APGO Educational Series on Women s Health Issues Contraception

APGO Educational Series on Women’s Health Issues Contraception Patient Counseling and Management APGO Educational Series on Women’s Health Education

Introduction § Most American women spend approximately 36 years in the reproductive stage of life (ages 15 -44)1 – They try to avoid pregnancy at some point in this interval – ~30% of pregnancies are unintended 1 – 14% of births are unwanted 1 – Annually, ~2% of women have an induced abortion 2 § Spacing children decreases infant morbidity and mortality 3, 4 and the risk of spontaneous abortion § Successful family planning has a positive impact on women, couples, families, and society 1. Chandra A, et al. Vital Health Stat. 2005. 2. Jones RK, et al. Perspect Sex Reprod Health. 2008; 40(1): 6 -16. 3. Klerman LV, et al. Am J Public Health. 1998; 88: 1182 -1185. 4. Mc. Calister DV, et al. Am J Obstet Gynecol. 1970; 106(4): 573 -580.

Contraception § Benefits often outweigh health risks § Side effects can often be managed or relieved § Variety of options available to US women: – Combination hormonal or progestin -only – pill, patch, vaginal ring – Injectable – long-acting, depot, or implant progestin – IUD – copper or levonorgestrel – Barrier methods – condom, diaphragm, vaginal cap, spermicide – Sterilization – female, male – Fertility awareness; withdrawal ACOG News Release: The ABCs of oral contraceptives. 2006 Oct 3

Health Benefits § Barrier effect – Condoms reduce transmission of infectious agents 1 § Endometrial cancer – Risk significantly reduced with combination oral contraceptives, depot medroxyprogesterone acetate (DMPA) and non-medicated IUDs 2, 3, 4 § Ovarian cancer – Risk reduced by combination oral contraceptives 5, 6, 7 – Even in women with BRCA 1 and BRCA 2 mutations 8 1. Grimes DA, et al. Am J Obstet Gynecol. 1995; 172: 227 -235. 2. The Cancer and Steroid Hormone Study…. JAMA. 1987; 257: 796 -800. 3. Burkman R, et al. Am J Obstet Gynecol. 2004; 190: S 5 -S 22. 4. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 236 -242. 5. Andersson K, et al. Contraception. 1994; 49(1): 56 -72. 6. Ness RB, et al. Am J Epidemiol. 2000; 152(3): 233 -241. 7. Westhoff C, et al. Am J Epidemiol. 2000; 152(3): 242 -246. 8. ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472.

Other Benefits § Withdrawal bleeding and dysmenorrhea – Regulated and reduced with use of combination oral contraceptives 1, 2, 3 § Menstrual blood loss in menorrhagia – Reduced with use of combination oral contraceptives, DMPA, or levonorgestrel IUD 4 -9 § Acne – Treated with combination oral contraceptives 10 § Perimenopause – Lighter, predictable bleeding; vasomotor symptom relief; positive effect on bone mineral density 11 -13 1. Kaunitz AM. 2007 Feb 7. 44 Power. Point slides. 2. Davis AR, et al. Obstet Gynecol. 2005; 106: 97 -104. 3. Edelman A. In: Practical gynecology: a guide for the primary care physician; 2008. 4. Hatcher RA, et al. Contraceptive Technology; 2004. 5. Fedele L, et al. Fertil Steril. 1997; 68(3): 426 -429. 6. Hubacher D, et al. Obstet Gynecol Surv. 2002; 57(2): 120 -128. 7. Davis A, et al. Obstet Gynecol. 2000; 96: 913 -920. 8. Marjoribanks J, et al. Cochrane Database Syst Rev. 2006; 2. 9. Lethaby AE, et al. Cochrane Database Syst Rev. 2005; 4. 10. Arowojolu AO, et al. Cochrane Database Syst Rev. 2004; 3. 11. Best KA, et al. In: Gynecology for the primary care physician; 2007. 12. Kaunitz AM. Am J Obstet Gynecol. 2001; 185: S 32 -S 37. 13. Kaunitz AM. N Engl J Med. 2008; 358: 1262 -1270.

Hormonal Contraceptives § Combination hormonal – pill, patch, vaginal ring – Oral contraceptives are the most commonly used method in the US 1 – Available in various dose and cycle combinations of estrogen and progestin § Progestin-only – pill, long-acting/depot injection, implant, levonorgestrel IUD – Candidates include women with cardiovascular risk factors, diabetes, lipid disorders, estrogen-related side effects, migraine headaches, 2 are post-partum or breastfeeding 3 1. Chandra A, et al. Vital Health Stat. 2005. 2. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 236 -242. 3. Mc. Cann MF, et al. Contraception. 1994; 50(6 Suppl 1): S 1 -S 195.

