Transcript Contraception - MCE Conferences

The Latest in Contraception:
Pearls for Busy Primary Care
Providers
Women’s Health in Primary Care
Orlando, Florida
March 16, 2011
Norma Jo Waxman MD
Assoc Professor of Family and Community Medicine
University of California San Francisco
[email protected]
Disclosures
 Norma
 No
Jo Waxman MD
pharmaceutical support or other
commercial disclosures
Objectives: After this talk you will be
able to:

Describe why pelvic exams and lab tests are not necessary
prior to prescribing hormonal contraception.

Integrate the use of the "Quick Start" method of initiating
contraception into their practice.

Encourage more efficacious and long-acting methods of
contraception

Update practice protocols to increase contraceptive use
and decrease unintended pregnancy in their office.
Outline
Unintended pregnancy
Barriers to contraceptive access
and use
Contraceptive methods updates




Continuous cycle combined hormonal
Evidence based IUD use
New Progestin Implant
New Sterilization techniques
6.3 Million Pregnancies in the
U.S.
25 % Unintended
Despite Method Used2
51%
Intended 1.
23 % Unintended
No Contraception
1. Finer et al, 2006
2. Jones RK, et al Perspectives on Sexual and Reproductive Health, 2002
Half of women at risk are not fully
protected from unintended pregnancy
No use,
8%
Consistent ,
correct use,
50%
Gap in use of
1 month or
more,
15%
Inconsistent
or incorrect
use,
27%
28 million adult women at risk for unintended
pregnancy
The Profound Impacts of
Unintended Pregnancy
 Increased
domestic violence1
 Increased
maternal drug and alcohol use
 Among


teens:
Decreased high school completion
Increased likelihood of life in poverty
1. Pallitto, et al. Trauma, Violence, & Abuse, 2005.
The Profound Impacts of
Unintended Pregnancy

Delayed prenatal care

Higher rates of fetal drug and alcohol exposure

Higher rates of low birth weight and infant mortality

Higher rates of developmental deficits

Higher rates of child abuse and life in poverty
Jane
27 year-old taking combined OCPS
Missed two periods
Urine Hcg is positive
Jane tells you that she ran out of birth control
pills last month, and that she tried to call the
office to get an appointment, but the receptionist
told her she was overdue for a pap smear and
couldn’t get a refill. Today was the first day she
could get an appointment with you.
What is required before starting
contraception?
1.
2.
3.
4.
5.
6.
Pelvic exam
Up to date Pap test
Breast Exam
STI testing
Pregnancy test
None of the above
And the evidence says….
 Medical
History:
Required
 BP:
Helpful
 Breast exam, Pelvic exam, Pap,
Hemoglobin, pregnancy test, STI
testing:
NOT REQUIRED!
Stewart F, et al. Clinical breast and pelvic examination requirements for hormonal
contraception: Current practice vs evidence. JAMA. 2001;285:2232-9.
When in her menstrual cycle can
she start contraception?
 The
first day of her period
 The Sunday after the first day of her cycle
 Any time in the month
 All of the above
“Quick Start”

“Quick Start” – start pill1,2 ( patch3, shot, ring4, ) on
day of visit- any time of the month.

EC if unprotected sex in last 5 days

Back up method for first week

Urine HCG if no withdrawal bleed at end of cycle,
or 2 weeks after DMPA injection

