1. WHO Medical Eligibility Criteria
for Contraceptive Use
AAFP Global Workshop
September 2012
Sharon Phillips MD, MPH
Medical Officer
Department of Reproductive Health and
Research, World Health Organization

2. Disclosure
•
•
No current conflicts of interest
Some recommendations may be inconsistent
with package labeling

3. Acknowledgement of Support
•
RHEDI

4. 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.

5. More than half of women of reproductive
age in developing countries are in need of
contraceptives
1.5 billion women of reproductive age
No need
(43%)
Infertile
Post-partum
or desires
pregnancy
In need (57%)
8%
11%
42%
Not sexually
active*
Currently using a
modern method
645 million
24%
15%
Unmet need for contraception
222 million
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for

6. Unintended pregnancy in the developing
world
80 million unintended pregnancies yearly
(67 million among those with unmet need)
Live
birth
0%
0%
30
million
Abortion
40
million
10
million
Miscarriage
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive Services—Estimates for

7. Projected benefits of meeting
unmet need in the developing world
 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
Singh S and Darroch JE, Adding It Up: Costs and Benefits of Contraceptive

8. Contraceptive methods
Long acting reversible contraceptives (LARCs)
Tier 1
Tier 2
Tier 3
Tier 4
Adapted from: WHO. Family Planning: A Global Handbook

9. 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,

10. 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

11. The Four Cornerstones of EvidenceBased Guidance for Family Planning
Medical Eligibility
Criteria for
Contraceptive Use
Selected Practice
Recommendations for
Contraceptive Use
Evidencebased
guidance
The Decision-Making
Tool for Family Planning
Clients and Providers
The Decision-Making Tool for Family Planning Clients
and Providers and Reference Guide
Decision-Making Tool
for Family Planning
Clients and Providers
Tools for
providers
and clients
Handbook for
Family Planning
Providers

12. WHO Medical Eligibility Criteria (MEC)


Goal: To provide policy- and decisionmakers, 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

13. 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)

14. 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

15. WHO Medical Eligibility Criteria: Categories
1
2
A condition for which there is no restriction for the
use of the contraceptive method
A condition where the advantages of using the
method generally outweigh the theoretical or proven
risks
3
A condition where the theoretical or proven risks
usually outweigh the advantages of using the method
4
A condition which represents an unacceptable health
risk if the contraceptive method is used

16. Conditions posing increased risk for adverse
health events as a result of pregnancy
Conditions Associated w/ ↑ Risk for Adverse Heath Events as a Result of Unintended Pregnancy
Should consider longacting, highly-effective
contraception for these
patients
Breast cancer
Malignant liver tumors (hepatoma) and
hepatocellular carcinoma of the liver
Complicated valvular heart disease
Schistosomiasis 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

17. Case Presentation 1

Is this method safe for her?
A.
B.
Yes
No

18. Migraine
18

19. Case Presentation 1

Is this method safe
for her?
A.
B.
Yes (Category 2)
No
But: Discuss other options
(POP, IUD, implant)

20. Updated guidance from WHO
October 2008: Progestogen-only
contraceptives during lactation

21. Case Presentation 2

Which hormonal methods
are safe for her to use?
A.
B.
C.
Combined hormonal methods only
Progestin-only methods
Any hormonal method

22. Breastfeeding

23. Breastfeeding

24. Case Presentation 2

Which hormonal methods
are safe for her to use?
A.
B.
C.
Combined hormonal methods only
Progestin-only methods
Any hormonal method

25. Updated Guidance from WHO
September 2010: Post-partum CHCs

26. 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, nonpostpartum women:
• 2.4-10/10,000 WY
CHC use increases risk:
• 3-7 fold
– Risk most pronounced in the first year of
use

27. Previous WHO MEC
recommendation
CHCs in postpartum women
< 21 days postpartum
3
≥ 21 days postpartum
1

28. CHCs for women during the postpartum period
Condition
Recommendation
Clarification
Postpartum
a. < 21 days
Without other risk factors
for VTE
With other risk factors
for VTE
3
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
With other risk factors
for VTE
c. > 42 days
2
2/3
1
The category should be assessed
according to the number,
severity, and combination of VTE
risk factors present.

