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92-1
CONTRACEPTION
Babies Aren’t Us Yet. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Level II
Julia M. Koehler, PharmD, FCCP
CASE SUMMARY
A 25-year-old woman with past medical history significant for
migraine headache disorder (without aura or focal neurologic
deficits and well controlled with prophylactic migraine medication)
presents to the women’s health clinic requesting a prescription
for hormonal contraception 4 months prior to her wedding. The
patient has no absolute contraindications to oral contraceptives
(OCs) but has a family history of hypertension (HTN), cardiovascular disease, and dyslipidemia, and her history of migraine headaches is considered a relative contraindication. Given her history of
menstrual irregularity and occasional menstrual-related headaches,
the patient is requesting a contraceptive that will allow for fewer
or no menstrual periods. Pharmacotherapeutic methods of contraception include oral estrogen/progestin combinations (including
extended or continuous cycle combinations), progestin-only OCs,
medroxyprogesterone acetate suspension for intramuscular (IM) or
subcutaneous injection, estrogen/progestin transdermal patch for
topical application, estrogen/progestin ring for intravaginal use, a
progestin-containing implantable hormonal contraceptive system,
or an intrauterine device (IUD). To make an informed choice, the
patient needs to be educated on the risks and benefits of each contraceptive type, typical failure rates, the importance of adherence,
and proper methods of use. When this patient complains of breakthrough bleeding and worsening acne within 2 months of starting
an OC, the reader must consider possible causes and potential
adjustments in the patient’s OC regimen.
• History of carcinoma of the breast (does not apply)
• History of any estrogen-dependent neoplasm (does not apply)
• Undiagnosed abnormal vaginal/uterine bleeding (does not
apply)
• Migraine headaches with focal neurologic symptoms (does not
apply; see relative contraindications in Question 1.c)
• Pregnancy (urine pregnancy test negative; therefore, does not
apply)
• History of hepatic tumors, whether benign or malignant (does
not apply)
• Active liver disease (need more information, but seems
unlikely)
1.c. What medical problems are relative contraindications to
hormonal contraceptive use, and do any of these apply to
this patient?
• Migraine headaches without focal neurologic symptoms
(applicable in this case)
• HTN: Positive family history of HTN/cardiovascular disease
may be a potential problem; although the patient’s blood
pressure is normal at today’s visit, her blood pressure should
be monitored closely, especially following the initiation of a
hormonal contraceptive
• Diabetes mellitus (does not apply)
• Smoking <15 cigarettes per day at any age (does not apply)
• Fibroid tumors of the uterus (does not apply)
• Elective major surgery requiring immobilization planned in
the next 4 weeks (does not apply)
• Sickle cell disease (does not apply)
• Breastfeeding (does not apply)
• Active gallbladder disease (does not apply)
• Age >50 years (does not apply)
QUESTIONS
Problem Identification
1.a. Create a list of this person’s potential drug therapy problems.
• Family history of dyslipidemia: Positive family history may be
a potential problem
1.d. What other information should be obtained before creating
a pharmacotherapeutic plan?
• History of thromboembolic disease (does not apply)1
• Test for HIV, chlamydia, and gonorrhea. The patient admits to
having occasional unprotected sex with her fiancé (inconsistent
use of male condoms as primary means of contraception).
Although she indicates that they have been in a monogamous
relationship for the past 2 years, prior history for either the
patient or the patient’s fiancé regarding sexual activity is not
known. The patient is requesting contraceptives as a means
of future contraception, and she should understand that most
nonbarrier-type contraceptives do not provide adequate protection against sexually transmitted infections (STIs). Based
on her age and sexual activity (ie, having unprotected sex in
a current monogamous relationship), the patient should be
evaluated for STIs with tests for chlamydia, gonorrhea, and
HIV, according to the United States Preventive Services Task
Force (USPSTF) guidelines.2 Per the USPSTF guidelines, she is
not considered “high risk”; therefore, screening for syphilis or
hepatitis B is not necessary at this time.2
• History of stroke or current cerebrovascular disease (does not
apply)
• Lipid profile. She has a family history of cardiovascular disease
and dyslipidemia. This is a good time to evaluate her fasting
• Occasional unprotected sexual intercourse (report of inconsistent use of male condoms as current method of contraception):
Patient is now requesting hormonal contraceptives as primary
means of pregnancy prevention.
• Irregular menses and report of prior menstrual-related
headaches.
