Contraceptive Update: CDC Medical Eligibility Criteria for Women With Certain Characteristics and Medical Conditions ARHP Learning Lab May 18, 2011 Emily Godfrey, MD, MPH

Expert Medical Advisory Committee Melanie Deal, WHNP Student Health Services, SF State University San Francisco, CA David Grimes, MD University of North Carolina School of Medicine Chapel Hill, North Carolina David Turok, MD University of Utah, Dept. of Ob/Gyn Salt Lake City, UT Susan Wysocki, WHNP-BC, FAANP National Association of NPs in Women’s Health Washington, DC

Learning Objectives List the 4 levels in the numeric scheme described in the US Medical Eligibility Criteria for Contraceptive Use, 2010 Explain the application of the numeric scheme to prescriptive practices for women with co- morbid conditions Describe the risks and benefits of the different contraceptive methods against the risks of pregnancy in women with health-related concerns

Unplanned pregnancy – U.S. Unintended Pregnancy Intended Unintended (49%)6.4 million pregnancies 51% 7% 20% 22% Fetal Loss Abortion Birth Finer LB, et al. Persp Sex Reprod Health million 1.4 million

Goals to Address Unintended Pregnancy Healthy People 2020 ▪ Increase proportion of pregnancies that are intended ▫51%  56% ▪ Reduce proportion of females experiencing pregnancy despite reversible contraception use ▫12.4%  9.9% CDC Winnable Battles ▪ Public health priorities with large-scale impact on health and with known, effective strategies to intervene ▪ To identify optimal strategies and to rally resources and partnerships to accelerate a measurable impact on health ▪ Prevention of teen pregnancy is one of the 6 winnable battles

Typical Effectiveness of Contraception Adapted from: WHO. Family Planning: A Global Handbook Long acting reversible contraceptives (LARCs) Tier 1 Tier 2 Tier 4 Tier 3

Contraception Use Mosher, W et al

Improving Contraception Access Improve access to and use of the most effective contraceptives Address barriers to use of Long Acting Reversible Contraceptives (LARC) Educate Providers ▪ Ensure dissemination of US MEC ▪ Recommend that young women and nulliparous may be eligible to use LARC methods Increase interest and acceptance through education and social marketing Address cost barriers to ensure publically funded services include LARC

US Medical Eligibility Criteria for Contraceptive Use 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 Recommendations for the use of specific contraceptives by women who have particular characteristics/medical conditions

WHO  CDC US MEC Existing WHO guidance Breastfeeding and hormonal methods Valvular heart disease and IUDs Postpartum IUD insertion Ovarian cancer and IUDs Fibroids and IUDs DVT/PE and hormonal methods and IUDs

WHO  CDC US MEC New medical conditions Rheumatoid arthritis Endometrial hyperplasia Inflammatory bowel disease Bariatric surgery Solid organ transplantation Peripartum cardiomyopathy

US Medical Eligibility Criteria for Contraceptive Use

US 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 No restriction for the use of the contraceptive method for a woman with that medical condition 2 Advantages of using the method generally outweigh the theoretical or proven risks 3 Theoretical or proven risks of the method usually outweigh the advantages – or that there are no other methods that are available or acceptable to the women with that medical condition 4 Unacceptable health risk if the contraceptive method is used by a woman with that medical condition US Medical Eligibility Criteria: Categories

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 diseasePeripartum cardiomyopathy Diabetes: insulin dependent; with nephropathy/retinopathy/neuropathy or other vascular disease; or of >20 years’ duration Schistosomiasis with fibrosis of the liver Endometrial or ovarian cancerSevere (decompensated) cirrhosis EpilepsySickle cell disease Hypertension (systolic > 160 mm Hg or diastolic > 100 mm Hg) Solid organ transplantation within the past 2 years History of bariatric surgery within past 2 yearsStroke HIV/AIDSSystemic lupus erythematosus Ischemic heart diseaseThrombogenic mutations Malignant gestational trophoblastic diseaseTuberculosis US Medical Eligibility Criteria: ↑ Risk for Adverse Health Events Should consider long- acting, highly-effective contraception for these patients

