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Women’s Health in Primary Care Orlando, Florida March 16, 2011 Norma Jo Waxman MD

The Latest in Contraception: Pearls for Busy Primary Care Providers. Women’s Health in Primary Care Orlando, Florida March 16, 2011 Norma Jo Waxman MD Assoc Professor of Family and Community Medicine University of California San Francisco njwaxman@fcm.ucsf.edu. Disclosures.

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Women’s Health in Primary Care Orlando, Florida March 16, 2011 Norma Jo Waxman MD

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  1. The Latest in Contraception: Pearls for Busy Primary Care Providers Women’s Health in Primary Care Orlando, Florida March 16, 2011 Norma Jo Waxman MD Assoc Professor of Family and Community Medicine University of California San Francisco njwaxman@fcm.ucsf.edu

  2. Disclosures • Norma Jo Waxman MD • No pharmaceutical support or other commercial disclosures

  3. Objectives:After this talk you will be able to: • Describe why pelvic exams and lab tests are not necessary prior to prescribing hormonal contraception. • Integrate the use of the "Quick Start" method of initiating contraception into their practice. • Encourage more efficacious and long-acting methods of contraception • Update practice protocols to increase contraceptive use and decrease unintended pregnancy in their office.

  4. Outline Unintended pregnancy Barriers to contraceptive access and use Contraceptive methods updates • Continuous cycle combined hormonal • Evidence based IUD use • New Progestin Implant • New Sterilization techniques

  5. 6.3 Million Pregnancies in the U.S. 25 % Unintended Despite Method Used2 51% Intended 1. 23 % Unintended No Contraception • Finer et al, 2006 • Jones RK, et al Perspectives on Sexual and Reproductive Health, 2002

  6. Half of women at risk are not fully protected from unintended pregnancy

  7. The Profound Impacts of Unintended Pregnancy • Increased domestic violence1 • Increased maternal drug and alcohol use • Among teens: • Decreased high school completion • Increased likelihood of life in poverty 1. Pallitto, et al. Trauma, Violence, & Abuse, 2005.

  8. The Profound Impacts of Unintended Pregnancy • Delayed prenatal care • Higher rates of fetal drug and alcohol exposure • Higher rates of low birth weight and infant mortality • Higher rates of developmental deficits • Higher rates of child abuse and life in poverty

  9. Jane 27 year-old taking combined OCPS Missed two periods Urine Hcg is positive Jane tells you that she ran out of birth control pills last month, and that she tried to call the office to get an appointment, but the receptionist told her she was overdue for a pap smear and couldn’t get a refill. Today was the first day she could get an appointment with you.

  10. What is required before starting contraception? • Pelvic exam • Up to date Pap test • Breast Exam • STI testing • Pregnancy test • None of the above

  11. And the evidence says…. • Medical History: Required • BP: Helpful • Breast exam, Pelvic exam, Pap, Hemoglobin, pregnancy test, STI testing: NOT REQUIRED! Stewart F, et al. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence.JAMA. 2001;285:2232-9.

  12. When in her menstrual cycle can she start contraception? • The first day of her period • The Sunday after the first day of her cycle • Any time in the month • All of the above

  13. “Quick Start” • “Quick Start” – start pill1,2( patch3, shot, ring4, ) on day of visit- any time of the month. • EC if unprotected sex in last 5 days • Back up method for first week • Urine HCG if no withdrawal bleed at end of cycle, or 2 weeks after DMPA injection • Reassure- exposure of embryo to OC not teratogenic • Westhoff et al Contraception 2002 2. Westhoff et al Fertil Steril 2003 3. Murthy AS, • et al. Contraception. 2005 4. Westhoff CW, et al. Obstet Gynecol. 2005

  14. http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdfhttp://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf

  15. Effectiveness Rates

  16. Effectiveness Rates Hatcher, RA et al; Contraceptive Technology 18th Edition,: 2007

  17. Access Issues and Unintended Pregnancy Jane tells you that her insurance permitted her to obtain only one pack of pills each month, and she was late in getting her pack last month because of working until after the pharmacy was closed.