• Migraine headache disorder (without aura or focal neurologic
deficits), although well-controlled currently, is a relative contraindication to the use of estrogen-containing contraceptives.
• Mild acne noted on physical exam may worsen or improve with
hormonal contraceptive use.
1.b.What medical problems are absolute contraindications to
hormonal contraceptive use, and do any of those conditions
apply to this patient?
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Contraception
Jennifer R. Guthrie, MPAS, PA-C
• Heavy smoking, especially if ≥15 cigarettes per day or
age >35 years (does not apply)
CHAPTER 92
92
• History of (or current) coronary artery disease, ischemic heart
disease, or peripheral vascular disease (does not apply)
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SECTION 9
Women’s Health (Gynecologic Disorders)
lipid profile: total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C),
and triglycerides. The progestin component of combined OCs
can cause a dose-related decrease in HDL-C and an increase
in LDL-C. If her lipid profile suggests cardiovascular risk (eg,
total cholesterol >200 mg/dL, LDL-C >160 mg/dL, triglycerides >150 mg/dL, or HDL-C <40 mg/dL), consideration
should be given to the progestin component of the OC. It is
generally believed that progestins with lower androgenicity,
such as norgestimate and desogestrel, may have the least effect
on plasma lipids.
• BP check. Classification of BP in patients who are 18 years
of age or older should be based on the mean of two or more
properly measured BP readings on each of two or more office
visits. Because the patient has a positive family history of HTN
and because HTN secondary to OC use is thought to occur in
up to 3% of women, her BP should be monitored closely and
rechecked at her next office visit. The World Health Organization (WHO) considers the health risk posed by OC use to be
unacceptable if SBP is ≥160 mm Hg or DBP is ≥90 mm Hg.3
• Assessment of headache characteristics. The patient should
be questioned regarding whether her migraine headaches
are accompanied with focal neurologic symptoms. OCs are
contraindicated in patients with headaches accompanied by
focal neurologic symptoms. Women with a history of migraine
headaches who use combined OCs are about 2–4 times as
likely to have an ischemic stroke as non-OC users with a history of migraines.3 Furthermore, when migraine headaches
are accompanied by aura (ie, focal neurologic symptoms), the
risk for stroke is higher than when migraine headaches are not
accompanied by aura.3,4 In general, migraine without aura is
not accompanied by focal neurologic symptoms4 (which seems
to be the diagnosis in this case). Thus, according to the Centers
for Disease Control and Prevention (CDC) US Selected Practice
Recommendations for Contraceptive Use 2013, the patient can
be considered a candidate for OC use.5
Desired Outcome
2.What are the goals of pharmacotherapy in this case?
• Prevention of pregnancy using a contraceptive method that is
not cost-prohibitive, has a low-failure rate, is convenient, and
has minimal risk to the patient and a low-adverse effect profile.
• Prevention of STIs.
• Participation by the patient in the selection of the contraceptive method, such that the choice is both acceptable to her and
commensurate with her contraceptive goals (ie, provides fewer
or no menstrual periods).
Therapeutic Alternatives
3.What pharmacotherapeutic alternatives are available for prevention of pregnancy in this patient, and what are the advantages or disadvantages of each?
• Estrogen/progestin OC combinations. The most desirable products in this class are either lower dose monophasic estrogen/
progestin combinations or the triphasic combinations. If using
combined hormonal OCs, the initial dose should be the lowest dose of estrogen (usually ethinyl estradiol [EE]) that is
effective (generally ≤35 mcg). The lower doses of estrogen and
progestin have the least effect on plasma lipids and BP. OCs
provide protection against ovarian and endometrial cancer,
reduced risk for iron deficiency anemia, relief of fibrocystic
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
breast disease, and protection against ovarian cysts. However,
OC combinations do not provide protection against STIs and
have an increased risk of benign hepatocellular adenomas.
They are reliable when taken correctly but are associated with
a high-failure rate in patients who do not properly adhere to
their OC regimen.
✓Monophasic OCs containing low doses of estrogen (eg, 20 mcg
of EE), low doses of progestin, and low androgenic activity
may have the advantage of reducing the risk of estrogenrelated side effects such as nausea and breast tenderness.
The disadvantages include a higher risk for spotting and less
margin for error if pills are missed. Examples of monophasic
pills containing 20 mcg of EE include Lessina (EE and levonorgestrel 0.1 mg) and Loestrin 21 1/20 (EE and norethindrone acetate 1 mg).
