Transcript Presentation Title Here - Linda Baier Files

Contraceptive Options
07/22/13
Authors
Primary Author: Sherry Nordstrom, MD
University of Illinois College of Medicine, Chicago
Contributors:
Kathleen McIntyre-Seltman, MD
Pittsburgh VA Healthcare System
Linda Baier Manwell, MS
University of Wisconsin-Madison Center for
Women’s Health Research
Molly Carnes, MD, MS
University of Wisconsin-Madison Center for
Women’s Health Research
VETERANS HEALTH ADMINISTRATION
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Objectives
• List the major issues regarding contraception for
women
• Describe the pharmacological effects of different
types of contraceptives
• Identify appropriate candidates for different types of
contraception
• Counsel patients regarding appropriate use and side
effects
VETERANS HEALTH ADMINISTRATION
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6.4 Million US Pregnancies in 2001
Intended
Pregnancies
(51%)
Abortion
20%
Birth
41%
Birth
22%
Unintended
Pregnancies
(49%)
Miscarriage
7%
Miscarriage
10%
Data from Finer & Henshaw. Perspect Sex Reprod Health, 2006.
4
Contraceptive Use During Month of
Unintended Pregnancy
Unintended Births
Elective Abortions
46% didn’t use
contraception
52% didn’t use
contraception
5
Contraceptive Use, 2006-2010
Vasectomy
6%
IUD 4%
Withdrawal 3%
DMPA 2%
Ring 1%
Implant/Patch 1%
Nat Fam Plan 0.7%
Other 0.3%
Other
50%
Oral
contraceptives
17%
Male condom
10%
Tubal
ligation
17%
Methods Available
• Hormonal
• Non-Hormonal
− Oral contraceptives: various
formulations
− ParaGard IUD
− DMPA injection
− Condoms
− Implanon / Nexplanon
− Sterilization
− Mirena IUD
− Natural Family Planning
− Diaphragm or cervical cap
− Contraceptive patch and ring
VETERANS HEALTH ADMINISTRATION
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Contraceptive Counseling
• Giving information
• Allowing patient to make an informed decision
• Interpersonal relations
– Be concerned with influencing the patient’s confidence,
satisfaction with services, and probability of continuity of
care
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Characteristics of the Ideal Contraceptive:
Provider ideals
•
•
•
•
•
Effective
Able to continue method
Able to comply with method
Safe
Minimal time required for counseling
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Characteristics of the Ideal Contraceptive:
Survey of 2,500 women from 5 countries
Ease of Use
Safety
Effectiveness
Minimal Side Effects
"Natural" Method
Nonhormonal Method
Immediate Reversibility
0
20
40
60
80
100
Percentage
The Contraception Report 2000;10(6):23
10
Factors in Contraceptive Selection
• Prior methods used
• Safety
• Efficacy
• Ease of use/Privacy of use/Initiation
• Side effects
• Hormonal versus natural method
• Reversibility
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No Such Thing as Perfect Use!
• Refers to method efficacy in TRIALS
• Healthy volunteers
• Counseling on proper use per protocol
• Diaries, frequent visits
• NOT REAL LIFE!
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Contraceptive agent
Implant
Pregnancy Vasectomy
rate in first Mirena
year of use Tubal ligation
ParaGard
DepoProvera
Pill, patch, ring
Male condom
Withdrawal
Diaphragm
Periodic abstinence
Data from:
Trussell, James. Sponge
Contraception, Spermicides
May 2011.
