Preventing the Unintended: Contraception News
Transcription
Preventing the Unintended: Contraception News
4/18/2013 Preventing the Unintended: Disclosures Contraception News & Evidence 46th Annual Advances & Controversies in Clinical Pediatrics I have nothing to disclose May 17, 2013 Norma Jo Waxman MD Department of Family and Community Medicine Bixby Center for Global Reproductive Health University of California San Francisco Private Practice San Francisco [email protected] So, Why Don’t Teens Use Contraception ? NYC Subway Ads Women Who Did Not Use Contraception Before A Recent Unintended Birth In US, 2006-2008 Reason for not using contraception Don’t think they can become pregnant or ambivalent about becoming pregnant Not aware of more highly efficacious methods Irrational fear of hormones Don’t expect to have sex or partner preference Confidentiality Access to care Birth Control is NOT equally effective Percent Did not expect to have sex ................... Did not think you could get pregnant ............. Didn’t really mind if you got pregnant ............. Worried about side effects of birth control .......... Male partner didn’t want you to use birth control ...... Male partner didn’t want to use birth control......... 14.1 43.9 22.8 16.2 7.3 9.6 Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. National Center for Health Statistics. Vital Health Stat 23(29). 2010. 1 4/18/2013 What are teens using? Current use in women age 15-19: OCP – 15.2% Condoms – 6.4% DMPA – 2.6% Implant or patch – 1.5% Withdrawal – 1.1% Ring – 1.0% IUD – 1.0% 4.6% Mosher WD. Vital and Health Statistics 2010. Finer LB, Jerman J, Kavanaugh MC. Changes in use of long-acting contraceptive methods in the United States, 2007–2009. Fertil Steril 2012 http://www.fhi.org/nr/shared/enFHI/Resources/EffectivenessChart.pdf First-tier methods Second-tier methods Short-acting reversible contraception: 9297% effective Implanon Copper T380A IUD Depot medroxyprogesterone acetate (DMPA): 3 months Vaginal ring (NuvaRing®): 3 weeks Patch (Ortho Evra®): 1 week Oral contraceptives pills (OCPs): 1 day Mirena IUD Third-tier methods Barrier methods:68-85% effective Male condoms: 85% effective Diaphragm (w/spermicide): 84% effective (spermicide alone: 71%) Sponge: • Parous women: 68% • Nulliparous women: 84% effective Fertility Maria awareness-based methods: 16 yo Sexually active for 3 years Heavy cramps G1P0 Declined birth control after abortion because “I’m never going to have sex again” “I hear hormones are dangerous” 75% effective 2 4/18/2013 Medical Benefits of Hormonal Contraception Combined hormonal contraception (CHC) reduces: Blood loss, PMS, dysmenorrhea, Ovarian cysts, acne, perimenopausal sxs, DUB, PCOS, Endometriosis OC users reduce risk of ovarian Ca by 40%1, and by 80% after 10 yrs2 OC reduces risk of endometrial CA by up to 40%3 No increase risk of Breast CA in OC users4 1. Vessey et al Br J Cancer 1995. 2. Rosenberg et al Am J Epidmiol 1994 3. JAMA 1987:257(6) 4. Marchbanks et al NEJM 2002;346:2025-2032 Do women need a “break” or “holiday” from contraception? NO! they get pregnant Risk Comparisons (slide credit: Association of Reproductive Health Professionals) Annual Risk of Death (per 100,000) Skydiving Driving Pregnancy Riding a bicycle Airplane crash Using OC* * 100 20 11.5 0.8 0.4 0.06 Nonsmoker, under age 35 Trussell J, Jordan B. Contraception in press. Chang J, et al. MMWR 2003. Harvard Center for Risk Analysis 2006. Bennett P. In: Risk Communication and Public Health 1999. Alissa 16 years old Afraid of pelvic exam Interested in the pill Is it safe to not have periods? Dispel myths around “need to bleed” Teach our patients that amenorrhea on progestin is safe vs. amenorrhea off hormones What is required before starting contraception? 1. 2. 3. 4. 5. 