Combination Oral Contraceptives § 20 -50 mcg of estrogen (ethinyl estradiol or equivalent dose of mestranol) + a progestin – Suppress pituitary gonadotropin secretion – Progestin is the more effective ovulation inhibitor – Progestin causes changes in cervical mucus and endometrium, hindering sperm transport and embryo implantation (if ovulation occurs)1, 2 § Monophasic (constant doses of hormones) or multiphasic (varying doses of hormones) +/- placebo phase 1. Hatcher RA, et al. Contraceptive Technology; 2004. 2. Best KA, et al. In: Gynecology for the primary care physician; 2007.

Combination Oral Contraceptives § Relatively effective: 8% failure rate during first year of use 1, since most women do not take them perfectly 2 § Fertility returns soon after discontinuation 1. Hatcher RA, et al. Contraceptive Technology; 2004. 2. Trussell J. In: Contraceptive technology ; 2007.

Combination Oral Contraceptive Health Risks Today’s lower-dose OC Formulations (< 50 mcg estrogen) Are Safe for Most Healthy Women and Have Been Extensively Studied 1 § Breast Cancer – Large British 2, US 2, 3, and Canadian 4 studies found no increased risk with former or current use – Results are inconsistent from studies of OC use among BRCA-positive women 5, 6 1. Hatcher RA, et al. Contraceptive Technology; 2004. 2. Hannaford PC, et al. Br Med J. 2007; 335: 651 -660. 3. Marchbanks PA, et al. N Engl J Med. 2002; 346(26): 2025 -2032. 4. Silvera SA, et al Cancer Causes Control. 2005; 16(9): 1059 -1063. 5. Milne RL, et al. Cancer Epidemiol Biomarkers Prev. 2005; 14(2): 350 -356. 6. Narod SA, et al. J Natl Cancer Inst. 2002; 94(23): 1773 -1779.

Combination Oral Contraceptive Health Risks Cervical Neoplasia § Data from 24 epidemiological studies involving 26 countries showed almost double the risk for invasive cervical cancer in women taking OCs for five or more years 1 § After stopping OCs, at 10 years the risk declined to same as never users 1 § Reanalysis found other factors to be: younger age at first intercourse, younger age at first full-term pregnancy, increasing parity, increasing number of sexual partners, and increasing duration of OC use 2 1. International Collaboration of Epidemiological Studies of Cervical Cancer. Lancet. 2007; 370: 1609 -1621. 2. International Collaboration of Epidemiological Studies of Cervical Cancer. Int J Cancer. 2007; 120(4): 885 -891.

Combination Oral Contraceptive Health Risks Venous Thromboembolism (VTE) § Varying reports regarding risk associated with estrogen dose or type of progestin 1 -7 § Pregnancy, childbirth and puerperium are associated with risk of VTE higher than that associated with the use of OCs: Low-Dose OC Users 1 VTE Incidence per 100, 000 Woman-Years Pregnant Women 9 Postpartum Women 9 10 - 15 95 - 96 511 § VTE risk is further increased with OCs if there are specific thromboembolic risk factors or underlying diseases 6 1. 2. 3. 4. Westhoff CL. Am J Obstet Gynecol. 1998; 179(3 Suppl 1): S 38 -S 42. Gallo MF, et al. Contraception. 2005; 71(3): 162 -169. Lidegaard Ø, et al. Contraception. 1998; 57(5): 291 -301. Lidegaard Ø, et al. Contraception. 2002; 65(3): 187 -196. 5. 6. 7. 8. 9. Sidney S, et al. Contraception. 2004; 70(1): 3 -10. Suissa S, et al. Contraception. 1997; 56(3): 141 -146. Farmer RDT, et al. Contraception. 1998; 57(2): 67 -70. Best KA, et al. In: Gynecology for the primary care physician; 2007. Heit JA, et al. Ann Intern Med. 2005; 143: 697 -706.

Combination Oral Contraceptive Health Risks Stroke § Low-dose formulations do not increase risk of thrombotic or hemorrhagic stroke in healthy, nonsmoking women 1 -4 § Risk increased in women with underlying predisposing diseases or other risk factors Myocardial Infarction § Risk of MI substantially increased among OC users over 35 who smoke; smoking and OCs act synergistically to increase risk 2, 5, 6 Metabolic Effects § Oral estrogen increases triglyceride levels 7 1. 2. 3. 4. World Health Organization Collaborative. Lancet. 5. 1996; 348: 505 -510. Lidegaard Ø, et al. Contraception. 2002; 65(3): 197 -205. 6. Siritho S, et al. Stroke. 2003; 34(7): 1575 -1580. Schwartz SM, et al. Stroke. 1998; 29(11): 2277 -2284. 7. Best KA, et al. In: Gynecology for the primary care physician; 2007. World Health Organization Collaborative. Lancet. 1996; 348: 498 -505. Godsland IF, et al. N Engl J Med. 1990; 323: 1375 -1381.

