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93-1
EMERGENCY CONTRACEPTION
Forget Me Not. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Level II
Emily C. Papineau, PharmD, BCPS
A healthy, 19-year-old woman started her combined oral contraceptive (COC) pill pack 2 days late, extending her pill-free
interval to 9 days. She had intercourse 2 days ago and wants to
avoid pregnancy at this time. Her four options for emergency
contraception include: (1) use of levonorgestrel (eg, Plan B OneStep [OTC]); (2) use of multiple COCs (Yuzpe method); (3) use
of ulipristal; or (4) off-label use of the copper-intrauterine device
(IUD). The patient should be counseled regarding the specific
method selected, including how it works, what side effects may
occur, and when to follow-up with her primary care provider if
menses do not occur. She should also be educated on when and
how to resume a routine form of birth control and the importance of remaining adherent to the regimen to avoid the need for
emergency contraception.
QUESTIONS
Problem Identification
1.Identify the patient’s drug therapy problem.
• The patient has extended her hormone-free interval to 9 days
as she forgot to reinitiate her new COC pill pack on time. The
patient had sexual intercourse 2 days ago and does not want to
become pregnant at this time. When a sexually active patient
misses two or more consecutive days of a COC (especially
one that contains ≤20 mcg of ethinyl estradiol), emergency
contraception is recommended.1 Extending the hormone-free
interval beyond 7 days can increase the chances of ovulation
and unintended pregnancy.1
Desired Outcome
2.What are the goals of pharmacotherapy in this case?
• Prevention of pregnancy using an emergency contraceptive
method that is acceptable to the patient.
Therapeutic Alternatives
3.a. What pharmacotherapeutic options are available for emergency contraception for this patient, and what are the
advantages or disadvantages of each?
• Levonorgestrel-only method. This oral emergency contraception regimen is approximately 60–94% effective at preventing
pregnancy when initiated within 72 hours of unprotected intercourse.2,3 On average, it is considered to reduce the pregnancy
rate by about 89%.4 Ideally, it should be taken as soon as possible for greatest efficacy. This method is more efficacious than
use of COC tablets and causes less nausea (18% incidence) and
vomiting (4% incidence) than use of COCs for this purpose.2
✓The primary mechanism of action is to prevent or delay
ovulation.4 Conflicting evidence exists as to whether or
not levonorgestrel can prevent implantation. It may impair
sperm motility through the genital tract but appears unlikely
to affect endometrial receptivity to a fertilized egg.2,3 If
implantation has occurred, levonorgestrel has not been
shown to cause any harm to the fetus. This emergency contraceptive option is not considered an abortifacient since it
does not promote the shedding of the endometrial lining
once implantation has occurred.2–4
• Multiple COC tablets. This method of emergency contraception was discovered prior to that of the progestin-only
method and is called the Yuzpe method. It lowers the chance
of pregnancy when initiated within 72 hours of unprotected
sex by about 74% on average.1,4 Some evidence indicates that
COCs used as emergency contraceptives may also work up to
120 hours after unprotected sex.1,2,4 This method of emergency
contraception is associated with a much higher likelihood of
nausea (43% incidence) and vomiting (16% incidence) when
compared with the levonorgestrel-only products and is not
as efficacious as levonorgestrel-only products or ulipristal
acetate.1,2 One study demonstrated that levonorgestrel was 85%
efficacious in preventing pregnancy as compared with 57%
demonstrated by the Yuzpe method.2
✓The primary mechanism of action is to prevent or delay
ovulation4; however, other mechanisms may exist.2
• Ulipristal acetate (ella). This selective progesterone receptor
modulator was FDA-approved in 2010 and is a third option
for emergency contraception. Unlike the levonorgestrelonly and Yuzpe methods, this product is actually labeled
for use up to 120 hours after inadequately protected intercourse and its efficacy does not appear to decrease during
that time window. On average, it reduces the pregnancy
rate by 90%.4 It is more efficacious than levonorgestrel,
especially when used 4–5 days after inadequately protected
intercourse.2 Ulipristal, like levonorgestrel, may also be less
efficacious in obese women.2 As our patient is not obese, this
product remains an option for her.
✓The primary mechanism of action is to prevent or delay
ovulation; however, ulipristal has also been shown to alter
the endometrial lining and may impair implantation.3–5 This
potential contribution to its efficacy cannot be excluded.
Animal models have demonstrated embryofetal loss in pregnant rats, rabbits, and monkeys.5 Because of this, ulipristal
may be undesirable for individuals who may have ethical or
religious concerns with a drug that could potentially prevent
implantation.
