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Introducing the 2010 US Medical Eligibility Criteria : An Evidenced Based Tool for Determining Safe Use of Contraception with Chronic and Other Medical Conditions. Womens Health in Primary Care Orlando Florida March 2011 Norma Jo Waxman MD Private Practice, San Francisco
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Introducing the 2010 US Medical Eligibility Criteria: An Evidenced Based Tool for Determining Safe Use of Contraception with Chronic and Other Medical Conditions Womens Health in Primary Care Orlando Florida March 2011 Norma Jo Waxman MD Private Practice, San Francisco Associate Professor of Family and Community Medicine University of California San Francisco firstname.lastname@example.org
Objectives At the end of the talk participants will be able to: • Utilize the CDC Medical Eligibility Criteria to find safe contraceptive options for women with medical problems. • Explain the safety of hormonal contraception • Remember to think about contraception when prescribing FDA Category D or X medications (dangerous in pregnancy)
WHO Medical Eligibility Criteria Unique contributions Evidence based Comprehensive, up-to-date Only “accepted” guideline of its kind Considerations for use in US WHO Criteria were written to include “lowest common denominator” health systems Conservative for use in the US Consider as “tools not rules”
WHO Medical Eligibility Criteria for Contraceptive Use – 4rdedition - 2009 www.who.int/reproductive-health/publications/mec/
WHO Medical Eligibility CriteriaMore evidence based than package insert Medical Eligibility Criteria For Contraceptive Use. Third Edition. WHO, 2004.
WHO Medical Eligibility Criteria Combined hormonal contraceptives (CHC) COC: Combined oral contraceptives CIC: Combined injectable contraceptives P/R: Patch and Vaginal Ring Progestin only contraceptives POP: Progestin only pills DMPA: Depo-MPA IMPLT: Implanon contraceptive implant Intrauterine contraceptives Cu-IUD: Copper T-380 IUD LNG-IUD: Levonorgestrel IUS
US MEC: Scope Current WHO MEC > 1800 recommendations No need to change majority of recommendations Science the same & widely used around the world CDC accepted majority of WHO recommendations Exceptions: existing WHO recommendations that needed to be adapted for US context A few additional areas
CDC MEC Guidelines • www.reproductiveaccess.org • Go to “providers” then under “clinical resources” you will see MEC guidelines. • Available in Word or PDF • Link to the comprehensive MEC list
Medical Benefits of Hormonal Contraception • Menstrual related health benefits: • Decreased dysmenorrhea • Decreased menstrual blood loss • Reduces menstrual related PMS symptoms • Improves acne and hirsutism • Reduction of: • Ectopic pregnancies • Benign breast conditions • Perimenopausal sxs, DUB, PCOS, Endometriosis • PID • Anemia
Medical Benefits of Hormonal Contraception • 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 users4,5 • Vessey et al Br J Cancer 1995. 2. Rosenberg et al Am J Epidmiol 1994 3. JAMA 1987:257(6)4. 4. Marchbanks et al NEJM 2002;346:2025-2032 5. Hannaford et al BMJ 2007; 335 : 651
Risk Misperception & the Patient “…incorrect perceptions of excess risk of contraceptive products may lead women to use them less than effectively or not at all.” “Throw away the package insert” “2 times a rare event is still a rare event” Gardner J, Miller L. J Womens Health 2005 David Grimes MD, September 2006
Risk Comparisons (slide credit: Association of Reproductive Health Professionals) Annual Risk of Death (per 100,000) Skydiving 100 Driving 20 Pregnancy 11.5 Riding a bicycle 0.8 Airplane crash 0.4 Using OC* 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.
LARC is safe when Estrogen containing hormonal methods are contraindicated WHO Medical Eligibility Criteria for Contraceptive Use. In Family Planning. 2007. 15
Case Study: Breastfeeding A 30 y.o. female is post partum day #2, ready to be discharged from hospital, and desires contraception. She plans to breastfeed. Which hormonal methods are safe for her to use?