Contraceptive Patch and Ring § Alternative combined hormone delivery systems, used on a 28 -day cycle – 1 patch applied weekly x 3, then removed for one patch-free week – 1 ring inserted and left for 3 weeks, then removed for one ring-free week § Time to achieve steady state hormone levels - backup contraceptive may be needed 1 -3 1. Ortho Evra Label Information. Ortho-Mc. Neil Pharmaceutical Inc; 2008 Jan. 2. Nuva. Ring Label Information. Organon; 2007. 3. Kaunitz AM. In: Gynecology for the primary care physician; 2008.

Contraceptive Patch and Ring § Transdermal patch produces higher exposure to estrogen 1 § Postmarketing surveillance found two-fold increase in risk of nonfatal VTE with the patch 2, 3 § Contraindications to use of combination OCs should also be considered to apply to the patch and ring 1. Ortho Evra Label Information. Ortho-Mc. Neil Pharmaceutical Inc; 2008 Jan. 2. Boston Collaborative Drug Surveillance Program. 3. U. S. Food and Drug Administration. Questions and Answers. Ortho Evra (norelgestromin/ethinyl estradiol); 2008 Jan 18.

Progestin-Only Contraceptives § Candidates include women with cardiovascular risk factors, diabetes, lipid disorders, estrogen-related side effects or contraindications, migraine headaches 1, are post-partum or breastfeeding 2 § In lactating women, no decrease in milk production has been shown with progestin-only contraceptives 1 § Irregular bleeding and spotting are the most common side effects 3, 4 1. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 236 -242. 2. Ortho Micronor Prescribing Information. Ortho-Mc. Neil Pharmaceutical Inc. ; 2005 Oct. 3. Westhoff C. Contraception. 2003; 68(2): 75 -87. 4. IMPLANON™ Package Insert. Organon USA Inc. 2006 Jul.

Progestin-Only Contraceptives Pill – Norethindrone 0. 35 mg § Amount of progestin is less than in low-dose combination OC formulations § Taken continuously without hormone-free interval § Need to be taken consistently: – Delay of 3 or more hours requires back-up contraception for 48 hours 1, 2 – If more than one pill is missed, emergency contraception is advised (as well as continuing the pills with back-up contraception until Day 8 of new pack)3 § Some clinicians prescribe 2 pills daily in women with normal ovulatory function (ie, if not postpartum or lactating)4 1. 2. 3. 4. Ortho Micronor Prescribing Information. Ortho-Mc. Neil Pharmaceutical Inc. ; 2005 Oct. Nor-QD facts and comparisons at Drugs. com. 2007 Dec 5. Edelman A. In: Practical gynecology: a guide for the primary care physician; 2008. Kaunitz AM. Up. To. Date; 2007.

Progestin-Only Contraceptives Depot medroxyprogesterone actetate Injection § Given every 3 months by injection: deep IM (150 mg of Depo-Provera)1 or SC (104 mg of deposub. Q provera 104)2 § 3% first year failure rate with typical use; 0. 3% first year failure rate with consistent use § Menses may not return for months after discontinuation 3 § Return to fertility may be delayed by 10 -18 months after discontinuation 1, 2 1. 2. 3. DEPO-PROVERA Contraceptive Injection. Pharmacia & Upjohn Company; 2004 Nov. depo-sub. Q provera 104™. Physician Information. Pfizer Inc. ; 2007 Oct. Hatcher RA, et al. Contraceptive Technology; 2004.

Progestin-Only Contraceptives Depot medroxyprogesterone actetate Injection § Bone mineral density: – Decreased with current use 1, 2 – Not linked to fractures or postmenopausal osteoporosis 1 – Appears to fully recover after discontinuation 3, 4 -11 § DMPA appears to have no impact on risk for cervical, ovarian, or breast cancer, but significantly reduces endometrial cancer risk 3 1. 2. 3. 4. 5. DEPO-PROVERA Contraceptive Injection. Pharmacia & Upjohn Company; 2004 Nov. depo-sub. Q provera 104™. Physician Information. Pfizer Inc. ; 2007 Oct. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 236 -242. Kaunitz AM. Up. To. Date; 2007. Rosenberg L, et al. Contraception. 2007; 76(6): 425 -431. 6. Kaunitz AM, et al. Contraception. 2006; 74(2): 90 -99. 7. Scholes D, et al. Arch Pediatr Adolesc Med. 2005; 159: 139 -144. 8. Scholes D, et al. Epidemiol. 2002; 13: 581 -587. 9. Petitti DB, et al. Obstet Gynecol. 2000; 95: 736 -744. 10. Orr-Walker BJ, et al. Clin Endocrinol. 1998; 49: 615 -618. 11. Cromer BA, et al. J Adolesc Health. 2006; 39: 296 -301.

