1. Choosing a Birth Control Method SNAP, 2014

2. Learning Objectives At the conclusion of this program, participants will be able to: Describe contraceptives currently available in the U.S. Discuss pros, cons, and efficacy of appropriate methods with patients Provide evidence-based contraceptive care Practice effective strategies to achieve patients’ contraceptive success Develop individualized strategies for provision of contraception to patients

3. Unintended Pregnancy in the US Finer LB. Contraception. 2011; Finer LB. Fertil Steril. 2012; Finer LB. Perspect Sex Reprod Health. 2006; Henshaw SK. Fam Plann Perspect. 1998. Unintended 49% Unintended births Elective abortions Fetal losses Intended: 51% 51% 23% 21% 5% 6.7 MILLION PREGNANCIES over one year

4. 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 http://healthypeople.gov/2020/ http://www.cdc.gov/WinnableBattles/TeenPregnancy/index.htm

5. Contraception Use Mosher, W et al. 2010.

6. 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 http://www.cdc.gov/WinnableBattles/TeenPregnancy/index.htm

7. US Medical Eligibility Criteria for Contraceptive Use

8. Current Contraceptive Options Extremely effective Effective >99% of the time Male/Female Sterilization IUD/IUS Implants Very effective Effective >92% of the time Pills Injectables Patch Ring Moderately effective Effective ~80% of the time Male/Female Condom Withdrawal Sponge Diaphragm Effective Effective up to 75% of the time Fertility Awareness Cervical cap Spermicide

9. Polling Question Which contraceptive method do you most often recommend to your patients?

10. 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

11. Case Study: Gwen Age: 43 Uses OCs Has two children Does not desire more children What would you recommend?

12. Standard of care = no-scalpel vasectomy (NSV) ▪ Small (few mms) opening is made in the scrotal sac skin to deliver vas deferens ▪ Ligate/cauterize ▪ No scalpel ▪ No sutures Extremely Effective Male Sterilization Hillis SD. Obstet Gynecol. 1999. The New York Times 2009. Nirapathpongporn A. The Lancet. 1990. Peterson H. U.S. Collaborative Review of Sterilization. 1996. Pollack AE. Contraceptive Technology. 2007. Trussel J. Contraceptive Technology. 2011.

13. Ligating Blocking (clips or rings) Cauterizing Peterson H. U.S. Collaborative Review of Sterilization. 1996. Hillis SD. Obstet Gynecol. 1999. Pollack AE. Contraceptive Technology. 2007. Ogburn T. Obstet Gynecol Clin North Am. 2007. et al. Female Sterilization: Surgical Tubal Occlusion Sterilization Regret Extremely Effective

14. Brand name: Essure ® Micro-inserts placed into proximal fallopian tubes 99.83% effective Choosing Essure. 2012. Pollack AE. Contraceptive Technology. 2007. Ogburn T. Obstet Gynecol Clin North Am. 2007. et al. Female Sterilization: Nonsurgical Tubal Occlusion Extremely Effective

15. Levonorgestrel Intrauterine System (LNG 52 IUS) Brand name: Mirena ® 20 mcg levonorgestrel/day Approved for 5 years of use Amenorrhea in ~20% of users by 1 year Mirena Prescribing Information. 2000.: Trussel J. Contraceptive Technology. 2011; Hidalgo M. Contraception. 2002. Extremely Effective www.youtube.com/watch?v=hlfV8tKgw6E

16. Levonorgestrel Intrauterine System (LNG 13.5 IUS) Brand name: Skyla ® 14 mcg levonorgestrel/day Approved for 3 years of use Amenorrhea in ~6% of users by 1 year Skyla Prescribing Information. 2013. Trussel J. Contraceptive Technology. 2011 Extremely Effective

17. Brand name: ParaGard ® Copper ions Approved for 10 years of use Can be used as emergency contraceptive Thonneau, PF. Am J Obstet Gynecol. 2008. Forrtney JA. J Reprod Med. 1999. Trussel J. Contraceptive Technology. 2011. Copper-T IUD Extremely Effective www.youtube.com/watch?v=FuPFbgSm0QQ

18. Characteristics of Intrauterine Contraception Very high patient satisfaction Rapid return of fertility Safe Long-term protection Highly effective May be inserted after delivery or abortion Belhadj H, et al. Contraception. 1986.; Skjeldestad F, et al. Advances in Contraception. 1988.; Arumugam K, et al. Med Sci Res. 1991.; Tadesse E. Easr Afr Med J. 1996. Extremely Effective