  18. How many refills can I give her? • One month? • 3 months • 13 cycles What if you have never seen her? Can you refill a new patient’s contraception until you could see her? YES, it is safe to continue her medication

  19. Dispensing 12 months of contraception increases continuation & lowers costs UCSF Bixby Center evaluated 2003 claims for 82,319 women dispensed OCPs via Fam PACT Outcomes: • Women who received 13 cycles more likely to be receiving pills in 2004 than women who received 1 or 3 cycles. • Women dispensed 13 cycles more likely to receive Pap & Chlamydia tests; less likely to have pregnancy test • Fam PACT saved $99/ year on women who received 13 cycles Foster, D et al. Obstetrics & Gynecology 108(5):1107-1114, November 2006.

  20. How can we help patients with access and adherence • Help patients obtain method of choice • Eliminate practice barriers • Review and offer all options • Posters and handouts in exam rooms • Anticipate side effects and forgetting • set expectations: improves continuation1,2 • Explain Medical Benefits 1. Lei Z, Contraception, 1996 2. Canto-DeCetina, Contraception 2001

  21. Systemic Barriers • Trouble with refills - can’t get through on phone, not called in to pharmacy quickly enough, formulary changes, only one month at a time covered by insurance… • Patients can’t contact provider about side effects, stops taking the method… • Provider links refills to BP check or pap test • Time constraints lead to incomplete contraceptive counseling • Provider not comfortable with full range of products • Others?

  22. PDR, Product Labeling & Inserts • Labeling change biased towards adding warnings vs. removal of incorrect information1 • New indication or removal of safety information requires two well-controlled studies • FDA approval not required to add warning • Liability concerns lead to unwarranted Black Box warnings • 1. Grossman D, et al. Am J Public Health. 2006;96(5):791-9

  23. PDR, Product Labeling & Inserts • PDR often outdated and incorrect1 • Package inserts cause irrational fear of rare health risks & decrease use of contraception2 • “Throw the package insert away” • 1. Mullen et al Ann Emerg Med Feb 1997;29:255-261 2. Grubb G. J Biosoc Sci. 1987;19:313–321

  24. Use absolute vs. relative risk  “Of every 1 million OC users, 4 develop heart attack each year compared with 2 nonusers.” “OC use increases risk of heart attack 1.5 fold.” Gigerenzer G, Edwards A.BMJ. 2003. Farley TMM, Collins J, Schlesselman JJ. Contraception. 1998. Sloman SA. Organizational Behavior and Human Decision Processes. 2003.

  25. Patient Centered History • Do you plan to become pregnant in the next year? • Ask about accidental pregnancy? How would it effect her life? • Explore tolerance of side effects: • spotting, headaches, weight gain, nausea • Is she comfortable touching her vagina? • How heavy &/or painful are her periods? • What method(s) has she used in the past? • What contraception did she come for today?

  26. Do women need a “break” or “holiday” from contraception? • NO! they get pregnant Is it safe to not have periods? • Dispel myths around “need to bleed” • Reassure our patients that amenorrhea on progestin is safe vs. amenorrhea off hormones

  27. Extended Cycle Advantages • Traditional prescription historic only • Increase of efficacy • 47% of women have follicle ready to ovulate by day 7 of placebo week1 • 24/3 pills found to have higher efficacy then 21/72 • Symptoms w/ OC worse during withdrawal bleed • Cyclic vs. extended cycle: less headaches, tiredness, bloating, menstrual pain 3,4 • Treats anemia, dysmenorrhea, heavy bleeding, PMS, menstrual migraines, endometriosis, PCOS 1. Baerwald, Contraception, 2004 2. Dinger et al Obstet Gynecol 2011;117(1):33-40 3. Edelman et al Cochrane Review 2006 4. Sulak

  28. Extended cycle: Is Something Building Up Inside? • Endometrial biopsy data – no hyperplasia1 • Tricycle regimen, short hormone-free, cont. • 1 year continuous: 11% weakly proliferative • Ultrasound data - thin endometrial stripe in study of continuous x 6 months 2 • Traditional use decreases risk of endometrial cancer 1. Bachman, Contraception, 2004; Johnson, Contraception, 2007. 2. Foidart, Contraception, 2006; Anderson, Contraception, 2003; Kwiecien, Contraception, 2003.

