Transcript 2. - MCE Conferences

Introducing the 2010 US Medical
Eligibility Criteria: An Evidenced
Based Tool for Determining Safe Use
of Contraception with Chronic and
Other Medical Conditions
Womens Health in Primary Care
Orlando Florida March 2011
Norma Jo Waxman MD
Private Practice, San Francisco
Associate Professor of Family and Community Medicine
University of California San Francisco
[email protected]
Objectives
At the end of the talk participants will be able to:



Utilize the CDC Medical Eligibility Criteria to find safe
contraceptive options for women with medical problems.
Explain the safety of hormonal contraception
Remember to think about contraception when prescribing
FDA Category D or X medications (dangerous in
pregnancy)
WHO Medical Eligibility Criteria

Unique contributions
– Evidence based
– Comprehensive, up-to-date
– Only “accepted” guideline of its kind

Considerations for use in US
– WHO Criteria were written to include “lowest common
denominator” health systems
– Conservative for use in the US
– Consider as “tools not rules”

WHO Medical Eligibility Criteria for
Contraceptive Use – 4rd edition 2009
– www.who.int/reproductivehealth/publications/mec/
WHO Medical Eligibility Criteria
More evidence based than package insert
Classification
1
Use method in any circumstances
2
Generally use the method
3
Use of method not usually recommended unless
other more appropriate methods are not available
4
Method not to be used
Medical Eligibility Criteria For Contraceptive Use. Third Edition. WHO, 2004.
WHO Medical Eligibility Criteria
Combined hormonal contraceptives (CHC)
– COC: Combined oral contraceptives
– CIC: Combined injectable contraceptives
– P/R: Patch and Vaginal Ring
Progestin only contraceptives
– POP: Progestin only pills
– DMPA: Depo-MPA
– IMPLT: Implanon contraceptive implant
Intrauterine contraceptives
– Cu-IUD: Copper T-380 IUD
– LNG-IUD: Levonorgestrel IUS
US MEC: Scope

Current WHO MEC > 1800 recommendations

No need to change majority of recommendations
– Science the same & widely used around the world



CDC accepted majority of WHO recommendations
Exceptions: existing WHO recommendations that
needed to be adapted for US context
A few additional areas
http://www.reproductiveaccess.org/contraception/downloads/WHO_Chart.pdf
CDC MEC Guidelines




www.reproductiveaccess.org
Go to “providers” then under “clinical
resources” you will see MEC guidelines.
Available in Word or PDF
Link to the comprehensive MEC list
Medical Benefits of Hormonal Contraception

Menstrual related health benefits:
– Decreased dysmenorrhea
– Decreased menstrual blood loss
– Reduces menstrual related PMS symptoms


Improves acne and hirsutism
Reduction of:
–
–
–
–
–
Ectopic pregnancies
Benign breast conditions
Perimenopausal sxs, DUB, PCOS, Endometriosis
PID
Anemia
Medical Benefits of Hormonal Contraception

OC users reduce risk of ovarian Ca by 40%1,
and by 80% after 10 yrs2

OC reduces risk of endometrial CA by up to 40%3

No increase risk of Breast CA in OC users4,5
1. Vessey et al Br J Cancer 1995. 2. Rosenberg et al Am J Epidmiol 1994 3. JAMA 1987:257(6)4.
4. Marchbanks et al NEJM 2002;346:2025-2032 5. Hannaford et al BMJ 2007; 335 : 651
Risk Misperception & the Patient
“…incorrect perceptions of excess risk
of contraceptive products may lead
women to use them less than
effectively or not at all.”
Gardner J, Miller L. J Womens Health 2005
“Throw away the package insert”
“2 times a rare event is still a rare
event”
David Grimes MD, September 2006
Risk Comparisons
(slide credit:
Association of Reproductive Health Professionals)
Annual Risk of Death (per 100,000)
*
Skydiving
Driving
Pregnancy
Riding a bicycle
Airplane crash
Using OC*
Nonsmoker, under age 35
100
20
11.5
0.8
0.4
0.06
Trussell J, Jordan B. Contraception in press. Chang J, et al. MMWR 2003.
Harvard Center for Risk Analysis 2006. Bennett P. In: Risk Communication and Public Health 1999.
LARC is safe when Estrogen containing
hormonal methods are contraindicated
CDC US Medical Eligibility for Initiating Contraception
Copper
IUD
LNG-IUS
Implant
Breastfeeding (>6 weeks postpartum)
1
1
1
Smoking
1
1
1
<159 / <99
1
1
1
>160 / >100
1
2
2
1
2
2
Migraines
1
2
2
Diabetes mellitus
1
2
2
1
1/3
1/3
1
3
3
1
1
1
Condition
Hypertension
+ Vascular disease
Liver disease
Mild/severe
Cirrhosis
Malig Tumors
Active hepatitis
WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007.
15
Case Study: Breastfeeding
A 30 y.o. female is post partum day #2, ready to
be discharged from hospital, and desires
contraception. She plans to breastfeed.
Which hormonal methods are safe for her to
use?
Post-partum Contraception:
General Considerations