Reassure- exposure of embryo to OC not
teratogenic
1. Westhoff et al Contraception 2002 2. Westhoff et al Fertil Steril 2003 3. Murthy AS,
et al. Contraception. 2005 4. Westhoff CW, et al. Obstet Gynecol. 2005
http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf
Effectiveness Rates
Typical
Use
Perfect Use
Implanon
0.05
0.05
IUD
Mirena (LNg releasing)
ParaGard (copperT)
0.2
0.8
0.2
0.6
Male Sterilization
0.15
0.10
Female Sterilization
0.5
0.5
Depo-Provera q3months
3.0
0.3
Combined Hormonal methods
8.0
0.3
(Pill, Patch and Vaginal Ring)
Effectiveness Rates
Typical Use
Perfect Use
Cap -- nullip
16
9
Sponge -- nullip
16
9
Diaphragm
16
6
Female Condom
21
5
Withdrawal
27
4
Male Condom
15
2
Hatcher, RA et al; Contraceptive Technology 18th Edition,: 2007
Access Issues and Unintended
Pregnancy
Jane tells you that her insurance permitted
her to obtain only one pack of pills each
month, and she was late in getting her
pack last month because of working until
after the pharmacy was closed.
How many refills can I give her?
 One
month?
 3 months
 13 cycles
What if you have never seen her?
Can you refill a new patient’s contraception
until you could see her?
YES, it is safe to continue her medication
Dispensing 12 months of contraception
increases continuation & lowers costs
UCSF Bixby Center evaluated 2003 claims for 82,319
women dispensed OCPs via Fam PACT Outcomes:

Women who received 13 cycles more likely to be
receiving pills in 2004 than women who received 1 or 3
cycles.

Women dispensed 13 cycles more likely to receive Pap
& Chlamydia tests; less likely to have pregnancy test

Fam PACT saved $99/ year on women who received 13
cycles
Foster, D et al. Obstetrics & Gynecology 108(5):1107-1114, November 2006.
How can we help patients with
access and adherence
 Help



patients obtain method of choice
Eliminate practice barriers
Review and offer all options
Posters and handouts in exam rooms
 Anticipate
side effects and forgetting
• set expectations: improves continuation1,2
 Explain
Medical Benefits
1. Lei Z, Contraception, 1996 2. Canto-DeCetina, Contraception 2001
Systemic Barriers






Trouble with refills - can’t get through on phone,
not called in to pharmacy quickly enough,
formulary changes, only one month at a time
covered by insurance…
Patients can’t contact provider about side effects,
stops taking the method…
Provider links refills to BP check or pap test
Time constraints lead to incomplete contraceptive
counseling
Provider not comfortable with full range of products
Others?
PDR, Product Labeling & Inserts
 Labeling
change biased towards adding
warnings vs. removal of incorrect
information1



New indication or removal of safety
information requires two well-controlled
studies
FDA approval not required to add warning
Liability concerns lead to unwarranted Black
Box warnings
1. Grossman D, et al. Am J Public Health. 2006;96(5):791-9
PDR, Product Labeling & Inserts
 PDR
often outdated and incorrect1
 Package
inserts cause irrational fear of
rare health risks & decrease use of
contraception2
 “Throw
the package insert away”
1. Mullen et al Ann Emerg Med Feb 1997;29:255-261 2. Grubb G. J Biosoc Sci.
1987;19:313–321
Use absolute vs. relative risk

“Of every 1 million OC users, 4
develop heart attack each year
compared with 2 nonusers.”
“OC use increases risk
of heart attack 1.5 fold.”
Gigerenzer G, Edwards A. BMJ. 2003.
Farley TMM, Collins J, Schlesselman JJ. Contraception. 1998.
Sloman SA. Organizational Behavior and Human Decision Processes.
2003.
Patient Centered History

Do you plan to become pregnant in the next year?
 Ask about accidental pregnancy? How would it
effect her life?
 Explore tolerance of side effects:


spotting, headaches, weight gain, nausea
Is she comfortable touching her vagina?
 How heavy &/or painful are her periods?
 What method(s) has she used in the past?
 What contraception did she come for today?
Do women need a “break” or
“holiday” from contraception?
 NO!
they get pregnant
Is it safe to not have periods?
Dispel myths around “need to bleed”
 Reassure our patients that amenorrhea on
progestin is safe vs. amenorrhea off hormones

Extended Cycle Advantages

Traditional prescription historic only

Increase of efficacy



47% of women have follicle ready to ovulate by day 7 of
placebo week1
24/3 pills found to have higher efficacy then 21/72
Symptoms w/ OC worse during withdrawal bleed


