across the lifespan the new us cdc medical eligibility...

Secor 2013 Copyright

Contraceptive Update 2013:Contraceptive Update 2013:Across the LifespanAcross the Lifespan

The New US CDC The New US CDC Medical Eligibility Criteria forMedical Eligibility Criteria for

Contraceptive UseContraceptive Use

R. Mimi R. Mimi SecorSecor, MS, , MS, M.EdM.Ed, FNP, FNP--BC, FAANPBC, FAANPOnset, MassachusettsOnset, Massachusetts

R. Mimi R. Mimi SecorSecor, MS, , MS, M.EdM.Ed, FNP, BC, FAANP, FNP, BC, FAANP

Nurse Practitioner for 36 yearsNurse Practitioner for 36 yearsNewton Wellesley Newton Wellesley ObGynObGyn, Newton, MA, Newton, MA2013 Lifetime Achievement Award, MCNP2013 Lifetime Achievement Award, MCNP

Massachusetts Coalition of NPsMassachusetts Coalition of NPsCoCo--author, The author, The GynGyn Exam, 2012, SpringerExam, 2012, SpringerCoCo--author, Advanced Health Assessment of author, Advanced Health Assessment of

Women: Skills and Procedures, 2010, SpringerWomen: Skills and Procedures, 2010, SpringerVisiting Scholar, Boston College Visiting Scholar, Boston College Fellow, AANPFellow, AANPOwned a private practice for 12 years in Owned a private practice for 12 years in Massachusetts (1984Massachusetts (1984--1996)1996)Worked in Alaska for 7 years (1992Worked in Alaska for 7 years (1992--1999)1999) Secor 2013 copyright 2

Mimi Mimi SecorSecor, MS, , MS, M.EdM.Ed, FNP, FNP--BC, FAANPBC, FAANPDisclosure Disclosure

SpeakerSpeaker-- GenPathGenPath LabLab

Secor 2013 copyright 3


Our DaughterOur DaughterKat Kat SecorSecor

4

Paintball Paintball TournyTourny

Huntington Huntington Beach, CaliBeach, Cali

5

Objectives (100% Objectives (100% PharmPharm))Contraception UpdateContraception Update

Describe trends and contraceptive challenges Describe trends and contraceptive challenges facing clinicians and patients. 5 minutesfacing clinicians and patients. 5 minutes

Explain the new CDC medical eligibility criteria Explain the new CDC medical eligibility criteria for prescribing various contraceptive methods for prescribing various contraceptive methods and medical conditions. 30 minutesand medical conditions. 30 minutes

Discuss new contraceptive research regarding Discuss new contraceptive research regarding efficacy, risks, benefits as this pertains to efficacy, risks, benefits as this pertains to prescribing. 25 minutesprescribing. 25 minutes





6.3 Million U.S. pregnancies:6.3 Million U.S. pregnancies:Intended vs.. UnintendedIntended vs.. Unintended

Henshaw, Family Planning Perspectives, 1998; 30:1

Birth43%

Miscarriage9%

Miscarriage6%

Abortion23%

Birth19%

IntendedPregnancies

UnintendedPregnancies

Higher in poor



Family Planning ChallengesFamily Planning Challenges

High unplanned pregnancy rate continuesHigh unplanned pregnancy rate continues

Few easy, effective methodsFew easy, effective methodsLow pt compliance & lack of knowledge Low pt compliance & lack of knowledge Societal conflict about family planningSocietal conflict about family planningClinical challenge: little time, tight budgetsClinical challenge: little time, tight budgets

Risk taking behaviors! Risk taking behaviors! Secor 2013 copyright 10

If you’ve been swept off your feetYou’ve got 3 days to get them back on the ground

Emergency contraceptionUse within 3 days of opening


Emergency ContraceptionEmergency ContraceptionLack of Public Awareness StillLack of Public Awareness Still……

Progestin only Progestin only -- 0.75 mg (Plan B)0.75 mg (Plan B)2 pills 2 pills popo STAT STAT : or 1 pill 12 hrs apart: or 1 pill 12 hrs apart

Taken within 72 hours of unprotected sex Taken within 72 hours of unprotected sex

95% effective if taken within 24 hours95% effective if taken within 24 hours89% effective if taken within 72 hours89% effective if taken within 72 hours

SAFE, few side effectsSAFE, few side effectsNEW:NEW:

OverOver--TheThe--Counter in most states > 15 yrsCounter in most states > 15 yrsIUC IUC may be inserted up to 5 days after !may be inserted up to 5 days after !



NEW: Emergency ContraceptionNEW: Emergency Contraception

UlipristalUlipristal ((EllaElla) 30 mg orally, 1 dose ) 30 mg orally, 1 dose Up to 5 days after unprotected intercourse, UPIUp to 5 days after unprotected intercourse, UPIDelays ovulation, NOT an Delays ovulation, NOT an abortifacientabortifacientPrescription required:Prescription required:

www.ellawww.ella--kwikmed.comkwikmed.com//Links to overnight prescription service, $55.00Links to overnight prescription service, $55.00

Avoid if already pregnantAvoid if already pregnantSide effects = placeboSide effects = placebo

Headache 18%, Nausea 12%, Headache 18%, Nausea 12%, AbdAbd pain 15%pain 15%Secor 2013 copyright 13

Contraceptive OptionsContraceptive OptionsCombination Hormonal Contraceptives Combination Hormonal Contraceptives (CHC)(CHC)

OralsOralsTransdermalTransdermal EthinylEthinyl EstradiolEstradiol (EE) Patch, ((EE) Patch, (Ortho Ortho EvraEvra))Vaginal EE Ring, (Vaginal EE Ring, (NuvaRingNuvaRing))

Progestin Only Contraceptives Progestin Only Contraceptives (POC)(POC)EtonogestrelEtonogestrel Implant, (Implant, (ImplanonImplanon) 3 year rod) 3 year rodDepot Depot MedroxyprogesteroneMedroxyprogesterone, DMPA , DMPA ““DepoDepo ProveraProvera””

