1. This presentation contains materials obtained from Linda Prine MD, Mark A. Goedecker, MD, Mark Deutchman MD and Laura Stein MD

2. Objectives Role of the rural physician in contraception Assessing the patient’s desire and need for contraception Non-Hormonal contraception Hormonal contraception Emergency contraception Male sterilization Female sterilization IUD video and lab

3. Role of the rural physician in contraception Office practice: individual patient visits Consultant to health department Information to concerned community members Parents Schools Religious groups News media Overall: improve access to contraceptive information and direct services Opportunity for health promotion and life skills counseling

4. Assessing the patient’s desire and need for contraception Full-time vs sporadic Long term vs short term STI protection Sexuality concerns Others………………

5. Background: Importance of Contraception Unintended pregnancy

6. Approximately 6.4 million pregnancies per year

9. 28 million U.S. women at risk for unintended pregnancy

10. Unintended pregnancy rate by race/ethnicity/income Unintended pregnancies per 1,000 women

11. What are the lifetime considerations of unintended pregnancy ? How many can you think of?

13. 85% No methodNo Method 3%14% Male latex condoms 5%21%Female condoms 9%-26%20%-40%Cervical cap 620%Diaphragm Perfect-Use Rate of Pregnancy Typical-Use Rate of Pregnancy Family Planning Method Effectiveness Group 1%-9%20%Fertility Awareness 4%19%Withdrawal 6%26%Spermicide Less effective

14. Perfect-Use Rate of Pregnancy Typical-Use Rate of Pregnancy Family Planning Method Effectiveness Group 0.1%-0.5%Unknown (8%)Vaginal ring 0.3%-0.8%Unknown (8%)Transdermal patch 0.1%-0.5%8%Birth control pills Effective

15. 0.3% Hormone shot Perfect-Use Rate of Pregnancy Typical-Use Rate of Pregnancy Family Planning Method Effectiveness Group 0.6%-1.5%0.8%-2% Intrauterine devices 0.1% Implants 0.1%-0.5%0.2%-0.5% Male and female sterilization Highly Effective (for all users)

16. Hormonal Contraception Combination estrogen/progesterone pills Sequential estrogen/progesterone Biphasic Triphasic Progesterone only Pills, Injection and subcutaneous capsule Extended cycle Transdermal patches Vaginal ring Hormone-containing IUD

17. How do Oral Contraceptives Work? Suppress, but not eliminate ovulation (Decrease FSH and LH by pituitary suppression) Thin the endometrium Thicken cervical mucous

18. Hormonal Contraceptives What is needed before prescribing pills? Medical history REQUIRED Blood pressure RECOMMENDED Pap smear Pelvic/breast exam STI testing Hemoglobin NOT REQUIRED

19. Estrogens in OCP’s Most pills use ethinyl estradiol (EE) as their estrogen (50 µg mestranol = 35 µg EE) Doses range from 20 µg – 50 µg, but most are 20 µg – 35 µg Lower dose estrogens have the benefits of less bloating and breast tenderness but may increase the rate of breakthrough bleeding especially in obese patients

20. “Older” vs. “Newer” Progestins Newer: Less androgenic (minimizes side effects such as acne, hirsutism, nausea, and lipid changes) Increase progestational effects Levonorgestrel is the most androgenic available in US First, second, third, and fourth generation progestins Estranes and gonanes

21. “Newer” Progestins Minimal androgenic effects Norgestimate Increases HDL and decreases LDL Desogestrel (etonogestrel) Possible increase risk in venous thromboembolism (VTE) (Jick S et al. Contraception 2006:73:566-70. SORT B) Drospirenone Antimineralocorticoid activity Theoretically could cause hyperkalemia Essentially no androgenic activity

22. Monophasics vs. Biphasics vs. Triphasics There is insufficient data that biphasic or triphasic combined oral contraceptive pills are better than monophasic pills (effectiveness, bleeding patterns, or discontinuation rates) SORT B Cochrane Database of Systematic Reviews 2007 Van Vliet HAAM, Grimes DA, Lopez LM, Schulz KF, Helmerhorst FM. Triphasic versus monophasic oral contraceptives for contraception Van Vliet HAAM, Grimes DA, Helmerhorst FM, Schulz KF. Biphasic versus monophasic oral contraceptives for contraception