6. Pelvic exam Up to date Pap test Breast Exam STI testing Pregnancy test None of the above Wants the one “with no period” What else does she need today? And the evidence says… Medical BP: History: Required Helpful Pelvic exam, Pap, Breast exam, Hemoglobin, pregnancy test, STI testing: NOT REQUIRED! Stewart F, et al. JAMA. 2001;285:2232-9. Tepper NK, et al. Contraception 2012 3 4/18/2013 Wait Until 21 To Start Pap Tests ACOG 2009 & USPSTF 2012 screening women < 21 years of age may be harmful and lacks benefit Don’t start until 21, regardless of age of first intercourse or number of partners Over-screening & treatment of teens with CIN Double to triple rate preterm birth after LEEP Why Wait Until 21 To Start Paps? Spontaneous regression of CIN is common 65% regression of CIN 2 after 18 mo; 75% after 36 mo When CIN 3 persists, >10 years are required for the lesion to acquire the capacity to become invasive UK starts pap screen at 25; some northern European countries start at 30 Most HPV infections are low-grade, transient and resolve completely without intervention “Quick Start” When can she start contraception? “Quick Start” – start pill1,2 ( patch3, shot, ring4, ) on day of visit - any time of the month. • The first day of her period? • The first Sunday after her period? Back up method for 1 week (if not first week of cycle) • Anytime in her cycle, including today? Urine HCG if no withdrawal bleed at end of cycle, or 2 weeks after DMPA injection • All of the above? Reassure - Exposure of embryo to OC not teratogenic EC if unprotected sex in last 5 days 1. 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 Dispensing 12 months of contraception increases continuation & lowers costs 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 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. 4 4/18/2013 Alissa Increasing Teen OCP Adherence Emphasize the noncontraceptive benefits of oral contraceptives Demonstrate concretely how to use pills. Have teens explicitly discuss their concerns about pill use so that they can be addressed Help the teen plan for crucial logistics such as pill storage and how to remember to take the pills each day 16 years old Afraid of pelvic exam Interested in the pill Wants the one “with no period” What else does she need today? Extended Cycle Dedicated Products Extended/ Continuous Cycle Advantages Traditional prescription flawed May increase efficacy 2- 4 days of placebo rather than 7 Suppresses follicular growth seen during placebo week Similar breakthrough bleeding 47% w/ follicle ready to ovulate by day 7 of placebo week!1 Loestrin 24 Fe ™ Symptoms w/ OC worse during withdrawal bleed Cyclic vs. extended cycle: less headaches, tiredness, bloating, menstrual pain 2 Treats anemia, dysmenorrhea, heavy bleeding, PMS, menstrual migraines, endometriosis, PCOS 1. Baerwald, Contraception, 2004 2. Edelman et al Cochrane Review 2006 3. Bachman, Contraception, 2004; Johnson, Contraception, 2007. Continuous Cycle Dedicated Products Lybrel ™ Seasonale ™ (generic version now available) 30 mcg EE/ 150 mcg LNG 84 active pills/ 7 placebo pills Yaz ™ . 20 mcg EE/ 150 mcg DSG 21 days active, 2 days placebo, 5 days 10 mcg EE 20 mcg EE/ 3 mg DRSP 24 active pills/ 3 placebo pills Alissa 16 years old Afraid of pelvic exam The condom broke 3 days ago Interested in the pill Seasonique ™ 20 mcg EE/ 90 mcg LNG Daily continuous use, no placebo, for a year Mircette ™ (Kariva generic) There is NO NEED TO BLEED3 20 mcg EE/ 1 mg NET 24 days active, 3 days of Fe 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 Wants the one “with no period” What else does she need today? 5 4/18/2013 EC Pills Available in the US: ParaGard® (Copper-T IUD) Dedicated products Off label use within 5 days after intercourse Effectiveness does not decline with delay Placed by a trained clinician Placed Trussell J, Raymond EG. 2011. Trussell J, Raymond EG. 2011. Emergency Contraception Plan B, Next Choice, Ella Ulipristal Acetate versus Levonorgestrel Ulipristal acetate more effective than LNg in postponing imminent ovulation In RCT, all 3 pregnancies with use from 73-120 h were in the LNg group Significantly more pregnancies prevented in the UPA group (p=0.037) Does not require an exam (or visit) OTC for all ages as of April 2013 If you write a Rx, teens obtain confidentially and free Advance Rx does not increase high risk behavior Glasier AF et al. Lancet 2010; Schwarz and Trussell. Contraceptive Technology 2011. Prescription ella ® Does not interrupt or harm established pregnancy