  29. 500 450 450 400 350 300 250 200 160 150 100 50 50 0 Prehistoric Modern Colonial America Lifetime Number of Menstrual Cycles Number of Cycles Adapted from Coutinho EM. Is Menstruation Obsolete? 1999. Eaton SB, et al. Quart Rev Biol. 1994;69:353-363.

  30. Continuous Cycle Dedicated Products • Lybrel ™ • 20 mcg EE/ 90 mcg LNG • Daily continuous use, no placebo, for a year • Seasonale ™ (generic version now available) • 30 mcg EE/ 150 mcg LNG • 84 active pills/ 7 placebo pills

  31. Continuous Cycle Dedicated Products • Seasonique ™ • 30 mcg EE/ 150 mcg LNG • 84 active pills/ 7 pills 10mcg EE • LoSeasonique ™ • 20 mcg EE/ 100 mcg LNG • 84 active pills/ 7pills 10mcg EE

  32. Extended Cycle Dedicated Products 2- 4 days of placebo rather than 7 Suppresses follicular growth seen during placebo week Similar breakthrough bleeding • Loestrin 24 Fe ™ • 20 mcg EE/ 1 mg NET • 24 days active, 3 days of Fe • Mircette ™ (Kariva generic) • 20 mcg EE/ 150 mcg DSG • 21 days active, 2 days placebo, 5 days 10 mcg EE • Yaz ™ • 20 mcg EE/ 3 mg DRSP • 24 active pills/ 3 placebo pills .

  33. Lawonda • 29 yo G5P2Tab3 • Currently using oral contraception (OCs), but admits to frequently forgetting to take her pill • Wants to try patch because her friends like it What do we know about adherence and OCs? What are the side effects of the patch we need to talk to her about?

  34. Adherence with Oral Contraception:What Women Do! Percent of Women (%) Active Pills Missed Potter L et al, Fam Plann Perspect. 1996.

  35. It is hard to take the pill • Nationally nearly half (47%) of pill users miss 1 or more pills per cycle (Rosenberg, 1999) • The third most common reason for missing a pill is “No new pill pack,” cited in 10% of the instances of missed pills. (JD Smith et al., 2005) • 1 in 7 women seeking abortion in US report using pills in the month they conceived. (RK Jones et al, 2002)

  36. Weekly:Contraceptive Patch (Evra) • Apply weekly x 3, then 1 wk off • EE: 20 mcg/ Norgestimate • Place on arm, trunk, buttock • Same contraindications as OCs. Typical use efficacy may be > than OCs1 • Decreased efficacy, not contraindicated in women >198 lbs2 • Breast discomfort and spotting > > than OC in cycles 1 & 23 • Average levels of circulating estrogen 60% higher though peak levels are lower compared to OCs • Sonnenberg et al, Am J Obstet Gynecol. 2005 , 2. Zieman M, Fertil & Steril, 2002 • 3. Audet, et al. JAMA. 2001;285:2347-2354.

  37. EE Exposure with CHC AUC (area under curve) ng.h/mL Patch 37.7 + 5.6 OC* 22.7 + 2.8 Ring 11.2 + 2.7 * 30 mcg EE/150 mcg LNG van den Heuvel, Contraception 2005 72:168

  38. Ortho Evra and risk of Venous Thromboembolism (VTE) Retrospective case-control studies from claims data • Jick et al, 2006 Nested case-control design based on information from PharMetrics; 59K patch, 147K OC users • did not show increased risk of VTE : OR .9 (CI 0.5–1.6) and OR 1.1 (CI 0.6–2.1) with 2006 data, when compared to OCs containing 35mcg ethinylestradiol (EE) and norgestimate Jick SS et al. Contraception 2006;73:223-228 and Contraception 2007;76:4-7

  39. Ortho Evra and risk of Venous Thromboembolism (VTE) Retrospective case-control studies from claims data • Cole et al, 2007. United Health Care claims data and chart reviews; 99K patch 257K OC users • did show odds ratio 2.4 (CI 1.1-5.5) for VTE among patch users compared to OCs with 35 mcg EE and norgestimate • Bias: new patch users vs. new and prior OC user Cole JA et al. Obstet Gynecol 2007;109:339-346

  40. Monthly: Vaginal Contraceptive RingNuvaring™ 15 mcg EE & 120 mcg desogestrel • Easily placed and removed • Rarely noticed during sex • Higher acceptability and compliance than pills • Less spotting compared to pills • constant serum estrogen levels • Obesity doesn’t affect efficacy • No liver first-pass metabolism