Post-partum Contraception: General Considerations Goals of postpartum (pp) contraception Efficacy: limit family size, plan birth spacing Support successful breastfeeding In GDMs, avoid conversion to frank diabetes Most women begin intercourse within 1-2 months 60-70% are sexually active by 6 weeks pp 4% abstinent by the end of the 12th pp week
Post-partum Ovulation Patterns Resumption of ovulation in non-lactating women Ovulate in 6-7 wks (median= 45 days) None before 25 days from the delivery Resumption of ovulation in lactating women Intensity, frequency, duration of suckling Time elapsed since delivery Maternal nutritional state Rate of weaning: rapid > gradual weaning Introduction of supplementary feeding (ovulation usually begins 6 weeks later)
Contraception and Breastfeeding • Two considerations • Potential effect on breastfeeding performance (initiation, maintenance, duration of lactation and need for supplementation) • Potential effect on infant health and development (infant weight, infant length, physical findings, health problems, and psychomotor development)
Breastfeeding- Evidence • Combined hormonal methods • 8 studies of combined hormonal methods • 4 studies reported decreased duration and higher rates of supplemental feeding • 1 study no difference in breastfeeding performance • No adverse effect on infant growth, health, or development through 8 years of age
Breastfeeding- Evidence • Progestin-only methods • 43 Studies • POPS, DMPA, implants, and LNG-IUD • No adverse effect on breastfeeding performance • No adverse effect on infant growth, health, or development through 6 years of age
Post-partum OC's: Maternal Risk Changes in maternal clotting factors persist for 4 weeks after term delivery Increased VTE risk up to 4 week post-partum Coagulation effects of pregnancy and OC's may increase risk of VTE However, VTE rates have not been studied in postpartum low-dose OC users vs. controls Greater VTE risks not expected with POPs, since no change in clotting factors
Breastfeeding- Gaps Most observational studies- need RCT Timing of initiation of contraceptive methods No consistent definitions of breastfeeding No consensus on outcome measures for breastfeeding or infant health No inclusion of ill or premature infants Need longer follow up
2009 WHO Medical Eligibility CriteriaPost-Partum Breastfeeding
2010 US Medical Eligibility CriteriaPost-partum Breastfeeding
Post-partum CHC: Clinical Guidelines Non-nursing women CHC starting 4 weeks postpartum Nursing women Conservative approach First 3 months: avoid CHC > 3 mo or weaned: switch to CHC Liberal approach CHC once lactation established ( > 4 wks) If COCs used, use 20 mcg estrogen dose
Post-partum Long-acting Progestins DMPA Mildly lactogenic; no change in milk content Implant (Implanon, Norplant studies) No effect on milk volume, content, or growth Administration before hospital discharge Advantage Protected if post-partum visit is missed Disadvantages Unnecessary for first 4 weeks Anatomic bleeding vs. drug side effect
2009 WHO MEC: Postpartum IUC Insertion • Guidelines are identical in lactating and non-lactating women • Insert IUC within 15 minutes of placental delivery • Use sponge forceps on cervical lip; 2nd sponge forceps to insert • Cut string flush with external cervical os
Case Study: Breastfeeding 30 y.o. Post partum desires contraception. Plans to breastfeed Which hormonal methods can she use? Answer POPs, DMPA, implants, LNG-IUD (Category 2) She should generally not use CHCs (Category 3)
32 y.o. woman G3P2 Gestational DM with both pregnancies DM type 2 since last birth 2 years ago Well controlled on metformin What type of contraception can she use? Case Study: Diabetes Mellitus
Diabetes and Contraception • Birth defects occur in 5-8% of children born to US women with diabetes • Double the general pop rate • 2/3 of women with diabetes have unintended pregnancies • Diabetic women are ½ as likely to receive contraceptive Rx or counseling
Category D or X medications • Use of Class D and X Rx common • Anxiolytics, anticonvulsants, statins, • doxycycline, warfarin, DHE and ergotamine • 1 of every 25 Rx • 1 of every 13 visits • 1 of every 6 women! • Contraceptive counseling < 20%1 to 50 %2 of visits documenting potential teratogen use or RX 1. Schwarz EB et al. Prescription of teratogenic medications in US ambulatory practices. Am J Med. 2005 Nov;118 (11): 1240-1249 2. Schwarz EB et al. Documentation of Contraception and Pregnancy When Prescribing Potentially Teratogenic Medications for Reproductive-Age Women. Ann Intern Med. 2007; 147(6): 370–376.
