Transcript “Morning After Pill” should not be readily available over the counter.

The “Morning After Pill” should not be
readily available over the counter.
Natalie Vander Kelen
Jere Whitbred
Lindsey Yunck
Defining our terms:
• Birth Control – the use of any practices,
methods, or devices in order to prevent
pregnancy.
– Condoms
– Birth control pills, patches, shots
– Emergency Contraception
– Abortion
Defining our terms continued:
• Abortion – the removal of an embryo or fetus
from the uterus in order to end a pregnancy
– Abortion pill: taken up to 9 weeks after first day of a
woman’s last period (COST: $350-$650)
– In-clinic abortion: most common is aspiration (use of
a medical vacuum), preformed no later than 16 weeks
(COST: $350-$900)
– D&E (Dilation and Evacuation): preformed no later
than 16 weeks, after 24 weeks this procedure is only
preformed for serious health risks
Defining our terms continued:
• “Morning-after-pill” –an oral drug usually containing
high doses of estrogen (birth control) that interferes
with pregnancy by blocking implantation of a
fertilized egg in the human uterus
– Plan B
– Preven
History of Women’s Heath
• Biblical Book of Genesis – oldest recorded reference
to birth control. Coitus interrupts also know as the
“withdraw method” or “pull-out method”
• 384-322 B.C. – Aristotle is the first person to mention
the use of spermicides
• 1839 – Charles Goodyear invents the technology, “to
vulcanize rubber and puts it to use manufacturing
condoms (American Experience)
Fertilization of the Sea Urchin
In 1875 Oscar Hartwig observed the fertilization of the Sea
Urchin (208 Bullough).
Fertilization of a Human Egg
A year after Oscar Hartwig observed the fertilization of the Sea
Urchin, Herman Fol observed a human egg being fertilized
(208 Bullough).
History of Women’s Health
Continued:
• In 1876, “Scientists conclude defiantly that for
human fertilization to occur there must be a union
of the egg and the sperm” (American Experience).
• In 1954 the birth control that we still use today
was developed (American Experience).
History of Women’s Health Continued:
• September 1998: the U.S. Food and Drug
Administration approved Pre-vent, the first
emergency contraception product. The kit
contained:
– A detailed patient information booklet
– Pregnancy test
– Emergency contraception pills
History of women’s health continued:
• After the release of Pre-vent in 1998 many
companies and governments pushed for more
options of emergency contraception
• There are over 100 versions of the “morning after
pill”
– Ranging from taking 1 pill to over 50 pills
– Plan B is most common form of
emergency contraception in the United
States
History of Plan B in the United States
• May 1999 - Plan B approved as Rx (prescription)
drug by the U.S. Food and Drug Administration
(FDA)
• April 2003 – application submitted to switch Plan
B from Rx to over the counter (OTC)
• May 2004 – application rejected by FDA for lack
of data of females younger than 16
• June 2004 – Congress requests that FDA does not
make the switch
History of Plan B in the United States
continued:
• August 2005 – FDA announced that Plan B is safe
for OTC use for women 17 and older, but still has
three main concerns:
1. Can Plan B be both Rx and OTC depending upon
age?
2. Can Rx and OTC versions of Plan B be marketed in
the same package?
3. Can an age restriction for Plan B be enforced?
History of Plan B in the United States
continued:
• August 24, 2006 – FDA approves making Plan B
available OTC to women 18 and older and Rx to
women aged 17 and younger
• November 2006 – Plan B begins shipping to
pharmacies
• April 22, 2009 -The FDA announces that Plan B may
be sold OTC to women and men aged 17 and
younger without a prescription
Plan B One-Step
• Most common today in the United States
• “The only single tablet, single dose emergency
contraception available in just one pill. It can
help prevent pregnancy up to 72 hours (3
days) after unprotected sex or contraceptive
failure” (Plan B One Step).
Plan B One-Step Molecular Structure
The Plan B One-Step tablet contains 1.5 mg of a single active
steroid ingredient, levonorgestrel [18, 19-Dinopregn-4-en-20yn-3-one-13-ethyl-17-hydroxy-, (17a)-(-)-], a totally synthetic
progestogen. The inactive ingredients are colloidal silicon
dioxide, cornstarch, lactose monohydrate, magnesium stearte,
potato starch, and talc. Levonorgestrel has a molecular
weight of 312.45, and the following structural molecular
formulas:
VIDEO
Plan B One-Step’s Effectiveness
• FDA and Plan B claim Plan B One-Step is 89%
effective in preventing pregnancy if used
correctly
• Many obstetricians and gynecologist disagree
with their percent of effectiveness.
– “When you base effectiveness on use throughout
the month, without considering the day of the
cycle, the results are misleading,” (Dr. Hager).
Does every woman need emergency
contraception after unprotected sex?
“You can only get pregnant on certain days of the
month – around the time you ovulate. Typically,
there are only about three to five days a month in
which a woman can get pregnant. Unfortunately,
most women looking for the morning-after-pill
are panicked because they think the clock is
ticking, and as a result they don’t take the time to
evaluate their situation” (Option Line).