IM 150 mg, SC 104 mgIM 150 mg, SC 104 mgLNGLNG--IUD, IUD, LevonorgestrelLevonorgestrel ((MirenaMirena, , SkylaSkyla))Progestin only Progestin only ““MiniMini--pillpill””: : NorgestrelNorgestrel ((OvretteOvrette) ) NorethindroneNorethindrone((MicronorMicronor, Nor, Nor--QD, QD, ErrinErrin, Camilla, Camilla))

Other:Other:Sterilization, male/female (Sterilization, male/female (EssureEssure))CUCU--IUD (IUD (ParagardParagard T380T380), EC, Condoms, Caps, Natural (NFP)), EC, Condoms, Caps, Natural (NFP)


Typical Effectiveness of ContraceptionTypical Effectiveness of Contraception

Adapted from: WHO. Family Planning: A Global Handbook

Long acting reversible contraceptives (LARCs)

Tier 1

Tier 2

Tier 4

Tier 3



2010 CDC: US Medical Eligibility Criteria 2010 CDC: US Medical Eligibility Criteria for Contraceptive Use for Contraceptive Use


1 No restriction for the use of the contraceptive method for a woman with that medical condition

2Advantages of using the method generally outweigh the theoretical or proven risks

3

Theoretical or proven risks of the method usually outweigh the advantages – or that there are no other methods that are available or acceptable to the women with that medical condition

4Unacceptable health risk if the contraceptive method is used by a woman with that medical condition

2010 CDC US Medical Eligibility Criteria: 2010 CDC US Medical Eligibility Criteria: CategoriesCategories

http://www.cdc.gov/mmwr/pdf/rr/rr5904.pdf Secor 2013 copyright 17



NEW CDC MEC Update: 2012NEW CDC MEC Update: 2012HIV and ContraceptivesHIV and Contraceptives

2010: Revised Recommendations for Use of Hormonal Contraception in Women at High Risk for HIV Infection or HIV+

CHC: OK, Cat 1, 2

Progestin Only Injectables: OK (Except DepoProvera)

Unclear risk re: acquisition of HIV

IUC: OK, no incr. sheddingIUC: OK, no incr. shedding

Tepper, Nami K | Curtis, Kathryn M | Jamieson, Denise J | Marchbanks, Polly AMorbidity and Mortality Weekly Report [Morb. Mortal. Weekly Rep.]. Vol. 61, no. 24, 449 p. 22 Jun 2012.

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Intrauterine Systems: IUCIntrauterine Systems: IUCEffectiveness = SterilizationEffectiveness = Sterilization

Copper T380 IUS (Copper T380 IUS (ParagardParagard))Approved for 10 yearsApproved for 10 yearsOffOff--label for 12 yearslabel for 12 yearsEasier to insert if Easier to insert if nulliparousnulliparous

LevonorgestrelLevonorgestrel IUC (IUC (MirenaMirena))((SkylaSkyla-- smaller device)smaller device)

Approved for 5 yearsApproved for 5 yearsReduced menstrual bleedingReduced menstrual bleedingMay reduce fibroidsMay reduce fibroids

XuXu. Contraception Sep 2010: 82; 301. Contraception Sep 2010: 82; 301--309, n 309, n --202021

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• Brand name: Paragard®

• Copper ions• Approved for 10 years’ use

• Can be used as emergency contraceptive – up to 5 days

Thonneau, PF. Am J Obstet Gynecol. 2008.: Forrtney JA. J Reprod Med.1999.: Trussel J. Contraceptive Technology. 2007.

Copper-T IUDMost

effective

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New, Smaller IUC (New, Smaller IUC (SkylaSkyla))LNG containing, Similar to LNG containing, Similar to MirenaMirena

LevonorgestrelLevonorgestrel--releasingreleasingTotal of 13.5 mg of LNGTotal of 13.5 mg of LNGApproved: January 2013 Approved: January 2013 For 3 yearsFor 3 yearsGood for Good for NulliparousNulliparous

www.skylawww.skyla--us.comus.comTel 1Tel 1--888888--842842--29372937Bayer HealthCare Bayer HealthCare Manufactured in Finland Manufactured in Finland


Dispelling Common Myths About Dispelling Common Myths About IUCsIUCs

In fact, In fact, IUCsIUCs::CanCan be used by be used by nulliparousnulliparous women women CanCan be used by women who have had an ectopic be used by women who have had an ectopic pregnancypregnancyDo notDo not need to be removed for PID treatmentneed to be removed for PID treatmentDo notDo not have to be removed if have to be removed if actinomycesactinomyces--like like organisms (ALO) are noted on a Pap testorganisms (ALO) are noted on a Pap test

Duenas JL. Contraception. 1996.; Stanwood NL. Obstet Gynecol. 2002. Forrest JD. Obstet Gynecol Surv. 1996; Lippes J. Am J Obstet Gynecol. 1999. Otero-Flores JB. Contraception. 2003.; WHO. 2009.; Penney G. J Fam Plann Reprod Health Care. 2004.


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Screening: Poor Candidates for Screening: Poor Candidates for Intrauterine Contraception Intrauterine Contraception

Known or suspected pregnancyKnown or suspected pregnancyPuerperal sepsisPuerperal sepsisImmediate post septic abortionImmediate post septic abortionUnexplained vaginal bleedingUnexplained vaginal bleedingCervical or endometrial cancerCervical or endometrial cancer

WHO. 2009.


Screening: Poor Candidates for Screening: Poor Candidates for Intrauterine ContraceptionIntrauterine Contraception

Uterine fibroids that interfere with placementUterine fibroids that interfere with placementUterine distortion (congenital or acquired)Uterine distortion (congenital or acquired)Current PIDCurrent PIDCurrent purulent Current purulent cervicitiscervicitis, , chlamydiachlamydia, or , or gonorrheagonorrheaKnown pelvic tuberculosis Known pelvic tuberculosis

WHO. 2009.