No Evidenced Based Contraindication Pregnancies per 1000 Women after Unprotected Intercourse Rx required for all ages May be ordered from online prescription service - https://www.ella-kwikmed.com/ Pill mailed the next day www.not-2-late.com. ParaGard, ella, Plan B/Next Choice, Yuzpe, Nothing 6 4/18/2013 Effectiveness: Obesity ECP Failure among obese versus non-obese women • LNg: OR = 4.41, 95%CI 2.05-9.44 • Ulipristal: OR = 2.62, 95%CI 0.89-7.00 ECP Mechanism of Action ? Strong evidence suggests ECPs primarily work by stopping or delaying ovulation Inhibits ovulation & luteal function, interferes with sperm migration The best available evidence indicates that ECPs have no effect post-fertilization Glasier A et al. Contraception 2011. Davidoff F, Trussell J. JAMA 2006; ICEC and FIGO statement. 2008; Novikova N, et al. Contraception 2007; Brache V et al. Hum Reprod 2010; Stratton P et al. Fertil Steril 2010; Gemzel-Danielsson K. Contraception 2010; Trussell J, Raymond E 2011. What else is known about EC and teens EC awareness is low: especially in immigrant and low-income communities (Foster, Harper AJOG 2004) Youth can be embarrassed to ask for EC (Free, BMJ Emergency Contraception And Medical Abortion: What’s The Difference? Emergency Contraception (EC or Morning After Pill) Medication Abortion Mifepristone/RU486 2002) What Does It Do? Prevents a pregnancy after intercourse Ends a pregnancy Primary Care Providers do not routinely counsel adolescents about EC (Chuang, Contraception 2004) When is it Used? Works within 5 days of unprotected sex Ends pregnancies in the first 9 weeks Brand Names Consider stocking EC in your office to dispense directly or RX to all as advance prescription Plan B or Next Choice Ella Levonorgestrel Ulipristal Mifeprex What’s In The Pills? STI Screening in Teens Alissa 16 years old Afraid of pelvic exam Interested in the pill Wants the one “with no period” What else does she need today? mifepristone (taken with misoprostol) Chlamydia - annually and with each new partner Sexually active women and MSM < 25 y.o. Chlamydia most common reportable STI • ¾ of infections asymptomatic • Causes PID & tubal infertility in women. Gonorrhea Sexually active women < 25 years old and MSM If practice-site prevalence >1% or diagnose with another STI HIV 30% of new HIV infections occur in 13 to 25 years old Any STI is an indication to screen for all other STIs. I.E. if patient has trichomoniasis, screen for Chlamydia, GC, Hepatitis, Syphilis and HIV. 7 4/18/2013 Urine Sampling for NAATs Nucleic Acid Amplification Tests (NAATS) Collection site Male and female urine Endocervical, vaginal, oral and anal swabs Sensitivity: 90-95%; specificity: 98-100% Non-invasive urine specimens are acceptable Detects tiny number of organisms Guess What, NO PELVIC needed ! At least one hour since last void Do not cleanse perineum before sampling Collect first part of urinary stream Collect only as much urine as required by test Draw line on collection cup Sample for urinalysis and culture with midstream sample, but no need to cleanse perineum between first and second cup Treatment and Testing Post-Treatment Cheryl Treatment Azithromycin 1gm p.o. x 1 for Chlamydia or Doxy 100mg BID for 7 days and Ceftriaxone 250 mg IM for GC Test of Cure Not necessary after high efficacy, single dose treatment except in pregnancy Re-testing: women treated for Chlamydia or GC should be re-tested in 3 months High likelihood of repeat infection Re-testing identifies highest risk patients Expedited Partner Treatment is legal in California Weekly: Contraceptive Patch (Evra) Apply weekly x 3, then 1 wk off Ethinyl Estradiol: 20 mcg/ day Norelgestromin (Norgestimate) 17yo G3P1 Forgets to take the pill Recurrent cervicitis from abusive boyfriend Really doesn’t want to get pregnant again EE Exposure with CHC AUC (area under curve) ng.h/mL Place on arm, trunk, buttock Same contraindications as OCs. Typical use efficacy may be better 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 1. Sonnenberg et al, Am J Obstet Gynecol. 