19. Choosing Appropriate Intrauterine Contraception Extremely Effective LNG 13.5, LNG 52 IUS Amenorrhea acceptable Irregular bleeding tolerable History of dysmenorrhea (LNG 52 IUS) History of menorrhagia (LNG 52 IUS) Copper-T IUD Wants regular menses Does not want hormones No history of dysmenorrhea No history of menorrhagia

20. Can be used: in women with multiple partners in women with history of STDs or PID in nulliparous women in teens immediately postpartum immediately post-abortion in women with past ectopic pregnancy Extremely Effective Dispelling Myths about Intrauterine Contraception MacIsaac L. Obstet Gynecol Clin N Am. 2007. Toma A. Pediatr Adolesc Gynecol. 2006. Otero-Flores JB. Contraception. 2003. Suhonen S. Contraception. 2004. WHO. 2004.

21. Intrauterine Contraception and Fertility Hubacher D, et al. NEJM. 2001. Extremely Effective IUD use not associated with infertility (OR=0.9) Chlamydia associated with infertility (OR=2.4) Results confirmed by similar studies ~2000 women enrolled in case-control study

22. Case Study: Nell Age: 32 Has one child Wants another in a few years Uses OCs but not consistently What would you recommend?

23. Implant Brand name: Nexplanon ® Contains etonogestrel Effective for 3 years Trussell J, et al. In: Hatcher RA, et al., eds Contraceptive Technology, 20 th Revised Edition. 2011. NEXPLANON [package insert]. Whitehouse, NJ: N.V. Organon, Oss; 2012 Extremely Effective

24. Timing of IUD/IUS/Implant Insertion Alvarez PJ. Ginecol Obstet Mex. 1994. O’Hanley K, et al. Contraception. 1992. Extremely Effective Anytime during menstrual cycle when pregnancy can be excluded (confirmed by negative pregnancy test and no report of unprotected sex in past two weeks)

25. 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

26. Case Study: Johanna Age: 35 Smoker (half pack/day) Recently divorced and dating Uses OCs successfully OCs help her headaches What would you recommend?

27. Combined Oral Contraceptives Contain estrogen & progestin Most newer formulations contain 20 – 35 mcg of ethinyl estradiol + 1 of 8 available progestins Trussel J. Contraceptive Technology. 2011. Rosenberg MJ. Reprod Med. 1995. Potter L. Fam Plann Perspect. 1996. Mosher WD. AdvanceData. 2004. Hardman JG. McGraw-Hill. 1996. Goldzieher JW. Fertil Steril. 1971. Moghissi KS. Fertil Steril. 1971. Very Effective

28. Progestin-Only Oral Contraceptives Called the “mini-pill” Two formulations: norethindrone & norgestrel No placebo week Timing of pill-taking is crucial Apgar BS. AFP. 2000. WHO MEC. 2004. Contraception Report. 1999. Apgar BS. AFP. 2000. et al. Very Effective

29. Extended Hormonal Contraception Delays or eliminates menstruation Menstrual and nonmenstrual benefits Extended methods: Continuous use of COCs, transdermal patch & vaginal ring Seasonale ®, Seasonique ®, Quartette™ & Lybrel ®, - dedicated extended OC regimen Anderson FD. Contraception. 2003. Kaunitz AM. Contraception. 2000. ARHP. 2003. NuvaRing Product Information. 2001. Stewart FH. Obstet Gynecol. 2005. Kwiecien M. Contraception. 2003. Sulak PJ. Am J Obstet Gynecol 2002. Very Effective

30. Extended/Continuous COC Options: Dedicated Products Seasonale ® 84 days active pills (30mcg EE + 150mcg LNG) 7 days inactive placebo pills Seasonique ® 84 days active pills (30mcg EE + 150mcg LNG) 7 days low- dose estrogen pills Lybrel ® Full year of continuous active pills (20mcg EE + 90mcg LNG ) Quartette TM 42 days: 20mcg EE + 150mcg LNG 21 days: 25mcg EE + 150 mcg LNG 21 days: 30mcg EE + 150 mcg LNG 7 days: 10mcg EE Anderson et al. 2003; Stewart et al. 2005; Portman. 2012.