IUC: MEC ConditionsIUC: MEC ConditionsAgeAge

Menarche to <20: C2Menarche to <20: C2>> 20:20: 11

NulliparousNulliparous women: women: 22Postpartum: Postpartum: 22

<10 minutes PP, CU 1<10 minutes PP, CU 1Puerperal sepsis: Puerperal sepsis: 44

PostabortionPostabortionFirst trimester: First trimester: 11Second trimester: Second trimester: 22


IUC: Cardiovascular DiseaseIUC: Cardiovascular Disease

Hypertension:Hypertension: 11exceptexceptS S >>160/D160/D>>100 & vascular disease: 100 & vascular disease:

LNG = 2 LNG = 2

DVT/PEDVT/PECu: Cu: 11LNG: LNG: 22

Acute DVT/PE: 2 Acute DVT/PE: 2 Known thrombosis 2Known thrombosis 2


Safety: Safety: IUC May Be Used by HIV+ WomenIUC May Be Used by HIV+ Women

No increased risk of No increased risk of complications compared w complications compared w HIVHIV--negative womennegative women

No incr. cervical viral sheddingNo incr. cervical viral shedding

WHO, CDC Category 2 WHO, CDC Category 2

WHO. 2009.; CDC. MMWR. 2010.; Morrison CS, et al. Brit J Obstet Gynaecol. 2001.; Richardson B, et al. AIDS. 1999.



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IUC Issues: InfectionIUC Issues: Infection

PID and IUC use: confined to early weeksPID and IUC use: confined to early weeksLow risk even thenLow risk even then

Large recent metaLarge recent meta--analysisanalysis 22,908 insertions22,908 insertionsGrimes et al. Cochrane Review 2004;3Grimes et al. Cochrane Review 2004;3Farley et al. Lancet 1992;339:785Farley et al. Lancet 1992;339:785--8 (18 (1stst large analysis)large analysis)

Infection in first 20 days 9.7/1,000Infection in first 20 days 9.7/1,000 woman yearswoman yearsFrom vaginal contaminationFrom vaginal contamination despite aseptic techniquedespite aseptic techniqueInfection rate after 20 days 1.4/1,000 woman yrs of useInfection rate after 20 days 1.4/1,000 woman yrs of use


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PID with IUC: NEW Guidelines PID with IUC: NEW Guidelines

May leave IUC in placeMay leave IUC in placeTreat infectionTreat infectionClose followClose follow--up, 1up, 1--3 days3 daysIf not improved, consider removing IUCIf not improved, consider removing IUCCounseling & CondomsCounseling & CondomsIf history of PID, increased risk for If history of PID, increased risk for STIsSTIs

CDC, WHO, ACOG 2009CDC, WHO, ACOG 2009--20102010


Combined Hormonal Contraceptives: Combined Hormonal Contraceptives: CHCCHC

Pills: medium PatchPills: medium Patch-- high Ringhigh Ring-- low low



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Serum EE Levels of Ring, OC & PatchSerum EE Levels of Ring, OC & PatchEthinylEthinyl EstradiolEstradiol (EE)(EE)

Vaginal Ring: Vaginal Ring: Lowest EE Lowest EE serum levelsserum levels

COC: MidCOC: Mid--range serum levels (dose variable)range serum levels (dose variable)

TransdermalTransdermal Patch: Patch: Highest EE Highest EE serum levelsserum levels

Van den Van den HeuvelHeuvel et al. Contraception Sept 05;72:168et al. Contraception Sept 05;72:168Secor 2013 copyright

NEW 2013: Risk of NEW 2013: Risk of ThromboembolismThromboembolism/CV Events in /CV Events in CHC UsersCHC Users-- DSP OC YES, Patch & Ring NO DSP OC YES, Patch & Ring NO

N 835,826, ages 10N 835,826, ages 10--50, population based cohort50, population based cohort

Conclusions: in new users, DSP* was associated w higher risk of Conclusions: in new users, DSP* was associated w higher risk of VTE/ ATE relative to low dose CHC comparatorVTE/ ATE relative to low dose CHC comparator

NO incr. risk w NGMN patch OR ETON vaginal ringNO incr. risk w NGMN patch OR ETON vaginal ring

VTE in younger group (77% increase) 10VTE in younger group (77% increase) 10--34 years34 yearsATE in older group (2 fold increase) 35ATE in older group (2 fold increase) 35--55 years55 years

**DrospirenoneDrospirenoneSidney et al. Contraception 2013 Jan; 87 (1) :95Sidney et al. Contraception 2013 Jan; 87 (1) :95--100100 Secor 2013 copyright 35

Hormonal Contraceptives and Hormonal Contraceptives and Coexisting Medical ConditionsCoexisting Medical Conditions



CHCCHC-- Category 4:Category 4:ContraindicationsContraindications

Smokers Smokers >>3535Breast cancerBreast cancerPostpartum <21 daysPostpartum <21 daysAcute hepatitis/ flareAcute hepatitis/ flareSevere cirrhosisSevere cirrhosisLiver tumorsLiver tumorsMigraine with auraMigraine with aura

Major surgeryMajor surgeryCVDCVD

Ischemic, stroke, Ischemic, stroke, Multiple risk factorsMultiple risk factorsHTN HTN >>160/160/>>100100

DVT/VTEDVT/VTEOn therapyOn therapyAcuteAcuteHistory ofHistory of


CHCCHC-- Category 3: Category 3: Relative ContraindicationsRelative Contraindications

Drug Drug interacationsinteracationsRifampicinRifampicinCertain antiCertain anti--seizure meds seizure meds ieieLamictilLamictil incrincr szszARV meds (t)ARV meds (t)

RitonavirRitonavir--boosted PIboosted PI

BP 140BP 140--159/90159/90--9999CVD: multiple risk factorsCVD: multiple risk factors

Migraine without auraMigraine without auraHepatitis acute Hepatitis acute Diabetes <20 yearsDiabetes <20 yearsNo vascular complicationsNo vascular complicationsBariatric surgery (bypass)Bariatric surgery (bypass)Postpartum 21Postpartum 21--42 days42 days


CHC: Age CHC: Age

Menarche to <40 years = C 1Menarche to <40 years = C 1

40 years old Cat 240 years old Cat 2

SmokingSmoking<35 and smoke: Cat 2<35 and smoke: Cat 2>>35 and smoke <15/day: 335 and smoke <15/day: 3

>35 and smoke > 15/day: 4>35 and smoke > 15/day: 4Secor 2013 copyright

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PostPost--partum: 2013 CDC MEC Updatepartum: 2013 CDC MEC UpdateNEWNEW

< 21 days postpartum: No < 21 days postpartum: No CHCsCHCs-- Cat 4 Cat 4 !!