Progestin-Only Contraceptives Implant – Etonogestrel 68 mg § Non-biodegradable rod implanted subdermally; left in place for up to 3 years, then removed (and replaced, if desired)1 § does not rely on user to remember taking or using the product (except at the end of the 3 -year term § Overall 3 -year failure rate is 0. 38%1 § Return to fertility after removal is within days to weeks 1, 2 1. 2. IMPLANON™ Package Insert. Organon USA Inc. 2006 Jul. Hatcher RA, et al. Contraceptive Technology; 2004.

Counseling for Hormonal Contraception § Provide information about all available products § Long-term options (IUD, depot injection, implant) are most effective, especially for women with difficulty managing their contraception (e. g. , due to access, privacy issues, lack of follow-up) § OCs can be initiated in 3 ways: – On first Sunday after menses begin – On first day of period – Immediately, regardless of timing of menses = “Quick Start” method 1 1. Westhoff C, et al. Contraception. 2002; 66(3): 141 -145.

Counseling for Hormonal Contraception § OCs need to be taken consistently for contraceptive efficacy and reduced side effects 1 § If combined OC pills are missed, patient to take pills according to the following schedule: 2 – 1 tablet missed – take as soon as remembered and continue taking remainder of tablets at the same time daily as before – 2 tablets missed – take 2 tablets as soon as remembered, then 2 on the following day, use back-up contraception for 7 days, take remainder of tablets at the same time daily as before – More than 2 consecutive tablets missed - continue taking 1 tab at the same time daily as before, use backup contraception (e. g. , condoms and spermicide) until current pill pack is finished 1. 2. Kaunitz AM. In: , Textbook of primary care medicine ; 2001. Edelman A. In: Practical gynecology: a guide for the primary care physician, ; 2008.

Counseling for Hormonal Contraception OC Side Effects § Commonly include nausea, breast tenderness, menstrual changes (e. g. , amenorrhea, unscheduled bleeding, and spotting) § Breakthrough bleeding occurs in about 25% of women within the first three months of use, becoming less frequent with time 1, 2 § Advise patients that side effects are most likely to occur during first three months of use and that these symptoms are not dangerous; with regular and consistent pill-taking, side effects should abate 1. Best KA, et al. In: Gynecology for the primary care physician; 2007. 2. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 220 -236.

Counseling for Hormonal Contraception OC Side Effects § Unscheduled bleeding continuing after 3 months of OC use, should be evaluated for other potential causes, including cervical or endometrial infection or neoplasia, pregnancy, polyps, fibroids, or use of medications that interfere with estrogen metabolism (e. g. , smoking, antiepileptics, rifampin, St. John’s Wort)1 § Chlamydial cervicitis has been reported as a cause of lateonset unscheduled bleeding in OC users 2 § If prolonged spotting/bleeding (ie, seven days or more) on an extended use OC, take a 3 -day pill holiday; this is more effective than continuing the contraceptive 3 1. 2. 3. Hatcher RA, et al. Contraceptive Technology; 2004. Krettek JE, et al. Obstet Gynecol. 1993; 81(5 Part 1): 728 -731. Best KA, et al. In: Gynecology for the primary care physician; 2007.

Counseling for Hormonal Contraception OC Side Effects § Some long-term OC users may experience amenorrhea, which is not medically harmful § Inadvertent use of OCs during early pregnancy is not associated with an increased risk for fetal anomalies or miscarriage § There are no consistent data to suggest associations between weight gain or headaches and OC use § If problems or noncompliance due to side effects, a formulation adjustment can be made

Barrier Methods § Have assumed greater importance in recent years due to their ability to reduce the risk of sexually transmitted infections § Are commonly used with other methods of contraception, e. g. , with OCs – the pill and condom are the most common contraceptive method combination 1 § Particularly appropriate for women in stable relationships who can predict when they will have intercourse 1. Chandra A, et al. Vital Health Stat. 2005.

Barrier Methods Male Condom § Inexpensive, available without prescription in various sizes § Available as latex (natural rubber), polyurethane, animal (lamb intestine), lubricated with spermicide or not § Do not use with latex condoms, to avoid degradation of the rubber – this is not a problem with synthetic condoms: – Oil-based lubricants (e. g. , petroleum jelly, baby or mineral oil)1 – Vaginal estrogen or antifungal creams 1, 2 § Failure rate is about 15% over the first year of typical use § Dual protection (ie, condom + more effective long-term method) is more likely to provide effective contraception 1. Hatcher RA, et al. Contraceptive Technology; 2004. 2. It’s Your Health—Condoms. Health Canada; 2005 Aug.

