Transcript Combination Oral Contraceptives

Contraception
PATIENT COUNSELLING AND
MANAGEMENT
Introduction
 Most women spend approximately 36 years in the
reproductive stage of life (ages 15-44)
– They try to avoid pregnancy at some point in this
interval
– ~30% of pregnancies are unintended
– 14% of births are unwanted
– Annually, ~2% of women have an induced abortion
 Spacing children decreases infant morbidity and mortality
and the risk of spontaneous abortion
 Successful family planning has a positive impact on
women, couples, families, and society
Contraception
 Benefits often outweigh health risks
 Side effects can often be managed
or relieved
 Variety of options available
– Combination hormonal or progestin
-only – pill, patch, vaginal ring
– Injectable – long-acting, depot, or
implant progestin
– IUD – copper or levonorgestrel
– Barrier methods – condom, diaphragm,
vaginal cap, spermicide
– Sterilization – female, male
– Fertility awareness; withdrawal
Health Benefits
 Barrier effect
– Condoms reduce transmission of infectious agents
 Endometrial cancer
– Risk significantly reduced with combination oral
contraceptives, depot medroxyprogesterone acetate
(DMPA) and non-medicated IUDs
 Ovarian cancer
– Risk reduced by combination oral contraceptives
– Even in women with BRCA1 and BRCA2 mutations
Other Benefits
 Withdrawal bleeding and dysmenorrhea
– Regulated and reduced with use of combination oral
contraceptives
 Menstrual blood loss in menorrhagia
– Reduced with use of combination oral contraceptives, or
levonorgestrel IUD
– Acne
– Treated with combination oral contraceptives
 Perimenopause
– Lighter, predictable bleeding; vasomotor symptom relief;
positive effect on bone mineral density
Hormonal Contraceptives
 Combination hormonal – pill, patch, vaginal ring
– Oral contraceptives are the most commonly used
method in the US
– Available in various dose and cycle combinations of
estrogen and progestin
 Progestin-only – pill, long-acting/depot injection,
implant, levonorgestrel IUD
– Candidates include women with cardiovascular risk
factors, diabetes, lipid disorders, estrogen-related
side effects, migraine headaches,2 are post-partum
or breastfeeding
Combination Oral Contraceptives
 Relatively effective:
8% failure rate during
first year of use, since
most women do not
take them perfectly
 Fertility returns soon
after discontinuation
Combination Oral Contraceptive
Health Risks
Today’s lower-dose OC Formulations (< 50 mcg estrogen)
Are Safe for Most Healthy Women and Have Been
Extensively Studied
Breast Cancer : Large( British, US , and Canadian) studies
found no increased risk with former or current use
Combination Oral Contraceptive
Health Risks
Venous Thromboembolism (VTE)
 Varying reports regarding risk
associated with estrogen dose or type of
progestin
 Pregnancy, childbirth and puerperium
are associated with risk of VTE higher
than that associated with the use of
OCs:
VTE Incidence
per 100,000 Woman-Years
Low-Dose
OC Users1
Pregnant
Women9
Postpartum
Women9
10 - 15
95 - 96
511
 VTE risk is further increased with OCs if there are specific
thromboembolic risk factors or underlying diseases
Combination Oral Contraceptive
Health Risks
Stroke
 Low-dose formulations do not increase risk of thrombotic
or hemorrhagic stroke in healthy, nonsmoking women
 Risk increased in women with underlying predisposing
diseases or other risk factor
Myocardial Infarction
 Risk of MI substantially increased among OC users over
35 who smoke; smoking and OCs act synergistically to
increase risk
Metabolic Effects
 Oral estrogen increases triglyceride levels
Contraceptive Patch and Ring
 Alternative combined
hormone delivery systems,
used on a 28-day cycle
– 1 patch applied
weekly x 3, then removed
for one patch-free week
– 1 ring inserted and left
for 3 weeks, then removed for one ring-free week
 Time to achieve steady state hormone levels - backup contraceptive may be needed
Progestin-Only Contraceptives
 Candidates include women with cardiovascular
risk factors, diabetes, lipid disorders, estrogenrelated side effects or contraindications,
migraine headaches, are post-partum or
breastfeeding
 In lactating women, no decrease in milk
production has been shown with progestin-only
contraceptives
 Irregular bleeding and spotting are the most
common side effects
Progestin-Only Contraceptives
 Pill – Norethindrone 0.35 mg
 Depot medroxyprogesterone actetate Injection, Given every 3
months by injection: deep IM (150 mg of Depo-Provera)1 or
SC (104 mg of depo-subQ provera 104) 3% first year failure
rate with typical use; 0.3% first year failure rate with consistent
use. 3% first year failure rate with typical use; 0.3% first year
failure rate with consistent use
 Implant – Etonogestrel 68 mg, Overall 3-year failure rate is
0.38%