2121--42 days Postpartum PLUS risk for VTE, 42 days Postpartum PLUS risk for VTE, Cat 3Cat 32121--42 days, no risk factors, Cat 242 days, no risk factors, Cat 2> 42 days, no restrictions, Cat 1> 42 days, no restrictions, Cat 1

> 1 month postpartum, breast feeding, Cat 2> 1 month postpartum, breast feeding, Cat 2< 1 month postpartum, breast feeding, < 1 month postpartum, breast feeding, Cat 3Cat 3Post abortion, Cat 1Post abortion, Cat 1


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CHC, Smokers, Obesity and VTE Risk: CHC, Smokers, Obesity and VTE Risk:

Smokers risk of CVD Death & using Smokers risk of CVD Death & using COCsCOCs3.3 per 100,000 women if < 35 yr 3.3 per 100,000 women if < 35 yr

29.4 per 100,000 women if > 35 yr29.4 per 100,000 women if > 35 yr

If BMI If BMI >> 30 and CHC user 30 and CHC user risk < death faced by smokers younger than 35 yrs old risk < death faced by smokers younger than 35 yrs old (2.4 >BMI (2.4 >BMI vsvs 3.3 smokers per 100,000)3.3 smokers per 100,000)

NO data on BMI > 40NO data on BMI > 40

TrussellTrussell J, et al. Commentary, Obesity, CHC and VTE. Contraception. J, et al. Commentary, Obesity, CHC and VTE. Contraception. 2008;77:1432008;77:143--4646.. Secor 2013 copyright

CHC: ObesityCHC: Obesity

BMI > 30BMI > 30Category 2 Category 2

Possible increased risk of Possible increased risk of VTE, MI, stokeVTE, MI, stoke

NOT more likely to gainNOT more likely to gain



Obesity & CHC Failure: Obesity & CHC Failure: 2013 Good News!2013 Good News!

Efficacy of pill, patch, or vaginal ring NOT impaired by high BMI

N 1523128 PregnanciesHigher parity and hx of unintended pregnancies

.


McNicholas C et al. Contraceptive failures in overweight and obese combinedhormonal contraceptive users. Obstet Gynecol 2013 Mar; 121:585. (http://dx.doi.org/10.1097/AOG.0b013e31828317cc) 43

Combined Oral Combined Oral Contraceptives Contraceptives

Contain estrogen & progestinContain estrogen & progestinMost newer formulations Most newer formulations contain 20 contain 20 –– 35 mcg of 35 mcg of ethinylethinylestradiolestradiol + 1 of 8 available + 1 of 8 available progestinsprogestins

Trussel J. Contraceptive Technology. 2007. Rosenberg MJ. Reprod Med. 1995. Potter L. Fam PlannPerspect. 1996. Mosher WD. AdvanceData. 2004. Hardman JG. McGraw-Hill. 1996. Goldzieher JW. FertilSteril. 1971. Moghissi KS. Fertil Steril. 1971.


New Contraceptive Approaches New Contraceptive Approaches

Quick startQuick start: In: In--office or same dayoffice or same dayFirst day startFirst day start: 1: 1stst day of menses day of menses

Extended regimensExtended regimensContinuousContinuous

Shorter Shorter ““placeboplacebo”” intervalintervalLowLow--dose placebo intervaldose placebo interval



COC: EE/LNG, (Quartette) COC: EE/LNG, (Quartette) by by TevaTeva: NEW 2013: NEW 2013

Goal: to Minimize BTBGoal: to Minimize BTB

9191--day oral regimenday oral regimenTriphasicTriphasic: with : with EthinylEthinyl EstradiolEstradiol/EE/EEEstrogen, EE increases at 3 distinct points Estrogen, EE increases at 3 distinct points over the first 84 days over the first 84 days Progestin, Progestin, ““LevonorgestrelLevonorgestrel”” remains consistent remains consistent 7 days of 7 days of ethinylethinyl estradiolestradiol 10mcg10mcg


47

EstradiolEstradiol ValerateValerate, , DienogestDienogest ((NataziaNatazia))2012 FDA Approved for 2012 FDA Approved for MenorrhagiaMenorrhagia

2 dark yellow = 3 mg 2 dark yellow = 3 mg EstradiolEstradiol ValerateValerate5 red = 2 mg EV and 2 mg 5 red = 2 mg EV and 2 mg DienogestDienogest17 light yellow =2 mg EV, 3 mg 17 light yellow =2 mg EV, 3 mg DienogestDienogest2 dark red = 1 mg EV2 dark red = 1 mg EV2 white = inert pills2 white = inert pills


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OCsOCs and Breakthrough Bleeding (BTB)and Breakthrough Bleeding (BTB)Early versus Later Use BTBEarly versus Later Use BTB

uu BTB declines over 1BTB declines over 1stst year , TTTyear , TTTRule out infectionRule out infection: Esp. : Esp. chlamydiachlamydiaTake same time each day: < 4 hoursTake same time each day: < 4 hoursChange progestin: Change progestin: drospirenonedrospirenone, , norgestimatenorgestimateIncrease estrogen Increase estrogen Generic to BrandGeneric to Brand

Later use BTB: 4 to 7 placebo pillsLater use BTB: 4 to 7 placebo pills

Am J Ob Am J Ob GynGyn, 2006;195:935, 2006;195:935Secor 2013 copyright


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Venous Thrombosis: Risk and Venous Thrombosis: Risk and COCsCOCs* * 2 2 -- 3 X incr. risk: 83 X incr. risk: 8--10/10,000 women/years10/10,000 women/years

RisksRisksFirst 3 months of COC use, RED FLAGS!First 3 months of COC use, RED FLAGS!Age, especially in smokersAge, especially in smokersBMI higher: no data > 40BMI higher: no data > 40ESTROGEN, higher doseESTROGEN, higher dose

20 mcg = 20% lower VT risk versus 30 mcg20 mcg = 20% lower VT risk versus 30 mcg50 mcg = 50% higher VT risk vs. 30 mcg50 mcg = 50% higher VT risk vs. 30 mcg