  41. Vaginal Contraceptive Ring:Off label, Extended cycle regimens • The Ring is effective for up to 35 days1 • Continuous cycling, increases breakthrough bleeding2 • “Calendar month” use 1-27th of month, then off for rest of month 1. Mulders & Dieben, Fertil Steril 2001;75:865-70. 2. Miller, et al. 2005

  42. Q 3 months:Progestin-Only Injection: Depo Medroxyprogesterone Acetate (DMPA -IM 150mg q12wk) • Irregular bleeding is expected • and Amenorrhea is normal: • 50% at 1 year, 80% at 5 years • May decrease seizure frequency and sickle crisis • Part responsible for decrease in teen birth & abortion • Advantages for teens: privacy, adherence, efficacy, decreased PID risk • Advise Calcium & Vit D, and weight bearing exercise

  43. DMPA-IM 150 & Black Box Warning • Loss of BMD happens in first 2 years Pregnancy and nursing cause similar or > bone loss than DMPA1 • In teens, bone loss reversed within 12 months of discontinuation, and ultimate BMD may be higher in the former users of DMPA 2,6 • No increased incidence of osteoporosis or fractures w/ DMPA in >30yrs of worldwide use3 • No role for BMD evaluation or treatment with bisphosphonates4 • Experts feel “FDA's recent additional labeling for DMPA is unnecessary and should be revised or rescinded” 5 1. Sowers Obstet Gynecol, 2000;96:189-93 2.Scholes Arch Pedatir Adol Med 2005;159:139-44 3. Westhoff C Contraception. 2003;68:75-87 4.ACOG Bulletin 2005 5. Kaunitz Contraception 2005;72:165-167 6. Harel et al Contraception, 2010;81: 281-291

  44. What about new LARC evidence? Long Acting Reversible Contraception Long over-due Acceptable Reliable Contraception

  45. Why are IUDs So Underused in the US? Lack of awareness of method and anxiety around insertion among patients Dearth of trained, willing clinicians to insert Misconceptions regarding difficulty of insertion Negative publicity, fear of litigation Upfront cost and insurance issues Non evidence based office protocols decrease access Despite being most cost-effective methods, high up front cost and inconsistent insurance coverage Weir E. CMAJ. 2003. Stanwood NL, et al. Obstet Gynecol. 2002. Steinauer JE, et al. Fam Plann Perspect. 1997 Asker C, et al. J Fam Plann Reprod Health Care. 2006..

  46. Intrauterine Contraception (IUDs) • Most Common Reversible Contraception Worldwide • Copper T 380A (ParaGard) • Effective 12 years and No hormones • Increased blood loss and cramping with regular periods • Levonorgestrel releasing system (Mirena) • Effective 5 (maybe 7) years • Irregular spotting & bleeding • Amenorrhea 20% at1yr 80% 5yr • Many non-contraceptive benefits • Negative US perception b/c Dalkon Shield. Caused plummet of US use (10% of women used IUD mid-70’s)

  47. Evidence based shift of eligible candidates • CuT380A-ParaGard Label Change 2005 • Mirena package insert outdated (grrr); can use Evidence Based indications off-label • Expanded patient profile • Nulliparous women • History of ectopic pregnancy • Past history of PID or STI • More than one partner • Contraindications • Acute cervicitis or PID, or high personal risk for cervicitis or PID

  48. LARC is safe when other hormonal methods are contraindicated WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007. 50

  49. Do IUDs cause STIs and PID? • Transient PID risk of 1/1000 likely due to infection or contamination at insertion 1,2 • Okay to screen for STI and insert IUD at same visit3 • Some protocols moving to “may, not must” screening for STIs (Family Pact and Planned Parenthood) • Okay to treat STI and PID with IUD in place3 • Do not remove unless treatment failure • Dose and duration does not change • Don’t remove for Actinomycosis • Prophylactic antibiotics not necessary4 • Grimes, D Lancet 2001; 7358:6-7, 2. Grimes, D Lancet 2000; 356:1013-9 • 3. WHO 2005 4. Grimes Cochrane Database 2001, revised 2003

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