✓Monophasic OCs containing low doses of estrogen (eg, 30 mcg
of EE), medium to high doses of progestin, and medium- to
high-androgenic activity may provide more margin of error
when pills are missed, while still providing fewer estrogenrelated side effects such as nausea and breast tenderness.
Additional advantages may include less potential for spotting and/or breakthrough bleeding. Examples include Altavera (EE and levonorgestrel 0.15 mg), Cryselle (EE and
norgestrel 0.3 mg), and Loestrin 21 1.5/30 (EE and norethindrone acetate 1.5 mg).
✓Monophasic OCs containing low doses of estrogen (eg, 30 mcg
of EE), high doses of progestin, and low-androgenic activity may have less potential for spotting and/or breakthrough bleeding as well as fewer androgenic side effects
(eg, increased appetite, weight gain, acne, oily skin, and
hirsutism). In addition, these products may have a more
favorable effect on lipid profile than products with higher
androgenic activity. Examples include Apri and Desogen
(EE and desogestrel 0.15 mg). Of note, the less androgenic
progestins, such as desogestrel and drospirenone, have
been reportedly associated with a higher risk of venous
thromboembolism (VTE). However, recent studies validating this risk have produced somewhat conflicting results.
The results of the International Active Surveillance Study
of Women Taking Oral Contraceptives, published in 2014,
demonstrated similar rates of VTE in women taking OCs
containing drospirenone, levonorgestrel, or other progestins.6 However, a more recent case-control study in over
10,000 women with VTE found that, while exposure to any
combination OC was associated with an increased risk of
VTE, certain progestins (including both desogestrel and
drospirenone) were associated with an even higher risk of
VTE compared with levonorgestrel.7
✓Monophasic OCs containing low doses of estrogen (eg, 20 or
30 mcg of EE) and antiandrogenic and antimineralocorticoid
activity may cause less fluid retention, less acne, and have
less potential for hirsutism. Despite these potential benefits,
as noted above, a potentially higher risk of VTE associated
with drospirenone-containing OCs should be noted. Thus,
careful assessment of a patient’s overall risk for VTE is warranted when considering this type of OC. Examples of combined OCs which contain EE and drospirenone include Yaz
and Beyaz (see extended-cycle and continuous cycle OCs
below) as well as Yasmin and Safyral.
✓Biphasic OCs, in general, do not offer significant advantages
over either monophasic or triphasic preparations. However,
Mircette (20 mcg of EE and desogestrel 0.15 mg) is an example of a biphasic preparation that may offer the advantage
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✓Quadriphasic OCs may also offer better cycle control compared to biphasic pills. In 2010, the FDA approved Natazia,
which is a unique four-phase combination OC containing
estradiol valerate and the progestin, dienogest. Estradiol
valerate is metabolized endogenously to estradiol, and
dienogest is a strong progestin with antiandrogenic activity. Natazia provides a novel estrogen step-down/progestin
step-up regimen: Days 1 and 2, estradiol valerate 3 mg alone;
days 3–7, estradiol valerate 2 mg/dienogest 2 mg; days 8–24,
estradiol valerate 2 mg/dienogest 3 mg; days 25 and 26,
estradiol valerate 1 mg alone; and days 27 and 28, placebo.
Like Mircette and the others listed above, this quadriphasic
preparation offers the advantage of a shorter hormone-free
interval, which results in fewer days of withdrawal bleeding
and may help with menstrual-related headaches.
• Extended-cycle and continuous cycle OCs:
✓Yaz (EE 20 mcg and drospirenone 3 mg) and Beyaz (EE 20 mcg,
drospirenone 3 mg, and levomefolate calcium 451 mcg) are
extended-cycle preparations that contain a low-dose estrogen
and antimineralocorticoid and antiandrogenic activity. Yaz
and Beyaz may cause less fluid retention (ie, less bloating and
weight gain), less acne (FDA-approved for the treatment of
acne), and have less potential for hirsutism compared with
other OCs. The addition of the levomefolate calcium in Beyaz
is intended to reduce the risk of neural tube defects when
conception occurs either during or shortly after OC use. A
potential disadvantage, however, of drospirenone-containing
preparations may include an increased risk for hyperkalemia
in patients with concomitant renal disease or in patients taking other medications that may also increase potassium. Yaz
contains 24 active tablets and 4 placebo tablets and Beyaz
contains 24 active hormone tablets and 4 levomefolate calcium tablets, which allow for shorter menstrual periods and
fewer menstrual-related symptoms (eg, menstrual-related
headaches, menorrhagia, anemia).