Cyclic vs. extended cycle: less headaches, tiredness,
bloating, menstrual pain 3,4
Treats anemia, dysmenorrhea, heavy bleeding, PMS,
menstrual migraines, endometriosis, PCOS
1. Baerwald, Contraception, 2004 2. Dinger et al Obstet Gynecol 2011;117(1):33-40 3.
Edelman et al Cochrane Review 2006 4. Sulak
Extended cycle: Is Something
Building Up Inside?
 Endometrial


biopsy data – no hyperplasia1
Tricycle regimen, short hormone-free, cont.
1 year continuous: 11% weakly proliferative
 Ultrasound
data - thin endometrial stripe in
study of continuous x 6 months 2
 Traditional use decreases risk of
endometrial cancer
1. Bachman, Contraception, 2004; Johnson, Contraception, 2007. 2. Foidart, Contraception,
2006; Anderson, Contraception, 2003; Kwiecien, Contraception, 2003.
Lifetime Number of Menstrual
Cycles
500
450
450
400
350
Number 300
of
250
Cycles
200
150
160
100
50
50
0
Prehistoric
Colonial America
Modern
Adapted from Coutinho EM. Is Menstruation Obsolete? 1999.
Eaton SB, et al. Quart Rev Biol. 1994;69:353-363.
Continuous Cycle Dedicated Products

Lybrel ™



20 mcg EE/ 90 mcg LNG
Daily continuous use, no placebo, for a year
Seasonale ™ (generic version now available)


30 mcg EE/ 150 mcg LNG
84 active pills/ 7 placebo pills
Continuous Cycle Dedicated Products

Seasonique ™



30 mcg EE/ 150 mcg LNG
84 active pills/ 7 pills 10mcg EE
LoSeasonique ™


20 mcg EE/ 100 mcg LNG
84 active pills/ 7pills 10mcg EE
Extended Cycle Dedicated Products
2- 4 days of placebo rather than 7
Suppresses follicular growth seen during placebo week
Similar breakthrough bleeding

Loestrin 24 Fe ™



Mircette ™ (Kariva generic)



20 mcg EE/ 150 mcg DSG
21 days active, 2 days placebo, 5 days 10 mcg EE
Yaz ™

.
20 mcg EE/ 1 mg NET
24 days active, 3 days of Fe

20 mcg EE/ 3 mg DRSP
24 active pills/ 3 placebo pills
Lawonda

29 yo G5P2Tab3

Currently using oral contraception (OCs), but admits to
frequently forgetting to take her pill

Wants to try patch because her friends like it
What do we know about adherence and OCs?
What are the side effects of the patch we need to talk
to her about?
Adherence with Oral Contraception:
What Women Do!
Diary
Electronic Device
Percent of Women (%)
70
60
Cycle 1
Cycle 2
Cycle 3
50
40
30
20
10
0
0
1
2
3
0
1
Active Pills Missed
2
Active Pills Missed
Potter L et al, Fam Plann Perspect. 1996.
3
0
1
2
3
It is hard to take the pill

Nationally nearly half (47%) of pill users miss 1
or more pills per cycle (Rosenberg, 1999)

The third most common reason for missing a pill
is “No new pill pack,” cited in 10% of the
instances of missed pills. (JD Smith et al., 2005)

1 in 7 women seeking abortion in US report
using pills in the month they conceived. (RK
Jones et al, 2002)
Weekly: Contraceptive Patch (Evra)

Apply weekly x 3, then 1 wk off
 EE: 20 mcg/ Norgestimate

Place on arm, trunk, buttock

Same contraindications as OCs. Typical use efficacy may be >
than OCs1

Decreased efficacy, not contraindicated in women >198 lbs2

Breast discomfort and spotting > > than OC in cycles 1 & 23

Average levels of circulating estrogen 60% higher though
peak levels are lower compared to OCs
1. Sonnenberg et al, Am J Obstet Gynecol. 2005 , 2. Zieman M, Fertil & Steril, 2002
3. Audet, et al. JAMA. 2001;285:2347-2354.
EE Exposure with CHC
AUC (area under
curve) ng.h/mL
Patch
OC*
Ring
37.7 + 5.6
22.7 + 2.8
11.2 + 2.7
* 30 mcg EE/150 mcg LNG
van den Heuvel,
Contraception 2005 72:168
Ortho Evra and risk of Venous
Thromboembolism (VTE)
Retrospective case-control studies from claims data