No method
Ideal Use
0.05 %
0.10 %
0.2 %
0.5 %
0.6 %
0.2 %
0.3 %
2.0 %
4.0 %
6.0 %
9.0 %
10.0 %
18.0 %
85.0 %
Typical Use
0.05 %
0.15 %
0.2 %
0.5 %
0.8 %
6.0 %
8.0 %
15.0 %
27.0 %
16.0 %
25.0 %
29.0 %
29.0 %
85.0 %
Improving Continuation Rates
• Choose a method that requires less attention
• Counsel on expected side effects and management
strategies
• Remove barriers to initiation
– No pelvic exam or Pap test requirements
– Avoid complicated instructions (Sunday start)
– No required follow-up for refills
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Multiple Choices
A: Combined hormonal
contraceptives
– Oral
– Vaginal ring
– Transdermal
B: Progestin-only
contraceptives
– Oral
– Injectable
– Implantable
C. Intrauterine
contraception
D: Barrier methods
E: Natural family planning
F: Permanent sterilization
G: Emergency
contraception
VETERANS HEALTH ADMINISTRATION
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A. Combined Hormonal Contraceptives
• Oral Contraceptive Pill (OCP) formulations
– Ethinyl estradiol < 35 mcg
– Various progesterones
– Typical efficacy ~93%
• Counseling Points
– Initiation
– Daily compliance
– Side effects
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A. Combined Hormonal Contraceptives
Side effects
Risks
• Breakthrough bleeding
• Blood clots (1-3/10,000)
• Nausea
• High blood pressure
(1/200)
• Headaches
• Heart attack (for women
with CAD symptoms)
• Breast tenderness
• Decreased libido
• Stroke
VETERANS HEALTH ADMINISTRATION
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Drug Safety Warning from FDA
• Oral contraceptives containing drospirenone (DRSP) may be
associated with higher risk for blood clots than birth control
pills containing other progestins
• Additonal risk beyond that associated with estrogen
• Pills with drospirenone are currently not on VA formulary, but
are available through non-VA formulary request
– Examples:
• Yasmin (3 mg DRSP, 30 mcg EE – generics avail)
• Yaz (3 mg DRSP, 20 mcg EE – generics avail)
• Beyaz (3 mg DRSP, 20 mcg EE, folate – no generics)
VETERANS HEALTH ADMINISTRATION
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Before prescribing DRSP-containing
combined OCPs…
Consider her overall
risks/benefits
Risks/benefits in light of
her risk factors for blood
clots
Risks/benefits in light of
her specific needs
New COC user? Used a COC in the
past? Switching COCs?
Smoking, obesity, and family history
of blood clots
Women who can’t tolerate other COC
formulation. Women who need
treatment for premenstrual
dysphoric disorder (PMDD).
VETERANS HEALTH ADMINISTRATION
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A: Combined Hormonal Contraceptives
Contraindications
Absolute
Relative
• Hx of breast cancer
• Hx of blood clots, stroke,
heart disease
• Undiagnosed abnormal
vaginal bleeding
• Pregnancy
• Acute liver disease
• Migraine with aura
• Smoking & age ≥ 35
•
•
•
•
“Classic” migraine
Uncontrolled hypertension
LDL cholesterol >160
Diabetes with secondary
complications or duration
>20 years
• Obesity
• Post-partum <3 weeks or
breastfeeding
VETERANS HEALTH ADMINISTRATION
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A: Combined Hormonal Contraceptives
Non-Contraceptive Benefits
• Regulates menstrual cycle; decreases bleeding and pain
• Eliminates ovulation pain
• Appears to protect against ovarian and uterine cancer
(5 years: 50% and 60% reduction) and colon cancer.
Literature is mixed with regard to risk of breast cancer.
• Favorably affects bone mass
• Decreases benign breast disease/ovarian cysts
• Improves acne and abnormal hair growth
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A: Combined Hormonal Contraceptives
Effectiveness (reported vs. actual pill use)
60
Diary
% Women
50
Electronic
device
40
30
20
10
0
0
0
1
1
2
2
Cycle 1
3
≥3
0
0
1
2
1
2
3
≥3
Cycle 2
0
0
1
1
2
2
3
≥3
Cycle 3
Active Pills Missed
Reproduced with permission: Potter L, et al. Fam Plann Perspect 1996;28(4):154-8.
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Strategies to Increase Adherence
• Discuss habit formation
• Use cell phone alarm
• Take whatever time of day is easiest for her
• Explain what to do if pill is missed
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Quick Start for Oral Contraceptive Pills
• Randomized trial
• Immediate or conventional start
• No difference in
–
–
–
–
bleeding patterns
acceptability
continuation rates
pregnancy rates
• Use back-up birth control for 7 days
Westoff C, et al. Contraception, 2002;66(3):141-5.