✓Quasense, Introvale, Amethia, Camrese, Daysee, and Jolessa
(EE 30 mcg and levonorgestrel 0.15 mg) are extended-cycle
preparations that contain a low-dose estrogen, a medium-dose
progestin, and a medium to high amount of androgenic activity. Each of these products offers a monophasic, extendedcycle treatment that provides 84 active tablets and 7 placebo
tablets, allowing for one menstrual cycle per “season,” or
4 menstrual periods per year. These extended cycle products may improve menstruation-related symptoms such as
menstrual-related headaches, menorrhagia, and anemia.
✓Quartette (EE 20 mcg and levonorgestrel 0.15 mg × 42 days,
EE 25 mcg and levonorgestrel 0.15 mg × 21 days, EE 30 mcg
and levonorgestrel 0.15 mg × 21 days, EE 10 mcg × 7 days)
was FDA approved in 2013. It is an extended-cycle combination OC containing increasing doses of EE to help
reduce unscheduled spotting or bleeding that is commonly
associated with extended-cycle preparations. In comparison to Quasense and Seasonique (but not LoSeasonique),
Quartette delivers a lower total dose of EE. Like most other
extended-cycle preparations, Quartette allows for one menstrual cycle per “season,” or four menstrual periods per
year. Menstruation-related problems that may improve with
Quartette include menstrual-related headaches, menorrhagia, and anemia.
✓Lybrel (EE 20 mcg and levonorgestrel 90 mcg) was the first
continuous-cycle OC approved by the FDA. Active pills are
taken every day throughout the year with no pill-free interval. The major advantage of this product is elimination of
menstrual periods, resulting in improvement in or elimination of menstrual-related symptoms (eg, headaches, menorrhagia, anemia, endometriosis-related menstrual pain). The
most bothersome side effect associated with Lybrel is a high
incidence of spotting and breakthrough bleeding, at least
during the initial months of use. It appears that the incidence
of breakthrough bleeding with Lybrel may decrease with
continued use.
• Progestin-only OCs. These products can be used in women
who are breastfeeding and wish to avoid estrogen-related side
effects (eg, bloating, nausea, breast tenderness). A disadvantage of progestin-only products is that they are associated
with irregular menses, causing both frequent spotting and
amenorrhea. Of note, the American College of Obstetricians
and Gynecologists (ACOG) and CDC consider progestin-only
OCs to be generally safer than combined OCs for women with
migraine headaches.3,5,9 Examples include Ortho Micronor,
Nor-QD, Camilla, Errin, and Heather, each of which contains
norethindrone 0.35 mg.
• Injectable contraceptives:
✓Depot medroxyprogesterone acetate (Depo-Provera) for IM
administration. This product for IM injection provides effective contraception for 3 months, has few drug interactions,
and is a “passive” contraceptive method. However, it can
decrease HDL-C, has progestin side effects, does not protect
against STIs, and requires an office visit for administration.
There exists some concern that severe headaches may actually increase with the use of depot medroxyprogesterone
acetate.9 Menstrual irregularities and weight gain are commonly reported with the use of this product. In addition, this
product carries a boxed warning in the labeling regarding
the potential for loss of bone mineral density (although this
effect is now known to be reversible). A potentially important disadvantage of this product can be a significant delay
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Contraception
✓Triphasic OCs, in general, may offer better cycle control
compared to biphasic pills. Two triphasic preparations,
Estrostep Fe and Ortho Tri-Cyclen, are FDA-approved for
the treatment of acne, similar to Yaz and Beyaz.