Jick et al, 2006 Nested case-control design based on
information from PharMetrics; 59K patch, 147K OC users
• did not show increased risk of VTE : OR .9 (CI 0.5–1.6)
and OR 1.1 (CI 0.6–2.1) with 2006 data, when compared
to OCs containing 35mcg ethinylestradiol (EE) and
norgestimate
Jick SS et al. Contraception 2006;73:223-228 and Contraception 2007;76:4-7
Ortho Evra and risk of Venous
Thromboembolism (VTE)
Retrospective case-control studies from claims data

Cole et al, 2007. United Health Care claims data and chart
reviews; 99K patch 257K OC users
• did show odds ratio 2.4 (CI 1.1-5.5) for VTE among patch
users compared to OCs with 35 mcg EE and norgestimate
• Bias: new patch users vs. new and prior OC user
Cole JA et al. Obstet Gynecol 2007;109:339-346
Monthly: Vaginal Contraceptive Ring
Nuvaring™ 15 mcg EE & 120 mcg desogestrel

Easily placed and removed

Rarely noticed during sex

Higher acceptability and
compliance than pills
 Less spotting compared to pills
 constant serum estrogen levels
 Obesity doesn’t affect efficacy

No liver first-pass metabolism
Vaginal Contraceptive Ring:
Off label, Extended cycle regimens
 The
Ring is effective for up to 35 days1
 Continuous
cycling, increases
breakthrough bleeding2
 “Calendar
month” use 1-27th of month,
then off for rest of month
1. Mulders & Dieben, Fertil Steril 2001;75:865-70. 2. Miller, et al. 2005
Q 3 months: Progestin-Only Injection:
Depo Medroxyprogesterone Acetate (DMPA -IM 150mg q12wk)
•Irregular bleeding is expected
and Amenorrhea is normal:
50% at 1 year, 80% at 5 years
•May decrease seizure frequency and sickle crisis
•Part responsible for decrease in teen birth & abortion
•Advantages for teens: privacy, adherence, efficacy,
decreased PID risk
•Advise Calcium & Vit D, and weight bearing exercise
DMPA-IM 150 & Black Box Warning

Loss of BMD happens in first 2 years
Pregnancy and nursing cause similar or > bone loss than DMPA1

In teens, bone loss reversed within 12 months of discontinuation, and
ultimate BMD may be higher in the former users of DMPA 2,6

No increased incidence of osteoporosis or fractures w/ DMPA in
>30yrs of worldwide use3

No role for BMD evaluation or treatment with bisphosphonates4

Experts feel “FDA's recent additional labeling for DMPA is
unnecessary and should be revised or rescinded” 5
1. Sowers Obstet Gynecol, 2000;96:189-93 2.Scholes Arch Pedatir Adol Med 2005;159:139-44
3. Westhoff C Contraception. 2003;68:75-87 4.ACOG Bulletin 2005 5. Kaunitz Contraception
2005;72:165-167 6. Harel et al Contraception, 2010;81: 281-291
What about new LARC evidence?
Long Acting Reversible
Contraception
Long over-due
Acceptable
Reliable
Contraception
Why are IUDs So Underused in the US?