• Insertion of copper-releasing IUD. While not FDA-approved for
this purpose, the copper IUD reduces the risk of pregnancy
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Emergency Contraception
CASE SUMMARY
CHAPTER 93
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Some evidence suggests that levonorgestrel-only containing
products may also work, albeit less effectively, up to 120 hours
after unprotected sex.1,2,4 Levonorgestrel may be less efficacious in women whose BMI is 25–29.9 kg/m2 and especially in
women whose BMI is ≥30 kg/m2.2 Product labeling in Europe
has been changed to reflect a similar weight-related warning
about decreased efficacy in overweight and obese women. Note
that there are no restrictions or specific contraindications to
using these products in women who are overweight and obese;
however, efficacy may be reduced.2 Given this patient has a
normal BMI, efficacy of emergency contraceptive products will
not be affected by her current weight.
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Women’s Health (Gynecologic Disorders)
by approximately 99% when inserted within 5 days of unprotected sex.2 It is also a more efficacious option compared with
oral emergency contraceptive options on day 4 or 5 after
unprotected sex and its efficacy is not affected by body weight,
unlike ulipristal and levonorgestrel.1,2 One potential disadvantage to this method may be a slightly higher chance for expulsion of the IUD, particularly in a woman who is nulligravida.
Since this patient has never been pregnant, it may be potentially more difficult for the uterus to accommodate the device
although this is not likely to be a problem.5 Expulsion rates in
adolescents range from 5 to 22%.6 The American College of
Obstetricians and Gynecologists Committee on Adolescent
Health Care recommends that long-acting reversible forms of
contraception (LARC) such as copper- or progestin-releasing
IUDs or Nexplanon (etonogestrel) be encouraged over the use
of other forms of reversible contraception in adolescents and
young adults.6 This is due to greater efficacy and patient satisfaction with LARC. Depending on how long our patient desires
contraception, this may be an ideal choice and would eliminate
the potential need for emergency contraception due to missed
pills in the future.2,6
✓Its proposed mechanism of action is preventing fertilization by the spermicidal activity of copper and by preventing
implantation as it alters the endometrial receptivity.4,7
✓Note: Levonorgestrel-releasing IUDs are not efficacious for
emergency contraception.2,4
3.b. What contraindications exist to the use of emergency contraception, and do they apply to this patient?
• The US Medical Eligibility Criteria for Contraceptive Use
do not identify any contraindications to the use of the
emergency contraceptive pills (ECPs) containing levonorgestrel or the Yuzpe method.8 Even the benefits of using the
estrogen-containing Yuzpe method are thought to outweigh
any potential estrogen-related risks. This holds true even for
women who would otherwise have contraindications to the
use of estrogen-containing products although the progestinonly method would be preferred for these individuals.2,4,8
Ulipristal is not included in the medical eligibility criteria
document as it was FDA-approved after the publication of
the criteria.
• The patient is unlikely to have any contraindications to the use
of an IUD such as an abnormally shaped uterus or recent exposure to sexually transmitted diseases (STDs) given her mutually
monogamous relationship.
• Pregnancy is identified as a contraindication to the use of
the levonorgestrel-containing emergency contraceptive products and the Yuzpe method, not because any fetal harm has
been identified, but because it is clearly too late to use these
products. A pregnancy test does not have to be administered
prior to initiating these types of emergency contraception
regimens.2,4 Ulipristal is also contraindicated in pregnancy;
however, its prescribing information specifically states that
pregnancy should be ruled out prior to administering the
product.5 If this cannot be accomplished by history and physical examination alone, then a pregnancy test is recommended.5
Patients in the ulipristal trials were given a pregnancy test prior
to receiving the drug because the risks of ulipristal to a fetus are
unknown.5 As expected, known hypersensitivity to any emergency contraception product component is a contraindication
for its use as is undiagnosed abnormal genital tract bleeding
prior to placing an IUD because this warrants investigation
before any therapy is initiated.2,8
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Optimal Plan
4.Recommend an appropriate emergency contraceptive method
and dose for this patient.
• Levonorgestrel-only products. This is the preferred method,
given its efficacy, tolerability, ease of use, and cost. It is available
in two dosing regimens:
✓Plan B was the first progestin-only emergency contraceptive available and was dosed as two 0.75 mg levonorgestrel
tablets taken 12 hours apart. At the time this chapter was
written, no brand or generic drug manufacturers were making this dosage.
