Patient Counselling and Management Contraception Patient Counselling and Management

Introduction Most women spend approximately 36 years in the reproductive stage of life (ages 15-44) They try to avoid pregnancy at some point in this interval ~30% of pregnancies are unintended 14% of births are unwanted Annually, ~2% of women have an induced abortion Spacing children decreases infant morbidity and mortality and the risk of spontaneous abortion Successful family planning has a positive impact on women, couples, families, and society 2

Contraception Benefits often outweigh health risks Side effects can often be managed or relieved Variety of options available 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 3

Health Benefits Barrier effect Endometrial cancer Ovarian cancer Condoms reduce transmission of infectious agents Endometrial cancer Risk significantly reduced with combination oral contraceptives, depot medroxyprogesterone acetate (DMPA) and non-medicated IUDs Ovarian cancer Risk reduced by combination oral contraceptives Even in women with BRCA1 and BRCA2 mutations 4

Other Benefits Withdrawal bleeding and dysmenorrhea Regulated and reduced with use of combination oral contraceptives Menstrual blood loss in menorrhagia Reduced with use of combination oral contraceptives, or levonorgestrel IUD Acne Treated with combination oral contraceptives Perimenopause Lighter, predictable bleeding; vasomotor symptom relief; positive effect on bone mineral density 5

Hormonal Contraceptives Combination hormonal – pill, patch, vaginal ring Oral contraceptives are the most commonly used method in the US 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 6

Combination Oral Contraceptives Relatively effective: 8% failure rate during first year of use, since most women do not take them perfectly Fertility returns soon after discontinuation 7

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 Breast Cancer : Large( British, US , and Canadian) studies found no increased risk with former or current use 8

Combination Oral Contraceptive Health Risks Venous Thromboembolism (VTE) Varying reports regarding risk associated with estrogen dose or type of progestin Pregnancy, childbirth and puerperium are associated with risk of VTE higher than that associated with the use of OCs: Low-Dose OC Users1 Pregnant Women9 Postpartum Women9 VTE Incidence per 100,000 Woman-Years 10 - 15 95 - 96 511 VTE risk is further increased with OCs if there are specific thromboembolic risk factors or underlying diseases 9

Combination Oral Contraceptive Health Risks Stroke Low-dose formulations do not increase risk of thrombotic or hemorrhagic stroke in healthy, nonsmoking women Risk increased in women with underlying predisposing diseases or other risk factor Myocardial Infarction Risk of MI substantially increased among OC users over 35 who smoke; smoking and OCs act synergistically to increase risk Metabolic Effects Oral estrogen increases triglyceride levels 10

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 - back- up contraceptive may be needed 11

Progestin-Only Contraceptives Candidates include women with cardiovascular risk factors, diabetes, lipid disorders, estrogen-related side effects or contraindications, migraine headaches, are post-partum or breastfeeding In lactating women, no decrease in milk production has been shown with progestin-only contraceptives Irregular bleeding and spotting are the most common side effects 12

Progestin-Only Contraceptives Pill – Norethindrone 0.35 mg Depot medroxyprogesterone actetate Injection, Given every 3 months by injection: deep IM (150 mg of Depo-Provera)1 or SC (104 mg of depo-subQ provera 104) 3% first year failure rate with typical use; 0.3% first year failure rate with consistent use. 3% first year failure rate with typical use; 0.3% first year failure rate with consistent use Implant – Etonogestrel 68 mg, Overall 3-year failure rate is 0.38%

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) 14

Counseling for Hormonal Contraception OCs need to be taken consistently for contraceptive efficacy and reduced side effects If combined OC pills are missed, patient to take pills according to the following schedule: 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 15

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 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 16

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) Chlamydial cervicitis has been reported as a cause of late-onset unscheduled bleeding in OC users 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 17

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 18

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 Male Condom, female condom, diaphragm, cervical cap, sponge, spermicides 19

Intrauterine Devices (IUDs) Highly effective; convenient; have non-contraceptive benefits Two IUDs are available in the US: Copper T 380A – for up to 10 years of use; cumulative ten-year pregnancy rate is about 2% Levonorgestrel-releasing IUD – for up to 5 years of use; cumulative five-year pregnancy rate is <1% Can be inserted at any time in the menstrual cycle, provided the woman is not pregnant 20

Intrauterine Devices (IUDs) Earlier concerns about infection and infertility are no longer appropriate: Cohort studies have identified rapid return to fertility after IUD discontinuation Prophylactic antibiotics at time of insertion appear unwarranted except in populations of women with a high prevalence of sexually transmitted diseases 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 21

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 The levonorgestrel device reduces measured blood loss by about 90% in heavy menstrual bleeding, providing comparable benefit to endometrial ablation techniques2 and superior benefit to oral medications, such as progestins and NSAIDs The levonorgestrel device can be used to prevent endometrial hyperplasia during menopausal treatment with estrogen 22

Emergency Contraception Intended to prevent pregnancy after intercourse Prevent pregnancy by: 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 Begin within 72 hours of unprotected sex to reduce risk of pregnancy by at least 75% 23

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 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 24

Surgical Contraception Sterilization The most common form of contraception reported by US females aged 35 to 44 years The types of procedures, in order of frequency: tubal sterilization, vasectomy, hysterectomy 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 Male – Vasectomy Ligation of the vas deferens under local anesthesia in the office setting 25

Contraception in Women with Medical Problems WHO lists conditions where pregnancy may exacerbate risk to a woman’s health 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” 26

Contraception in Women with Medical Problems In general, hormonal contraception is not contraindicated in women with migraines, however need to review predisposing factors and migraine patterns before prescribing it Appropriate alternatives include progestin-only, intrauterine and barrier methods

Contraception in Women with Medical Problems Drug Interactions Hepatic enzyme inducers (most commonly antiepileptic medications) decrease contraceptive blood levels, of estrogen and progestin, in users of combined OC and patch, progestin-only pill and implant Simplest option may be to change to contraceptive where reduced efficacy has not been demonstrated: DMPA or an IUD (copper or levonorgestrel Antiepileptic Drugs that May Reduce Contraceptive Efficacy via Enzyme Induction carbamazepine felbamate oxcarbazepine phenobarbital phenytoin primidone topiramate 28

Contraception in Women with Medical Problems Drug Interactions Rifampin, a known enzyme inducer, reduces OC hormone levels; herbal medications can also have an effect on OC metabolism Various antiviral agents (for treatment of HIV) can have different hepatic enzyme effects, being substrates, inducers, or inhibitors, therefore contraceptive methods that bypass the potential for drug interactions are recommended, ie., IUDs 29

Contraindications to Contraceptives (adapted from WHO1) Condition/Personal Characteristics Contraindicated Contraceptive Methods Breastfeeding < 6 weeks postpartum Combination OC, patch, ring Smoker > 35 years old High blood pressure (systolic >160 mm Hg; diastolic > 100 mm Hg) Vascular disease Previous or current DVT or pulmonary embolism; thrombogenic mutations; stroke or previous cerebrovascular accident Major surgery with prolonged immobilization Previous or current ischaemic heart disease; complicated valvular heart disease Migraine with aura Distorted uterine cavity Copper and progestin IUD 30

Contraindications to Contraceptives (adapted from WHO1) 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; Pelvic infections - do not initiate; monitor devices already in situ Pregnancy All forms of contraception Allergies To any component(s) in any form of contraception Medical eligibility criteria for contraceptive use. WHO; 2004. 31

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. non-reversible method 32

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