31. Age: 14 May be ready for sex No current contraceptive method Case Study: Brianna What would you recommend?

32. Brand name: OrthoEvra ® Beige-colored patch applied once/week 3 weeks on, 1 week off 9 days of medication in each patch Abrams LS. Fertil Steril. 2002. Ortho Evra Prescribing Information. Archer DF. Fertil Steril. 2002. Zacur HA, et al. Fertil Steril. 2002. Zieman M. Fertil Steril. 2002. Archer DF. Contraception. 2004. Audet MC. JAMA. 2001. Transdermal Patch Very Effective

33. Vaginal Ring Brand name: NuvaRing ® Flexible, unfitted ring placed in vagina In 3 weeks/out 1 week 4 weeks of medication in ring Continuous use: change once every 4 weeks NuvaRing Prescribing Information. Organon. 2001: Timmer CJ. Clin Pharmacokinet. 2000. Herndon EJ. Am Fam Physician. 2004: Dieben TO. Obstet Gynecol. 2002: Linn ES. Int J Fertil. 2003. et al. Very Effective

34. Menstrual-related health benefits: Decreased dysmenorrhea Decreased menstrual blood loss and anemia May reduce PMS symptoms Decreased risk of: Ectopic pregnancies Endometrial and ovarian cancer Benign breast conditions PID Very Effective Health Benefits: Combined Hormonal Contraception Larsson G. Contraception. 1992. Parsey KS. Contraception 2000. Freeman EW. Fertil Steril. 2005. Davis A. Obstet Gynecol. 2005

35. Side Effects: Hormonal Contraception Very Effective Estrogen-Related Breast tenderness Nausea Vomiting Headaches Elevated blood pressure (rare) Progestin-Related Bloating Anxiety Irritability Depression Menstrual irregularities Reduced libido

36. Very Effective Contraindications: Combined Hormonal Contraception WHO. 2000. Clotting disorders History of deep vein thrombosis or pulmonary embolism Migraine with aura or focal neurological deficit Uncontrolled hypertension

37. Quick Start: Improving Contraceptive Initiation Start contraceptive method (OCs, implant, patch, ring, injection) in presence of clinician or on day of visit Menstrual cycle timing not a factor Use back-up method for 1 st 7 days Very Effective Lara-Torre E. Contraception. 2002. Leeman L. Obstet Gynecol Clin N Am. 2007. Westoff C. Contraception. 2002.

38. Missed or Late Hormonal Contraception Combined Oral Contraceptive Pills Take missed pill ASAP Take next pill at regular time Use back-up method for 1 week if missed1-2 pills at the start of pack or 3 or more pills in the first 3 weeks of pack Progestin Only Pills Take missed pill ASAP Take next pill at regular time Use back-up method for 2 days if pill is taken >3 hours past regular time Very Effective Transdermal Patch Use back-up method for 1 week if patch has been on >9 days, off > 7 days or falls off and is not reaffixed within 24 hours Vaginal Ring Use back-up method for 1 week if ring has been in >5 weeks, out >7 days or falls out and is not reinserted within 3 hours

39. Case Study: Mikayla Age 19 Used DMPA for 2 years Physician told her to stop injections Is not using contraception now What would you recommend?

40. Case Study: Mikayla (continued) Key Points About DMPA: No evidence it causes fracture increase Bone mineral density returns to baseline after cessation of DMPA Bone health largely dependent on nutrition and exercise ACOG and WHO support long term use ACOG practice bulletin. Obstet Gynecol. 2006. Cromer BA. Am J Obstet Gynecol. 2005. DiVasta AD. Adolesc Med. 2006. Kaunitz AM. Contraception. 2008. Leeman L. Obstet Gynecol Clin N Am. 2007. WHO. 2006

41. Depot Medroxyprogesterone Acetate (DMPA) Brand name: Depo-Provera ® Intramuscular or subcu- taneous injection every 3 months Trussel J. Contraceptive Technology. 2011. Cromer BA. Am J Obstet Gynecol. 2005. Trussel J. Contraception. 2004.; Westhoff C. Contraception. 2003. et al. Injectable Very Effective

42. Protection from Pregnancy Immediately: Copper T IUD After 7 Days: LNG 52 IUS, LNG 13.5 IUS* Implant Pills Patch Ring Injectable *Backup contraception is not needed when either LNG IUS is inserted as directed

43. 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

44. Moderately Effective Contraceptives Male Condom, Withdrawal Female Condom, Sponge, Cervical Cap Diaphragm, Spermicide Fertility Awareness

45. Satisfaction with Contraceptive Methods 4.6 4.5 4.1 4.1 3.9 3.6 3.8 % Satisfied Vaginal Ring IUD Injection OC Patch Condoms Other 87 86 80 79 75 60 52 Revisiting Your Regular Women’s Health Care Visit. 2004.