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OCPs in Women Over Age 35
• Safe in healthy, nonsmoking women older than 35
years
• Perimenopausal women may benefit from more
regular menses, positive effect on BMD, reduced
vasomotor symptoms, and reduced risk of
endometrial and ovarian cancers
• Discontinue OCPs between ages of 50 and 55 when
85% will be menopausal
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A: Combined Hormonal Contraceptives
The NuvaRing©
• Contraceptive vaginal ring
–
–
–
–
15 mcg/day ethinyl estradiol
120 mcg/day etonogestrel (3-keto-desogestrel)
54 mm in diameter, 4 mm in thickness
Efficacy: equivalent to OC
• Worn for three weeks out of four
• Replaced every four weeks
• No need for fitting/special placement
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A: Combined Hormonal Contraceptives
The NuvaRing©
• Counseling points:
–
–
–
–
–
–
–
Insertion and use
Schedule
Use during sex
What to do if the Ring falls out
Vaginal product use
Expected vaginal discharge
Does not protect against HIV and other STDs
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A: Combined Hormonal Contraceptives
Ortho Evra© Patch
• Transdermal Delivery System
– 20 mcg/day ethinyl estradiol
– 150 mcg/day norelgestromin
– Efficacy: equivalent to OC
• Worn 3 weeks out of four
• Changed once per week
• Efficacy affected by body weight >90 kg
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A: Combined Hormonal Contraceptives
Ortho Evra© Patch
• Risks
– Higher blood levels of estrogen than equivalent OCP –
possible increased risk of VTE and stroke
– Jick et al: no increased risk of VTE
– Cole et al: increased risk for VTE
– Much lower risk than pregnancy
Jick et al, Contraception, 2007;6:4-7. Cole et al, Obstet Gynecol, 2007;109:339-46.
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A: Combined Hormonal Contraceptives
Extended Cycle Use
• Eliminate or delay the placebo week to reduce
frequency of menses or manipulate timing of menses
• Treatment for
–
–
–
–
heavy bleeding
painful menses
menstrual migraine
desire to menstruate less often (athletes, women in the
military, travelers, etc.)
• Thins uterine lining over time
• Safe and equally (or possibly more) effective
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A: Combined Hormonal Contraceptives
Extended Cycle Use
• Jolessa is on VA formulary
• Side effects: Spotting
– 26 days of unscheduled bleeding per
13- week cycle compared to 13 days
in traditional cyclic use
– Only 1.5 days per month by the 4th
13-week cycle
Anderson & Hait. Contraception, 2003;68:89-96.
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B: Progestin-Only Contraceptives
Injection, Pill, Implant
• Contraindications
– Breast cancer
– Severe liver disease
– ?? thrombotic events – DMPA packaging says
contraindicated, but no evidence that it increases clotting
• Risks
– Decreased bone density with DMPA
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B: Progestin-Only Contraceptives
DMPA (Depo-Provera)
• Black Box Warning, November 2004
• Several studies have confirmed bone loss
• 9 studies showed that such loss is reversible
– Similar to temporary BMD reduction that occurs during
pregnancy and lactation
• Recent expert opinion:
– No absolute limit should be placed on length of time DMPA
can be used, regardless of user age
– No need to monitor BMD
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B: Progestin-Only Contraceptives
DMPA (Depo-Provera)
• 150 mg MPA IM Q 3 months; SubQ also available but not
on VA formulary
• Medroxyprogesterone acetate
• Efficacy >97%
• Counseling points:
–
–
–
–
–
Initial disruption of bleeding pattern
Amenorrhea over time
Weight gain (avg 15 lbs over 5 yrs)
Weight-bearing exercise and calcium
Return to fertility after discontinuation
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B: Progestin-Only Contraceptives
DMPA (Depo-Provera)
Advantages
Disadvantages
•
•
•
•
• Injection
• Weight gain, hair loss, mood
Dosing schedule
No estrogen
Effects on cycle
May decrease risk of
gynecologic cancer or PID
•
•
•
•
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changes, headache
Irregular bleeding first 6-9
mos
May worsen uncontrolled
depression
Delayed return of fertility
No STD protection
B: Progestin-Only Contraceptives
Oral
• No estrogen
• Typical efficacy ~93%
• Counseling points:
− Strict adherence to schedule (use back-up for 5 days if
missed by more than 3 hrs)
− What to do if pill is missed – condoms!