2005 , 2. Zieman M, Fertil & Steril, 2002 3. Audet, et al. JAMA. 2001;285:2347-2354. Patch OC* Ring 37.7 + 5.6 22.7 + 2.8 11.2 + 2.7 * 30 mcg EE/150 mcg LNG van den Heuvel, Contraception 2005 72:168 8 4/18/2013 Monthly: Vaginal Contraceptive Ring 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 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 Jick SS et al. Contraception 2006;73:223-228 and Contraception 2007;76:4-7 Cole JA et al. Obstet Gynecol 2007;109:339-346 Vaginal Contraceptive Ring: Nuva Ring Lowest and constant serum estrogen levels of all options Obesity doesn’t affect efficacy microflora content1 No GI interference with absorption Avoids liver first-pass metabolism Improves 1. Archer et al. Fertil Steril 2002 Tiffany 18 y/o G1P0 Has been using depoprovera successfully since her abortion 3 years ago Plans to start college in the fall Got headaches on OC’s, and likes not having a period. She wants to stay on depo One ring each month Failure rate lower than pill Easily placed and removed Rarely noticed during sex Continuation in teens > OCPs Less spotting compared to pills Lowest and constant serum estrogen levels of all options Avoids liver first-pass metabolism Miller, Obstetrics and Gynecology, 2005 Vaginal Contraceptive Ring: Off label, Alternative use 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 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 •Advantages for teens: privacy, adherence, efficacy, decreased PID risk, decreased cramps & anemia •May decrease seizure frequency and sickle crisis •Part responsible for decrease in teen birth & abortion •Calcium & Vit D, and weight bearing exercise 9 4/18/2013 DMPA-IM 150 & Black Box Warning Pregnancy & nursing cause similar or > bone loss than DMPA1 In teens, bone loss reversed w/in 12 months of discontinuation; ultimate BMD may be higher in former DMPA users 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” 4,5 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 Teens on DMPA gain more weight than teens on COCs1 Teens who gained > 5% of baseline weight at 3 months were at high risk at gaining even more weight at 12 months2 Overweight teens may be more likely to have significant weight gain on DMPA1,2 1. Mangan SA, et al. Overweight Teens at Increased Risk for Weight Gain While Using Depot Medroxyprogesterone Acetate. J Pediatr Adolesc Gynecol 2002;15:79– 82. 2. Risser WL, Gefter LR, Barratt MS, Risser JM. Weight change in adolescents who used hormonal contraception. J Adolesc Health 1999;24(6):433–436 Intrauterine Contraception (IUD) in Teens Lawonda DMPA and Weight Gain 16 yo nullip Sexually active for 2 years 3 lifetime partners partners h/o Chlamydia Plays basketball Goes between 2 homes Safe and effective in nulliparous women and women <20yrs old CDC class 21-4 Higher continuation rates than with OCs in teens1 Progestin IUCs great choice for menorrhagia & dysmenorrhea Does not affect future fertility Lower PID risk b/c thicker cervical mucus & thinner endometrium 1. Suhonen S. Contraception 2004 2. Nelson AL. Obstet Gynecol Clin North Am. 2000 3.Dardano KL, Burkman RT. Am J Obstet Gynecol. 1999 4. Li C. Contraception 2004 5.Treiman K Population Reports. 1995. Intrauterine Device and Adolescents. ACOG Committee Opinion December 2007 Do IUDs cause STIs and PID? Screen for STI and insert IUD at same visit1 Transient PID risk of 1/1000 likely due to contamination at insertion 2,3 Treat STI and PID with IUD in place4,5,6 Do not remove unless treatment failure Dose and duration does not change 1.Suffrin,C et al, Obstetrics & Gynecology. 120(6):1314-1321, December 2012 2. Grimes, D Lancet 2001; 7358:6-7, 3. Grimes, D Lancet 2000; 356:1013-9 4. CDC MEC 2010 5. Grimes Cochrane Database 2001, revised 2003 6. Tepper NK, et al. Contraception Oct 2012 What about the risk of Infertility? The evidence shows: IUDs DO NOT increase risk of infertility or STI1 PID risk with cervicitis similar with & w/o IUD1,2 Tubal infertility linked to presence of Chlamydia antibodies, but NOT history of IUD3 1. Grimes, D. Lancet 2000; 356: 1013-19. 2. 1.Suffrin,C et al, Obstetrics & Gynecology. 2012 120(6):1314-1321 3. Hubacher D, et al. NEJM 2001; 345:561-7. 