Barrier Methods Female Condom § Much more expensive than the male condom § Acts as a vaginal liner, with end of sheath remaining outside to cover vulva § Failure rate is about 21% over the first year of typical use § Should not be used with male condom – possibility of adherence and slippage

Barrier Methods Diaphragm § Available in several materials, styles and sizes § Prescription-only; fitted by a health professional § Positioned to completely cover the cervix, fitting behind the pubic bone and the posterior vaginal fornix; 1, 2 may be used with a male condom 1 § First-year pregnancy rate for typical use is 16% § UTIs can be a side effect of diaphragm use 3 – could switch to a smaller diaphragm or one with a different rim 1 § Vaginal irritation, recurrent yeast infection, and bacterial vaginosis may also be caused by use of a diaphragm 1 1. Hatcher RA, et al. Contraceptive Technology; 2004. 2. Title 21 – Food and Drugs, U. S. Food and Drug Administration Center for Devices and Radiological Health; April 1, 2007. 3. Hooton TM, et al. N Engl J Med. 1996; 335: 468 -474.

Barrier Methods Cervical Cap § Prescription-only § Deeper, smaller cup than diaphragm; more difficult to fit and place § First-year failure rate varies between parous and nulliparous women: 32% vs. 16%, respectively Sponge § After wetting is placed high in vagina § Can be inserted up to 24 hours before intercourse and needs to be kept in place for 6 hours after last encounter 1 § Associated with higher discontinuation and pregnancy rates than diaphragm 2 1. How Do You Use the Today® Sponge. Synova Healthcare Inc. ; 2007. 2. Kuyoh MA, et al. Cochrane Database Syst Rev. 2002; 3.

Barrier Methods Spermicides § Chemical contraceptive barrier: 1 surfactants (nonoxynol-9, octoxynol-9) that destroy sperm’s cell membrane § Recommended to be inserted into the vagina no more than 1 hour before intercourse; should be kept in place at least 6 -8 hours afterwards 2 § Failure rate during the first year of typical use of spermicides alone is approximately 29% § Efficacy may be dose-related, based on concentration of spermicide 3 § Spermicides do not protect against STIs and HIV 4 1. ACOG Education Pamphlet; 2003 Feb. 2. Birth Control Guide. FDA Office of Public Affairs; 2003 Dec. 3. Raymond EG, et al. Obstet Gynecol. 2004; 103: 430 -439. 4. FDA News. U. S. Food and Drug Administration; 2007 Dec 18.

Intrauterine Devices (IUDs) § Highly effective; convenient; have non-contraceptive benefits 1, 2 § Two IUDs are available in the US: – Copper T 380 A – for up to 10 years of use; cumulative ten-year pregnancy rate is about 2%3 – Levonorgestrel-releasing IUD – for up to 5 years of use; cumulative five-year pregnancy rate is <1%4 § Can be inserted at any time in the menstrual cycle, provided the woman is not pregnant 1. 2. 3. 4. Curtis KM, et al. Contraception. 2007; 75(6 Suppl): S 60 -S 69. Varma R, et al. Eur J Obstet Gynecol Reprod Biol. 2006; 125: 9 -28. Sivin I. Contraception. 2007; 75(6 Suppl): S 70 -S 75. Andersson K, et al. Contraception. 1994; 49(1): 56 -72.

Intrauterine Devices (IUDs) § Earlier concerns about infection and infertility are no longer appropriate: – Cohort studies have identified rapid return to fertility after IUD discontinuation 1, 2 – Prophylactic antibiotics at time of insertion appear unwarranted except in populations of women with a high prevalence of sexually transmitted diseases 3 – Case controlled studies revealed no increase risk of upper genital tract infection in women who had undetected chlamydial infections at the time of IUD insertion 4, 5 1. Skjeldestad F, et al. Adv Contracept. 1988; 4: 179 -184. V 2. Wilson JC. Am J Obstet Gynecol. 1989; 160: 391 -396. 3. Grimes DA, et al. Contraception. 1999; 60(2): 57 -63. 4. Faúndes A, et al. Contraception. 1998; 58(2): 105 -109. 5. Skjeldestad FE, et al. Contraception. 1996; 54(4): 209 -212.

Intrauterine Devices (IUDs) Benefits § Non-medicated and copper IUDs are associated with a 40% reduction in the risk of endometrial cancer, prevention that is statistically significant and clinically important 1 § The levonorgestrel device reduces measured blood loss by about 90% in heavy menstrual bleeding, providing comparable benefit to endometrial ablation techniques 2 and superior benefit to oral medications, such as progestins and NSAIDs 3 § The levonorgestrel device can be used to prevent endometrial hyperplasia during menopausal treatment with estrogen 1. Andersson K, et al. Contraception. 1994; 49(1): 56 -72. 2. Marjoribanks J, et al. Cochrane Database Syst Rev. 2006; 2. 3. Milsom I, et al. Am J Obstet Gynecol. 1991; 164: 879 -883.