PROGESTIN type, risk may differPROGESTIN type, risk may differ

*Combination Oral contraceptives = COC, *Combination Oral contraceptives = COC, LidegaardLidegaard et al. et al. BMJ 2009 AugBMJ 2009 Aug; 339: van ; 339: van HylckamaHylckama et al. MEGA case control study. et al. MEGA case control study. BMJBMJ 2009 Aug2009 Aug; 339: ; 339:


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NEW FDA Warning 2011:NEW FDA Warning 2011:DrospirenoneDrospirenone & Risk of Non& Risk of Non--fatal VTEfatal VTE

2 fold increased risk,2 fold increased risk,compared to compared to LevonorgestrelLevonorgestrel

30.8/100,000 woman years for 30.8/100,000 woman years for DrospirenoneDrospirenone12.8/100,000 woman years for 12.8/100,000 woman years for LevonorgestrelLevonorgestrel

JickJick, Hernandez. BMJ 2011;340:d2151 doi:10.1136/bmj.d2151 , Hernandez. BMJ 2011;340:d2151 doi:10.1136/bmj.d2151


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Research: Research: DrospirenoneDrospirenone & Risk of Non& Risk of Non--fatal VTEfatal VTE2 Fold Increased Risk, Compared to 2 Fold Increased Risk, Compared to LevonorgestrelLevonorgestrel

Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM. Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 2007; 110(3):587-93. Dinger JC, Heinemann LA, Kühl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception 2007; 75:344-54. Lidegaard Ø, Løkkegaard E, Svendsen AL, Agger C. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009; 339:b2890. Van Hylckama V, Helmerhorst FM, Vandenbroucke JP, Doggen CJM, Rosendaal FR. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009; 339:b2921. Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 2011; 342:d2139. Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011; 342:d2151. Secor 2013 copyright


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Combination Hormone Contraceptives, CHCCombination Hormone Contraceptives, CHCNEW Medical Criteria: OK=2, NO=3NEW Medical Criteria: OK=2, NO=3

Hepatitis acute viral = 3, 4Hepatitis acute viral = 3, 4, , Chronic = 1Chronic = 1

Liver adenoma, or Liver adenoma, or hepatomahepatoma = = 44

Sickle cell = 2Sickle cell = 2Anticonvulsants & Anticonvulsants & RifampicinRifampicin = = 33-- Reduced efficacy of OC/CHCReduced efficacy of OC/CHC


53

Combination Hormonal Contraceptives/ CHC Combination Hormonal Contraceptives/ CHC NEW 2010 Medical CriteriaNEW 2010 Medical Criteria

Hypertension: Hypertension: Controlled = 3 Controlled = 3 BP 140BP 140--159/90159/90--99 = 399 = 3BP > 160/100 = 4BP > 160/100 = 4

HTN in Pregnancy = 2 HTN in Pregnancy = 2

Vascular disease = 4Vascular disease = 4CDC.gov/mec 2010.


CHC and NEW Medical CriteriaCHC and NEW Medical Criteria

History of DVT/PE = History of DVT/PE = 44Acute DVT/PE = Acute DVT/PE = 44

Family History of DVT/PE Family History of DVT/PE 11stst degree relative = 2degree relative = 2ThrombogenicThrombogenic mutation = mutation = 44Factor V Leiden, Factor V Leiden, prothrombinprothrombin, protein S, protein S22--20 x Fold increased risk!20 x Fold increased risk!



CHC: History of DVT, PE CHC: History of DVT, PE

NOT on anticoagulant NOT on anticoagulant

Higher risk of recurrence: 4Higher risk of recurrence: 4

•• Estrogen associatedEstrogen associated•• Pregnancy associatedPregnancy associated•• IdiopathicIdiopathic•• ThrombophiliaThrombophilia•• CancerCancer•• History of recurrenceHistory of recurrence

LowerLower risk for recurrence: 3 risk for recurrence: 3 Secor 2013 copyright 55

CVD: DVT & PECVD: DVT & PE

Family History: 1Family History: 1stst degree 2degree 2

Major surgeryMajor surgery::Prolonged immobilization: 4Prolonged immobilization: 4

No prolonged immobilization: 2No prolonged immobilization: 2

Minor surgery: no immobilization 1Minor surgery: no immobilization 1


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NEW: Headaches andNEW: Headaches andCHC/ Combination Hormonal ContraceptivesCHC/ Combination Hormonal Contraceptives

NonNon--migraine = 1, 2 migraine = 1, 2

Migraines Migraines Without auraWithout aura

Age < 35 = 2, 3 Age < 35 = 2, 3 Age > 35 Age > 35 = 3, 4= 3, 4

With aura, any age = 4, 4 With aura, any age = 4, 4 WHO, CDC, ARHP, Planned ParenthoodWHO, CDC, ARHP, Planned ParenthoodInternational Headache Society 2009International Headache Society 2009--20102010



CHCsCHCs: Drug Interactions : Drug Interactions

AntiretroviralAntiretroviral therapytherapyNRTIsNRTIs:: 11NNRTIsNNRTIs:: 22RitonavirRitonavir--boostedboosted proteaseproteaseinhibitors:inhibitors: 33

AnticonvulsantAnticonvulsant therapytherapyDecreaseDecrease OCOC effectivenesseffectivenessMinimumMinimum 3030μμgg EEEE

LamictalLamictal:: possiblepossible incr.incr. seizuresseizures

Antimicrobial therapyAntimicrobial therapyBroadBroad--spectrum spectrum

antibiotics 1antibiotics 1AntifungalsAntifungals 11AntiparasiticsAntiparasitics 11RifampicinRifampicin 33

(reduces OC efficacy)(reduces OC efficacy)



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Breast Cancer Family History and OCBreast Cancer Family History and OCNO Increased Risk NO Increased Risk

Systematic review 1966 Systematic review 1966 –– 2008 (US PSTF)2008 (US PSTF)10 studies, 1 pooled analysis of 54 studies10 studies, 1 pooled analysis of 54 studies4 studies suggest some women may be at 4 studies suggest some women may be at increased risk esp. if took increased risk esp. if took OCsOCs prior to 1975prior to 1975

ConclusionConclusion::OCsOCs did NOT significantly influence riskdid NOT significantly influence risk

GaffieldGaffield et al. Contraception 2009 Oct; 80:372et al. Contraception 2009 Oct; 80:372--8080Secor 2013 copyright


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Ovarian Cancer and Ovarian Cancer and OCsOCsProtection with 15 years of Use !Protection with 15 years of Use !