Goals of postpartum (pp) contraception
– Efficacy: limit family size, plan birth spacing
– Support successful breastfeeding
– In GDMs, avoid conversion to frank diabetes

Most women begin intercourse within 1-2 months
– 60-70% are sexually active by 6 weeks pp
– 4% abstinent by the end of the 12th pp week
Post-partum Ovulation Patterns

Resumption of ovulation in non-lactating women
– Ovulate in 6-7 wks (median= 45 days)
– None before 25 days from the delivery

Resumption of ovulation in lactating women
– Intensity, frequency, duration of suckling
– Time elapsed since delivery
– Maternal nutritional state
– Rate of weaning: rapid > gradual weaning
– Introduction of supplementary feeding (ovulation
usually begins 6 weeks later)
Contraception and Breastfeeding

Two considerations
– Potential effect on breastfeeding performance
(initiation, maintenance, duration of lactation and
need for supplementation)
– Potential effect on infant health and development
(infant weight, infant length, physical findings, health
problems, and psychomotor development)
Breastfeeding- Evidence

Combined hormonal methods
– 8 studies of combined hormonal methods
– 4 studies reported decreased duration and higher
rates of supplemental feeding
– 1 study no difference in breastfeeding performance
– No adverse effect on infant growth, health, or
development through 8 years of age
Breastfeeding- Evidence

Progestin-only methods
– 43 Studies
– POPS, DMPA, implants, and LNG-IUD
– No adverse effect on breastfeeding performance
– No adverse effect on infant growth, health, or
development through 6 years of age
Post-partum OC's: Maternal Risk

Changes in maternal clotting factors persist for 4
weeks after term delivery
– Increased VTE risk up to 4 week post-partum

Coagulation effects of pregnancy and OC's may
increase risk of VTE
– However, VTE rates have not been studied in
postpartum low-dose OC users vs. controls

Greater VTE risks not expected with POPs, since
no change in clotting factors
Breastfeeding- Gaps






Most observational studies- need RCT
Timing of initiation of contraceptive methods
No consistent definitions of breastfeeding
No consensus on outcome measures for
breastfeeding or infant health
No inclusion of ill or premature infants
Need longer follow up
2009 WHO Medical Eligibility Criteria
Post-Partum Breastfeeding
CONDITION
OC/P/R POP DMPA Implant
< 6 weeks
4
3
3
1
3
1
3
1
2
1
1
1
6 weeks6 months
> 6 months
2010 US Medical Eligibility Criteria
Post-partum Breastfeeding
CONDITION
OC/P/R
POP
DMPA
Implant
<1 month
postpartum
1 month to 6
months
3
2
2
2
2
1
1
1
> 6 months
postpartum
1
1
1
1
Post-partum CHC: Clinical Guidelines

Non-nursing women
– CHC starting 4 weeks postpartum

Nursing women
– Conservative approach
 First
3 months: avoid CHC
 > 3 mo or weaned: switch to CHC
– Liberal approach
 CHC

once lactation established ( > 4 wks)
If COCs used, use 20 mcg estrogen dose
Post-partum Long-acting Progestins

DMPA
– Mildly lactogenic; no change in milk content

Implant (Implanon, Norplant studies)
– No effect on milk volume, content, or growth

Administration before hospital discharge
– Advantage

Protected if post-partum visit is missed
– Disadvantages
Unnecessary for first 4 weeks
 Anatomic bleeding vs. drug side effect

2009 WHO MEC:
Postpartum IUC Insertion
LNG-IUS
Cu-IUD
Comment
< 48 hours
48 hours to
4 weeks
> 4 weeks
3
3
2
3
1
1
Evidence: There was some
increase in expulsion rates
with immediate insertion
compared to delayed
postpartum insertion and
interval insertion.
Endometritis
4
4




Guidelines are identical in lactating and non-lactating women
Insert IUC within 15 minutes of placental delivery
Use sponge forceps on cervical lip; 2nd sponge forceps to insert
Cut string flush with external cervical os
2010 US MEC:
Postpartum IUC Insertion
Postpartum (BF or non-BF women)
including C/S
LNG-IUS Cu-IUD
<10 min after delivery of
placenta
2
1
10 min after delivery of placenta
to <4 wks
2
2
>4 wks post partum
1
4
1
4
Puerperal sepsis
Case Study: Breastfeeding
30 y.o. Post partum desires
contraception. Plans to breastfeed
Which hormonal methods can she use?
Answer
POPs, DMPA, implants, LNG-IUD
(Category 2)
She should generally not use CHCs
(Category 3)
Case Study: Diabetes Mellitus





