14/03/2019 Birth Control: Contraceptive Choices & Management TITLE Subtitle Alexandra Sible Herman, PharmD Date NMNPC 2019 Spring Conference April 1, 2019 OBJECTIVES • Understand the mechanisms of action of contraceptive methods discussed, including long-acting reversible contraception (LARC), such as IUDs and implants, and short- acting hormonal contraception. • Describe differences in efficacy and safety among contraceptive options. • Recognize and manage adverse effects of contraceptive methods. • Given a patient scenario, discuss how to choose and initiate an appropriate contraceptive method, including evaluation of contraindications and indications and patient preferences. CONTRACEPTION MANAGEMENT • Undesired fertility: a “chronic condition”? • “Childbearing age” defined by CDC as 15-44 years old • Average age at menarche in U.S. is ~12.5 years old • Average of menopause in U.S. ~51 years old • Patient’s reproductive life plan; contraceptive preferences; safety of methods – all may change • Should be re-evaluated and managed appropriately throughout patient’s entire reproductive lifetime 1 14/03/2019 CONTRACEPTION MANAGEMENT • Unintended pregnancy • Nearly half of U.S. pregnancies are described as “unintended” • Women who did not use a contraceptive method: 54% • Women who inconsistently used a contraceptive method: 41% • Women who consistently used a contraceptive method: 5% • Pregnancy ambivalence • Do you want to become pregnant? Yes / No / Maybe • Often influences choice of method (especially re: effectiveness) Source: Guttmacher.org CONTRACEPTION MANAGEMENT • The best contraceptive method is the one the patient will consistently use • Shared, informed decision making helps a patient choose the most effective option that is safe for her and fits her lifestyle and preferences EFFECTIVENESS • Sterilization • Long-acting reversible contraception (LARC) • IUD, implant • Short-acting reversible hormonal contraception • Shot • Pill, patch, ring • Barrier & behavioral methods • Emergency contraception 2 14/03/2019 Source: Bedsider.org SAFETY • U.S. Medical Eligibility Criteria (MEC) for contraceptive use: https://www.cdc.gov/reproductivehealth/contracepti on/mmwr/mec/summary.html • App available for iOS and Android systems SAFETY Example of the MEC – many more disease states are included in full document 3 14/03/2019 LIFESTYLE & PREFERENCES • A method that worked in the past • A method she heard about from a friend/family member/etc. • Methods in the news • Adherence • Convenience • Periods or no periods • Need to keep method hidden? • Return to fertility/desire for future pregnancies • Timing and spacing of pregnancies • …and more Source: https://www.guttmacher.org/fact-sheet/contraceptive-use-united-states LIFESTYLE & PREFERENCES • The pill and female sterilization are the most popular forms of contraception in the U.S. • Contraceptive CHOICE Project: participants offered a method of their choice at no cost for 2-3 years • 75% of participants chose LARC (IUD or implant) • LARC methods were 20 times more effective than non-LARC methods • LARC methods had higher continuation rates at 12 & 24 months • The Contraceptive CHOICE Project in Review: https://www.ncbi.nlm.nih.gov/pubmed/25825986 4 14/03/2019 • Robert Hatcher, et al. Managing Contraception, 14th ed. • $25 • https://managingcontraception.com/ METHODS Sterilization (>99% effective) • Male sterilization: vasectomy (no anesthesia) • Female sterilization • Essure – withdrawn from market Dec 2018 • Tu b a l l i g a t i o n ( laproscopic surgery, requires anesthesia) POP QUIZ! True or False: A woman who has never given birth should not use an IUD. 5 14/03/2019 METHODS IUD (>99% effective) • Non-hormonal: Copper IUD (Paragard®) • Mechanism of action: Copper ions inhibit sperm; inflammatory reaction in endometrium • FDA approved for 10 years; effective 12+ years • Hormonal: all contain levonorgestrel (a progestin; LNG) • Mechanism of action: Thickening of cervical mucus; alteration of endometrium; some anovulatory effects • Serum levels of LNG are lower than with implant or pill • Good option for women who cannot take estrogen • IUDs are an appropriate option for adolescents; women who have not had children; women not in a monogamous relationship Source: Mirena; Skyla; Kyleena; and Liletta prescribing information; Managing Contraception; Paragard prescribing information METHODS LNG IUDS Name Levonorgestrel Replace after _ years FDA / off-label Mirena ® 52 mg (20 mcg/day) 5 years / 7 years Liletta ® 52 mg (18.6 mcg/day) 5 years / 7 years Kyleena ® 19.5 mg (17.5 mcg/day) 5 years Skyla ® 13.5 mg (14 mcg/day) 3 years Source: Mirena; Skyla; Kyleena; and Liletta prescribing information; Micromedex: Levonorgestrel METHODS Implant (>99% effective) • Nexplanon ® • Contains 68mg etonogestrel (a progestin) • Releases ~40-70 mcg daily Source: Nexplanon prescribing information. 