✓Seasonique (EE 30 mcg × 84 days and 10 mcg × 7 days and
levonorgestrel 0.15 mg) and LoSeasonique (EE 20 mcg ×
84 days and 10 mcg × 7 days and levonorgestrel 0.1 mg)
are also extended-cycle preparations that are similar to
Quasense, and the others listed above, but instead contain 7 tablets with low-dose estrogen rather than placebo. Menstruation-related problems that may improve
with Seasonique or LoSeasonique include menstrual-related
headaches, menorrhagia, and anemia. In addition, endometriosis-related menstrual pain may be relieved by providing
a continuous regimen without a pill-free interval.8
CHAPTER 92
of a shorter hormone-free interval. Other similar examples
include Kariva, Pimtrea, and Viorele. Each of these products
provide 21 pills with 20 mcg of EE plus desogestrel, followed
by 2 days of placebo pills and 5 days of pills containing
only 10 mcg of EE. The shorter hormone-free interval may
help with menstrual-related headaches by decreasing the
amount of “estrogen withdrawal” during the usual pill-free
period and may allow for less overall bleeding during the
menstrual cycle. Lo Loestrin Fe is a product that contains a
very low dose (10 mcg) of EE with a low-dose, less androgenic progestin (norethindrone acetate 1 mg). Like Mircette
and others, this biphasic preparation may also provide the
advantage of a shorter hormone-free interval, and given its
low-estrogen dose, fewer estrogen-related side effects.
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SECTION 9
(6–12 months; median 10 months) in return of fertility following discontinuation of use.
Women’s Health (Gynecologic Disorders)
✓Depot medroxyprogesterone acetate for subcutaneous administration (Depo-SubQ Provera 104). This product, similar to
Depo-Provera, is administered as 104 mg given subcutaneously every 3 months. Overall, the product provides 30%
less hormone compared with Depo-Provera for IM use.
However, it is not known at this time whether the lower
progestin dose will lessen the potential for long-term side
effects. As with Depo-Provera, there exists some concern
that severe headaches may actually increase with the use of
this product.9 This product also carries a boxed warning in
the labeling regarding the potential for loss of bone mineral
density.
• Transdermal contraceptives:
✓Norelgestromin/EE transdermal system (Xulane). This product is for topical application and is applied once weekly to
the buttock, lower abdomen, back, or upper outer arm for
3 weeks. Week 4 is patch-free. The patch has been shown to
provide similar efficacy in terms of contraception and cycle
control to that of OCs. Its side-effect profile is generally
similar to that of other combined contraceptives. However,
the manufacturer of Xulane reports an estimated 60% higher
estrogen exposure versus that observed with combined OCs
containing 35 mcg of EE. Higher overall rates of breast discomfort and local skin irritation may lead to discontinuation
of the patch. Like OCs, the patch does not protect against
STIs. The patch also has been demonstrated to have a highfailure rate in patients with a body weight >90 kg.
• Intravaginal contraceptives:
✓Etonogestrel/EE vaginal ring (NuvaRing). This product is
inserted intravaginally on or before day 5 of the cycle and is
removed after 3 weeks. The ring has also been demonstrated
to provide similar contraceptive efficacy and cycle control
to combined OCs. However, it is more expensive than most
combined OCs and does not provide protection against
STIs.
• Implantable contraceptives:
✓Etonogestrel implantable hormonal contraceptives (Nexplanon). Either of these progestin-containing contraceptive
systems can be surgically implanted under the skin of the
upper arm. The implants are effective for up to 3 years.
Similar to other progestin-only products, Nexplanon may
be associated with a high rate of bleeding abnormalities.
Additionally, there is some concern that severe headaches
could increase with the use of these products.9 A potentially
important advantage of contraceptive implants, however, is
rapid return of fertility upon removal of the system.
• Intrauterine devices:
✓There are currently four IUDs available for contraceptive
use in the United States: ParaGard T380A, Mirena, Liletta,
and Skyla. ParaGard T380A is a copper-containing IUD,
whereas Mirena, Liletta, and Skyla are each levonorgestrelreleasing IUDs. ParaGard T380A is FDA-approved for up to
10 years of use. Mirena is FDA-approved for up to 5 years
of use while Liletta and Skyla are FDA-approved for up
to 3 years. Mirena releases 20 mcg of levonorgestrel daily
initially, but gradually over the 5 year period, the amount
of levonorgestrel released decreases to 10 mcg daily. Liletta
releases 18.6 mcg of levonorgestrel daily initially, decreasing
gradually to 12.6 mcg daily over the 3 year period. Skyla
releases a lower amount of progestin compared with Mirena
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
and Liletta; specifically, Skyla releases 14 mcg daily of levonorgestrel into the uterine cavity, and the amount gradually
decreases over the 3-year period to 5 mcg daily. Although
the occurrence of ovarian cysts may be more frequent in
users of Mirena and possibly Liletta, the side effect profile
of each of the three levonorgestrel-releasing IUDs seems to
be similar with respect to the incidence of headache, acne,
weight gain, spotting, and irregular bleeding. One potential
advantage of Skyla over the other available IUDs may be its
size; as the smallest of the four IUDs, insertion of Skyla may
be less painful for nulliparous women. Of additional note,
Liletta will be available commercially as well as at a lower
cost to clinics enrolled in the 340B drug pricing program;
thus, cost of this product may be significantly lower for
some patients, and this may represent an important advantage over the other IUDs. In general, the most common
adverse effects associated with IUDs are abdominal/pelvic
cramping, abnormal uterine bleeding, and expulsion of the
device. Other adverse effects can include ectopic pregnancy,
pelvic pregnancy, embedment of the device, uterine or cervical perforation, and ovarian cysts. Bleeding irregularities
are more frequent with the copper-containing IUD. While
bleeding irregularities are also common during the first
3–6 months of levonorgestrel-releasing IUD use, menstruation may cease altogether in some patients after 6 months
of continued use. Potential advantages of all IUDs include
rapid return of fertility following device removal as well as
the convenience of not having to take a daily pill.