23. Choosing the Right Pill Low androgenic activity is desirable in most if not all If patient weighs more than 160 pounds consider higher estrogen and progestin activity Low dose estrogen if: History of nausea, edema or hypertension in pregnancy Uterine fibroids Fibrocystic breasts Heavy menses Migraines

24. Choosing the Right Pill Low progesterone if: History of preeclampsia, excessive weight gain, tiredness, or varicose veins during pregnancy, Depression Excessive premenstrual If history of polycystic ovaries, high progestational and low androgenic

25. Estrogen contraindications: Migraine with aura Uncontrolled hypertension Postpartum < 6 weeks History of DVT Smoking: NOT a contraindication in women/teens under age 35

27. Femcon Fe Femcon Fe ® The new name for Ovcon Fe chewable Chewable spearmint flavored tablet EE 35 µg, norethindrone 0.4 mg (21 days) Placebo contains 75 mg ferrous fumarate ADVANTAGE: For those who cannot swallow pills (and need fresh breath)

28. Yaz 24/4 ® Same ingredients as Yasmin but… EE 20 µg (instead of 30 µg) 3 mg of drospirenone 24 days of active medication and 4 days of placebo (as compared to the usual 21/7) ADVANTAGE: Has an FDA indication for premenstrual dysphoric disorder (the only hormonal contraceptive with this) Shorter periods

29. Loestrin 24 Fe ® 24 days of hormones (similar to Yaz 24/4 ® ) EE 20 µg, Norethindrone 1 mg Placebo pills contain iron ADVANTAGE: Periods last less than 3 days More pronounced suppression of follicular development

30. Extended Cycle Regimens

31. Extended Cycle Contraceptives Seasonale ®, Seasonique ®, Lybrel ® Oral contraceptives taken continuously for more than 28 days compare favorably to traditional cyclic oral contraceptives (bleeding, discontinuation rates, and reported satisfaction) SORT A Edelman AB, Gallo MF, Jense JT, Nichols MD, Schulz KF, Grimes DA. Continuous Or extended cycle versus cyclic use of combined oral contraceptives for contraception. The Cochrane Database of Systematic Reviews 2007 Issue 2

32. Seasonique Seasonique ® Like Seasonale ® : EE 30 µg, levonorgestrel 0.15 mg for 12 weeks But… 13 th week contains EE 10 µg (instead of placebo) ADVANTAGES: Low dose EE may reduce hormone withdrawal symptoms (migraines and dysmenorrhea) May cause less breakthrough bleeding then with Seasonale (main reason women stop Seasonale)

33. Lybrel Lybrel ® Taken in a continuous 365-day regimen EE 20 µg and levonorgestrel 0.09 mg 28 pills in a pack FDA approved and will be released July 2007 ADVANTAGE: No menstrual bleeding During the 13 pill pack: 59% of women achieve amenorrhea 20% of women have spotting only 21% of women required sanitary protection due to breakthrough bleeding http://www.drugs.com/newdrugs/fda-approves-lybrel-first-low- combination-oral-contraceptive-offering-women-opportunity-period-free- 491.html?printable=1http://www.drugs.com/newdrugs/fda-approves-lybrel-first-low- combination-oral-contraceptive-offering-women-opportunity-period-free- 491.html?printable=1

34. Contraindications to Combined Oral Contraceptives Unexplained VTE or VTE associated with pregnancy or exogenous estrogen use (unless on anticoagulants) Women age 35 and older who smoke Poorly controlled diabetes or diabetes with complications such retinopathy, nephropathy, or other vascular complications Level A Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

35. Contraindications to Combined Oral Contraceptives OCP’s should be stopped one week prior to surgery or heparin prophylaxis should be considered Women with CAD, CHF, or cerebral vascular disease Use caution in obese women over the age of 35 Poorly controlled HTN (or complications) Patients with Factor V Leiden gene mutation or prothrombin gene mutations Level B Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

