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

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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

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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

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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