32 y.o. woman G3P2
Gestational DM with both
pregnancies
DM type 2 since last birth
2 years ago
Well controlled on
metformin
What type of
contraception can she
use?
Diabetes and Contraception
DM
OC/P/R
POP DMPA
IMPL
LNGIUD
CuIUD
Gestational
DM in past
1
1
1
1
1
1
DM w/o
vascular
disease
2
2
2
2
2
1
DM w/
end-organ
damage or
> 20 yrs
duration
3
2
3
2
2
1
Diabetes and Contraception

Birth defects occur in 5-8% of children
born to US women with diabetes
– Double the general pop rate


2/3 of women with diabetes have
unintended pregnancies
Diabetic women are ½ as likely to
receive contraceptive Rx or counseling
Category D or X medications




Use of Class D and X Rx common
Anxiolytics, anticonvulsants, statins,
doxycycline, warfarin, DHE and ergotamine
– 1 of every 25 Rx
– 1 of every 13 visits
– 1 of every 6 women!
Contraceptive counseling < 20%1 to 50 %2 of visits
documenting potential teratogen use or RX
1. Schwarz EB et al. Prescription of teratogenic medications in US ambulatory practices. Am J
Med. 2005 Nov;118 (11): 1240-1249 2. Schwarz EB et al. Documentation of Contraception
and Pregnancy When Prescribing Potentially Teratogenic Medications for
Reproductive-Age Women. Ann Intern Med. 2007; 147(6): 370–376.
Case Study: h/o Deep Vein
Thrombosis
24 year old G1P0 woman requests Pill or
Patch
h/o DVT right calf at 18 years old
Hospitalized 1 week: “shots” for 5 days;
then “pills” for 3 months
Mother “had blood clot go to her lungs”
during pregnancy
Healthy non-smoker; stable relationship;
intercourse once or twice a week
Risk Factors for DVT and VTE
Age (especially >40 years old)
Pregnancy, post-partum period (< 3-4 weeks)
Obesity
Immobilization with venous stasis
Personal history of DVT or VTE
Family history (inherited clotting disorder)
– Factor V Leiden mutation (Protein C resistance)
– Protein S, Protein C deficiency
Venous Thrombosis and CHC
▲DVT rates with increasing dose of estrogen
 OC and OrthoEvra have similar DVT risk (Jick, 2006)
– NGM OCs:
4.2/10,000 women/year
– Patch:
5.3/10,000 women/year
– Age-adj RR: 1.1 (95% CI: 0.7-1.8)
 DVT risk declines with increasing duration of use
 Progestin type, dose have no (or minimal) impact
 No attributable risk of fatal PTE in OC users
 HTN, hypercholesterolemia, and diabetes not risk factors
for venous disease
Incidence of VTE per
100,000 woman-years
Comparative Risks of VTE
60
60
40
20-30
20
15
5
0
Shulman, LP. J Reprod Med. 2003. Chang, J. In: Surveillance Summaries. 2003.
Prior Venous Thrombosis and CHC
Conventional wisdom
If a woman has h/o idiopathic or post-partum
DVT or VTE, may be predisposed to recurrence if
given exogenous estrogen
– Hence, avoid E- containing contraceptives
If DVT related to another condition (e.g.,
immobilization, trauma), without a history of
recurrence, E-containing contraceptives may be
considered
Venous Thrombosis and CHC
Factor V Leiden mutation (FVLM), DVT risk, and OCs
 Individuals with the FVLM have activated Protein C resistance a
hypercoagulability
 Present in 70-90% of inherited thrombophilias
– 20-40% of patients having a first DVT
– 50% of those with > 1 episode of DVT
 1-5% US pop; 5% Europeans; 15% of Scandinavians
 OC users with FVLM have 15 fold increased risk of DVT
Eur J
Contracept Reprod Health Care. 2000 Jun;5(2):105-12. Factor V Leiden mutation and the risks for
thromboembolic disease: a clinical perspective Ann Intern Med. 1997 Nov 15;127(10):895-903.
Venous Thrombosis and
CHC
Superficial varicose veins do not increase the
risk of DVT or VTE, regardless method
Women who are about to undergo major
surgery should discontinue OC’s 30 days before
the procedure is scheduled
Not necessary to interrupt OC’s before short
operative procedures with early physical activity
USMEC:
Deep Venous Thrombosis
a) History of DVT/PE,
not on anticoagulant
therapy
i.) Higher risk for
recurrent DVT/PE
ii.) Lower risk for
recurrent DVT/PE
(no risk factors)
OC/P/R POP DMPA Impl LNGIUD
CuIUD
4
2
2
2
2
1
3
2
2
2
2
1
USMEC: History of DVT/PE
Not on Anticoagulant Therapy

