WHO's Medical Eligibility Criteria: Global Contraceptive Guidance

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  • 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.
  • WHO's Medical Eligibility Criteria: Global Contraceptive Guidance

    1. 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. 2. Disclosure • • No current conflicts of interest Some recommendations may be inconsistent with package labeling
    3. 3. Acknowledgement of Support • RHEDI
    4. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 17. Case Presentation 1  Is this method safe for her? A. B. Yes No
    18. 18. Migraine 18
    19. 19. Case Presentation 1  Is this method safe for her? A. B. Yes (Category 2) No But: Discuss other options (POP, IUD, implant)
    20. 20. Updated guidance from WHO October 2008: Progestogen-only contraceptives during lactation
    21. 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. 22. Breastfeeding
    23. 23. Breastfeeding
    24. 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. 25. Updated Guidance from WHO September 2010: Post-partum CHCs
    26. 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. 27. Previous WHO MEC recommendation CHCs in postpartum women < 21 days postpartum 3 ≥ 21 days postpartum 1
    28. 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. 29. Updated Guidance from WHO February 2012: Hormonal contraception and HIV
    30. 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. 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. 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. 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. 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. 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. 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. 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. 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. 39. 3 2 2 4 1 FHI360 Quick Reference for MEC (2009) MEC available in multiple languages MEC Wheel MEC mobile (2012)
    40. 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. 41. MEC adaptations by Pacific Island countries (WPRO) Present versions of MEC wheel UK MEC on the IPAD 2011
    42. 42. US Medical Eligibility Criteria for Contraceptive Use
    43. 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. 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. 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. 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. 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. 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. 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. 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

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