36. Patients Who it is OK to Use OCP’s Benign breast disease or family history of breast cancer Mild lupus with no antiphospholipid antibodies Level A Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

37. Patients Who it is OK to Use OCP’s Healthy, non-smoking women can continue their OCP’s until age 50-55 Well-controlled HTN <35 who do not smoke and are healthy Well-controlled DM <35 who do not smoke and are healthy Women with migraines who are healthy, do not smoke, and have no focal neurologic signs Women with depressive disorders Level B Use of hormonal contraception in women with coexisting medical conditions. ACOG Practice Bulletin No. 73. American College of Obstetricians and Gynecologists. Obstet Gynecol 2006: 107:1453-72.

38. 1 patch weekly for 3 weeks, then one week off Same efficacy & contraindications as OCs OK to shower, swim, exercise with patch on Failures in trials were in women over 198 pounds, but still rare Higher risk of clots? Conflicting studies… Gallo MF, et al. Cochrane Reviews. 2003, Issue 1. Art. No. CD003552. Jick S, et al. Contraception 73 (2006)

39. Ortho Evra Transdermal Contraceptive Patch Ortho Evra ® Transdermal Contraceptive Patch EE 20 µg/d and norelgestromin 0.15 mg/d One patch weekly for three consecutive weeks followed by one patch-free week Mean serum concentrations are not affected by heat, humidity, exercise or cold-water immersion Contraceptive failure is higher in women with body weight >90 kg

40. Ortho Evra Transdermal Contraceptive Patch Ortho Evra ® Transdermal Contraceptive Patch Possible increased risk of venous thromboembolism (VTE) This is due to the increased serum concentration Peak serum estrogen concentration is 25% less than the peak level with the pill (30 µg) But women with the patch are exposed to 60% more estrogen than taking the pill NuvaRing – 3.4 times less estrogen exposure than patch and 2.1 less than the pill Thacker H, Falcone T, Atreja A, Jain A, Harris CM. How should we advise patients about the contraceptive patch given the FDA warning? Cleveland Clinic Journal of Medicine 2006: 73(1): 45-47.

41. The Patch and VTE Two-fold increase in the risk of VTE versus norgestimate-containing oral contraceptives with 35 µg of EE Overall, the number needed to harm (NNH) was 4,444 (AMI, VTE, stroke) There is a five-fold increase in risk of VTE in pregnancy There is no increased risk for acute myocardial infarction or stroke Cole J, Norman H, Doherty M, Walker A. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol 2007: 109(2):339-46.

42. Injectable Contraceptives Only one currently available is Depo-Provera ® Lunelle ® was withdrawn from the US due to lack of demand and a recall (half-filled syringes)

43. Depo-Provera ® Medroxyprogesterone 150 mg given IM every 11- 13 weeks New Depo-subQ Provera 104 ® Given every 12-14 weeks Can be administered by the patient in the thigh or abdomen Side effects are similar Slow return to fertility (14 weeks to 9 months) Irregular bleeding Short-term loss of bone mineral density

44. Depo-Provera ® and Osteoporosis FDA has required a black-box warning since 2004 “only use as long-term birth control method(>2 years) if other methods inadequate” It has not been associated with postmenopausal osteoporosis or fractures Society for Adolescent Medicine, ACOG and WHO have recommended continuing Depo after appropriately counseling

45. Active for at least 3 weeks Lowest estrogen dose: 15 mcg / day Same efficacy and contraindications as OCs May remove for up to 3 hours QuickStart same as with OCs

46. NuvaRing ® EE 15 µg/day and etonogestrel 0.12mg/day Inserted into vagina and left in for three weeks Removed for one week Can be re-inserted if it has been out for less than three hours (rinse with cold or warm water, not hot) 8/10 partners do not feel the ring during intercourse (can removed prior to intercourse) http://www.nuvaring.com/HCP/PrescribingNuvaRing/StartingYourPatients/index.asp