✓Plan B One-Step (or equivalent product such as Opcicon
One-Step or My Way) has combined the dose to be 1.5 mg of
levonorgestrel taken once. This larger dose does not increase
side effects but may increase adherence to the regimen as a
single dose.2
✓For many years, these products were available without a
prescription to any individual 17 years of age and older
and were available only by prescription to those younger
than 17 years. Now, Plan B One-Step was ultimately
granted OTC status without age restriction in 2013. Other
1.5 mg levonorgestrel products are now also available over
the counter. This 19-year-old patient should be able to
obtain Plan B One-Step or an equivalent product without
difficulty.2
• Multiple COC tablets (Yuzpe method). This involves taking one
dose of 100 mcg of ethinyl estradiol with 0.5 mg of levonorgestrel followed by a second dose 12 hours later. This method is
not preferred due to lesser efficacy and greater gastrointestinal
side effects.
✓There are no FDA-approved products solely marketed for
this purpose. The FDA has identified certain COCs containing ethinyl estradiol and levonorgestrel to be considered
safe and efficacious for emergency contraception use when
used at specified doses higher than those used as daily
contraception.
✓An example of such use is taking five orange Aviane pills
(her current birth control medication containing ethinyl
estradiol 20 mcg/levonorgestrel 0.1 mg per tablet) now and
five pills 12 hours later.
✓Meclizine taken 1 hour prior to the first COC dose can
lessen nausea and vomiting.1,2
• Ulipristal acetate (ella) is available by prescription only and
is dosed as a single 30 mg tablet taken with or without food.5
• Regardless of which version of oral emergency contraception is selected, some professional organizations (including
the Women’s Health Practice and Research Network of the
American College of Clinical Pharmacy, the American College of Obstetricians and Gynecologists, and the American
Academy of Pediatrics) recommend that patients should obtain
these products in advance of their actual need.2,4,9,10 While
having emergency contraception available before it is needed
may encourage its use, studies have not shown a decrease of
unintended pregnancies even with advance provision of the
medication.1–3
• Use of emergency contraception may be repeated during the
same menstrual cycle. Patients should be educated that emergency contraception, while thought to be safe to use repeatedly,
is not as efficacious at preventing pregnancy as are other forms
of hormonal contraception or IUDs.
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• Copper-releasing IUD:
5.What clinical and laboratory parameters are necessary to
evaluate the efficacy of the therapy?
• Absence of pregnancy. When emergency contraception is used,
the menstrual cycle usually occurs 1 week before or after when
it is expected to occur.2 This is typically earlier than expected
for levonorgestrel products and later than expected for ulipristal. If she does not have menses after 3 weeks or a week
after she would normally have menses, a urine pregnancy test
should be performed to rule out pregnancy.1,5 The patient may
also experience some unscheduled bleeding with use of these
products.1,2
Patient Education
6.a. Counsel the patient regarding how the emergency contraceptive regimen works, how to take it, and what side effects
may occur.
How emergency contraception works:
• Depending on the patient’s social or religious beliefs, it may be
important to her to know how the various emergency contraception products work.
✓Emergency contraceptive pills or ECPs like levonorgestrel or
the Yuzpe method (which involves taking multiple traditional
birth control pills in 12 hours) are anywhere from about 60%
to 94% effective at preventing pregnancy, but you could still
become pregnant even after taking this medication. ECPs are
thought to help prevent pregnancy mainly by preventing or
delaying ovulation. It is still unclear whether or not they can
decrease the ability of a fertilized egg to implant into the lining of the uterus. These pills are not considered to be “abortion pills.” Pregnancy is defined as occurring once a fertilized
egg has implanted into the lining of the uterus. Once this
has happened, ECPs containing levonorgestrel or traditional
birth control pills will not work, and they have not been
shown to harm a fetus if you are already pregnant.2,4,7
✓The emergency contraceptive pill, ulipristal, is very effective
at preventing pregnancy, even more effective than the other
oral emergency contraceptive options, especially 4–5 days
after inadequately protected sex.4 It prevents or delays ovulation and can change the lining of the uterus to make it
harder for a fertilized egg to implant.4 This could be partly
why it is so effective. Unlike the levonorgestrel or Yuzpe
methods which have not shown harm to the fetus if you are
already pregnant, it is unknown whether or not ulipristal
could cause harm if you are already pregnant.5 For this reason, your primary care provider may have you take a pregnancy test before using this pill if he or she is not reasonably
sure that you are not pregnant.
