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WHO Medical Eligibility Criteria for Contraceptive Use
AAFP Global WorkshopSeptember 2012
Sharon Phillips MD, MPHMedical OfficerDepartment of Reproductive Health and Research, World Health Organization
Disclosure
• No current conflicts of interest• Some recommendations may be
inconsistent with package labeling
Acknowledgement of Support
• RHEDI
Learning Objectives
1) List the 4 levels in the numeric scheme described in the WHO Medical Eligibility for Contraceptive Use (MEC).2) Explain the application of the numeric scheme to provision of contraception to women with medical conditions.3) Describe the risks and benefits of contraceptive methods against the risks of pregnancy in women with health conditions.4) Describe key recent updates to the WHO Medical Eligibility Criteria recommendations for women at high risk of HIV, women living with HIV, and women in the immediate post-partum period.
More than half of women of reproductive age in developing countries are in need of contraceptives
No need (43%) In need (57%)
1.5 billion women of reproductive age
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for 2012, New York: Guttmacher 2012,
645 million
222 million
42%
15%
24%
11%8%
Currently using a modern method
Unmet need for contraception
Not sexually active*
Post-partum or desires pregnancy
Infertile
Unintended pregnancy in the developing world
Abortion
80 million unintended pregnancies yearly (67 million among those with unmet need)
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for 2012, New York: Guttmacher 2012,
40 mil-lion
10 million
30 mil-lion
Miscarriage
Live birth
Projected benefits of meeting unmet need in the developing world
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for 2012, New York: Guttmacher 2012,
Number of unintended pregnancies yearly would drop from 80 million to 26 million– 26 million fewer abortions
• 16 million fewer unsafe abortions– 21 million fewer unplanned births– 7 million fewer miscarriages
79,000 fewer maternal deaths yearly
Contraceptive methods
Adapted from: WHO. Family Planning: A Global Handbook
Long acting reversible contraceptives (LARCs)
Tier 1
Tier 2
Tier 4
Tier 3
How do we improve access to contraceptives? Financial commitments from
governments, NGOs, and donors Changes in laws and policies that
prevent equitable access to contraceptive methods
Changes in service provision Changes in medical practices
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for 2012, New York: Guttmacher 2012,
How do we improve access to contraceptives? Financial commitments from
governments, NGOs, and donors Changes in laws and policies that
prevent equitable access to contraceptive methods
Changes in service provision
Changes in medical practices
Addressed by WHO’s Four Cornerstones of evidence-based guidance for family planning
Medical Eligibility Criteria for
Contraceptive Use
The Four Cornerstones of Evidence-Based Guidance for Family Planning
Selected Practice Recommendations for
Contraceptive Use
Decision-Making Tool for Family Planning
Clients and Providers
Evidence-based
guidance
Tools for providers and clients
Handbook for Family Planning
Providers
The Decision-Making Tool for Family Planning Clients and Providers
The Decision-Making Tool for Family Planning Clients and Providers and Reference Guide
WHO Medical Eligibility Criteria (MEC)
Goal: To provide policy- and decision-makers, and the scientific community, with recommendations that can be used to develop or revise national guidelines on medical eligibility criteria for contraceptive use
Recommendations on safety of methods for people with certain health conditions
12
WHO Medical Eligibility Criteria for Contraceptive Use
• Fourth edition published 2009• Recommendations for the use of specific
contraceptives by women who have particular characteristics/medical conditions
• Recent updates since 2009 include 1. recommendations for women at high risk of, or living
with, HIV (2012)2. Recommendations for use of combined hormonal
contraceptives for post-partum women (2010)3. Recommendations for use of progestogen-only
contraceptives among breastfeeding women (2008)
WHO Medical Eligibility Criteria: Organization
• Criteria are organized according to:– Contraceptive method
– Patient characteristics (age, smoking status, etc.)
– Preexisting conditions (hypertension, epilepsy, etc.)
