg A, HaskellS, Shochet T, Trussell J. Modifying the Yuzpe
regumen of emergency contraception: a multicenter randomized, controlled trial. Obstet Gynecol
2003;101:1160 – 7.
Gold MA, Sucato GS, Conard LA, Hillard PJ. Provision of Emergency Contraception to Adolescents:
Position Paper of the Society for Adolescent Medicine. Journal of Adolescent Health 2004;35:6670.
Klein JD, Barratt MS, Blythe MJ, Diaz A, Rosen DS, Wibbelsman CJ. Emergency Contraception.
Pediatrics 2005;116:1038-1047.
Wood AJJ, Drazen JM, Greene MF. A sad day for science at the FDA. N Engl J Med 2005;353:1197-8.
Davidoff F, Trussell J. Plan B and the politics of doubt. J Am Med Assoc 2006;296:1775-8.
Cheng L, Gulmezoglu AM, Piaggo G, Ezcurra E, Van Look PFA. Interventions for emergency
contraception. Cochrane Database Syst Rev 2008, Issue 2.
Goyal M, Shao H, Mollen C. Exploring emergency contraception knowledge, prescription practices
and barriers to prescritption for adolescents in the emergency department. Pediatrics
2009;123:765-70.
Cremer M, Holland E, Adama B, Klausner D, Nichols S, Ram RS, Alonzo TA. Adolescent
Comprehension of Emergency Contraception in New York City. Obstetrics & Gynecology
2009;113:840-844.
Hickey MT. Female College Students’ Knowledge, Perceptions, and Use of Emergency
Contraception. JOGNN 2009:38:399-405.
Guttmacher Institute. Facts on American Teen’s Sexual and Reproductive Health. Available at:
www.guttmacher.org/pubs/fb_ATSRH.html. Accessed December 5th 2009.