Transcript New Options in Contraception

New Contraceptive Options in
Primary Care
Kelly Kruse Nelles MS, RN-C, NP
Clinical Associate Professor
UW School of Nursing
UW Women’s Health Center
Learning Objectives:
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1. Recognize the role of family planning
as an important part of primary health
care.
2. Identify 3 new methods of contraception and the correct use for each.
3. Select candidates that may benefit
from new contraceptive methods.
Statement of Financial Disclosure:
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This talk has not been sponsored by
any organization.
Why Family Planning in
Primary Care?
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A typical woman in the U.S. spends about 36
years – almost half of her lifespan at potential
biological risk of pregnancy.
Nearly half of pregnancies in the US are still
unintended – 3.2 million
Among industrialized countries, the US still
has the highest rate of teenage pregnancies,
unintended pregnancies, and abortions
Of women aged 15-44, 49% will experience
unintended pregnancy
Impacts
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Preconception care
Maternal and child morbidity
Maternal and child mortality
Resulting consequences for the family
and society
Dissatisfaction with
Contraceptive Methods
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Plays a large role in unintended pregnancy
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As many as 60% of women starting OCs stop
within the first 6 months resulting in >1 million
unintended pregnancies
Most stop current contraception due to side effects
20% of women selecting sterilization at age 30
years or younger later express regret
Contraceptive Properties
Desired by Women
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Highly effective
Prolonged duration of action
Rapidly reversible
Privacy of use
Protection against STI
Easily accessible
Perfect vs Typical Use
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Typical Use – pregnancy rates during typical
use reflect how effective methods are for the
average person who does not always use
methods correctly or consistently.
Perfect Use – predicts the probability of
method failure (pregnancy) during the first
year of use when a method is used perfectly
and consistently
Typical use reflects the user while perfect use
reflects the method
Current Trends in
Contraception
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Development of new delivery systems
Increased access to a full range of
options
Emphasis on greater success
Decreased side effects
Wider use of emergency contraception
Recognition of Health Benefits
of Hormonal Contraception
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Menses related benefits
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Cycle regulation
Decreased blood loss with resulting
decreased iron deficiency anemia
Improved dysmenorrhea
Benefits of inhibiting ovulation
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Decreased incidence of ovarian cysts
Decreased incidence of ectopic pregnancy
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Other health benefits
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Decreased benign breast disease and
fibroadenomas
Decreased incidence of acute PID
Protection against Endometrial and Ovarian
cancers
Maintains bone mass
Possible decreased risk of Colorectal cancer
Often improves Rheumatoid Arthritis
Candidate Selection for Hormonal
Contraception
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Art vs Science
Helpful to assess the woman’s body
type when selecting hormonal
contraceptive options
Determine if she can safely use
estrogen
Determining if Estrogen Can Safely Used
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Ask yourself:
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Is this person a good candidate for a
method with estrogen?
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Absolute Contraindications to Estrogen Use
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Thrombophlebitis or thromboembolic disorder
Family history of hereditary thrombophilia in a first degree
relative
Cerebrovascular disease
Coronary artery or ischemic heart disease
Known or suspected breast cancer
Known or suspected estrogen-dependent neoplasia
Known or suspected pregnancy
Benign or malignant liver tumor
Current impaired liver function
Undiagnosed vaginal bleeding
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Relative Contraindications (exercise caution):
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Vascular or migraine headaches, especially if they
began or worsened with the use of combined
hormones
Hypertension
Acute mononucleosis or recent hepatitis
Presence of factors predisposing to
thromboembolic disorder: illness or surgery
requiring immobilization, long leg cast, trauma to
lower leg
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Relative Contraindications (exercise caution):
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Cardiac or renal dysfunction (or hx of)
Diabetes mellitus
Obesity (>20% ideal weight)
Lactation
Age over 50
Age over 35 for a smoker
Psychic depression
History of MI in an immediate family member
before age 50 – especially a mother or sister
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Relative Contraindications (exercise caution):
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Hyperlipidemia
Active gallbladder disease
Sickle cell or Sickle cell C Disease
Completion of a term pregnancy in the past 10-14
days
Ulcerative colitis
Asthma
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If Yes, base your selection on:
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Body type – estrogenic vs androgenic
Monophasic vs triphasic method
Number of micrograms of ethinyl estradiol
Availability of the method
Ability to understand and use the method correctly
Cost
Prior experience with other methods
Acronym of Contraceptive Counseling
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BRAIDED:
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Benefits of the method
Risks of the method
Alternatives to the method
Inquiries about the method are the patients right and
responsibility
Decision to withdraw from the method without penalty
Explanation of the method that is understandable
Documentation that the hcp has ensured understanding of
each of the proceeding points
Hormonal Side Effects
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Estrogen Sensitivity
Progesterone Sensitivity
The Contraceptive Patch
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Ortho Evra transdermal system
Combination hormonal method
releasing 20 mcg ethinyl estradiol/150
mcg norelgestromin daily
20 cm square applied to abdomen,
buttocks, upper outer arm or upper
torso – not breast.