Emergency Contraception § Intended to prevent pregnancy after intercourse § Prevent pregnancy by: 1 – Inhibiting or delaying ovulation – Hormones may alter sperm or ovum transport – Hormones may alter the endometrium, making it inhospitable to the implantation of an embryo § Hormonal ECs do not affect an established pregnancy, nor do they harm a fetus if taken inadvertently during early gestation 1 § Begin within 72 hours of unprotected sex to reduce risk of pregnancy by at least 75%2 1. Food and Drug Administration. Federal Register. 1997; 62(February 25): 8609 -8612. 2. Trussell J, et al. Contraception. 1998; 57(6): 363 -369.

Emergency Contraception § Emergency contraceptives (ECs) have included: progestins only, combination estrogen-progestin oral contraceptives, synthetic estrogens and conjugated estrogens, antiprogestins, and insertion of a copper-releasing intrauterine device 1 § If menses are delayed more than a week, it may indicate that the EC has failed § Women using intermediate or high failure rate contraception should be educated and encouraged to keep an advance supply of EC, and given a prescription for Plan B 1. ACOG Practice Bulletin No. 69. Obstet Gynecol. 2005; 106: 1443 -1452.

Emergency Contraception Plan B – levonorgestrel 0. 75 mg x 2 Tablets § Approved for over the counter § § 1. 2. 3. sale to women over age 17 Instructions are to take 1 tablet within 72 hours of unprotected intercourse, and the second 12 hours later Clinical trial supports taking both tablets as soon as possible after unprotected intercourse 1 ACOG suggests taking the two tablets as a single dose, or spacing them 12 to 24 hours apart 2, 3 ACOG notes that pills should be taken within 3 days and no later than 5 days after unprotected sex 2 Von Hertzen H, et al. Lancet. 2002; 360: 1803 -1810. ACOG Education Pamphlet AP 114 ; 2007 May. ACOG Practice Bulletin No. 69. Obstet Gynecol. 2005; 106: 1443 -1452.

Emergency Contraception Copper Intrauterine Device § Another EC option, but not approved for this indication in the US § When inserted up to 7 days after unprotected intercourse, or 5 days after ovulation, has a 1% failure rate 1 § Has additional advantage of providing continuing method of contraception 1. Hatcher, et al. Contraceptive Technology; 2004.

Surgical Contraception Sterilization § The most common form of contraception reported by US females aged 35 to 44 years 1 § The types of procedures, in order of frequency: tubal sterilization, vasectomy, hysterectomy benefits: – Perceived permanence – User controlled; confidential – Avoidance of cumbersome options (barrier) or those requiring consistent use (barrier, OCs) – Alternative to contraindicated methods, e. g. , estrogen-containing 1. Chandra A, et al. Vital Health Stat. 2005.

Surgical Contraception Sterilization Female - Tubal Sterilization § Actions taken on the fallopian tubes: § ligation with excision, occlusion with rings, clips or insertion of coils, and electrocoagulation/cautery of a portion of the tubes 1 -4 § Does not cause changes in menstruation 1, 4 § As an ambulatory procedure, is performed in about 50% of cases, 5 mostly laparoscopically 6 § Done transcervically by tubal occlusion 1, 3, 7 – as an office procedure, without incisions or general anesthesia 1, 3 § Many observational studies have noted that tubal sterilization results in a decreased risk of ovarian cancer 5, 7 1. 2. 3. 4. 5. 6. 7. Edelman A. In: Practical gynecology: a guide for the primary care physician; 2008. Hatcher RA, et al. Contraceptive Technology; 2004. Fortin CA, et al. J Obstet Gynaecol Can. 2004; 26(4): 368 -376. Peterson HB. Obstet Gynecol. 2008; 111(1): 189 -203. Westhoff C, et al. Fertil Steril. 2000; 73(5): 913 -922. Kulier R, et al. Cochrane Database Syst Rev. 2004; 3. ACOG Practice Bulletin No. 46. Obstet Gynecol. 2003; 102: 647 -658.

Surgical Contraception Sterilization Male – Vasectomy § Ligation of the vas deferens under local anesthesia in the office setting § Does not provide immediate contraception: – There may be sperm remaining in the vas up to three months after the procedure 1, 2 – Scheduled testing of ejaculate to determine when it becomes negative for sperm – Alternate contraceptive practices are required during this time – Not using back-up contraception is often the reason for perceived vasectomy failure 1 1. Fortin CA, et al. J Obstet Gynaecol Can. 2004; 26(4): 368 -376. 2. ACOG Education Pamphlet AP 011; 2005.

Fertility Awareness-Based Methods § Periodic abstinence § Patients need to identify potentially fertile days and abstain from intercourse or use barrier methods § Best in women with regular cycles § Vaginitis or cervicitis can affect signs of fertility § Estimated to have a 25% failure rate during first year of use

Contraception in Women with Medical Problems § WHO lists conditions where pregnancy may exacerbate risk to a woman’s health 1 § Need to determine contraceptive methods that are safest, given a woman’s underlying diseases or conditions § ACOG Practice Bulletin Number 73 provides a consolidated summary of “clinical considerations and recommendations” 2 1. 2. Medical eligibility criteria for contraceptive use. WHO; 2004. ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472.