29. Updated Guidance from WHO
February 2012: Hormonal contraception
and HIV

30. 2009 MEC Recommendation for
women at high risk of HIV
COC/CIC/POP
1
Patch/Ring
1
DMPA/NET-EN
1
Implant
1

31. Questions considered: Does hormonal
contraception increase risk for:
1.
2.
3.
HIV acquisition in non-infected
women?
HIV disease progression in HIVpositive women?
HIV transmission to non-infected male
partners?

32. Does hormonal contraception increase
risk for:
1.
2.
3.
HIV acquisition in non-infected
women?
HIV disease progression in HIVpositive women?
HIV transmission to non-infected male
partners?

33. Does hormonal contraception (HC)
biologically alter risk of HIV
acquisition?



Several potential
biological mechanisms
postulated
Some possible
mechanisms supported
by animal data
While some strong
studies suggest
increased risk…
• 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
33

34. 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

35. 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

36. New 2012 MEC Recommendation for
women at high risk of HIV
COC/CIC/POP
1
Patch/Ring
1
DMPA/NET-EN
11
Implant
1
See clarification

37. Clarification
Some 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

38. The Four Cornerstones of EvidenceBased Guidance for Family Planning
Medical Eligibility
Criteria for
Contraceptive Use
Selected Practice
Recommendations for
Contraceptive Use
Evidencebased
guidance
Tools for
providers
and clients
Decision-Making Tool
for Family Planning
Clients and Providers
Handbook for
Family Planning
Providers

39. 3
2
2
4
1
FHI360 Quick Reference for MEC
(2009)
MEC available in multiple languages
MEC Wheel
MEC mobile (2012)

40. Module on Provider Initiated
HIV testing and counselling
(PITC)
A guide to family planning for CHWs
and their clients (released June 2012)
Module on PITC for DMT (to be
released soon)
Reproductive choices and family
planning for people living with HIV
(updated version to be released soon)
40

41. MEC adaptations by Pacific Island countries (WPRO)
Present versions of MEC wheel
UK MEC on the IPAD 2011

42. US Medical Eligibility Criteria for Contraceptive Use

43. 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/Uninten
dedPregnancy/USMEC.htm

44. 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

45. Prospective, observational studies of OC pills & HIV
acquisition
Adjusted OR, IIR, or HR (log scale) and 95% CI
Plummer 1991
Sinei 1996
Kilmarx 1998
Heffron 2011*
Feldblum 2010
Baeten 2007
Morrison 2007/2010*
Kiddugavu 2003
Kapiga 1998
Saracco 1993
No relative risk calculated
Wand 2012
Reid 2010
Laga 1993
Morrison 2012*
Myer 2007
Ungchusak 1996
OCs DECREASE HIV risk
0.1
* includes MSM and Cox estimates
1
NO EFFECT
OCs INCREASE HIV risk
10

46. Prospective, observational studies of injectables & HIV
acquisition
Adjusted OR, IIR, or HR (log scale) and 95% CI
Ungchusak 1996
Kumwenda 2008
Wand 2012
Feldblum 2010
Heffron 2011*
Bulterys 1994
Kleinschmidt 2007
Baeten 2007
Watson-Jones 2009
Kilmarx 1998
LEGEND
Morrison 2007/2010*
Morrison 2012*
= DMPA
Myer 2007
= Net-En
alone
alone
Reid 2010
= Any
injectable
= Mostly
injectable,
some OC
Kiddugavu 2003
Kapiga 1998
0.1
* includes MSM and Cox estimates
Injectables DECREASE HIV risk
1
NO EFFECT
Injectables INCREASE HIV risk
10

47. Does hormonal contraception increase
risk for:
1.
2.
3.
4.
HIV acquisition in non-infected
women?
HIV disease progression in HIVpositive women?
HIV transmission to non-infected male
partners?
Interaction with antiretroviral
therapy?

48. Key Questions
Are women living with HIV who use
hormonal contraception at increased
risk of:
1. Death or progression to AIDS
a. Measured by CD4 <200, initiation of ART, or
clinical AIDS
2. Change in CD4 or viral load (considered,
evidence limited, will not discuss today)
08
_X
XX

49. HIV Progression: Results overview
Mortality 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)

50. 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