Lack of awareness of method and anxiety around
insertion among patients

Dearth of trained, willing clinicians to insert
 Misconceptions regarding difficulty of insertion
 Negative publicity, fear of litigation
 Upfront cost and insurance issues

Non evidence based office protocols decrease access

Despite being most cost-effective methods, high up
front cost and inconsistent insurance coverage
Weir E. CMAJ. 2003. Stanwood NL, et al. Obstet Gynecol. 2002.
Steinauer JE, et al. Fam Plann Perspect. 1997
Asker C, et al. J Fam Plann Reprod Health Care. 2006..
Intrauterine Contraception (IUDs)


Most Common Reversible Contraception Worldwide
Copper T 380A (ParaGard)



Levonorgestrel releasing system (Mirena)





Effective 12 years and No hormones
Increased blood loss and cramping with regular periods
Effective 5 (maybe 7) years
Irregular spotting & bleeding
Amenorrhea 20% at1yr 80% 5yr
Many non-contraceptive benefits
Negative US perception b/c Dalkon Shield. Caused
plummet of US use (10% of women used IUD mid-70’s)
Evidence based shift of eligible candidates

CuT380A-ParaGard Label Change 2005

Mirena package insert outdated (grrr); can use
Evidence Based indications off-label

Expanded patient profile





Nulliparous women
History of ectopic pregnancy
Past history of PID or STI
More than one partner
Contraindications

Acute cervicitis or PID, or high personal risk for
cervicitis or PID
LARC is safe when other hormonal methods
are contraindicated
WHO Medical Eligibility for Initiating Contraception
Copper
IUD
LNGIUS
Implant
Breastfeeding (>6 weeks postpartum)
1
1
1
Smoking
1
1
1
<159 / <99
1
1
1
>160 / >100
1
2
2
+ Vascular
disease
1
2
2
Migraines
1
2
2
Diabetes mellitus
1
2
2
Liver disease
Cirrhosis
1
2/3
2/3
Tumors
1
3
3
1
3
3
Condition
Hypertension
WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007.
Active hepatitis
50
Do IUDs cause STIs and PID?

Transient PID risk of 1/1000 likely due to infection or
contamination at insertion 1,2

Okay to screen for STI and insert IUD at same visit3


Okay to treat STI and PID with IUD in place3




Some protocols moving to “may, not must” screening for STIs
(Family Pact and Planned Parenthood)
Do not remove unless treatment failure
Dose and duration does not change
Don’t remove for Actinomycosis
Prophylactic antibiotics not necessary4
1. Grimes, D Lancet 2001; 7358:6-7, 2. Grimes, D Lancet 2000; 356:1013-9
3. WHO 2005 4. Grimes Cochrane Database 2001, revised 2003
What about the risk of PID & infertility?
 The evidence shows:
1,2
 IUDs DO NOT increase risk of infertility or STI


PID risk with cervicitis similar with & w/o IUD1
Tubal infertility linked to presence of Chlamydia
antibodies, but NOT history of IUD
1. Grimes, D. Lancet 2000; 356: 1013-19. 2. Grimes, D Lancet 2000; 356:1013-9
3. Hubacher D, et al. NEJM 2001; 345:561-7.
IUD Myths Debunked

IUDs DO NOT cause Abortion:



IUDs DO NOT increase risk of ectopic pregnancy


LNG IUDs thicken cervical mucus, suppress endometrium,
& have some anovulatory effect
Copper IUDs act as a spermicide
recommended in women w/ H/O ectopicWHO Class 1
Rapid return to fertility after IUD removal
Hubacher NEJM 2001;108:784-90 , Grimes Cochrane Database 2004 .Andersson
Contraception 1994;49 4. Medical eligibility criteria for contraceptive use. 3nd
edition, Geneva: WHO, 2004
More IUD Myths Debunked

Insert at any point in the menstrual cycle1

Rapid return to fertility after removal

May insert both devices immediately post-1st
trimester abortion and 4 weeks post-partum

Safe in woman with HIV and AIDs stable on
ARVs- WHO class 2;

no increased risk of infection or viral shedding3,4,5
1.Medical eligibility criteria for contraceptive use WHO, 2004. 2. Hubacher NEJM 2001 3.
IUDs in Young and Nulliparous
Women

Safe and effective in nulliparous women and women
<20yrs old with low risk of PID- WHO class 21-4

