Contraception Update

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Dr Sarah Gatiss Consultant in Obstetrics and Gynaecology Sunderland Royal Hospital
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Contraception Update. Dr Sarah Gatiss Consultant in Obstetrics and Gynaecology Sunderland Royal Hospital. OVERVIEW. Combined Contraceptive methods New Pills Yaz & Qlaira Missed Pills Pill taking Regimes Nuvaring Nexplanon New faculty guidance Drug interactions Quick start guidance - PowerPoint PPT Presentation

Transcript of Contraception Update

  • Dr Sarah GatissConsultant in Obstetrics and Gynaecology Sunderland Royal Hospital

  • OVERVIEW

    Combined Contraceptive methods New Pills Yaz & QlairaMissed PillsPill taking RegimesNuvaringNexplanonNew faculty guidanceDrug interactionsQuick start guidanceUKMEC 2009 guidance changes from 2005EssureQuestions

  • YazQlairaMissed PillsFlexible Pill taking Regimes

  • COCP: Yaz20mcg EE + 3 mg DrospirenoneNew regime 24/28Take active Pills for 24 days then 4 day placebosShorter PFI is more effectiveLicensed USAContraception, acne and PMDDBenefitsLess Dysfunctional BleedingLess PMS Less Blood loss by 50-60%

  • COCP: YazInitial efficacy data from USA3-5 year follow up of new starters or switchersProspective recruitment434 unplanned pregnanciesBy March 2008Pearl Index for 24day regime 0.94Pearl Index for 21 day regime DRSP/EE 1.5Pearl Index for 21day regime other COCP 2.22

  • COCP: QlairaOestradiol Valerate+ DienogestBenefitsMore natural,effective and safeCycle control like 20mcg LNG PillLittle effect on glucose, lipids, BP, coagulation factorsDisadvantagesNew so limited data on VTE / CHD risk etcNeed to take all 28 Pills in correct order (EE: Prog)Different Missed Pills rules

  • Qlaira regime26/2Maintain stable E2 levels, optimise cycle control, inhibit ovulation

    Tabelle1

    SAP Data DE-00658 Jan. - Dec. 05

    update:19.01.2006

    Daten

    ProjektcodeProject nameDS/DPKSt Text2005Sec.Plan[MM]2005Sec.act.[MM]2006Sec.Plan[MM]2005Sec.Plan[TEU]2005Sec.act.[TEU]2006Sec.Plan[TEU]2005Prim.Plan[TEU]2005Prim.act.[TEU]2006Prim.Plan[TEU]2005TotalPlan[TEU]2005Totalact.[TEU]2006TotalPlan[TEU]

    DE-00658GA E2 PillDP1726, Phc.Dev. Mgmt.&Admin.000

    1727, SAG CCD PhcDev Oral Process5.02.73.0159861095056209142109

    1734, SAG CCD PhcDev IDS Packag./Label.16.66.32.83571355962523870982373129

    1894, SAG CCD PhcDev Preclin. Formulation6.0999900

    7625, SAG CCD PhcDev Packaging/Systems0.96.0171100250017360

    7673, SAG CCD Analytical Development31.519.311.271043525323215733437268

    7718, Phc. Dev. Transdermal0.6160160

    9126, SAG CCD Managem.&Admin0.250050

    BXE-1051, Clinical Supplies13.72.32.5379624714833937050

    BXE-1058, Phc. Technology (Operations)2.01.22.0312136603372139

    BXE-1066, Analytical Services1.11.01.7201932201932

    BXE-1189, Quality Assurance5.50.61.06461464614

    Production Berlin0.7150150

    DS7625, SAG CCD PhcDev Packaging/Systems1010

    7673, SAG CCD Analytical Development0.6140140

    Gesamtergebnis81.436.430.2181983065971830534125371135.11000

    Tabelle2

    DNG3mg

    2mg

    E2V3mg

    2mg

    1mgPlacebo

    Day12345678910111213141516171819202122232425262728

    Phase12a2b34

    Tabelle3

  • Qlaira packet

  • Take missed pillContinue with pack as usualUse a barrier contraception (e.g. condoms) for the next 9 daysMissed Pill AdviceTake missed pillContinue with packet as usual No additional contraception necessaryHad sex in the 7 days before forgetting?Seek advice from your HCPYESNOday 1-9day 10-17day 18-24day 25-28Missed only 1 pill (more than 12 hours late )Missed 2 or more coloured pills or forgotten to start new packYESCheck pill number on packYESHCP, Healthcare professional