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Use is based on a 28 day cycle
On the first day of each of the first
three weeks, a new patch is applied and
worn 7 days, then discarded
During the 4th week, no patch is worn
and withdrawal bleeding occurs
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Ideally, first patch should be applied on the
first day of menses and is considered
immediately protected
If patch is applied at any other time in the
cycle, a back up method should be used for 7
days
The patch should be applied on the same day
of each week (patch change day)
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Apply to clean, dry, healthy skin free of
creams or lotions
May bathe, shower, swim, exercise while
wearing
Partial or complete detachment has been
shown to occur in <5% of cases
If it does fall off, immediately apply a new
patch and then replace it on her regular
patch change day
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When prescribing the patch, write for a
single replacement patch as well.
If the patch is off for longer than 24
hours, a new cycle must be initiated
with a new patch, and back up for the
next 7 days.
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Effectiveness:
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An analysis of pooled data from studies
involving >3,300 women showed that the
overall probability of pregnancy in patch
users was 0.8%
Comparable to OCs
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Ideal for women who find it difficult to
remember to take a pill at the same
time daily
Among patch users, the mean
proportion of cycles with perfect
compliance is 88.2% as compared with
77.7% among OC users
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97-98% women stay with the patch
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Easy and convenient
Break through bleeding less with the
patch vs the pill
If worn on buttocks, BTB is even less as
absorption is better
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Adverse effects similar to OCs although
breast tenderness is more prevalent (19%
patch vs 6% pill)
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Resolves after 1-2 months
Application site reactions (1-2.4%)
Women weighing 198 lbs or > may
experience a higher failure rate
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Inform that risk of pregnancy is higher
Counsel on use of combined methods
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No significant impact on LDL/HDL ratios
Drug interactions reported with OCs are assumed to
pertain to patch
Contraceptive effectiveness may be reduced when
coadministered with some antibiotics, anitfungals,
anticonvulsants, and other drugs that increase
metabolism of contraceptive steroids
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Barbiturates, griseofulvin, rifampin, phenylbutazone,
phenytion, carbamazepine, felbamate, oxcarbazepine,
topiramate, and possibly ampicillin
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Contraindications similar to OCs
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Valvular heart disease with complications
Severe hypertension
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Acute or chronic hepatocellular disease with
abnormal liver function
Hypersensitivity to any component of the product
The Vaginal Ring
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The NuvaRing is a flexible transparent device
made of ethylene vinyl that is inserted into
the vagina
It is a combination contraceptive releasing 15
mcg ethinyl estradiol/120 mcg etonogestrel
daily over 3 weeks of use
It is removed for week 4 during which time
withdrawal bleeding occurs
A new ring is then inserted
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Requires lower hormone doses than
OCs as administration vaginally
precludes hepatic or GI interference
Effectiveness similar to combined OCs,
the ring offers more uniform plasma
hormone concentrations
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Women report:
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Easy to use
Does not require fitting
Convenient – needs to be administered
only once each month
Can be left in place during swimming,
bathing and intercourse
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Combined data from 1,950 North American and
European women who use the ring for at least 3
months:
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96% of those who completed 13 cycles of use were satisfied
or very satisfied
85% of women and 71% of their sexual partners said they
never or rarely felt the ring during intercourse
85% of women reported menses of the same or shorter
durations
85% reported menstrual pain as unchanged or reduced
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Of 821 women (35%) who did not
complete the study:
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52% gave reasons not related to the
device (ex: wishing to become pregnant)
43% referred to adverse effects (ex:
tendency for the ring to fall out)
2.6% said they were pregnant
2.3% complained of irregular bleeding
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Ring specific adverse effects include
vaginal irritation, infections and
discharge
Vaginal medications (such as antifungal