Massive reanalysis study; 45 studies, n= 23,257 womenMassive reanalysis study; 45 studies, n= 23,257 women

50% lower risk if used for 15 years50% lower risk if used for 15 years: even non: even non--continuous!continuous!Longer duration associated w/ lower riskLonger duration associated w/ lower riskProtection up to 30 yrs after stopping OC Protection up to 30 yrs after stopping OC Protects low AND high risk womenProtects low AND high risk women

100,000 deaths prevented worldwide !100,000 deaths prevented worldwide !Could prevent 30,000 cases annually in USCould prevent 30,000 cases annually in US

Collaborative Group. Collaborative Group. EpidEpid studies on ovarian cancer; 45 studies; 23,257 women, 87,303 studies on ovarian cancer; 45 studies; 23,257 women, 87,303 controls. controls. Lancet.Lancet. 2008. Jan 26;371:3032008. Jan 26;371:303


NEW Package Insert Update: 2012NEW Package Insert Update: 2012TransdermalTransdermal Patch: Package Information (PI)Patch: Package Information (PI)

““You will be exposed to about You will be exposed to about 60% more estrogen60% more estrogen than an than an OCP OCP with 35 mcg of estrogen.with 35 mcg of estrogen.”” = = 56 mcg56 mcg

NEW per FDANEW per FDA (May 2012) (May 2012) ““the benefits outweigh the risksthe benefits outweigh the risks””, , but consumers must be educated but consumers must be educated

about the risksabout the risks


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2010: NO Incr. Risk of Nonfatal VTE in Users of 2010: NO Incr. Risk of Nonfatal VTE in Users of Contraceptive Contraceptive TransdermalTransdermal Patch: n 297,262 Patch: n 297,262

Compared to users of Compared to users of OCsOCs containing NGM/EE 35 mcgcontaining NGM/EE 35 mcgObservational caseObservational case--control study control study

56 cases of VTE, 212 matched controls: 56 cases of VTE, 212 matched controls: New users only!New users only!PharMetricsPharMetrics USUS--based, longitudinal database on 55 million lives based, longitudinal database on 55 million lives back to 1995back to 1995

Medical claims & diagnoses from managed care Medical claims & diagnoses from managed care OR 1.1 (95% CI 0.6OR 1.1 (95% CI 0.6--2.1) 2.1) NO increased risk compared to NGM /EE containing NO increased risk compared to NGM /EE containing OcsOcs

Dore et al. Contraception 2010 May; 81(5):408Dore et al. Contraception 2010 May; 81(5):408--413)413)VTE OR 2.0 extension study, n 38, c 148 (297,262 women)VTE OR 2.0 extension study, n 38, c 148 (297,262 women)When new data pooled w previous data no increased riskWhen new data pooled w previous data no increased risk

JickJick, Kaye, Li and , Kaye, Li and JickJick. Contraception 2007;76: 4. Contraception 2007;76: 4--7. (BU SOM Boston)7. (BU SOM Boston)Same authors. Contraception 2006;73:223Same authors. Contraception 2006;73:223--228. 17 month study228. 17 month study



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NEW May 2012: Incr. Risk of Nonfatal VTE in Users of NEW May 2012: Incr. Risk of Nonfatal VTE in Users of Contraceptive Patch and Ring: n 1.5 million Contraceptive Patch and Ring: n 1.5 million

Using Danish national registriesUsing Danish national registries

Risk of thrombosis: Risk of thrombosis: NonNon--users 2/10,000users 2/10,0006.2/10,000 exp years w COC (26.2/10,000 exp years w COC (2--3 x incr. risk)3 x incr. risk)9.7/10,000 exp years w Patch (7.5 x incr. risk)9.7/10,000 exp years w Patch (7.5 x incr. risk)7.8/10,000 exp years w Ring (6.5 x incr. risk)7.8/10,000 exp years w Ring (6.5 x incr. risk)

Implant or LNG IUS users: No increased riskImplant or LNG IUS users: No increased risk

BMJ2012;344doi: 10.1136/bmj.e2990(Published 10 May 2012)BMJ2012;344doi: 10.1136/bmj.e2990(Published 10 May 2012)BMJ 2012; 344:e2990.BMJ 2012; 344:e2990.


Who Says Women Pro Golfers are at a Who Says Women Pro Golfers are at a Disadvantage to Men ? Disadvantage to Men ?

Michelle Wie, pro golfer:

Matching lavender outfit: $2,000

New pair of French sunglasses: $500

NIKE products Endorsements: $10,000,000

Having that special place to hold your putter ....

Priceless !!!


66

Very low steady doseVery low steady dose120 120 μμg/day g/day etonogestreletonogestrel15 15 μμg/day g/day ethinylethinyl estradiolestradiol

Flexible (54 mm)Flexible (54 mm)Easy to insertEasy to insertOne ring per cycleOne ring per cycle: :

3 weeks in, 1 week ring3 weeks in, 1 week ring--freefreeOr change monthlyOr change monthly

Less BTB than with OCLess BTB than with OCWith With ““Quick StartQuick Start””

WesthoffWesthoff et al. Ob et al. Ob GynGyn 2005 Jul;106:892005 Jul;106:89--96. 96.