  • MISSED PILL RULES

  • Missed PillsMultiple sources of adviceFSRH guidanceSPC- leaflet in box of PillsFPA leafletBNFALL DIFFERENT

    Conflicting advice leads to confusionInaccurate & inconsistent Pill taking

  • Missed Pills

    MHRA decided not acceptable to have so much conflicting informationNew set of missed Pill rulesNot dependant on doseNB separate rules for QLAIRA-Quadraphasic Pill use SPCCerazetteProgestogen only Pills

  • Missed Pill RulesCEU- May13th 20111 missed Pill ( >24 hrs late or PFI lengthened by 1 day)Take Pill as soon as rememberContinue rest of pack No additional contraception neededHave 7 day break as normal

  • Missed Pill RulesCEU- May13th 20112 missed Pills ( or PFI lengthened by 2 days)Take Pill as soon as rememberContinue rest of pack Use additional contraception for 7 daysEC if 2 pills are in first week of packetNo break if less than 7 Pills left in packet

  • FLEXIBLE PILL TAKING REGIMES

  • COCP :Flexible regimeTricycling3 packets back to back with no break 63 continuous daysReduce Pill free interval to 3-4 daysReduce bleedingMinimise risk of lengthening breakBreak at bleedTake Pills continuously until break through bleed occursBreak for 4 -7 days then restart

  • When to use alternative regime?PFI side effects Heavy/painful bleed in PFIHeadaches/ migraines in PFIPMSCyclical symptomsEndometriosisPrevious Pill failureWomens Choice/ convenience

  • Alternative ways of delivering combined EE & Progestogen

  • Nuva RingVaginal Ring15g/day EE and 120g/day EtonogestrelFlexible transparent ring,4mm thick x 54mm diameterLatex freeUse1 Ring for 3 weeks then 7 day breakCan be used with tampons and during SIPharmacologyAvoids first pass metabolism& GI interference with absorptionSystemic EE is 50% of that of 30g EE COCPEfficacyPearl Index 0.64 ( perfect use)Comparable to COCP

  • Nuva RingCompliance>85% of cycles compliant in trialsAcceptibilityLow incidence of Break through bleedingBetter than COCP for cycle control>90% trial subjects found easy to insert and remove SafetySame metabolic and coagulation effects as most combined methodsStorage 2-8C before dispensing to patientCost27 for 3 rings ( 9 per month)

  • Failure ratesManagement of bleeding problems

  • NexplanonSubdermal implantEtonogestrel 68mg released over 3 yearsMost effective method available for womenChange insertion deviceNew techniqueReduced chance of leaving device in inserterChange componentBarium SulphateRadio opaque

  • NexplanonPregnancies>50% linked with non-insertion25% with liver enzyme inducers (carbemazepine)Pregnancy rate0.049/100 implants fitted0.01/100 true method failureNew insertion SiteInner side of non-dominant upper arm 8-10cm above medial epicondyle of the humerus

  • Irregular Bleeding PatternsMedian number of days bleeding /spotting in LARC users over 3 months

  • Irregular Bleeding Patterns-Management OptionsPre-insertion/fitting/injection CounsellingProgestogen InjectionShorten interval to 8/52 until amenorrhoeicIUS / NexplanonChange earlier is bleeding starts in final year of useDrug treatmentsCOCP cyclically for 2-3 monthsNSAIDs/ Mefanamic Acid( little evidence)Doxycycline (little evidence)NET 5mg tds for 3 weeks for 2-3 cyclesProblemsRecurrence of bleeding when discontinues treatment