46. Case Study: Heather Age: 26 Abortion 2 years ago Relying on partner’s use of condoms What would you recommend?

47. Emergency Contraception LNG Pills (Brand) Plan B ® One Step: One 1.5mg LNG pill LNG Pills (Generic) Next Choice One Dose™ : One 1.5mg LNG pill My Way™: One 1.5mg LNG pill LNG tablets: two 0.75mg LNG pills Ulipristal acetate ella ® : One 30 mg ulipristal acetate pill Copper T IUD Highly effective method of EC Can be used as an ongoing contraception for 12 years Trussell 2011; www.not-2-late.com; www.rhtp.org; Piaggio G. Lancet. 1999. Task Force on Postovulatory Methods. Lancet. 1998. Grimes DA. Ann Intern Med. 2002. Croxatto HB. Contraceptin 2001. Raine T. Obstet Gynecol. 2000. Gold MA. J Pediatr Adolesc Gynecol. 2004. Grimes DA. Ann Intern Med. 2002.www.not-2-late.comwww.rhtp.org

48. Dedicated Emergency Contraception Pills Available Glasier, et al. 2011; Moreau, Trussell 2011.

49. Case Study: Margarite Age: 29 In a lesbian relationship Has had unprotected sex with men What would you recommend?

50. CDC MEDICAL ELIGIBILITY CRITERIA FOR WOMEN WITH CERTAIN CHARACTERISTICS AND MEDICAL CONDITIONS PART II

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

52. 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 http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/USMEC.htm

53. 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

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

55. 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 http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf

56. 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 http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf

58. 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 http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf US Medical Eligibility Criteria: ↑ Risk for Adverse Health Events Should consider long- acting, highly-effective contraception for these patients

59. Pregnancy-Related Mortality Increase in pregnancy-related mortality, 1998-2005 ▪ 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;116:1302-1309.

60. 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

61. Breastfeeding

62. 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

63. 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

64. Inflammatory Bowel Disease

65. 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

66. 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

67. 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)

68. 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

69. Bariatric Surgery Consensus: Pregnancy should be avoided for 12-24 months after surgery Paulen, ME et al. Contraception 82 (2010) 86-94.

70. History of Bariatric Surgery

71. 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

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

73. Updated Guidance from WHO September 2010

74. 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

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

76. 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

77. 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

78. Contraception: It’s More Than a Prescription

79. The Importance of Collecting a Sexual History Medical history Circumstances Lifestyle issues that affect adherence Preconceptions about contraceptive methods

80. What Does Patient-Centered Care Look Like?

81. Clinician Limitations

82. Patient Follow-up Schedule a recheck visit Ask follow-up questions: Are you satisfied with your contraceptive method? Is there anything you would change? Are you having bleeding problems or other side effects? ARHP. Clinical Proceedings. 2004.

83. Recommendations for Providers Frost JJ. In Brief. 2008. Provide ongoing support for contraceptive use Improve women’s knowledge of contraceptive risk and benefits Anticipate and manage side effects Recognize fluidity in reproductive goals Offer the widest range of contraceptive options Address logistical and cost barriers Enhance professional education and offer mutual support

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

85. Resources US MEC published in CDC’s Morbidity and Mortality Weekly Report (MMWR): ▪ http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a1.ht m?s_cid=rr5904a1_w http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a1.ht m?s_cid=rr5904a1_w CDC evidence-based family planning guidance documents: ▪ http://www.cdc.gov/reproductivehealth/UnintendedPregna ncy/USMEC.htm http://www.cdc.gov/reproductivehealth/UnintendedPregna ncy/USMEC.htm WHO evidence-based family planning guidance documents: ▪ http://www.who.int/reproductivehealth/publications/family_ planning/en/index.html http://www.who.int/reproductivehealth/publications/family_ planning/en/index.html

86. Additional Resources Association of Reproductive Health Professionals (ARHP) ▪ www.arhp.org www.arhp.org National Association of Nurse Practitioners in Women’s Health (NPWH) ▪ www.npwh.org www.npwh.org