Pregnancy-Related Mortality Increase in pregnancy-related mortality, ▪ De-identified death certificates of women who died during or within 1 year of pregnancy ▪ Matched birth or fetal death certificates Pregnancy-related mortality ▪ 14.5 per 100,000 live births ▫African American, 3-4 times greater risk ▫Decreased deaths due to hemorrhage and hypertensive disorders ▫Increased deaths due to medical conditions, especially CVD Berg, CJ et al. Obstet Gynecol. 2010;116:

Case Presentation 1 Which hormonal methods are safe for her to use? A. Combined hormonal methods only B. Progestin-only methods only C. Any hormonal method 30-year-old PPD #2 Ready to be discharged from hospital & desires contraception Plans to breastfeed

Breastfeeding

Case Presentation 1 Which hormonal methods are safe for her to use? A. Combined hormonal methods only B. Progestin-only methods only C. Any hormonal method 30-year-old PPD #2 Ready to be discharged from hospital & desires contraception Plans to breastfeed

Case Presentation 2 Is this method safe for her? A. Yes B. No 25-year-old Has Crohn’s disease Desires long- term reversible contraception Thinking about levonorgestrel- releasing IUD

Inflammatory Bowel Disease

Case Presentation 2 Is this method safe for her? A. Yes (Category 1) B. No 25-year-old Has Crohn’s disease Desires long- term reversible contraception Thinking about levonorgestrel- releasing IUD

Case Presentation 3 What do you need to know before deciding whether to recommend this method? A. How much weight has she lost? B. What type of surgery did she have? C. What pill formulation did she use previously? 30-year-old History of bariatric surgery 6 months ago Was using COCs before surgery & wants to restart

Bariatric surgery Most effective weight loss treatment for morbid obesity From 1998 to 2005, incidence increased 800% Women account for 83% of procedures among reproductive age (ages 18-45)

Types of Bariatric surgery Restrictive procedures: ▪ Decrease storage capacity of stomach ▪ Ex: vertical banded gastroplasty, laparoscopic adjustable gastric band, laparoscopic sleeve gastrectomy Malabsorptive procedures: ▪ Decrease absorption of nutrients and calories by shortening functional length of small intestine ▪ Ex: Roux-en-Y gastric bypass (most common in US), biliopancreatic diversion

Bariatric Surgery Consensus: Pregnancy should be avoided for months after surgery Paulen, ME et al. Contraception 82 (2010)

History of Bariatric Surgery

Case Presentation 3 What do you need to know before deciding whether to recommend this method? A. How much weight has she lost? B. What type of surgery did she have? C. What pill formulation did she use previously? 30-year-old History of bariatric surgery 6 months ago Was using COCs before surgery & wants to restart

Next Steps Work with partners: ▪ dissemination ▪ implementation Keeping guidance up to date

Updated Guidance from WHO September 2010

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: ▪ /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 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

US MEC-Postpartum period New evidence Updated recommendations from WHO ▪ CDC held consultation in Jan 2011 ▪ Substantial increased risk in early weeks postpartum with no benefit ▪ Multiple risk factors Access issues Safety of other contraceptive methods Will be published as MMWR

Next Steps Work with partners: ▪ dissemination ▪ implementation Keeping guidance up to date Research gaps US adaptation of WHO Selected Practice Recommendations for Contraceptive Use

Resources US MEC published in CDC’s Morbidity and Mortality Weekly Report (MMWR): ▪ m?s_cid=rr5904a1_w m?s_cid=rr5904a1_w CDC evidence-based family planning guidance documents: ▪ ncy/USMEC.htm ncy/USMEC.htm WHO evidence-based family planning guidance documents: ▪ planning/en/index.html planning/en/index.html

Additional Resources Association of Reproductive Health Professionals (ARHP) ▪ National Association of Nurse Practitioners in Women’s Health (NPWH) ▪