− Method of action
− No placebo week
− Side effects similar to DMPA, less severe
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B: Progestin-Only Contraceptives
Implant
• Nexplanon® is replacing IMPLANON™
− Nexplanon® is radio opaque; can be detected by x-ray
− Nexplanon® applicator makes insertion easier -- insertion
failure less likely
•
•
•
•
•
Single rod, progestin-only, subdermal implant
Effective for 3 years; efficacy >99%
Clinical trials in over 17 countries
Does not affect bone mineral density
Side effects
– Irregular menses; doesn’t get better with time
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B: Progestin-Only Contraceptives
Implant
• Supplied in a sterile,
disposable, preloaded
applicator
• Inserted subdermally in the
groove between the biceps
and triceps muscles
• Procured through prosthetics
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Contraceptive Options (continued)
Contraceptives Discussed in Part 2
• Intrauterine devices
• Barrier methods
• Natural family planning
• Sterilization
• Emergency contraception
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C. Intrauterine Contraception
• Counseling points:
– Expected bleeding patterns
– Risks of insertion, IUD use
– Description of procedure
– Efficacy is equivalent to sterilization
– Does not protect against STDs
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C: Intrauterine Contraception
Levonorgestrel IUS: Mirena©
•
•
•
•
Levonorgestrel 20 mcg/day
Efficacy 99.9%
Effective up to 5 years
Side effects
– Irregular bleeding/spotting
– 20% amenorrhea at 1 year
Courtesy of Bayer
• Inhibits sperm motility, thickens cervical mucus,
suppresses growth of the uterine lining, inhibits
ovulation in some cycles
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C. Intrauterine Contraception
Copper T 380A: ParaGard©
•
•
•
•
•
•
380 coils of copper
Efficacy 99.4%
Effective up to 10 years
Inserted by provider in office setting
Inhibits sperm motility, fertilization and implantation
Side effects
– Vaginal discharge
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C: Intrauterine Contraception
• Contraindications
– Active infection
– Distorted uterine cavity
• No longer contraindicated
– Nulliparas
– History of STDs
• Procured through prosthetics
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C: Intrauterine Contraception
Young Women
• “WHO eligibility classification 2”
– A condition for which the advantages of using the method
generally outweigh the theoretical or proven risks.
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C: Intrauterine Contraception
Young Women
• Infection risk with current devices1
– Rate of pelvic inflammatory disease (PID) <1% even in a
setting with high prevalence of STDs
– Highest in first 3 weeks after insertion: 1/1000
• Infertility risk2
– Multiple studies show no increase in infertility after
discontinuing IUD use
1. Shelton JD. Lancet. 2001;357:443; 2. Hubacher D, et al. NEJM. 2001;345:561-7.
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C: Intrauterine Contraception
• Advantages
‒ Long-term method requiring no maintenance
‒ Overall, the most cost-effective method
‒ “Reversible sterilization”
• Non-contraceptive uses of the Mirena©
–
–
–
–
–
Decreased heavy menstrual bleeding
Decreased menstrual pain
Decreased bleeding and pain from fibroids
Decreased risk of uterine cancer
Decreased need for surgery
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D. Barrier Methods
• Condoms
• Diaphragm
• Cervical cap
• Spermicide/Sponge
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D. Barrier Methods
Male Condoms
• Perfect use failure of 2%
• Typical use failure of 15%
• Advantages:
– STD protection (unless lambskin)
– Non-prescription, inexpensive, easily obtained
• Disadvantages
– Breakage, slippage
– Allergies
– Tied to intercourse
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D. Barrier Methods
Female Condoms
•
•
•
•
•
Polyurethane sheath with inner and outer ring
Perfect use failure of 5%
Typical use failure of 21%
Used by some sex workers
Advantages
– STD protection
• Disadvantages
–
–
–
–
Tied to intercourse
Noisy
Expensive
High displacement rate
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D. Barrier Methods
Diaphragm
•
•
•
•
Latex or silicone dome filled with spermicide
Perfect use failure 6.0%
Typical use failure 16%
Disadvantages
–
–
–
–
–
Tied to intercourse
Spermicide-related timing
Fitting necessary
Allergy/UTI risk
Must also use condoms for STD protection
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D. Barrier Methods
Cervical Cap
• FemCap
• Typical use failure of 20%
• Disadvantages
– Tied to intercourse
– 6 hours before and after sex (48 hrs max)
– Fitting necessary (refit after childbirth, miscarriage,
abortion, or gaining 15 pounds)
– Can be dislodged during sex
– Increased risk of cervical inflammation
– Must also use condoms for STD protection
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D. Barrier Methods
Spermicides
• Typical use failure of 29%
• Available in cream, foam, gel, film, suppository
• No STD protection
• Possible increased risk of HIV transmission when
Nonoxyl-9 is used alone!