47. Highly effective and rapidly reversible Discreet Not user-dependent Contain no estrogen Can be used during lactation Active hormone: etonogestrel (68 mg) Reinprayoon. Contraception 2000 Diaz. Contraception 2000

48. Causes spotting Requires certified clinician visits for insertion and removal

49. Implantable Contraceptives Norplant ® was on the US market from 1991-2002 Six rods containing levonorgestrel Several class action law suits over: Failure to disclose side effects (irregular bleeding) Difficulty removing rods

50. Implantable Contraceptives IMPLANON™ released August 2006 One rod containing etonogestrel Can be left in for up to three years Only providers who have completed a “comprehensive practical training session” can insert IMPLANON™ (sponsored by Organon) www.implanon-usa.com

51. IMPLANON™ Mean insertion time 1.3 minutes (range 1-15 minutes) Mean removal time 3.8 minutes (range 1-60 minutes) 4 cm long and 2 mm in diameter

52. Take at once, up to 5 days after unprotected sex. Lowers risk of pregnancy by 58-89%

53. Levonorgestrel EC: Mechanism of Action Inhibits ovulation Does NOT cause abortion

54. Ulipristal acetate: a new emergency contraceptive option Decreases risk of unintended pregnancy by about 90% Maintains nearly full efficacy up to 5 days after unprotected intercourse

56. IUDs can be used safely by nulligravid women and teens! IUDs DO NOT raise risk of PID. IUDs DO NOT raise risk of infertility. IUDs DO NOT raise risk of ectopic pregnancy.

57. IUDs DO NOT cause abortion. OK to insert IUD at any point in the menstrual cycle. OK to insert immediately post-partum or following surgical abortion OK to test for STIs at time of insertion (& treat infections with IUD in place)

59. Lost Your IUD? Lost Your IUD? (Can’t feel the string? Look with ultrasound !) Sagittal view Transverse view

60. Male Sterilization: Vasectomy

61. Vasectomy Methods 1 Dassow P, Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

62. Vasectomy Methods 2 Dassow P, Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

63. Vasectomy Methods 3 Dassow P, Bennett J. Vasectomy: An Update Am Fam Physician 2006;74:2069-74, 2076.

64. Female Sterilization Tubal Ligation Tubal occlusion (Essure ® )

65. Pomeroy technique ©2001

66. Parkland technique ©2001

67. Filshie Clip ® OpenClosed Early Later ©2001

68. Filshie Clip Application Filshie Clip ® Application

69. Essure ® Hysteroscopically-placed tubal occlusion device Requires hysterosalpingogram in 3 months Hysteroscopic PlacementCoil in place

70. Hysterosalpingogram Fallopian tubes open A=Right, C= left B= uterus D= balloon tip catheter Tubes blocked

71. Counseling to Enhance Adherence LISTEN to her ideas about the best method. EXPLORE lifestyle issues that may impact adherence. ENCOURAGE her to call you with problems/concerns.

72. Percent of pill users who missed one or more pills during the past three months

74. % of at-risk women experiencing contraceptive non-use in the past year

75. DE-LINK pap smears from birth control prescriptions. ROUTINELY prescribe 1-year supply with 3 packs at a time. Use Quickstart. Ask about contraceptive needs at all types of visits. Emphasize high-efficacy methods, but honor women’s choice whenever possible.

76. Hatcher et al, Contraceptive Technology 2007 Managing Contraception – book online @ www.managingcontraception.org Medical Eligibility Criteria for Contraceptive Use 2010 by WHO www.who.int/reproductive-health Association of Reproductive Health Professionals www.arhp.orgwww.arhp.org Alan Guttmacher Institute www.agi-usa.orgwww.agi-usa.org Planned Parenthood www.plannedparenthood.orgwww.plannedparenthood.org The Cochrane Collaboration www.cochrane.orgwww.cochrane.org www.Not-2-Late.com Reproductive Health Access Project www.reproductiveaccess.orgwww.reproductiveaccess.org