✓The copper IUD is a contraceptive device that is inserted into
the uterus and is very effective at preventing pregnancy for
How to take it and side effects:
• Levonorgestrel only products. Plan B One-Step, Opcicon OneStep, and My Way are examples of a one-dose 1.5 mg levonorgestrel tablet that should be taken with 72 hours of unprotected
intercourse, available OTC. Ideally, it should be taken right
away, as the sooner it is taken after inadequately protected
intercourse, the more effective it is.
✓ Most women do not experience side effects with these medications. There is a small chance that it could cause nausea or
vomiting. Repeat the dose if vomiting occurs within 2 hours
after taking a dose.2 You may also experience a small amount
of bleeding in the week after taking this medication.
✓If you experience persistent abdominal pain or irregular
bleeding, contact your healthcare provider.
✓If you do not restart your Aviane, your period may start a
week sooner or later than the expected 3 weeks.2
• Multiple COCs. Take five of the orange Aviane pills now and
five pills 12 hours later.
✓ Because taking five pills at once can cause nausea and vomiting, take meclizine 25 mg, an antinausea medication, 1 hour
prior to the first dose to lessen these side effects. Repeat the
dose if vomiting occurs within 2 hours after taking a dose.2
These birth control tablets may be administered vaginally if
you cannot keep them down.2
✓If you experience persistent abdominal pain or irregular
bleeding, contact your healthcare provider.
• Ulipristal. Take one 30 mg tablet now with or without food.
✓Most women do not experience side effects with this
medication. You may experience a headache, nausea, or
abdominal pain. If you vomit within 3 hours of taking the
medication, ask your primary care provider if you should
take it again.5
✓Contact your healthcare provider if you experience persistent abdominal pain or if your period is delayed by more
than 1 week.5
• Copper-IUD. This may cause some abdominal discomfort,
vaginal bleeding, or a small amount of vaginal bleeding known
as spotting, for a couple of days after the IUD is inserted.4
✓During the first few months after IUD placement, spotting
is common. A copper-releasing IUD can also cause more
menstrual bleeding and cramping with your periods; however, this tends to diminish after the first 2–3 months. Taking
a medication like ibuprofen or naproxen at the start of your
period can lessen this.4
✓Most women do not have unusual side effects from having
an IUD. Talk to your primary care provider if you experience
anything in the acronym PAINS. “P” stands for a period that
is late. “A” stands for severe abdominal pain. “I” stands for
infection. Tell your primary care provider if you have any
abnormal or foul-smelling vaginal discharge. “N” stands for
not feeling well such as getting a fever or chills. “S” stands for
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Emergency Contraception
Outcome Evaluation
CHAPTER 93
✓If only used for emergency contraception, it is an expensive
option for the healthcare system with prices for Paragard
estimated to be around $500. Due to the Affordable Care
Act, insurance companies typically cover this product for
free. If the patient does not have insurance, a patient assistance program may provide an eligible patient the IUD at
little to no cost. If continued contraception is desired, this
product can remain in place for 10 years.
10 years. When used for emergency contraception purposes,
it is thought to help prevent fertilization by affecting the
sperm movement in the female reproductive tract, and it
could also make it harder for a fertilized egg to implant into
the lining of the uterus, should a fertilized egg be present.4,7
While the copper IUD is 99% effective at preventing pregnancy, you could still become pregnant even after receiving
the IUD.
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string. Monitor the IUD string length to make sure that the
IUD has not moved.4
6.e. Counsel the patient regarding how she can minimize the
need for emergency contraception in the future.
6.b. Explain to the patient how she will know if the emergency
contraception regimen was effective.
• You may continue to use your oral birth control pill if you
desire. If you choose not to take the seven pills in the last week
of your pill pack, consider discarding them one day at a time
to help keep you in the habit of using your pill pack and so you
do not start your next pack too late.
Women’s Health (Gynecologic Disorders)
• Your period may come 1 week earlier or 1 week later than
expected, especially if you do not restart your Aviane right
away. You should expect a period within the next 3 weeks. If
this does not occur, you should take a pregnancy test or contact your primary care provider.1,2 You may also experience
some bleeding during the first week after using emergency
contraception.4
6.c. Instruct the patient on when emergency contraception may
be warranted, should she need to use it in the future.
• Contact your primary care provider or pharmacist if you forget
to take any of your birth control pills in the future. Depending
on the strength of your birth control pill and when you have
missed it in your cycle, you may be at risk for pregnancy. Using
ECPs at that time may decrease your chance of pregnancy.