10 4/18/2013 Benefits of LARC High Benefits of LARC High satisfaction rate: 4.6% continuation/low pregnancy: IUD (adolescents and young women): • 75% continuation rate for LNG-IUD (vs. 45% for Cu-IUD) at 6 mos1 70-90% young women satisfied with choosing IUD (Godfrey 2010, Toma 2006, Suhonen 2004) 1 pregnancy (of 23 pts) after Cu-IUD removal • 80% continuation rate for LNG-IUD (vs. 73% OCP) at 1 yr2 Majority of postpartum teen Implanon users did not identify anything they disliked (Lewis 2010) No pregnancies reported in 200 women. • Average time use 19.6 months in 21 adolescents3 1 Godfrey EM Contraception 2010. 2Suhonen S. Contraception 2004. 3Toma A. J Pediatr Adolesc Gynecol 2006. LARC is safe when other hormonal methods are contraindicated Side effects & benefits LARC Benefits of LARC WHO Medical Eligibility for Initiating Contraception Copper IUD LNGIUS Implant Breastfeeding (>6 weeks postpartum) 1 1 1 Smoking 1 1 1 <159 / <99 1 1 1 >160 / >100 1 2 2 + Vascular disease 1 2 2 Migraines 1 2 2 Diabetes mellitus 1 2 2 Liver disease Cirrhosis 1 2/3 2/3 Tumors 1 3 3 1 3 3 Decrease in menorrhagia Decrease in dysmenorrhea Decrease in endometriosis pain Condition Hypertension Implanon • Average decrease in pain 63% with Implanon vs 53% with DMPA after 6 mos1 LNG-IUD • 9 studies have shown improvement2 1 Walch K. Contraception 2009. 2Bahamondes L. Contraception 2007. WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007. Active hepatitis IUD Myths Debunked Side Effects of LARC LNG-IUD:1 Cu-IUD:2 IUDs during 1st 6 months Abnormal bleeding in 50% Abd/back pain or cramping in 27% <15%: wt gain, mood changes, loss of libido, acne during 1st 9 weeks Heavier menses: up to 68% Pain/dysmenorrhea: up to 40% Both decreased by 39 weeks 1 Wong RC. Contraception 2010. 2Hubacher DO NOT cause Abortion: LNG IUDs thicken cervical mucus, suppress endometrium, & have some anovulatory effect Copper IUDs act as a spermicide IUDs DO NOT increase risk of ectopic pregnancy D. Contraception 2009. 64 recommended in women w/ H/O ectopicWHO Class 1 Hubacher NEJM 2001;108:784-90 , Grimes Cochrane Database 2004 .Andersson Contraception 1994;49 4. Medical eligibility criteria for contraceptive use. 3nd edition, Geneva: WHO, 2004 11 4/18/2013 Progesterone Implant: Implanon™ & Nexplanon™ More IUD Myths Debunked Insert at any point in the menstrual cycle1 Rapid return to fertility after removal May insert both devices immediately post-1st trimester abortion and 4 weeks post-partum Safe in woman with HIV and AIDs stable on ARVs- CDC class 2; no increased risk of infection or viral shedding3,4,5 Highest Efficacy and continuance Lasts 3 years & rapid return to fertility Irregular bleeding primary side effect Significant decrease in cramping and overall bleeding Must be trained by company to insert Glasier A, Contraception 2002 Zheng SR, et al. Contraception. 1999;60:1-8. Croxatto HB, et al. Hum Reprod. 1999;14:976-81. 1.Medical eligibility criteria for contraceptive use CDC, 2010. 2. Hubacher NEJM 2001 3 Sinei et al Lancet 1998 4 Morrison et al BJOG 2001 5 Richardson et al AIDS 1999 Implanon in teens High continuation/low pregnancy: Implanon for teenage mothers • Implanon users pregnant later (23.8 mos) than OCP/DMPA (18.1 mos) and barrier/none groups (17.6 mos). • Mean duration Implanon use 18.7 mos (compared to 11.9 mos for OCP/DMPA). • Implanon more likely to be continued at 2 yrs than OCP/DMPA. Lewis LN. Contraception 2010. Helpful Resources The Teen Contraception Visit http://bedsider.org/ Non-judgmental, direct, open-ended ?s work best Teens need concrete information- role play and practice help (bananas, abstinence) http://www.thenationalcampaign.org/ Your conversation and treatment is CONFIDENTIAL EC info for providers& teens http://ec.princeton.edu/ RX (or give out) condoms and EC to all Screen for Chlamydia annually and with each new partner www.reproductiveaccess.org No Pelvic needed if asymptomatic! Association of Reproductive Health Professionals (ARHP) (www.arhp.org) If you are really uncomfortable, or concerned about confidentiality consider referring to colleague, Planned Parenthood or Family Pact clinic Guttmacher Institute (www.agi-usa.org) http://www.plannedparenthood.org/info-for-teens/ 12