• Criteria use a numeric scheme to provide the recommendations for contraceptives being used for contraceptive purposes only, not for treatment of medical conditions
1 A condition for which there is no restriction for the use of the contraceptive method
2A condition where the advantages of using the method generally outweigh the theoretical or proven risks
3A condition where the theoretical or proven risks usually outweigh the advantages of using the method
4A condition which represents an unacceptable health risk if the contraceptive method is used
WHO Medical Eligibility Criteria: Categories
Conditions Associated w/ ↑ Risk for Adverse Heath Events as a Result of Unintended Pregnancy
Breast cancerMalignant liver tumors (hepatoma) and hepatocellular carcinoma of the liver
Complicated valvular heart diseaseSchistosomiasis with fibrosis of the liver
Diabetes: insulin dependent; with nephropathy/retinopathy/neuropathy or other vascular disease; or of >20 years’ duration
Severe (decompensated) cirrhosis
Endometrial or ovarian cancer Sickle cell disease
Epilepsy Untreated STI
Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)
Stroke
HIV/AIDS Systemic lupus erythematosus
Ischemic heart disease Thrombogenic mutations
Malignant gestational trophoblastic disease Tuberculosis
Conditions posing increased risk for adverse health events as a result of pregnancy
Should consider long-acting, highly-
effective contraception for
these patients
Case Presentation 1
Is this method safe for her?
A. YesB. No
• 32-year-old
• Has a history of
migraines
without aura
• Would like to
use combined
oral contraceptives
18
Migraine
Case Presentation 1
Is this method safe for her?
A. Yes (Category 2)B. No
But: Discuss other options (POP, IUD, implant)
• 32-year-old
• Has a history of
migraines
without aura
• Would like to
use oral contraceptives
Updated guidance from WHOOctober 2008: Progestogen-only contraceptives during lactation
Case Presentation 2
Which hormonal methods are safe for her to use?
A. Combined hormonal methods only
B. Progestin-only methodsC. Any hormonal method
• 30-year-old
• 6 weeks post-
partum• Currently
breastfeeding
Breastfeeding
Breastfeeding
Case Presentation 2
Which hormonal methods are safe for her to use?
A. Combined hormonal methods only
B. Progestin-only methodsC. Any hormonal method
• 30-year-old
• 6 weeks post-
partum• Currently
breastfeeding
Updated Guidance from WHOSeptember 2010: Post-partum CHCs
What increased risk is posed by use of Combined Hormonal Contraceptives? No data specifically delineates risk
of CHC use during the postpartum Baseline risk of VTE in non-pregnant,
non-postpartum women:• 2.4-10/10,000 WY
CHC use increases risk:• 3-7 fold
– Risk most pronounced in the first year of use
Previous WHO MEC recommendation
CHCs in postpartum women
< 21 days postpartum3≥ 21 days postpartum1
CHCs for women during the postpartum period
Condition Recommendation
Clarification
Postpartum
a. < 21 days
Without other risk factors for VTE
3
With other risk factors for VTE
3/4 The category should be assessed according to the number, severity, and combination of VTE risk factors present.
b. > 21 days to 42 days
Without other risk factors for VTE
2
With other risk factors for VTE
2/3 The category should be assessed according to the number, severity, and combination of VTE risk factors present.
c. > 42 days 1
Updated Guidance from WHOFebruary 2012: Hormonal contraception and HIV
2009 MEC Recommendation for women at high risk of HIV
COC/CIC/POP 1
Patch/Ring 1
DMPA/NET-EN 1
Implant 1
Questions considered: Does hormonal contraception increase risk for:1. HIV acquisition in non-infected
women?
2. HIV disease progression in HIV-positive women?
3. HIV transmission to non-infected male partners?
Does hormonal contraception increase risk for:
1. HIV acquisition in non-infected women?
2. HIV disease progression in HIV-positive women?
3. HIV transmission to non-infected male partners?
• Unclear which biological mechanisms may be relevant
• Unclear if animal data or doses apply to humans
• …findings are inconsistent with other strong studies, and all have limitations
Several potential biological mechanisms postulated
Some possible mechanisms supported by animal data
While some strong studies suggest increased risk… 33
Does hormonal contraception (HC) biologically alter risk of HIV acquisition?
OCPs and Net-EN: increased risk not likely
The available body of evidence does not suggest an increase in risk of HIV acquisition associated with use of OCPs
Evidence specific to Net-En is limited, but no currently available study suggests that Net-En is likely to increase HIV risk, including the largest study available to date
34
DMPA/non-specified injectables
Available data do not rule out the possibility of increased risk of HIV acquisition associated with injectables, but data are inconsistent and do not establish a clear causal relationship
DMPA and Net-En share some similarities, but are different types of progestins and could theoretically have different biological effects
35
New 2012 MEC Recommendation for women at high risk of HIV
COC/CIC/POP 1
Patch/Ring 1
DMPA/NET-EN 11 See clarification
Implant 1
ClarificationSome studies suggest that women using progestogen-only injectable contraception may be at increased risk of HIV acquisition, other studies do not show this association. A WHO expert group reviewed all the available evidence and agreed that the data were not sufficiently conclusive to change current guidance. However, because of the inconclusive nature of the body of evidence on possible increased risk of HIV acquisition, women using progestogen-only injectable contraception should be strongly advised to also always use condoms, male or female, and other HIV preventive measures. Expansion of contraceptive method mix and further research on the relationship between hormonal contraception and HIV infection is essential. These recommendations will be continually reviewed in light of new evidence.