Counseling for Hormonal
Contraception
 Provide information
about all available products
 Long-term options (IUD,
depot injection, implant)
are most effective, especially
for women with difficulty
managing their contraception
(e.g., due to access,
privacy issues, lack of follow-up)
Counseling for Hormonal
Contraception
 OCs need to be taken consistently for contraceptive efficacy
and reduced side effects
 If combined OC pills are missed, patient to take pills according
to the following schedule:
– 1 tablet missed – take as soon as remembered and continue
taking remainder of tablets at the same time daily as before
– 2 tablets missed – take 2 tablets as soon as remembered,
then 2 on the following day, use back-up contraception for
7 days, take remainder of tablets at the same time daily
as before
– More than 2 consecutive tablets missed - continue taking
1 tab at the same time daily as before, use backup
contraception (e.g., condoms and spermicide) until current
pill pack is finished
Counseling for Hormonal
Contraception
OC Side Effects
 Commonly include nausea, breast tenderness,
menstrual changes (e.g., amenorrhea, unscheduled
bleeding, and spotting)
 Breakthrough bleeding occurs in about 25% of women
within the first three months of use, becoming less
frequent with time
 Advise patients that side effects are most likely to occur
during first three months of use and that these symptoms
are not dangerous; with regular and consistent pilltaking, side effects should abate
Counseling for Hormonal
Contraception
OC Side Effects
 Unscheduled bleeding continuing after 3 months of OC
use, should be evaluated for other potential causes,
including cervical or endometrial infection or neoplasia,
pregnancy, polyps, fibroids, or use of medications that
interfere with estrogen metabolism (e.g., smoking,
antiepileptics, rifampin, St. John’s Wort)
 Chlamydial cervicitis has been reported as a cause of lateonset unscheduled bleeding in OC users
 If prolonged spotting/bleeding (ie, seven days or more) on
an extended use OC, take a 3-day pill holiday; this is more
effective than continuing the contraceptive
Counseling for Hormonal
Contraception
OC Side Effects
 Some long-term OC users
may experience amenorrhea,
which is not medically
harmful
 Inadvertent use of OCs
during early pregnancy is
not associated with an
increased risk for fetal
anomalies or miscarriage
 There are no consistent data to suggest associations
between weight gain or headaches and OC use
 If problems or noncompliance due to side effects, a
formulation adjustment can be made
Barrier Methods
 Have assumed greater importance in recent
years due to their ability to reduce the risk of
sexually transmitted infections
 Are commonly used with other methods of
contraception, e.g., with OCs – the pill and
condom are the most common contraceptive
method combination
 Male Condom, female condom, diaphragm,
cervical cap, sponge, spermicides
Intrauterine Devices (IUDs)
 Highly effective; convenient;
have non-contraceptive benefits
 Two IUDs are available
in the US:
– Copper T 380A – for up to
10 years of use; cumulative
ten-year pregnancy rate
is about 2%
– Levonorgestrel-releasing IUD –
for up to 5 years of use;
cumulative five-year pregnancy rate is <1%
 Can be inserted at any time in the menstrual cycle,
provided the woman is not pregnant
Intrauterine Devices (IUDs)
 Earlier concerns about infection and infertility are no
longer appropriate:
– Cohort studies have identified rapid return to fertility
after IUD discontinuation
– Prophylactic antibiotics at time of insertion appear
unwarranted except in populations of women with a
high prevalence of sexually transmitted diseases
– Case controlled studies revealed no increase risk of
upper genital tract infection in women who had
undetected chlamydial infections at the time of
IUD insertion
Intrauterine Devices (IUDs)
Benefits
 Non-medicated and copper IUDs are associated
with a 40% reduction in the risk of endometrial
cancer, prevention that is statistically significant and
clinically important
 The levonorgestrel device reduces measured blood
loss by about 90% in heavy menstrual bleeding,
providing comparable benefit to endometrial
ablation techniques2 and superior benefit to oral
medications, such as progestins and NSAIDs
 The levonorgestrel device can be used to prevent
endometrial hyperplasia during menopausal
treatment with estrogen
Emergency Contraception
 Intended to prevent pregnancy after intercourse
 Prevent pregnancy by:
– Inhibiting or delaying ovulation
– Hormones may alter sperm or ovum transport
– Hormones may alter the endometrium, making
it inhospitable to the implantation of an embryo
 Hormonal ECs do not affect an established
pregnancy, nor do they harm a fetus if taken
inadvertently during early gestation