Some women choose to keep a supply of ECPs at home in case
they are needed.1,4 If you find it difficult to remember to take
your Aviane pills every day, you may want to discuss other
contraception options with your healthcare provider such as
long-acting reversible forms of contraception like an IUD or
Nexplanon.
• Keep in mind that ECPs are not as effective as taking oral contraceptive pills on a regular basis and should only be used as a
“back-up” plan, not as the only method to prevent unintended
pregnancy.2,4
6.d.Instruct the patient when she should reinitiate her combined oral contraceptive regimen.
• ECPs will not prevent you from getting pregnant if you have
unprotected sex in the days following therapy. You should
resume a regular method of birth control the day after your ECP
regimen is completed.1,2 If you used the levonorgestrel or the
Yuzpe method, use a back-up method of birth control, such as
a condom, until you have taken your new birth control pill pack
for seven consecutive days. This is because it will take 7 days for
your Aviane to begin working again. If you used ulipristal, it is
recommended you wait 5 days before restarting your Aviane.2
You will need to use an additional back-up method of birth
control, such as a condom, until you have had your next period
or until you have taken your contraceptive pill for 14 days,
whichever is less.1 This is because Aviane may make ulipristal
less effective and ulipristal may make your birth control pills
less effective within that same menstrual cycle.2,5 It would probably be best to wait until after your next period to begin your
next pack of Aviane to avoid this.4 If you choose to wait to start
your pack until after your period has begun, remember to use
a barrier method of contraception during that entire time and
until you have taken the Aviane for seven consecutive days. If
the copper-IUD is used, it will work immediately to help prevent pregnancy and continue to do so for 10 years.2
• As you may know, birth control pills or an IUD can help prevent pregnancy but do not protect against STDs. Use a condom
if you, or your husband, have an additional sexual partner.
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
• There are also extended-cycle birth control options that would
allow you to only have a period once every 3 months or potentially not at all. This could be taken in the form of a daily birth
control pill or a birth control injection administered every
3 months typically by a healthcare professional. Longer birth
control options include a small hormone rod called Nexplanon
which sits under the skin of your upper arm for 3 years, or
an IUD which can remain in your uterus for 3, 5, or 10 years,
depending on the device. Both the hormone rod and the IUDs
are more effective at preventing pregnancy than birth control
pills and can be removed at any time should you want to
become pregnant.6 If these options interest you, discuss them
with your healthcare provider who can describe the risks and
benefits to using these methods. The nonoral forms of birth
control could be started after your next menstrual cycle.2
REFERENCES
1. Centers for Disease Control and Prevention. U.S. Selected Practice
Recommendations for Contraceptive Use, 2013: adapted from the
World Health Organization selected practice recommendations for
contraceptive use, 2nd edition. MMWR Recomm Rep 2013;62:1–60.
Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6205a1.htm.
Accessed April 29, 2016.
2. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 152: emergency contraception. Obstet Gynecol
2015;126(3):e1–11.
3. Shrader SP, Hall LN, Ragucci KR, Rafie S. Updates in hormonal emergency contraception. Pharmacotherapy 2011;31:887–895.
4. Zieman M, Hatcher RA, Allen AZ. Managing Contraception for your
Pocket, 13th ed. Tiger, Georgia: Bridging the Gap Foundation, 2015.
5. Ulipristal prescribing information. Morristown, NJ: Watson Pharma,
Inc, 2010. Revised March 2015.
6.American College of Obstetricians and Gynecologists. Committee
Opinion No. 539: adolescents and long-acting reversible contraception:
implants and intrauterine devices. Obestet Gynecol 2012;120:983–988.
7.Baird DT. Emergency contraception: how does it work? Reprod
Biomed Online 2009;18(1):32–36.
8. Centers for Disease Control and Prevention. U.S. Medical Eligibility
Criteria for Contraceptive Use, 2010: Adapted from the World Health
Organization Medical Eligibility Criteria for Contraceptive Use, 4th ed.
MMWR Recomm Rep 2010;59:1–86. Available at: http://www.cdc.gov
/mmwr/preview/mmwrhtml/rr5904a1.htm?s_cid=rr5904a1_e.
Accessed April 29, 2016.
9. Rafie S, McIntosh J, Gardner DK, et al. Over-the-counter access to
emergency contraception without age restriction: an opinion of the
Women’s Health Practice and Research Network of the American
College of Clinical Pharmacy. Pharmacotherapy 2013;33:549–557.
10. American Academy of Pediatrics. Policy statement: emergency contraception. Pediatrics 2012;130:1174–1182.