  • Quick start regimes

  • Quick startIf we can be reasonably sure that a woman is not pregnant or at risk of a pregnancy from recent UPSI, contraception can be started immediately.Use may be out of licenceIf method of choice is not available use bridging method- COCP, POP or Injectable ProgestogenIUCD can be used if meet EC criteriaIUS insertion should be delayed until pregnancy excluded

  • Quick startIf pregnancy cannot be excluded (eg after EC administration) &women will not abstain until pregnancy is excluded or is keen to start method immediately COCP, POP, Nexplanon can be started .Injectable progestogen should only be used if other options are not appropriate or acceptableFollow-up with pregnancy test after 3 weeksUse may be out of licence

  • Quick startStarting hormonal contraception after POEC (eg Levonelle)Advise condom use or abstainance for

    7 days for COCP, Nexplanon, Injectable Progestogen 2days for POP9days for Qlaira

  • Quick startStarting hormonal contraception after Ullipristal(EllaOne)Advise condom use or abstainance for an extra week

    14 days for COCP, Nexplanon, Injectable Progestogen 9 days for POP16 days for Qlaira

  • Pregnancy after quickstartIf pregnancy is diagnosed after quick starting contraceptionStop or remove methodDo not remove IU contraceptives after 12 weeks gestation if threads not visible

  • Drug interactions

  • Drug interactions- AntibioticsCEU no longer advises that additional precautions are required when using CHC with non-enzyme inducing antibioticsEVIDENCE in line with World Health OrganisationUS Medical eligibility Criteria for Contraceptive Use

  • Drug interactions- AntibioticsEVIDENCESeveral studies show no decrease in EE levels with antibiotic useSmall non randomised trials no effect on pharmacokinectocs of EE/ progestogen when used with tetracyclinc/amoxicillin/doxycyclineSmall non randomised trials failed to show that ampicillin has any effect on gonadotrophin conc or progesterone levels in women using >30g COCPSmall RCTs showed Ofloxacin & Ciprofloxacin may not affect COC efficacy ( no ovulation)

  • Drug interactions-Enzyme inducersRifampicin-like drugs are enzyme inducers and are the only antibiotics that have been shown to reduce EE levelsMethods unaffected IUCDIUSInjectable progestogen

  • Drug interactions-Enzyme inducers

    Combined PillChange method(or long term 2 x50g COC)Patch/ RingChange method(2Patches/ 2Rings not recommended)POP/NexplanonChange methodPOEC- Levonelle Use 3mg LNG asapUllipristal Acetate- EllaOneElla One contraindicatedUse IUCD if enzyme-inducers in last 28days

  • Drug interactions- no longer includedWarfarinIncrease or decrease of anticoagulant effect with hormonal contraceptionLack of consistant evidence therefore no longer includedGriseofulvinNot a clinically important enzyme inducerLanzoprazoleNo longer listed as an enzyme inducer

  • Drug interactions- LamotrigineCHC not recommended in women on Lamotrigine monotherapy ( UKMEC3)Risk of reduced seizure controlPotential for toxicity in the CHC free intervalProgestogensLevels of some progestogens may be reducedMay increase levels of LamotrigineNeed more evidence (still UKMEC1 for PO methods)

  • UKMEC 1Unrestricted UseUKMEC2Benefits outweigh RisksUKMEC 3Risks outweigh BenefitsUKMEC4Contraindicated

  • UKMEC New changesObesity>30-34kg/m2 BMI UKMEC 2 for CHC> 35kg/m2 BMI UKMEC 3 for CHCPrevious >40kg/m2 UKMEC4no longer includedCurrent VTE On anticoagulants CHC UKMEC 4All other methods UKMEC 2Previously UKMEC 3 except POP

  • UKMEC New changesGestational trophoblastic diseaseDecreasing or undetectable levels All methods (UKMEC 1)Persistant elevated hcg levels/malignant diseaseAll methods ( UKMEC 1) except IUS/IUD( UKMEC4)Distorted cavity insertion of IUS/IUD (UKMEC 3)Chlamydia or GC positive Initiation of IUS/IUD ( UKMEC 4)Continuation of IUS/IUD ( UKMEC 2) previously 1