 Begin within 72 hours of unprotected sex to reduce
risk of pregnancy by at least 75%
Emergency Contraception
 Emergency contraceptives (ECs) have included:
progestins only, combination estrogen-progestin
oral contraceptives, synthetic estrogens and
conjugated estrogens, antiprogestins, and insertion
of a copper-releasing intrauterine device
 If menses are delayed more than a week, it may
indicate that the EC has failed
 Women using intermediate or high failure rate
contraception should be educated and encouraged
to keep an advance supply of EC, and given a
prescription for Plan B
Surgical Contraception
Sterilization
 The most common form of contraception reported by
US females aged 35 to 44 years
 The types of procedures, in order of frequency: tubal
sterilization,
vasectomy, hysterectomy
Female - Tubal Sterilization
 Actions taken on the fallopian tubes: ligation with
excision, occlusion with rings, clips or insertion of coils,
and electrocoagulation/cautery of a portion of the tubes
Male – Vasectomy Ligation of the vas deferens under
local anesthesia in the office setting
Contraception in
Women with Medical Problems
 WHO lists conditions where
pregnancy may exacerbate risk to
a woman’s health
 Need to determine contraceptive
methods that are safest, given a
woman’s underlying diseases or
conditions
 ACOG Practice Bulletin
Number 73 provides a consolidated
summary of “clinical considerations
and recommendations”
Contraception in
Women with Medical Problems
 In general, hormonal
contraception is not
contraindicated in women
with migraines, however
need to review predisposing
factors and migraine patterns
before prescribing it
 Appropriate alternatives
include progestin-only,
intrauterine and barrier
methods
Contraception in
Women with Medical Problems
Drug Interactions
 Hepatic enzyme inducers
(most commonly antiepileptic
medications) decrease
contraceptive blood levels, of
estrogen and progestin, in
users of combined OC and
patch, progestin-only pill and
implant
 Simplest option may be to
change to contraceptive
where reduced efficacy has
not been demonstrated:
DMPA or an IUD (copper or
levonorgestrel
Antiepileptic Drugs that May
Reduce Contraceptive
Efficacy via Enzyme
Induction
carbamazepine
felbamate
oxcarbazepine
phenobarbital
phenytoin
primidone
topiramate
Contraception in
Women with Medical Problems
Drug Interactions
 Rifampin, a known enzyme inducer, reduces OC
hormone levels; herbal medications can also have
an effect on OC metabolism
 Various antiviral agents (for treatment of HIV) can
have different hepatic enzyme effects, being
substrates, inducers, or inhibitors, therefore
contraceptive methods that bypass the potential for
drug interactions are recommended, ie., IUDs
Contraindications to Contraceptives
(adapted from WHO1)
Condition/Personal Characteristics
Contraindicated
Contraceptive Methods
Breastfeeding < 6 weeks postpartum
Combination OC, patch, ring
Smoker > 35 years old
Combination OC, patch, ring
High blood pressure
(systolic >160 mm Hg; diastolic > 100 mm Hg)
Combination OC, patch, ring
Vascular disease
Combination OC, patch, ring
Previous or current DVT or pulmonary embolism;
thrombogenic mutations; stroke or previous
cerebrovascular accident
Combination OC, patch, ring
Major surgery with prolonged immobilization
Combination OC, patch, ring
Previous or current ischaemic heart disease;
complicated valvular heart disease
Combination OC, patch, ring
Migraine with aura
Combination OC, patch, ring
Distorted uterine cavity
Copper and progestin IUD
Contraindications to Contraceptives
(adapted from WHO1)
Condition/Personal Characteristics
Contraindicated
Contraceptive Methods
Breast cancer
All combination estrogen-progestin
and progestin-only methods
Active viral hepatitis;severe
decompensated cirrhosis;hepatoma
Combination OC, patch, ring
Malignant gestational trophoblastic
disease
Copper and progestin IUD
Puerperal sepsis; postseptic abortion;
Copper and progestin IUD
Pelvic infections
Copper and progestin IUD
- do not initiate; monitor devices
already in situ
Pregnancy
All forms of contraception
Allergies
To any component(s) in any form of
contraception
1. Medical eligibility criteria for contraceptive use. WHO; 2004.
Patient-Centered
Contraceptive Decision Making
Appropriate Contraceptive Selection Should Take Several
Variables Into Account:
 Effectiveness (typical use failure rate); side effects
 Perceptions and misperceptions about risks and benefits of
contraceptive use and pregnancy
 Likelihood and ability to comply with the regimen
 Frequency of intercourse
 Age
 Cost of the method and ability to pay for it
 Concomitant drug use; health status and habits
 Desired duration of contraception; reversible vs. nonreversible method
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