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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
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Our DaughterOur DaughterKat Kat SecorSecor
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Paintball Paintball TournyTourny
Huntington Huntington Beach, CaliBeach, Cali
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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
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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
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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
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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
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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 !
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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)
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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
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2010 CDC: US Medical Eligibility Criteria 2010 CDC: US Medical Eligibility Criteria for Contraceptive Use for Contraceptive Use
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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
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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
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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.
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
.
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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.
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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
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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
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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
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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
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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.
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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!
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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
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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
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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
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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.
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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 !!!
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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:
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Bea, Katie, our KatherineBea, Katie, our Katherine
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Pills (POP), injections, implantsPills (POP), injections, implants
ProgestinProgestin--Only Only ContraceptivesContraceptives
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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
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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
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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
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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
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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!
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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
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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.
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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