creams) can be used while the ring is in
place
Mirena Intrauterine System
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Like the copper T IUD, Mirena is
inserted by the clinician into the uterine
cavity to prevent pregnancy
Also T shaped it is the size of a quarter
and made of a soft flexible plastic
containing 52 mg of levonorgestrel in a
release controlling membrane with a
monofilament string
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Levonorgestrel is released at
20mcg/day
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Thickens cervical mucus
Suppresses ovarian function
Inhibits sperm movement
Thins uterine lining making it an
unfavorable environment for implantation
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Approved for 5 years of continuous use
Is appropriate for women in whom estrogen
is contraindicated
Can be an effective treatment for women
with dysmenorrhea, menorrhagia, and
anemia
Low maintenance – only need to check
strings after each menstrual period to ensure
device is in place
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For women who choose to become
pregnant
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Device can be removed at any time
No waiting period is required before
conception
Mirena is not associated with decline in
fertility
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Women need to be counseled that
complete or temporary amenorrhea is
likely to occur within 1 year of use (2056%)
Bleeding irregularities rarely contributed
to discontinuation of use
Combined Oral Contraceptives
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Popular method since introduction in
the 1960s
Initial doses contained as much as 150
mcg of estrogen thus posing significant
health threats (DVT, PE, CVA, MI)
Today 98% of all pills contain less than
35mcg of estrogen
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Ethinyl Estradiol
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20, 25, 30, 35 mcg (low dose)
50mcg (high dose)
Pills with low estrogen are considered safer
for certain patients
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Perimenopausal women
Those with a family history of heart disease
Smokers younger than 35 (although risk of MI and
stroke due to OC-associated changes in
coagulation factors remain)
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Progestins have changed as well
Today’s combined OCs contain about
10% of amount found in OCs
manufactured in the 1970s
Decreased progesterone related side
effects: nausea, breast tenderness,
bloating
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Progestins
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Norethindrone
Levonorgestrel
Norgestrel
Desogestrel
Drospierone
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Yasmin
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FDA approved in 2000
Contains drospirone (DRSP) with antiandrogenic
and anitmineralocorticosteriod properties
Associated with less water retention, less negative
emotional affect, less appetite increase after 6
months of use
Women who took this pill did not experience
statistically significant changes in weight or BP
after 13 months of use
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DRSP contains spironolactone and may
benefit women with androgenic
presentation (acne, hirsutism, obesity)
Should not be used by women with:
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History of hyperkalemia secondary to renal
insufficiency
Hepatic dysfunction
Adrenal insufficiency
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Consider prescribing a different type of OC for
women who take medications that affect
serum potassium levels
Monitor potassium levels in the first cycle
with these drugs
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Angiotensin-converting enzyme inhibitors
Angiotensi II receptor antagonists
Other potassium-sparing diruetics, heparin,
aldosterone antagonists, NSAIDs
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25mcg Pills
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Triphasic with desogestrel (Cyclessa)
Triphasic with norgestimate (Ortho Tricyclen Lo)
Monophasic with norgestimate (Ortho
Cyclen Lo)
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Estrostep
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Only pill that steps estrogen instead of
progestin
20/30/35 mcg EE
Helpful option for women experiencing
estrogen related pill side effects
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New pill taking patterns to shorten or
eliminate pill-free period
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First day start every cycle
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Need to prescribe extra cycles
Continuous use
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Bicycling – 2 months continuous use = 6 periods/year
Tricycling – 3 months continuous use = 4 periods/year
Monophasic pill recommended
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Seasonale
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Approved September 2003
30mcg EE and .15mg levonorgestrel
Taken 84 days consecutively, followed by 7 days of
placebo pills
Tested in randomized clinical trials of 1,400
women ages 18-40, comparing it to traditional
OCs.