Contraception in Women with Medical Problems Migraines § Chinese review of 3901 stroke patients reported that oral contraceptives and migraine were significant risk factors for stroke 1 § Studies have reported that individuals experiencing migraines with an aura are more likely to have strokes 2 -7 § Some women experience migraines in relation to menses, associated specifically with estrogen level fluctuations 8 – Use of extended cycle or continuous combination OCs may control hormonal fluctuations and be a treatment option for contraception and migraine control 1. Liu XF, et al. Chin Med Sci J. 2005; 20(1): 35 -39 [abstract]. 2. Stang PE, et al. Neurology. 2005; 64: 1573 -1577. 3. Kurth T, et al. Neurology. 2005; 64: 1020 -1026. 4. Etminan M, et al. Br Med J. 2004 Dec 13. 5. Carolei A, et al. Lancet. 1996; 347: 1503 -1506. 6. Donaghy M, et al. J Neurol Neurosurg Psychiatry. 2002; 73: 747 -750. 7. Tzourio C, et al. Br Med J. 1995; 310: 830 -833. 8. Mac. Gregor EA, et al. Neurology. 2006; 67: 2154 -2158.

Contraception in Women with Medical Problems Migraines § The WHO 1: – Advocates caution (category 2 or 3) in the use of hormonal contraception in migraineurs – Disapproves use (category 3 or 4) in women older than 35 – Classifies those with aura as having unacceptable health risk (category 4) for this method of contraception § In general, hormonal contraception is not contraindicated in women with migraines, however need to review predisposing factors and migraine patterns before prescribing § Appropriate alternatives include progestin-only, intrauterine and barrier methods 2 1. Medical eligibility criteria for contraceptive use. WHO; 2004. 2. Teal SB, et al. Obstet Gynecol Clin N Am. 2007; 34: 113 -126.

Contraception in Women with Medical Problems Obesity § Combination oral and transdermal contraceptives may be less effective in the obese woman 1 § Obesity, combination OCs, and age all represent independent risk factors for venous thromboembolism (VTE)1, 2 § Progestin-only contraception does not appear to increase VTE risk 2 § Contraceptives for obese women older than age 35 include DMPA, progestin implant, IUD, vasectomy of the partner; 3 or barrier methods 1. ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472. 2. Grimes DA, et al. Contraception. 2005; 72(1): 1 -4. 3. Holt VL, et al. Obstet Gynecol. 2002; 99: 820 -827.

Contraception in Women with Medical Problems Drug Interactions § Hepatic enzyme inducers (most commonly antiepileptic medications) decrease contraceptive blood levels, of estrogen and progestin 1 -3, in users of combined OC and patch, progestin-only pill and implant 3 Antiepileptic Drugs that May Reduce Contraceptive Efficacy via Enzyme Induction § Simplest option may be to change to contraceptive where reduced efficacy has not been demonstrated: DMPA or an IUD (copper or levonorgestrel)1, 3, 4 1. 2. 3. 4. ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472. Kaunitz AM; 2007 Feb 7. 39 Power. Point slides. O'Brien MD, et al. Epilepsia. 2006; 47(9): 1419 -1422. Teal SB, et al. Obstet Gynecol Clin N Am. 2007; 34: 113 -126. carbamazepine felbamate oxcarbazepine phenobarbital phenytoin primidone topiramate

Contraception in Women with Medical Problems Drug Interactions § Rifampin, a known enzyme inducer, reduces OC hormone levels 1; herbal medications can also have an effect on OC metabolism, e. g. , St. John’s Wort 2, 3 § Various antiviral agents (for treatment of HIV) can have different hepatic enzyme effects, being substrates, inducers, or inhibitors 1, 2, 4, therefore contraceptive methods that bypass the potential for drug interactions are recommended, ie. , IUDs 4 § OCs have been shown to increase drug levels of lamotrigine; 5 with problems occurring during pill-free phases or when starting or stopping OCs 1. 2. 3. 4. 5. Johns Cupp M, et al. Am Fam Phys. 1998; 57(1). ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472. Black A, et al. J Obstet Gynaecol Can. 2004; 26(3): 220 -236. Teal SB, et al. Obstet Gynecol Clin N Am. 2007; 34: 113 -126. Christensen J, et al. Epilepsia. 2007; 48(3): 484 -489.