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D. Barrier Methods
Sponge
•
•
•
•
Barrier + spermicide
Typical use failure of 29%
No STD protection
Can be left in place for 24 hours and used throughout
multiple sexual acts
• Side effects:
―Allergy to the spermicide and increased risk of yeast infections
and UTIs
―Leaving the sponge in too long may result in toxic shock
syndrome
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E: Natural Family Planning / Withdrawal
• Natural family planning can be very effective in
selected cases
– Motivated, educated patients
– Regular cycles
– Some sources quote efficacies of >95% but typical use
failure is likely higher
• No contraindications, risks or side effects other than
failure
• Withdrawal
– Not recommended - failure rate of 27%
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E: Natural Family Planning
• Mucous or ovulation method
– Mucous alone
• Sympto-thermal method
– Based on cervical mucous and basal body temperature
• “Timed abstinence” or Rhythm/Calendar Method
– Not recommended due to high failure rate of 25%
• Lactational amenorrhea
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F. Sterilization
• Available for Males and Females
– Tubal ligation
– Essure – hysteroscopic tubal occlusion
– Vasectomy
• Counseling Points
– >99% effective, but failures can occur
– Should be considered IRREVERSIBLE
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F. Sterilization
Tubal Ligation
•
•
•
•
Done postpartum or as an “interval” procedure
Failure rate of 0.8-2%
Risk of ectopic pregnancy
Risk of regret
– Rates of 20% in women under 30!
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F. Sterilization
Essure©
• Hysteroscopic placement of soft,
flexible micro-inserts
– Causes growth of scar tissue
– Results in blocked fallopian tubes
• Advantages: no incisions, minimal
anesthesia, failure rate <1%
• Disadvantages: 3 month wait for
confirmatory testing with HSG
• Procured through prosthetics
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Courtesy of Conceptus
F. Sterilization
Vasectomy
• As effective as tubal ligation
• Interrupts the vas deferens
• Office procedure
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F. Sterilization
Cons
• Contraindications
– Severe medical problems not allowing anesthesia
• Side Effects
– Heavier menses, more dysmenorrhea
• Risks
– Surgical risks
– Regret/reversibility?
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G: Emergency Contraception (EC)
• Plan B/Next Choice – Offer in advance because…
–
–
–
–
–
–
–
Condoms break, slip, or stay in the package
Pills, patches, rings are forgotten
Injection visits are missed
Sex can happen when unexpected or uninvited…
Increases the likelihood that EC is used
Decreases the time interval to use
Does NOT decrease contraception use
• IUD
– Provides up to 10 yrs of continued contraception
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G: Emergency Contraception (EC)
Plan B/Next Choice
• Plan B: single dose levonorgestrel (150 mcg) within 5 days
• Next Choice: two doses levonorgestrel (0.75 mg each); one
taken within 72 hours and second 12 hours later
• Efficacy: 1.1% failure or 89% reduction
• Mechanism
– Delayed ovulation
– Depending on timing of administration, inhibits ovulation,
fertilization, or implantation
• No risk to developing fetus if patient should be pregnant
• Side effects: Nausea, abdominal pain, fatigue, headache
• Advanced provision
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G: Emergency Contraception (EC)
ParaGard IUD
• Place within 5 days
• Consider antibiotic prophylaxis while waiting for
cultures
• Screen women as always for STD
• Failure rate of 0.1-0.7%
• Not FDA approved for this use – counsel
appropriately
Thonneau PF. Am J Obstet Gynecol, 2008;198:248-53.
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Guidance on Rights of Conscience (ROC)
and Emergency Contraception
• VHA is obligated to offer and provide FDA-approved
EC when medically indicated
• Individual clinicians may raise objections to providing
ECs based on ROC
• Clinician’s claim to ROC cannot supersede the
patient’s right to information about, and access to,
EC when it is clinically indicated
• Information Letter (IL 10-2012-006, January 2012)
provides information and guidance for ROC issues
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Helpful References
1. Association of Reproductive Health Professionals. Patient
Resources. http://www.arhp.org/patienteducation/index.cfm
2. CDC. United States Medical Eligibility Criteria (USMEC) for
Contraceptive Use.
http://www.cdc.gov/reproductivehealth/UnintendedPregnan
cy/USMEC.htm
3. Cope JR, et al. Determinants of contraceptive availability at
medical facilities in the Department of Veterans Affairs. J Gen
Intern Med. 2006;21(S3):S33-9.
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