Contraceptive Vaginal Ring:Contraceptive Vaginal Ring:



Bea, Katie, our KatherineBea, Katie, our Katherine


Pills (POP), injections, implantsPills (POP), injections, implants

ProgestinProgestin--Only Only ContraceptivesContraceptives


Progestin Only:Progestin Only:

AgeAge: :

•• POP = 1POP = 1•• DMPA <18 , >45 DMPA <18 , >45 = = 22BreastfeedingBreastfeeding

< 1 month< 1 month = = 22>> 1 month = 11 month = 1

PostpartumPostpartum = 1= 1PostabortionPostabortion: = 1: = 1Past ectopicPast ectopic

POP = 2POP = 2



Progestin Only: Misc ConditionsProgestin Only: Misc Conditions

SmokingSmoking: = 1: = 1

ObesityObesity: : = 1 = 1 <18 = 2<18 = 2

BariatricBariatric: : MalabsorptiveMalabsorptive procedures procedures POPsPOPs (Pills) only = 3(Pills) only = 3

SzSz meds, meds, RifampinRifampin, ARV = 3, ARV = 3


Progestin Only: HypertensionProgestin Only: Hypertension

Adequately controlledAdequately controlledPOP, I: 1POP, I: 1DMPA: 2DMPA: 2

Elevated BP levelsElevated BP levelsS 140S 140--159/D 90159/D 90--9999

POP, I: 1POP, I: 1DMPA: 2DMPA: 2

S S >> 160/D 160/D >> 100100POP/ I: C 2POP/ I: C 2DMPA: 3DMPA: 3

HBP during pregnancy: 1HBP during pregnancy: 1


Progestin Only: Progestin Only: No Evidence of Incr. DVT/ PE RiskNo Evidence of Incr. DVT/ PE Risk

DVT/ PEDVT/ PE

History or acute: 2History or acute: 2On or off anticoagulant: 2On or off anticoagulant: 2Major surgery, immobilized: 2Major surgery, immobilized: 2

Thrombotic mutations: 2Thrombotic mutations: 2Family History: 1Family History: 1Superficial thrombosis: 1Superficial thrombosis: 1



RheumaticRheumatic NeurologicNeurologic

SLESLEPositive or unknown APL Positive or unknown APL antibodies: antibodies: 33Severe thrombocytopenia: 3Severe thrombocytopenia: 3

ImmunosuppressedImmunosuppressed: : 22RARA

POP, I = 1POP, I = 1DMPA = 2DMPA = 2

Liver tumors/Severe cirrhosis = 3Liver tumors/Severe cirrhosis = 3Breast cancer currentBreast cancer current = 4= 4

Headaches, nonHeadaches, non--migraine: migraine: 11MigrainesMigraines

No aura 2 No aura 2 Start OC 1Start OC 1Aura:Aura:

StartStart 22

Aura: Aura: Continue 3Continue 3

EpilepsyEpilepsy: 1: 1Depressive disordersDepressive disorders: 1: 1

Progestin Only: Headache w Aura! Progestin Only: Headache w Aura!


Contraceptive Implant: Contraceptive Implant: ““NexplanonNexplanon”” with NEW Inserterwith NEW Inserter

SingleSingle rod,rod, ““RadiopaqueRadiopaque””ProgestinProgestin onlyonly

EtonogestrelEtonogestrel33 yearyear contraceptivecontraceptiveHighHigh efficacyefficacy >> 99%99%NoNo weightweight restrictionrestriction

BUTBUTUnpredictableUnpredictable bleedingbleedingSpecialSpecial trainingtraining requiredrequired

MansourMansour etet al.al. ContraceptionContraception 20102010 sep;82:243sep;82:243--4949 74

Adapted from www.contraceptiononline.org


Advantages Advantages DMPA: DMPA: MedroxyprogesteroneMedroxyprogesterone AcetateAcetate

Effective, easy, convenientEffective, easy, convenientShorter menses, no mensesShorter menses, no mensesNo backup needed 1st monthNo backup needed 1st monthNo BMI weight restrictionNo BMI weight restrictionMay be used in smokers esp. >35 yrsMay be used in smokers esp. >35 yrsOK if ESTROGEN contraindicatedOK if ESTROGEN contraindicatedInjection schedule: Injection schedule: 4 week grace period4 week grace period

PaulenPaulen et al. Contraception 2009 Oct; 80: 391et al. Contraception 2009 Oct; 80: 391--408.408.



DMPA, HIV or at High Risk for HIV and MEC: DMPA, HIV or at High Risk for HIV and MEC: NEW: CDC Update June 2012NEW: CDC Update June 2012

Safe: Category 1,2 (encourage condoms too)Safe: Category 1,2 (encourage condoms too)Combined oral contraceptivesCombined oral contraceptivesProgestinProgestin--only pillsonly pillsDepot DMPA (Caution)Depot DMPA (Caution)ImplantsImplants

Women at high risk for HIVWomen at high risk for HIVCaution re: use of ProgestinCaution re: use of Progestin--only only ““injectablesinjectables””

Inconclusive evidence re: HIV acquisition riskInconclusive evidence re: HIV acquisition risk

MMWR, June 22, 2012 / 61(24);449MMWR, June 22, 2012 / 61(24);449--452452 Secor 2013 copyright76

DMPA DMPA –– Category 3, 4Category 3, 4

Cat 3Cat 3CVDCVD

Hypertension Hypertension >>160/160/>>100100StrokeStrokeIschemic CVDIschemic CVDMultiple risk factorsMultiple risk factors

Liver tumors, cirrhosisLiver tumors, cirrhosis

Cat 4Cat 4Breast cancerBreast cancer--currentcurrentUnexplained vaginal Unexplained vaginal

bleedingbleeding


NEW DMPA ResearchNEW DMPA Research-- 2012: 2012: Breast Cancer Risk Increased?Breast Cancer Risk Increased?

Possible 2 fold increased riskPossible 2 fold increased riskOnly during useOnly during useBut absolute risk very low But absolute risk very low Risk reverses when DMPA stoppedRisk reverses when DMPA stopped

Li CI, Beaber EF, Tang MT, et al. Effect of depo-medroxyprogesterone acetate on breast cancer risk among women 20-44 years of age. Cancer Res. 2012 Feb 27. [Epub ahead of print]



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Effects of Long Term DMPA on BMDEffects of Long Term DMPA on BMD

DMPA > 2 yrs had a significant adverse effect on BMD DMPA > 2 yrs had a significant adverse effect on BMD 2.8% loss after 1 yr, 5.8% loss after 2 years2.8% loss after 1 yr, 5.8% loss after 2 years

Arias et al. Dialogues in Contraception. Spring 2007; 11(1):1Arias et al. Dialogues in Contraception. Spring 2007; 11(1):1--11.11.ShaarawyShaarawy et al. Contraception. 2006; 74: 297et al. Contraception. 2006; 74: 297--302.302.