6 14/03/2019 METHODS Implant Mechanism of Action How to Use Notes Thickening of cervical mucus; Implanted under the skin in the FDA approved for 3 years of use; evidence alteration of endometrium; upper arm that it remains effective for 4-5 years suppression of ovulation Steady delivery of hormones Good option for women who cannot take estrogen Source: Nexplanon prescribing information; Ali, et al. Extended effectiveness of the etonogestrel-releasing contraceptive implant… for 2 years beyond U.S. FDA Product Labeling. 2017. METHODS Ring • Nuvaring ® etonogestrel/ethinyl estradiol 120/15 mcg/day • AnnoveraTM segesterone acetate/ethinyl estradiol 150/13 mcg/day • Approved August 2018 • >99% effective (perfect use) • 91% effective (typical use) Source: Nuvaring and Annovera package insert METHODS Ring Mechanism of Action How to Use Notes Progesterone and estrogen combination Nuvaring Adherence may be higher vs. pill 1 ring inserted into the vagina Prevention of ovulation; thickening of for 3 weeks, then removed for 1 Easier to hide than patch or pill cervical mucus, inhibiting sperm week (off-label: use continuously for 4 weeks, then replace with Estrogen component also helps to new ring) Continuous, steady release of hormones & lowest serum levels of stabilize endometrium, decreasing Annovera hormones vs. other combined breakthrough bleeding 1 ring inserted into vagina for 3 weeks, then removed for 1 week; hormonal methods clean, dry, and store ring during off week; repeat Source: Nuvaring and Annovera package insert 7 14/03/2019 METHODS Patch • Xulane ® norelgestromin and ethinyl estradiol 150/35 mcg/day • >99% effective with perfect use • 91% effective typical use METHODS Patch Mechanism of Action How to Use Notes Progesterone and estrogen combination 1 patch applied each week for Adherence may be higher vs. pill 3 weeks, then 1 week off (off- Prevention of ovulation; thickening of label: wear for 3 weeks, Higher estrogen exposure than pills or cervical mucus, inhibiting sperm remove and replace with new ring à may increase VTE risk patch immediately) Estrogen component also helps to stabilize endometrium, decreasing Less effective in women >90kg (198 lbs) breakthrough bleeding Source: Xulane prescribing information; Managing Contraception METHODS Shot • Depomedroxyprogesterone (DMPA) 150 mg (IM), 104 mg (SQ) • 99.8% effective perfect use • 94% effective typical use 8 14/03/2019 METHODS Shot Mechanism of Action How to Use Notes Prevention of ovulation; thinning of IM or SQ injection every 3 May require appointment or pharmacy endometrium months (11-15 weeks) visit for injection Easier to keep hidden vs. other methods High discontinuation rate compared to other methods (~44-77% in various studies) Good option for women who can’t take estrogen Slow baseline return to fertility (~10 months avg; up to 18+ months) Source: Depo Provera prescribing information; Managing Contraception METHODS Barrier Methods Method Effectiveness – perfect use Effectiveness – typical use Male Condom 98% 82% Female Condom 95% 79% Sponge 80-91% 76-88% Diaphragm N/A 71-85% Spermicide 82% 72% *best used with another method Source: Bedsider.org; Managing Contraception METHODS Behavioral Methods Method How to do it Notes Abstinence Complete avoidance of vaginal intercourse Poor real-world adherence Rhythm method Avoidance of vaginal intercourse during woman’s TM fertile period (~3-6 days before & 24 hours after ~88% effective (typical use of cyclebeads ) ovulation). Examples: Calendar tracking; cyclebeads TM Withdrawal Male withdraws his penis from the vagina prior to 96% effective with perfect use; 78% effective ejaculation typical use Fertility awareness Cervical mucus checks; Basal body temperature; 95-99% effective with perfect use; 76-88% etc. Natural Cycles app is FDA approved effective typical use Lactational up to 6 months after birth IF exclusively Effectiveness up to ~98% in some studies breastfeeding, at least q4h during the day and q6h at night, and amenorrheic Source: Bedsider.org; Managing Contraception; Natural Cycles FDA approval: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm616511.htm 9 14/03/2019 METHODS Emergency Contraception Method Mechanism of Action How to Use Notes Levonorgestrel Prevention of ovulation 1 tablet taken within 72 hours - Should be offered to all women (Plan B One Step; Next of unprotected intercourse using short-acting hormonal Choice; My Way, etc. ) (more effective the earlier it is contraception to have on hand in taken; may use up to 120 hrs the event of missed doses but less effective) ~98-99% effective; less effective in obese women Ulipristal acetate 30 mg Progesterone receptor