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 financial conflicts of interest Some recommendations may be inconsistent with package labeling Recommendations presented are based on WHO guidance; US guidance differs in some cases

3. Acknowledgement of Support

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 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 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 Currently using a modern method Unmet need for contraception Not sexually active Post-partum or desires pregnancy Infertile

6. 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, Miscarriage Live birth

7. 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

8. 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,

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 Addressed by WHO’s Four Cornerstones of evidence-based guidance for family planning

10. 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

11. 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 11

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)

13. 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

14. 1 A condition for which there is no restriction for the use of the contraceptive method 2 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 WHO Medical Eligibility Criteria: Categories

15. Conditions Associated w/ ↑ Risk for Adverse Heath Events as a Result of Unintended Pregnancy Breast cancer Malignant 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 cancerSickle cell disease EpilepsyUntreated STI Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg)Stroke HIV/AIDSSystemic lupus erythematosus Ischemic heart diseaseThrombogenic mutations Malignant gestational trophoblastic diseaseTuberculosis Conditions posing increased risk for adverse health events as a result of pregnancy Should consider long- acting, highly-effective contraception for these patients

16. Case Presentation 1  Is this method safe for her? A.Yes B.No 32-year-old Has a history of migraines without aura Would like to use combined oral contraceptives

17. 17 Migraine

18. 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

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

20. Case Presentation 2  Which hormonal methods are safe for her to use? A.Combined hormonal methods only B.Progestin-only methods C.Any hormonal method 30-year-old 6 weeks post- partum Currently breastfeeding

21. Breastfeeding

22. Breastfeeding

23. Case Presentation 2  Which hormonal methods are safe for her to use? A.Combined hormonal methods only B.Progestin-only methods C.Any hormonal method 30-year-old 6 weeks post- partum Currently breastfeeding

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

25. 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

26. Previous WHO MEC recommendation CHCs in postpartum women < 21 days postpartum3 ≥ 21 days postpartum1

27. CHCs for women during the postpartum period ConditionRecommendationClarification Postpartum a. < 21 days Without other risk factors for VTE 3 With other risk factors for VTE 3/4The 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 2/3The category should be assessed according to the number, severity, and combination of VTE risk factors present. c. > 42 days1

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

29. 2009 MEC Recommendation for women at high risk of HIV COC/CIC/POP1 Patch/Ring1 DMPA/NET-EN1 Implant1

30. 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?

31. 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 31

32. 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 32

33. New 2012 MEC Recommendation for women at high risk of HIV COC/CIC/POP1 Patch/Ring1 DMPA/NET-EN1 See clarification Implant1

34. 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. 34

35. 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

36. MEC available in multiple languages MEC Wheel MEC mobile (2012) FHI360 Quick Reference for MEC (2009) 1 22 3 4

37. 37 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)

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

39. US Medical Eligibility Criteria for Contraceptive Use

40. CDC published criteria in June ‘10 –Based on the 4 th 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

41. 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 Education in Family Medicine 41 http://www.who.int/reproductivehealth/publications/fami ly_planning/en/ CONTACT ME: sharonphillipsmd@gmail.com