Case Study: h/o Deep Vein Thrombosis 24 year old G1P0 woman requests Pill or Patch h/o DVT right calf at 18 years old Hospitalized 1 week: “shots” for 5 days; then “pills” for 3 months Mother “had blood clot go to her lungs” during pregnancy Healthy non-smoker; stable relationship; intercourse once or twice a week
Risk Factors for DVT and VTE Age (especially >40 years old) Pregnancy, post-partum period (< 3-4 weeks) Obesity Immobilization with venous stasis Personal history of DVT or VTE Family history (inherited clotting disorder) Factor V Leiden mutation (Protein C resistance) Protein S, Protein C deficiency
Venous Thrombosis and CHC ▲DVT rates with increasing dose of estrogen OC and OrthoEvra have similar DVT risk (Jick, 2006) NGM OCs: 4.2/10,000 women/year Patch: 5.3/10,000 women/year Age-adj RR: 1.1 (95% CI: 0.7-1.8) DVT risk declines with increasing duration of use Progestin type, dose have no (or minimal) impact No attributable risk of fatal PTE in OC users HTN, hypercholesterolemia, and diabetes not risk factors for venous disease
Comparative Risks of VTE General population Low-dose OC High-dose OC Pregnancy 60 60 40 Incidence of VTE per 100,000 woman-years 20-30 15 20 5 0 Shulman, LP. J Reprod Med. 2003. Chang, J. In: Surveillance Summaries. 2003.
Prior Venous Thrombosis and CHC Conventional wisdom If a woman has h/o idiopathic or post-partum DVT or VTE, may be predisposed to recurrence if given exogenous estrogen Hence, avoid E- containing contraceptives If DVT related to another condition (e.g., immobilization, trauma), without a history of recurrence, E-containing contraceptives may be considered
Venous Thrombosis and CHC Factor V Leiden mutation (FVLM), DVT risk, and OCs Individuals with the FVLM have activated Protein C resistance and hypercoagulability Present in 70-90% of inherited thrombophilias 20-40% of patients having a first DVT 50% of those with > 1 episode of DVT 1-5% US pop; 5% Europeans; 15% of Scandinavians OC users with FVLM have 15 fold increased risk of DVTEur J Contracept Reprod Health Care. 2000 Jun;5(2):105-12. Factor V Leiden mutation and the risks for thromboembolic disease: a clinical perspective Ann Intern Med. 1997 Nov 15;127(10):895-903.
Venous Thrombosis and CHC Superficial varicose veins do not increase the risk of DVT or VTE, regardless method Women who are about to undergo major surgery should discontinue OC’s 30 days before the procedure is scheduled Not necessary to interrupt OC’s before short operative procedures with early physical activity
USMEC: Deep Venous Thrombosis
USMEC: History of DVT/PENot on Anticoagulant Therapy • Higher risk for recurrent DVT/PE • History of estrogen-associated DVT/PE • Pregnancy-associated DVT/PE • Idiopathic DVT/PE • Thrombophilia; antiphospholipid syndrome • Active cancer (metastatic, on therapy, or < 6 months after clinical remission) • History of recurrent DVT/PE
Case Study: Prior DVT Recommend coagulation studies, since may affect contraceptive choice and pregnancy management Preferred methods Cu-IUD Acceptable methods POP, DMPA, IMPLT, LNG-IUD Unacceptable risk COC, patch, ring
Case Study • A. Yes • No A 25 y.o. female with Crohn’s disease desires long-term reversible contraception and is thinking about the levonorgestrel-releasing IUD. Is this method safe for her?
Inflammatory Bowel Disease (IBD) • New condition added to US MEC • Two chronic relapsing and remitting disorders of GI tract • Ulcerative colitis • Crohn's disease • Common symptoms: diarrhea, abd cramps, rectal bleeding, frequent bowel mov't, weight loss, anemia
Inflammatory Bowel Disease • More common among women • UC: 160/100:000 women • Crohn's: 103/100,000 women • Risks • Thrombosis • Some studies show increased risk, others not • Risk greater during active-disease phase • Malabsorption • Osteoporosis and osteopenia • All may be of concern for contraceptive use
IBD- Evidence 10 studies Relapse rates- no difference in time to relapse in women using POPS or COCs Exacerbation- case reports of LNG-IUD use causing exacerbation Absorption- pharmacokinetic studies showed no difference among UC patients compared with healthy women in absorption of EE or LNG