Optimal Plan
4.What contraceptive method, dose, and schedule are best for
this patient?
• Contraceptive choice is very dependent on patient preference.
To make an informed choice, patients need to be aware of
the risks and benefits of each type of contraceptive available.
Patients should be informed of the failure rates, the importance
of adherence, and how each method should be used to ensure
efficacy. (Refer to the corresponding textbook chapter for comparative information on first-year failure rates with typical use
vs perfect use of the various contraceptive methods.)
• Although this patient presented to the clinic requesting hormonal contraceptives that will allow for fewer or no menstrual
periods, she should be made aware of the other nonoral forms
of hormonal contraception that are available. She should be
questioned about her willingness to take a pill every day, and
she must be informed that OCs will not protect her from STIs.
Additionally, it is important to understand the patient’s fertility
goals, as these can vary from patient to patient. For example,
when selecting an appropriate contraceptive for a specific
patient, it must be determined if the goal is to simply postpone
conception, to space out the next pregnancy, or to avoid a
future pregnancy altogether, as some contraceptive options
may be associated with significant delay in return of fertility (as
described in the “Therapeutic Alternatives” section).
• If, after understanding the variety of available options, she still
chooses OCs as her preferred contraceptive method, several
options are available.
✓In general, the clinician should start most patients on a
product that contains 35 mcg or less of EE (or equivalent)
and a low dose of a progestin. Although ACOG and the
CDC consider progestin-only OCs to be safer than combined OCs for women with migraine headaches,3,5,9 the
characteristics of this patient’s migraine headaches (without
92-5
✓Another option could include continuous administration
of a monophasic, biphasic, or triphasic OC (ie, skipping the
hormone-free interval altogether). A cross-sectional study
of 493 women who used combined OCs demonstrated that
headache occurrence was related more often to the hormonefree interval in those with migraine headaches than in those
with nonmigraine headaches.10 Thus, in addition to allowing
for either fewer or no menstrual periods, these products may
also decrease the occurrence of menstrual-related headaches
as well as potentially reduce the frequency or occurrence of
other side effects related to estrogen withdrawal. Because
the patient is 2 weeks from the date of her last menses, the
clinician must decide whether to start the OC immediately
or wait until onset of her next menses.
✓Because her pregnancy test was negative, the OC can be
started as soon as possible. Discussion with the patient
will determine when to start the medication. (Lybrel, eg,
is typically started on the first day of the last menstrual
period.) Most patients prefer to start OCs on a Sunday to
avoid weekend periods.
Outcome Evaluation
5.What clinical and laboratory parameters are necessary to
evaluate the therapy for efficacy and adverse effects?
Efficacy:
• Lack of pregnancy. If she continues to have menstrual irregularity or misses a period, perform another urine pregnancy test to
rule out pregnancy.
Adverse effects:
• Encourage the patient to have pelvic exams annually and Pap
tests regularly. Guidelines from USPSTF, the American Cancer
Society (ACS), and ACOG recommend that women undergo
their first Pap test at age 21, and then every 3 years until
age 30.2,11,12 Women age 30 and older who have a normal Pap test
along with a negative HPV screen and who have no abnormal
history can be rescreened at intervals of once every 5 years.11
• While ACS no longer recommends routine clinical breast exams
for women at average risk of breast cancer in a recent revision
of their guidelines, ACOG continues to recommend clinical
breast exams every 1–3 years for women between the ages of
20 and 39 years.12,13 ACOG further recommends that patients
aged 40 years and older be offered yearly mammography, and
they continue to recommend breast self-awareness (which can
include breast self-exams).12 Patients should be instructed to
report any changes to their healthcare provider right away.