Contraception in Women with Medical Problems Systemic Lupus Erythematosus § Reluctance to use combined OC contraception due to concerns of causing disease flares and venous thromboses (related to vasculitis and prothrombotic antibodies)1 § Two 2005 studies (randomized, controlled, in women under 40 with stable disease and negative for antiphospholipid antibodies): 2, 3 – Rates of disease flare similar for combination OC, progestin-only pill, and copper IUD; no differences in disease activity among the three treatment groups over the one-year follow-up 3 – Thromboses in Mexican trial - 2 with progestin-only pill, 2 with combination OC 3 – Rates of disease flare similar in combination OC and placebo groups 2 1. Teal SB, et al. Obstet Gynecol Clin N Am. 2007; 34: 113 -126. 2. Petri M, et al. N Eng J Med. 2005; 353: 2550 -2558. 3. Sánchez-Guerrero J, et al. N Engl J Med. 2005; 353: 2539 -2549.

Contraception in Women with Medical Problems Systemic Lupus Erythematosus § Combined OCs and progestin-only pills can be safe in the woman with mild, stable lupus § With history of vascular or renal disease, or antiphospholipid antibodies present, combination estrogen-progestin contraceptives should be avoided and progestin-only contraceptives would represent prudent alternatives 1 § Note that the US Food and Drug Administration has removed immunosuppression as a contraindication for the copper IUD 2 1. ACOG Practice Bulletin No. 73. Obstet Gynecol. 2006; 107(6): 1453 -1472. 2. Teal SB, et al. Obstet Gynecol Clin N Am. 2007; 34: 113 -126.

Contraindications to Contraceptives (adapted from WHO 1) Condition/Personal Characteristics Contraindicated Contraceptive Methods Breastfeeding < 6 weeks postpartum Combination OC, patch, ring Smoker > 35 years old Combination OC, patch, ring High blood pressure (systolic >160 mm Hg; diastolic > 100 mm Hg) Combination OC, patch, ring Vascular disease Combination OC, patch, ring Previous or current DVT or pulmonary embolism; thrombogenic mutations; stroke or previous cerebrovascular accident Combination OC, patch, ring Major surgery with prolonged immobilization Combination OC, patch, ring Previous or current ischaemic heart disease; complicated valvular heart disease Combination OC, patch, ring Migraine with aura Combination OC, patch, ring Distorted uterine cavity Copper and progestin IUD 1. Medical eligibility criteria for contraceptive use. WHO; 2004.

Contraindications to Contraceptives (adapted from WHO 1) Condition/Personal Characteristics Contraindicated Contraceptive Methods Breast cancer All combination estrogen-progestin and progestin-only methods Active viral hepatitis; severe decompensated cirrhosis; hepatoma Combination OC, patch, ring Malignant gestational trophoblastic disease Copper and progestin IUD Puerperal sepsis; postseptic abortion; Copper and progestin IUD Pelvic infections Copper and progestin IUD - do not initiate; monitor devices already in situ Pregnancy All forms of contraception Allergies To any component(s) in any form of contraception 1. Medical eligibility criteria for contraceptive use. WHO; 2004.

Patient-Centered Contraceptive Decision Making Appropriate Contraceptive Selection Should Take Several Variables Into Account: § Effectiveness (typical use failure rate); side effects § Perceptions and misperceptions about risks and benefits of contraceptive use and pregnancy § Likelihood and ability to comply with the regimen § Frequency of intercourse § Age § Cost of the method and ability to pay for it § Concomitant drug use; health status and habits § Desired duration of contraception; reversible vs. nonreversible method

Counseling for Contraceptive Success § Inform the woman about all available products, including long-term options § Educate post-partum lactating women on the limitations of the lactational amenorrhea method § Many post-partum women experience unplanned pregnancy due to false perception of reduced fertility

Counseling for Contraceptive Success § Strategies that may increase uptake and continuation of contraceptive use include: § Counsel thoroughly on all contraceptive options, even if patient states a preference for a particular contraceptive 1 § Encourage long-acting reversible contraceptives having top tier effectiveness § Avoid “bundling” of unrelated preventive care (e. g. , Pap smear) with contraceptive initiation § Avoid unnecessary delays of waiting for a menstrual period or a follow-up exam after a pregnancy event 1. Lamvu G, et al. Contraception. 2006; 73(4): 399 -403.

Counseling for Contraceptive Success Strategies That May Increase Uptake and Continuation of Contraceptive Use Include: § Encourage dual protection, 1 particularly in young women 2 § Include male partner in counseling when possible and appropriate 3 § Dispense advance EC, if possible, giving advance EC prescription to all women under age 184, 5 1. 2. 3. 4. 5. Berer M. Reprod Health Matters. 2006; 14(28): 162 -170. Department of Health and Human Services. Data from the National Health and Nutritional Examination Survey (NHANES) 2003 -2004. Beenhakker B, et al. Contraception. 2004; 69(5): 419 -423. Raine T, et al. Obstet Gynecol. 2000; 96(1): 1 -7. Lo SS, et al. Hum Reprod. 2004; 19(10): 2404 -2410.