37
Medical Eligibility Criteria for
Contraceptive Use
The Four Cornerstones of Evidence-Based Guidance for Family Planning
Selected Practice Recommendations for
Contraceptive Use
Decision-Making Tool for Family Planning
Clients and Providers
Evidence-based
guidance
Tools for providers and clients
Handbook for Family Planning
Providers
MEC available in multiple languages
MEC Wheel
MEC mobile (2012)
FHI360 Quick Reference for MEC (2009)
122
3
4
40
Reproductive choices and family planning for people living with HIV (updated version to be released soon)
A guide to family planning for CHWs and their clients (released June 2012)
Module on PITC for DMT (to be released soon)
Module on Provider Initiated HIV testing and counselling (PITC)
MEC adaptations by Pacific Island countries (WPRO)
UK MEC on the IPAD 2011Present versions of MEC wheel
US Medical Eligibility Criteria for Contraceptive Use
US Medical Eligibility Criteria for Contraceptive Use
• CDC published criteria in June ‘10– Based on the 4th edition of the World Health
Organization guidelines from ‘09– Adapted for US women by panel of experts
and CDC
http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/USMEC.htm
Thank you!
Acknowledgments: Drs Mario Festin and Mary Lyn
Gaffield, Promoting Family Planning, Department of Reproductive Health and Research
Dr Kathryn Curtis, Division of Reproductive Health, Centers for Disease Control and Prevention
RHEDI: The Center for Reproductive Health in Family Medicine
44
Prospective, observational studies of OC pills & HIV acquisitionAdjusted OR, IIR, or HR (log scale) and 95% CI
0.1 1 10
Plummer 1991
Sinei 1996
Kilmarx 1998
Heffron 2011*
Feldblum 2010
Baeten 2007
Morrison 2007/2010*
Kiddugavu 2003
Kapiga 1998
Saracco 1993
Wand 2012
Reid 2010
Laga 1993
Morrison 2012*
Myer 2007Ungchusak 1996
OCs DECREASE HIV risk OCs INCREASE HIV risk
No relative risk calculated
* includes MSM and Cox estimates NO EFFECT
Prospective, observational studies of injectables & HIV acquisitionAdjusted OR, IIR, or HR (log scale) and 95% CI
0.1 1 10Injectables DECREASE HIV risk Injectables INCREASE HIV risk
Ungchusak 1996
Kumwenda 2008
Wand 2012
Feldblum 2010
Heffron 2011*
Bulterys 1994
Kleinschmidt 2007
Baeten 2007
Watson-Jones 2009
Kilmarx 1998
Morrison 2007/2010*
Morrison 2012*
Myer 2007
Reid 2010
Kiddugavu 2003Kapiga 1998
= DMPA alone= Net-En alone= Any in-jectable
LEGEND
= Mostly in-jectable, some OC
* includes MSM and Cox estimates NO EFFECT
Does hormonal contraception increase risk for:
1. HIV acquisition in non-infected women?
2. HIV disease progression in HIV-positive women?
3. HIV transmission to non-infected male partners?
4. Interaction with antiretroviral therapy?
08_XXX_MM
48
Key Questions
Are women living with HIV who use hormonal contraception at increased risk of:
1. Death or progression to AIDSa. Measured by CD4 <200, initiation of
ART, or clinical AIDS
2. Change in CD4 or viral load (considered, evidence limited, will not discuss today)
HIV Progression: Results overviewMortality or progression to AIDS
7 observational studies find no association between HC and HIV disease progression
1 RCT found increased rates of – time to CD4 count < 200 and – time to CD4 count < 200 and mortality – among HC users compared with IUD users (both
OC and DMPA users, in both ITT and actual-use analyses)
Conclusion
New evidence remains consistent and generally reassuring
Prevention of unintended pregnancy among women living with HIV is critical, for health of women and PMTCT