Higher risk for recurrent DVT/PE
– History of estrogen-associated DVT/PE
– Pregnancy-associated DVT/PE
– Idiopathic DVT/PE
– Thrombophilia; antiphospholipid syndrome
– Active cancer (metastatic, on therapy, or < 6
months after clinical remission)
– History of recurrent DVT/PE
USMEC: Deep Venous Thrombosis
b) Acute DVT/PE
c) DVT/PE,
established on
anticoagulants >3
mo
i) Higher risk for
recurrent DVT/PE
ii) Lower risk for
recurrent DVT/PE
OC/P/R POP DMPA Imp LNG- Cul IUD IUD
4
2
2
2
2
2
4
2
2
2
2
2
3
2
2
2
2
2
USMEC: Deep Venous Thrombosis
OC/P/R POP DMPA Impl LNG- CuIUD IUD
2
1
1
1
1
1
(i) with prolonged
immobilization
4
2
2
2
2
1
(ii) without prolonged
immobilization
2
1
1
1
1
1
f) Minor surgery
without immobilization
1
1
1
1
1
1
d) Family history (firstdeg relatives)
e) Major surgery
Case Study: Prior DVT
Recommend coagulation studies, since may affect
contraceptive choice and pregnancy management
Preferred methods
– Cu-IUD
Acceptable methods
– POP, DMPA, IMPLT, LNG-IUD
Unacceptable risk
– COC, patch, ring
Case Study
A 25 y.o. female with Crohn’s disease
desires long-term reversible
contraception and is thinking about
the levonorgestrel-releasing IUD. Is
this method safe for her?
A. Yes
B. No
Inflammatory Bowel
Disease (IBD)
New condition added to US MEC
 Two chronic relapsing and remitting disorders
of GI tract

– Ulcerative colitis
– Crohn's disease

Common symptoms: diarrhea, abd cramps,
rectal bleeding, frequent bowel mov't, weight
loss, anemia
Inflammatory Bowel
Disease

More common among women
– UC:
– Crohn's:

160/100:000 women
103/100,000 women
Risks
– Thrombosis
Some studies show increased risk, others not
 Risk greater during active-disease phase

– Malabsorption


Osteoporosis and osteopenia
All may be of concern for contraceptive use
IBD- Evidence




10 studies
Relapse rates- no difference in time to relapse in
women using POPS or COCs
Exacerbation- case reports of LNG-IUD use
causing exacerbation
Absorption- pharmacokinetic studies showed no
difference among UC patients compared with
healthy women in absorption of EE or LNG
IBD- Gaps




Small number of studies, small sample sizes,
methodologic concerns
No studies examining risk of thrombosis in women with
IBD using hormonal contraceptives
No studies on IBD, DMPA, bone loss / fracture risk
Pharmokinetic studies only among women with UC
(affects large bowel)
Inflammatory Bowel
Disease
CONDITION
COC/ POP
P/R
IBD (Ulcerative 2/3
colitis, Crohn’s
disease)
2
DMPA
Implants
LNGIUD
CuIUD
2
1
1
1
Inflammatory Bowel
Disease


For women with mild IBD, with no other risk
factor for \/TE, the benefits of COC/P/R use
generally outweigh the risks (Category 2)
For women with IBD with increased risk of \/TE
(e.g., those with active or extensive disease,
surgery, immobilization, steroid use, vitamin
deficiency, fluid depletion), risks > benefit
(Category 3)
USMEC: History of
Bariatric Surgery
OC/P/R
POP DM Im Cu
PA pla IUC
nt
LNIUC
Restrictive procedures: 1
decrease stomach
storage capacity
1
1
1
1
1
Malabsorptive
procedures: shorten
functional length of
the SB
3
1
1
1
1
COCs: 3
P/R: 1
USMEC: Solid Organ
Transplantation
OC/P/R
POP DMPA Imp Cu-IUC LN-IUC
lant
Complicated: graft
failure, rejection,
cardiac allograft,
vasculopathy
4
2
2
2
I = I =
3
3
C =2 C =2
Uncomplicated
2
2
2
2
2
2
Women with Budd-Chiari syndrome should not use
COC/P/R because of the increased risk for thrombosis
Summary



The CDC Medical Eligibility Criteria is an evidence based
tool to determine safe contraceptive options for women
with medical problems
Most woman overestimate the risks of contraception and
don’t understand the medical benefits and safety of
hormonal contraception
Remember to think about contraception when prescribing
FDA Category D or X medications (potentially dangerous in
pregnancy)