• Evaluate the patient’s BP at baseline and at least annually.
Because this patient has a positive family history for HTN,
close BP monitoring is recommended, and it would be reasonable to bring her back for follow-up and reassessment of her
BP in 3 months. If the patient’s BP remains unchanged for
several months following OC initiation, OC use can be safely
continued.
• Monitor regularly for recurrence of headaches as well as any
new medical complaints, including weight gain, edema, signs
of thromboembolic disease, depression, nausea/emesis, breakthrough bleeding and/or spotting, worsening acne, etc.
Patient Education
6.What information should be provided to the patient to
enhance adherence, ensure successful therapy, and minimize
adverse effects?
General information for hormonal contraception:
• There can be a delay of several weeks in the onset of contraceptive effectiveness. Therefore, it is generally recommended that
you continue to use a barrier method (eg, condom) throughout
the first menstrual cycle. (A backup or barrier method of contraception is typically not needed with Lybrel, however.)
• With many combined OCs, you may notice a change in
your usual pattern of menses or new vaginal bleeding during your cycle, including cycle irregularity (too long or too
short), breakthrough bleeding (between usual menses), or lack
of bleeding (termed amenorrhea). If breakthrough bleeding
occurs, it should lessen or stop altogether with time. (Breakthrough bleeding or spotting is very common during the
first several months of Lybrel use.) Contact your healthcare
provider if you are bothered by any of these bleeding changes.
• Watch for any of the following effects, which you can remember by the word ACHES.
A = abdominal pain
C = chest pain or shortness of breath
H = headaches (severe, throbbing headaches on one side of the
head)
E = eye problems (blurred vision, double vision, and blindness)
S = swelling or severe leg pain
If any of these problems develop, contact your healthcare provider as soon as possible, or seek immediate medical care if the
problem is severe.
• If you have or will have more than one regular sexual partner,
or if you believe that your partner has or has had more than
one partner, you may be at risk of contracting an STI (including human immunodeficiency virus infection). Routine use
of condoms during sexual activity or intercourse can help to
drastically reduce this risk. You cannot generally tell who has
or does not have an STI or human immunodeficiency virus
when you have sex, even with a “faithful” partner.
• Diarrhea or vomiting may reduce the amount of the pill that
is absorbed into your system and may result in breakthrough
bleeding or even pregnancy. If nausea or vomiting continues
more than 1 or 2 days, it is advisable to call your healthcare
provider and/or use a barrier method for the remainder of
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
Contraception
✓ Given this patient’s report of irregular menses and her desire
for fewer or no menstrual periods, progestin-only products,
which are associated with a high incidence of menstrual
irregularities, would likely not be acceptable to this patient.
A preferable product, which could help achieve the patient’s
goal of fewer or no menstrual periods while effectively preventing pregnancy, will likely include one of the extendedcycle or continuous-cycle contraceptives.
• It is generally recommended that a fasting lipid profile be measured in all adults who are ≥20 years of age at least once every
5 years. Consider checking a serum lipid profile for this patient
before initiation of OC therapy.
CHAPTER 92
aura or other focal neurologic deficits) and the fact that they
have been well-controlled with prophylactic medication
represent a relative, rather than absolute, contraindication
to combined OC use for this patient. In general, combined
OCs can be considered in patients with migraine headache
without focal neurologic deficits, particularly if the patients
do not smoke, are otherwise healthy, and are younger than
35 years of age.1,3,5
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SECTION 9
your cycle, or until you have properly consulted with your
healthcare provider.
• Birth control pills can cause weight gain, nausea, worsening
of acne, facial skin darkening or rash, and depression. Call
your healthcare provider if any of these symptoms become
troublesome.
Lybrel:
Women’s Health (Gynecologic Disorders)
• Lybrel is a birth control pill that delivers the same low dose of
hormones every day. As with other birth control pills, it prevents pregnancy by suppressing ovulation.
• When you take Lybrel, the lining of your uterus does not
undergo the changes needed for menstruation; and therefore,
you will not have regular menstrual periods. Because the pill
will prevent you from ovulating, you are likely not have a
period every month.