Higher continuation rates than with OCs in teens1

Progestin IUS great choice with menorrhagia and/or
dysmenorrhea

IUD expulsion, bleeding, and pain slightly more likely
among nulliparous women2-5
1. Suhonen S. Contraception 2004;69:507-512. 2.Nelson AL. Obstet Gynecol Clin North Am.
2000;27:723-740. 3.Dardano KL, Burkman RT. Am J Obstet Gynecol. 1999;181:1-5. 4.Li C.
Contraception 2004;69:247-250. 5. Treiman K, et al. Population Reports. 1995.
LARC methods are the most costeffective methods of contraception
Chiou CF et al. Contraception. 2008. Mavranezouli I et al. Human Reprod.
2008. Trussell J et al. Contraception. 2009.
56
Copper IUD: Most Effective Form of
Emergency Contraception
 Pregnancy
Rate after Copper IUD for
Emergency Contraception 0.0-0.6%
 Insertion


of Copper IUD
up to 5 days after unprotected sex or
up to 5-7 days after suspected ovulation
Trussell et al. American Journal of Obstetrics and Gynecology. (2004) 190; S30-8
Progesterone Implant: Implanon™

4cm flexible rod (etonogestrel)

Highest Efficacy and continuance

Lasts 3 years & Rapid return to fertility

Inhibits ovulation and thickens cervical mucous

Minor procedure to insert and remove
Glasier A, Contraception 2002 Zheng SR, et al. Contraception. 1999;60:1-8.
Meckstroth & Darney P, Obstet Gynecol Clin North Am, 2000. Croxatto HB, et al.
Hum Reprod. 1999;14:976-81.
Implant and Vaginal Bleeding

Bleeding pattern unpredictable but less bleeding
than cycling women

Continuous progestin prevents EM hyperplasia;
endometrial biopsy unnecessary for this purpose

Management options
• Counseling and reassurance
• Estradiol 1-2 mg PO QD for 10-14 days, or
• OCs, given for 2-3 cycles, or
• Ibuprofen 400-800 mg TID for 7-days
Sterilization Comparisons
Hysteroscopic
Sterilization
Tubal
Ligation
Vasectomy
None
1-2
1-2
Local or
IV Sedation
General
Local
No
Yes
No
1-2 days
4.4 days
2 days
98.82%
@ 4 yrs
98.87%
@ 5 yrs
Incisions
Typical
anesthesia
Peritoneal entry
Resume activities
Effectiveness rate E: 99.7% @ 5 yrs
A: 98.4% @ 3 yrs
E: Essure®
A=Adiana®
Hysteroscopic Sterilization

Essure Procedure®
 Micro-insert placed in proximal portion of
fallopian tubes…expands upon release and
permanently anchored in the tube
 Adiana Permanent Contraception®
 Radiofrequency burn in the proximal portion of
each tube lumen, then rice-grain sized silicon
matrix inserted
 Subsequent benign local tissue in-growth over a
3-month period…scarring blocks fallopian tube
Hysteroscopic Sterilization:
Candidates

Women who prefer this approach to laparoscopy
 Especially, for women with …
 Obesity (BMI of > 45)
 Abdominal mesh that prevents laparoscopy
 Permanent colostomy
 Multiple abdominal/pelvic surgeries (adhesions)
 Use of anticoagulation medications
 Medical problems that contraindicate general
anesthesia
Optimizing Contraceptive Use

Separate contraceptive prescription from health
screening

Simplify renewal process and maximize refills

Participate in resolving insurance/ pharmacy issues

Use US MEC Guidelines to screen for contraindications

Describe all forms of contraception and noncontraceptive benefits- put risks in perspective

Encourage more efficacious methods like LARC
Managing Contraception – book online @
(www.managingcontraception.org)
Association of Reproductive Health Professionals (ARHP)
(www.arhp.org)
The Guttmacher Institute- http://www.guttmacher.org/
www. contraceptiononline.org
Reproductive Health Access Project
http://www.reproductiveaccess.org
A Clinical Guide for Contraception Speroff and Darney