BUT GOOD NEWS!BUT GOOD NEWS!Large, cross sectional study of 3500 ethnically diverse ptsLarge, cross sectional study of 3500 ethnically diverse pts

Used DMPA >10 years Used DMPA >10 years Reversibility of loss complete in 2 to 3 years Reversibility of loss complete in 2 to 3 years

JWWH Jan 2008, p3 and National Vital Stat Rep 2007;56:1JWWH Jan 2008, p3 and National Vital Stat Rep 2007;56:1


NEW 2013: DMPA and Bone HealthNEW 2013: DMPA and Bone HealthNo Increased Fracture RiskNo Increased Fracture Risk

Large retrospective cohort study shows DMPA did NOT raise fracture risk.N 312,395

Fracture risk did NOT increase after initiation of DMPA“Black Box warning should be removed by the FDA”

Lanza LL et al. Use of depot medroxyprogesterone acetate contraception and incidence of bone fracture. Obstet Gynecol 2013 Mar; 121:593. (http://dx.doi.org/10.1097/AOG.0b013e318283d1a1)


81

BMD, Identifying BMD, Identifying ““at Risk Patientsat Risk Patients””

Vaginal pH check routinelyVaginal pH check routinelyNormal pH of 4.0 is yellow = normal estrogen levels !Normal pH of 4.0 is yellow = normal estrogen levels !

Atrophic Atrophic VaginitisVaginitisHigh pH, pallor, scant discharge, High pH, pallor, scant discharge, WBCsWBCs, small cells , small cells

Add back EstrogenAdd back Estrogen-- may be consideredmay be consideredEthinylEthinyl EstradiolEstradiol 20 mcg oral daily20 mcg oral dailyVaginal Ring: may reduce BTB and bone loss!Vaginal Ring: may reduce BTB and bone loss!

Dempsey et al, Contraception 82 (Sept 2010)Dempsey et al, Contraception 82 (Sept 2010) 2525----255255Secor 2013 copyright



Progestin Only: Progestin Only: No Evidence of Incr. DVT/PE RiskNo Evidence of Incr. DVT/PE Risk

DVT/PEDVT/PEHistory or acute: 2History or acute: 2On or off anticoagulant: 2On or off anticoagulant: 2Major surgery, immobilized: 2Major surgery, immobilized: 2

Thrombotic mutations: 2Thrombotic mutations: 2Family History: 1Family History: 1

Superficial thrombosis: 1Superficial thrombosis: 183Secor 2013 copyright

Progestin Only: Progestin Only: Cardiovascular DiseaseCardiovascular Disease

Ischemic heart Ischemic heart disease/Strokedisease/Stroke

Initiation: Initiation: POP: 2POP: 2

DMPA: 3DMPA: 3

Continuation: Continuation: POP: 3POP: 3

ValvularValvular heart diseaseheart disease: 1: 1

PeripartumPeripartum cardiomyopathycardiomyopathyMild: 1Mild: 1Moderate/severe: 2Moderate/severe: 2

HyperlipidemiaHyperlipidemia: 3: 3



PO: Reproductive Tract ConditionsPO: Reproductive Tract Conditions

Category Category 1:1:EndometriosisEndometriosisBenign ovarian tumorsBenign ovarian tumorsSevere Severe dysmenorrheadysmenorrheaGestational Gestational trophoblastictrophoblasticdiseasediseaseBenign breast diseaseBenign breast diseaseFHxFHx breast cancerbreast cancerEndometrial hyperplasia or Endometrial hyperplasia or cancercancerOvarian cancerOvarian cancerUterine fibroidsUterine fibroidsSTIsSTIs, PID, PIDHIV/AIDSHIV/AIDS

Category Category 2:2:Irregular, heavy, or prolonged Irregular, heavy, or prolonged vaginal bleedingvaginal bleedingCIN/Cervical cancer CIN/Cervical cancer (DMPA)(DMPA)Undiagnosed breast massUndiagnosed breast mass

CategoryCategory 3:3:Past breast cancer (>5 years)Past breast cancer (>5 years)Unexplained vaginal bleedingUnexplained vaginal bleeding

Category Category 4:4:Current breast cancerCurrent breast cancer


86

ResourcesResources

Journal Watch WomenJournal Watch Women’’s Healths Health800.843.6356800.843.6356www.jwatch.orgwww.jwatch.org

Hatcher et al. 2010. Contraceptive Technology Hatcher et al. 2010. Contraceptive Technology Update (20Update (20ndnd edition), Ardent Pressedition), Ardent Press

www.Amazon.comwww.Amazon.com


87

ResourcesResources

CarcioCarcio, , SecorSecor. 2010. Advanced Health . 2010. Advanced Health Assessment of Women (2Assessment of Women (2ndnd eded). Springer ). Springer publishing, NY, publishing, NY, www.springerpub.comwww.springerpub.comwww.mimisecor.comwww.mimisecor.com

ARHP.orgARHP.org““ContraceptionContraception”” Journal with membershipJournal with membershipMany other resourcesMany other resourcesContraceptive choices, online tool kit for patientsContraceptive choices, online tool kit for patients



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Objectives (100% Objectives (100% PharmPharm):):Contraception UpdateContraception Update

Describe trends and contraceptive challenges Describe trends and contraceptive challenges facing clinicians and patients. 5 minutesfacing clinicians and patients. 5 minutes

Explain the new CDC medical eligibility criteria Explain the new CDC medical eligibility criteria for prescribing various contraceptive methods for prescribing various contraceptive methods and medical conditions. 30 minutesand medical conditions. 30 minutes

Discuss new contraceptive research regarding Discuss new contraceptive research regarding efficacy, risks, benefits as this pertains to efficacy, risks, benefits as this pertains to prescribing. 25 minutesprescribing. 25 minutes



Questions Questions

Thank you and good luck!Thank you and good luck!

Mimi Mimi SecorSecor, MS, Med, FNP, MS, Med, FNP--C, FAANPC, FAANP

www. www. mimisecormimisecor. com. com Twitter, Twitter, FacebookFacebook, LinkedIn, LinkedIn


across the lifespan the new us cdc medical eligibility...

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