Ovulation Calendar
Unlimited Access to Emergency
Contraception
• FDA states not to take Plan B more than twice
a month, however they allow unlimited access
to it.
• Women are using Plan B up to five times per
month on a regular basis.
• Some insurance companies cover emergency
contraception, however they do not cover
birth control.
Emergency Contraception around the
World:
Country
Availability
Ireland
Requires a visit to a doctor or familyplanning clinic
Russia
Requires a prescription
Spain
Requires a visit to the doctor
Canada
Consultation with a pharmacist
United Kingdom
Available OTC to women only 16 & older
Romania
Requires a medical prescription
Italy
Requires a medical prescription
Finland
Available without a prescription, but only
1 pack may be purchased at a time
United States
Available without prescription to men and
women 17 and older with no limitations
Plan B One-Step’s Adverse Reactions
Most Common Adverse Events
Plan B One-Step
N = 1,359 (%)
Heavier menstrual bleeding
30.9
Nausea
13.7
Lower abdominal pain
13.3
Fatigue
13.3
Headache
10.3
Dizziness
9.6
Breast tenderness
8.2
Delay of menses ( > 7 days)
4.5
U.S. Food and Drug Administration
Plan B One-Step’s Adverse Reactions
• Plan B One-Step should not be taken more
than two times per month (FDA).
• FDA does not list adverse reactions that occur
in less than 4% of women or that occur when
taken more than the recommended usage.
– Internal bleeding
– Ectopic Pregnancy
– Alter the endometrium
Plan B One-Step & Ectopic Pregnancy
“Ectopic pregnancies account for approximately
2% of all reported pregnancies. Up to 10% of
pregnancies reported in clinical studies of
routine use of progestin-only contraceptives
are ectopic” (FDA).
FDA Warning: Ectopic Pregnancy
“Seek medical attention if you experience
severe lower abdominal pain 3 to 5
weeks after taking Plan B One-Step, in
order to be evaluated for an ectopic
pregnancy.”
Plan B One-Step and Altering the
Endometrium
• The FDA claims Plan B One-Step is "not
effective if a woman is pregnant", will not
"harm an unborn fetus," and "is not an
abortifacient.”
• However, they also state that Plan B may
inhibit implantation by altering the
endometrium [i.e. the lining of the womb].
– In other words, this may cause an embryo to be
expelled, causing the embryo to die
Emergency Contraception and STD’s
Statistics from the United Kingdom four years after the “morning
after pill” was distributed without a prescription:
Sexually Transmitted Disease
Percent
Chlamydia
Up 76%
Gonorrhea
Up 55%
Syphilis
Up 54%
Genital Warts
Up 20%
Emergency Contraception and
Preventing Unplanned Pregnancy
• Teenage pregnancy in Scottish schools among 1315 year olds rose 10 percent in one year with
increased access to the morning-after-pill
• Scotland reported the highest number of
abortions in 2006 since abortion was legalized in
1967 in their country
• Abortions rose by 6,000 in a year after the
morning after pill was made available without a
prescription. The largest leap was among girls
younger than 16 years old.
Emergency Conception and
Pharmacists Knowledge
• In conjunction with Planned Parenthood of
Nassau County, Save Our Services Long Island
surveyed 176 pharmacists on their knowledge of
the morning after pill
– 24% of them could not full describe the effects of
emergency contraception on the body
– 52% of the 176 pharmacists could not even technically
describe emergency contraception
– 5% of them confused emergency contraception with RU486 or the abortion pill (a pill that induces an abortion
once a female is already pregnant)
Emergency Conception and
Pharmacists Knowledge Continued:
• “If you vomit within two hours of taking the
tablet, immediately contact your healthcare
provider to discuss whether to take another
tablet.”
– Most likely the pill was received from a
pharmacists who may have a limited knowledge of
the pill
Emergency Conception and
Pharmacists Views
• All pharmacies in the United States are required
to stock and distribute emergency contraception
to any one over the age of 17 without a
prescription with no limitations
– After many pharmacists refused to distribute
emergency contraception due to religious beliefs the
9th Circuit panel declared, “the right to freely exercise
one’s religion does not relieve an individual of the
obligation to comply with a valid and neutral law of
general applicability”
Future of Emergency Contraception
• Several studies have found that prescribing
emergency contraception in advance
increases the likelihood of young women's
and teens' use of emergency contraception
when needed.
– Limitations on bulk purchases of Plan B
Vivian M. Dickerson, MD, President of The
American College of Obstetricians and
Gynecologists
“FDA leaders bear significant responsibility for public health
failure to reduce these [unintended pregnancy and
abortion] rates if they fail to consider sound scientific
evidence. Given the accumulating sound scientific
evidence that over the counter access to emergency
contraception doesn’t impact unintended pregnancy or
abortion rates, this accusation is simply reckless rhetoric
and political grandstanding. Further, to continue to claim
that over the counter access will cut unintended
pregnancy rates and abortions in half, when sound
scientific evidence exists to the contrary, is to betray
public trust.”