• Breakthrough bleeding and spotting are likely to occur, at least
initially, while you are taking Lybrel. Breakthrough bleeding
or spotting occurs most often during the first seven-pill packs
of Lybrel. For most patients, this tends to decrease with subsequent pill packs of use. If this does occur and is bothersome to
you, however, please let your healthcare provider know.
• Take the pill once a day as directed, at the same time every day.
• If you miss a pill, take the missed pill as soon as you remember. Then, take the next pill at your regular time. (This means
you may take two pills in 1 day.) Missed pills may increase the
chance of contraceptive failure. In other words, if you miss
a pill, you could become pregnant, especially if you have sex
during the 7 days after you restart your pills. In this situation,
in order to adequately prevent pregnancy, you should use a
backup, nonhormonal birth control method (such as condoms
and/or spermicide) for those 7 days.
• If you suspect that you may be pregnant, or if you have symptoms of pregnancy, such as nausea/vomiting or unusual breast
tenderness, you should take a pregnancy test and contact your
healthcare provider. If you do become pregnant while taking
Lybrel, discontinue the pill immediately.
• Should you desire at some point to become pregnant, simply
stop taking Lybrel. It is possible that pregnancy could occur
within days of stopping the pill. It is also possible, however,
that there could be a delay in becoming pregnant when you
stop using OCs, especially if you had irregular menstrual cycles
before using them.
• OC use may increase your risk for high blood pressure and
high cholesterol. Because of your family history of hypertension and cardiovascular disease, it is important for you to
follow-up with your healthcare provider regularly to have your
blood pressure and cholesterol checked.
• OC use may either worsen or improve headaches. Should you
experience a recurrence of your migraines while taking Lybrel,
notify your healthcare provider immediately.
• Your risk for serious cardiovascular problems may be increased
if you take OCs and continue to smoke. You should stop smoking immediately in order to avoid serious health-related problems while taking OCs.
■■ FOLLOW-UP QUESTIONS
1.What medical conditions can be the cause of breakthrough
bleeding?
• Ectopic pregnancy
• Pelvic inflammatory disease
Copyright © 2017 by McGraw-Hill Education. All rights reserved.
• Cervical lesions (cervicitis, polyps, cancer, and condylomas)
• Endometrial lesions (polyps and cancer)
• Uterine fibroids
• Endometriosis
• Thyroid disorder (hypothyroidism or hyperthyroidism)
• Blood dyscrasias
2.If breakthrough bleeding is not caused by an underlying medical condition, how can it be managed?
• Remind the patient to take the pills at the same time each day.
✓Note: With Lybrel, breakthrough bleeding is a common
complaint during the first several pill cycles. The patient
should be advised of this common adverse effect and
instructed that in most women, breakthrough bleeding with
Lybrel will diminish over time. If the patient is willing to
continue taking Lybrel to see if the breakthrough bleeding
resolves, she should be instructed to use sanitary protection
in the meantime.
• If the patient is taking a noncontinuous cycle OC, the patient
should be questioned about the timing of the occurrence of the
breakthrough bleeding (ie, does the bleeding occur early or midway through the pill cycle, or does it occur late in the pill cycle?).1
✓If the patient is taking a monophasic pill and the bleeding
occurs early or midway through the pill cycle, recommend
increasing the estrogen content.
✓If the patient is taking a monophasic pill and the bleeding
occurs late in the pill cycle, recommend increasing the progestin content.
✓If the patient is taking a biphasic or triphasic pill, recommend switching to a monophasic product with greater progestin activity.
3.What recommendations can be made to address this patient’s
complaint of worsening acne?
• All combination OCs can improve acne by increasing sex
hormone binding globulin and decreasing free testosterone
concentrations.1 Progestins, such as desogestrel and norgestimate, are believed to have less androgenic activity. However,
it is not clear that combined OCs containing these progestins
confer any advantage over other combined OCs with respect
to their ability to improve acne control. Agents containing the
progestin drospirenone are considered to have antiandrogenic
activity and may therefore also improve acne. If this patient’s
complaint of worsening acne overrides her desire for fewer
or no menstrual periods, a recommendation could be made
to switch to either Ortho Tri-Cyclen (EE and norgestimate),
Estrostep (EE and norethindrone acetate), or Yaz (EE and drospirenone), or Beyaz (EE, drospirenone, and levomefolate), all
of which are approved by the FDA for the treatment of acne.
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92-7
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Contraception
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