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Effectiveness and Safety profile very similar to traditional
pill
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Advantages to continuous cycling
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Option for women with dysmenorrhea,
PMS
Convenient (military, travel, sports,
upcoming events)
Decreased iron deficiency anemia from
menorrhagia
Helpful for women with cognitive
impairment or physical disability
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Concerns
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Presentation of menstrual suppression as
the more natural or healthier option (no
studies to support)
May cause women who prefer a monthly
cycle to worry about the health effects of
their decision not to control their periods
May send a negative message to young
girls about menstruation and their bodies
Drug-Drug Concerns Related
to OCs
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Amoxicillin and tetracycline – circulation levels
still within normal range
Rifampin, antinconvulsants, St. John’s Wort,
phenylbutazone decrease circulating hormone
levels
Drugs causing increased uptake of hormones
include atrovastatin, ascorbic acid,
acetaminophen, cyclosporine, prednisolone,
theophylline
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OCs decrease levels of anticonvulsants,
temazepam, ASA, morphine, clofibric
acid
Carefully choose formulations for
women with
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Lactose intolerance
IBS with diarrhea
Bulemia
Other Progestin Only Methods
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Mini-pill (Micronor)
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Taken continuously
May or may not get a withdrawal bleed
Timing is important in maintaining efficacy
Very helpful pill for post-partum women and women who
cannot tolerate estrogen
Depo Provera
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Injectable contraceptive that prevents pregnancy for 3
months at a time.
Also, a great alternative for women who cannot tolerate
estrogen, who are breastfeeding, or have a history of seizure
disorder
Emergency Contraception
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Plan B
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Levonorgesterol only
0.75mg as soon as possible within 72 hours or
risked pregnancy and second dose 12 hours later
Preferred formulation – higher efficacy and fewer
side effects
Side effects: nausea 20%, vomiting 6%,
headache 15%, menstrual changes depend on
when in cycle EC is used
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Preven
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Combination 100mcg EE + 0.5 mg LNG as soon as
possible within 72 hours of risked pregnancy and
second dose 12 hours later
40% women experience severe nausea and
vomiting
Recommended that OTC antiemetics (Meclizine 25
mg, Dramamine II or Bonine 2 tablets PO) be
offered 1 hour prior to first dose to halve GI
complaints
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Note: 30% women report drowsiness with use of
antiemetics
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Efficacy improved if taken early
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Failure rate if taken in first 12 hours: 0.5%
Failure rate if taken after 60-72 hours: 4%
Residual benefit with higher failure rate after 7296 hours
ACOG initiative: offer advance EC
prescription to all reproductive aged women
at routine visits
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Better utilization if patient has EC in possession
Future Methods
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Non-incisional Sterilization Techniques
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Essure
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Transcervical insertion of a spring-like
mechanism into the opening of the fallopian
tubes
Over several weeks scar tissue grows around
the spring to occlude the tube
Office procedure
Highly effective, well tolerated
For more information contact:
Jim Robinson, MD
OB-GYN Residents Clinic
UW Women’s Health Center
451 Junction Road
Madison
(608) 263-0150
www.Essure.com
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Lunelle (hoping for a come back)
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Once a month combination contraceptive
injection
Efficacy and contraindications same as OCs
Administered IM every 28 days +/- 5 days
Recalled not because of the product but
rather the delivery system
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Implants
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Implanon
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Progestin only implant (etonogestrel) that is good for 1
year
Efficacy: 0 pregnancies for 13 trials with 70,000 cycles
Mechanism of action: Works by suppressing ovulation
over time and thickening cervical mucus
Return to fertility: ENG levels not detectable 1 week
after removal. 94% of women ovulated within 3 weeks
after removal.
Side effects: changes in vaginal bleeding – similar to all
progestin-only methods
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Norplant II (Jadelle)
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New Female Barriers
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Similar to previous Norplant only for 2 years instead of 5
Improved insertion and removal
Femcap
Lea’s Shield
Disposable diaphragms
Improved spermicidal/virucidal agents
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Today Sponge
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New fertility monitors to improve
success of natural family planning
New delivery systems for sex steriods
(eg, bracelets)
GnRH agonists with estrogen/progestin
add-back
Male hormonal methods
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Progestin and Testosterone (MENT)
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Other compounds for Emergency
Contraception
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Mifepristone 10mg
Other levonorgestrel pills
Vaccines
In Summary:
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Not only is every recommended method
of birth control safer than pregnancy,
but recent studies (Trussell) have now
clearly shown that every method of
birth control is more cost effective than
pregnancy
Kelly Kruse Nelles MS, RN-C, WHNP
UW School of Nursing
UW Women’s Health Center
451 Junction Road
Madison, WI 53715
(608) 263-0150 (WHC)
(608) 263-5337 (SON)
[email protected]