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WHO's Medical Eligibility Criteria: Global Contraceptive Guidance
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
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
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
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
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
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.
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
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
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
Hinweis der Redaktion
Talking PointsI currently have no conflicts of interest.This presentation may include information that is not on FDA-required product labels.ReferencesBulleted list of references here
Talking Points
Talking PointsOne of the most important strategies to decrease the proportion of unintended pregnancies is the use of effective family planning methods. This chart shows the relative typical effectiveness of various family planning methods – typical effectiveness refers to how effective the different methods are at preventing pregnancy during actual use, including inconsistent or incorrect use. At the top you will find male and female sterilization, along with long acting reversible contraceptives or LARCS, which include intrauterine devices or IUDs and contraceptive implants. More commonly used, and less effective methods, are listed below such as injectables and oral contraceptives shown in the second row from the top and condoms shown in the third row from the top. ReferencesAdapted from: WHO. Family Planning: A Global Handbook
Talking PointsThe intent on successfully reaching HP 2020 should include improving contraception access. The CDC addresses ways in which we can improve contraception access .According to the CDC, contraception access can be improved in the following ways:Improving access to and use of the most effective contraception, i.e. Tier 1 contraception or LARC methods—Educating providers about the US MEC through webinars such as this one, and educating providers that populations (such as teenagers) that have been traditionally excluded from certain LARC methods like the IUD may, in fact, be appropriate candidates.Disseminating information to both consumers and health care providers about contraception through new venues of communication such as social marketingAnd addressing cost barriers to contraception use.Referenceshttp://www.cdc.gov/WinnableBattles/TeenPregnancy/index.htm
Talking PointsThe intent on successfully reaching HP 2020 should include improving contraception access. The CDC addresses ways in which we can improve contraception access .According to the CDC, contraception access can be improved in the following ways:Improving access to and use of the most effective contraception, i.e. Tier 1 contraception or LARC methods—Educating providers about the US MEC through webinars such as this one, and educating providers that populations (such as teenagers) that have been traditionally excluded from certain LARC methods like the IUD may, in fact, be appropriate candidates.Disseminating information to both consumers and health care providers about contraception through new venues of communication such as social marketingAnd addressing cost barriers to contraception use.Referenceshttp://www.cdc.gov/WinnableBattles/TeenPregnancy/index.htm
Talking PointsWhen you examine the MMWR, you will see that it is organized into type of contraceptive method, such as combined hormonal contraception, progestin-only methods, etc. The US MEC not only addresses women with underlying medical conditions, but also certain characteristics, such as age, smoking status etc.A numeric scheme is used to indicate to the health care provider about the risk/benefit ratio regarding safety of a particular contraceptive method in a woman with that medical condition. The MEC does not address whether the contraceptive method treats that medical condition, baring in mind, however, that there may be a different risk/benefit consideration when a method is being used for treatment of a particular medical condition.Referenceshttp://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf
Talking PointsThe numeric scheme used in the US MEC is a 1 through 4 scale.A number 1 means that there is no restriction in using a particular contraceptive method for a woman with a particular medical condition. A number 2 means that most evidence suggests that it is generally safe to use a particular method with a particular medical condition, and that the advantages of using the method generally outweigh the theoretical or proven risks.A number 3 means that the theoretical or proven risks of the method usually outweigh the benefits of using that method, and other methods should be considered, if possibleA number 4 means that the risk of using a particular contraceptive method for a woman with a particular medical condition is unacceptable and alternative methods should be chosen.Referenceshttp://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf
Talking PointsAside from the numeric scheme indicating safety of particular contraceptive methods with certain medical conditions or characteristics, the other thing to be aware of in the MMWR is a list of medical conditions that can be worsened should an unintended pregnancy occur. [CLICK] Thus, regarding the medical conditions listed, providers should seriously consider counseling about and using LARC methods for these women who do not wish to achieve pregnancy in the near future.Referenceshttp://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf
Talking PointsHere is one example of interim guidance provided by WHO. Most guidance is updated every 4 years, however, there may be important or ground breaking evidence seen prior to the 4 year update in which we place interim guidance.This statement noted in this slide is interim guidance placed by the WHO regarding combined hormonal contraception during the postpartum period.ReferencesBulleted list of references here
Talking PointsGoing to the Colored chart on the CDC website, we can see that under the characteristic of “Breastfeeding,” using a combined hormonal method is given a number 3, because of theoretical and some supporting evidence which suggest that breastfeeding performance may be affected by combined hormonal methods. However, after one month postpartum, the concern about breastfeeding performance once lactation is established are less, and thus was given a “2”. Progestin-only methods, are given a number 2, because there are little data to support a concern about how these methods affect breastfeeding performance. ReferencesBulleted list of references here
Talking PointsGoing to the Colored chart on the CDC website, we can see that under the characteristic of “Breastfeeding,” using a combined hormonal method is given a number 3, because of theoretical and some supporting evidence which suggest that breastfeeding performance may be affected by combined hormonal methods. However, after one month postpartum, the concern about breastfeeding performance once lactation is established are less, and thus was given a “2”. Progestin-only methods, are given a number 2, because there are little data to support a concern about how these methods affect breastfeeding performance. ReferencesBulleted list of references here
Talking PointsHere is one example of interim guidance provided by WHO. Most guidance is updated every 4 years, however, there may be important or ground breaking evidence seen prior to the 4 year update in which we place interim guidance.This statement noted in this slide is interim guidance placed by the WHO regarding combined hormonal contraception during the postpartum period.ReferencesBulleted list of references here
Talking PointsTo provide you a little background about this interim guidance, what prompted the WHO to place this updated guidance was some new evidence that CHC in the postpartum period is more dangerous than previously thought and that the risk of VTE persists longer than previously thought.ReferencesBulleted list of references here
Talking PointsAfter examining the new evidence, the consultation group at WHO refined the recommendations depending on whether VTE risk factors exists and into three time periods of less than 21 days, 21-42 days, and then >42 days postpartum. Overall, these recommendations are slightly more restrictive than the recommendations given in the prior WHO MEC.ReferencesBulleted list of references here
Talking PointsHere is one example of interim guidance provided by WHO. Most guidance is updated every 4 years, however, there may be important or ground breaking evidence seen prior to the 4 year update in which we place interim guidance.This statement noted in this slide is interim guidance placed by the WHO regarding combined hormonal contraception during the postpartum period.ReferencesBulleted list of references here
The recent WHO technical consultation addressed several issues – HIV acquisition in non-infected women (recommendations for women WITHOUT HIV=, HIV disease progression in HIV-infected women, and HIV transmission to non-infected male partners. It did not address interaction with antiretroviral therapy.Access to voluntary family planning is a critical component of comprehensive reproductive health care for women living with HIV given its potential to decrease maternal mortality and prevent mother-to-child transmission of the virus. Because hormonal contraceptive methods are among the most popular, effective and accessible family planning methods, understanding their safety in women at risk of, and living with, HIV is crucial.
The recent WHO technical consultation addressed several issues – HIV acquisition in non-infected women (recommendations for women WITHOUT HIV), HIV disease progression in HIV-infected women, and HIV transmission to non-infected male partners. It did not address interaction with antiretroviral therapy.Access to voluntary family planning is a critical component of comprehensive reproductive health care for women living with HIV given its potential to decrease maternal mortality and prevent mother-to-child transmission of the virus. Because hormonal contraceptive methods are among the most popular, effective and accessible family planning methods, understanding their safety in women at risk of, and living with, HIV is crucial.
Talking PointsThis is a depiction of the MMWR document that was released in June 2010 by the CDCs Division of Reproductive Health.This document is intended for health care providers to use when counseling women, men, and couples about contraceptive method choice, as a way to increase access to contraception and most importantly to increase use of the most effective methods.ReferencesBulleted list of references here
The recent WHO technical consultation addressed several issues – HIV acquisition in non-infected women (recommendations for women WITHOUT HIV), HIV disease progression in HIV-infected women, and HIV transmission to non-infected male partners. It did not address interaction with antiretroviral therapy.Access to voluntary family planning is a critical component of comprehensive reproductive health care for women living with HIV given its potential to decrease maternal mortality and prevent mother-to-child transmission of the virus. Because hormonal contraceptive methods are among the most popular, effective and accessible family planning methods, understanding their safety in women at risk of, and living with, HIV is crucial.