  • UKMEC New changes- Liver diseaseHepatitis

    Cirrhosis

    CHC -ICHC-CPOPDMPAImplantIUCDIUSHepatitis A3/4221111Carrier1111111Current1111111

    CHC -ICHC-CPOPDMPAImplantIUCDIUSMild1111111Severe4333313

  • UKMEC New changes- Liver diseaseLiver tumours

    CHC POPDMPAImplantIUCDIUSFocal nodular type222212Hepatocellular Adenoma433313Malignant Liver Ca433313

  • UKMEC New changes- SLESLE

    CHC POPDMPA-IDMPA-CImplantIUCD-IIUCD-CIUSPositive antibodies43333113Severe Thrombocytopenia22322322Immunosuppressive treatment22222212None of the above22222112

  • UKMEC New changesLamotrigineCHC (UKMEC 3)All other methods (UKMEC 1)Broad spectrum AntibioticsAll methods( UKMEC 1)Antiretroviral therapy

    CHCPOPDMPANEXIUD -IIUD-CIUS-IIUS-CNRTI11112/322/32NNRTI22122/322/32RBPI33122/322/32

  • Permanent contraceptionImplant placed into each tube which involves an occlusion Hysteroscopic approach Without General AnesthesiaNo scar, no incision

    Essure

  • Mechanism of action OCCLUSION after benign inflammatory reaction into the intra mural part of the uterus

  • IndicationsPermanent contraception / SterilizationImpossibility to use another contraception Contraindication to laparoscopyContraindication to general anaesthesiaContraindicationsUncertain patientPregnancy or suspected pregnancy Immediate post-partum and post termination (< 6 weeks)InfectionUnexplained bleedingCorticosteroids and immuno suppressor treatment

  • Before a procedure

    First part of cycle or reliable contraception

    Anti-inflammatory one hour before the procedure

    Pregnancy test just before the procedure

    Contraception for the 3 months following the procedure

  • Essure ESS 305Gold Ring

  • Implant detailsDynamic expanding outer coils in NitinolPET FibersExpanded diameter : 1,8 mmTotal lenght : 3,75 cmStainless steel 316L inner coil

  • Procedure

  • Essential

    The contraception must be used until the validation of the success of the procedure by the surgeon

    There are 3 possibilities Standard x-rayUltrasoundHysterosalpinogramm

    THE 3 MONTHS CHECK

  • X-RAY 1234

  • Ultrasound

  • HysterosalpingographyHSG : Radiologic procedure to exam the fallopian tubes occlusion, injection of a radio-opaque fluid into the cervical canal.

  • Conclusion

    Patient satisfaction in all publications is more than 95%The patients who has already done the procedure recommend it to their friendsMore than 250 publications worldwide96.9% of placement success rate No pregnancies in the 800 patients in the clinical trial after 5 years of follow-upGold standard in Netherlands, France, Finland,

  • If the woman is less than 12 hours late in taking the pill, she should take the missed pill as soon as she remembers and proceed as normal; contraceptive protection is not reduced. If a woman has forgotten to take more than one coloured tablet or forgotten to start a new pack, she should contact her HCP. If she only missed one pill and is more than 12 hours late in taking it, contraceptive protection may be reduced. This is how she should proceed:She should check pill number on the pack.For days 19, she should take the missed tablet immediately. If she has had sex in the 7 days before the missed pill, she should contact HCP. If she has not had sex in the last 7 days, she should proceed as for days 10-17.For days 1017, she should take the missed pill, then continue with pack as usual (even if it means taking two pills on the same day). She should use back-up contraception, e.g. condoms, for the next 9 days. For days 1824, she should not take the missed pill but rather start immediately with the next pack. She should also use back-up contraception, e.g. condoms, for the next 9 days.For days 2528, she should take the missed pill, then continue pack as usual.There is no need for backup contraception.

    If a woman misses pills and doesnt follow missed pill guidelines properly, then has no withdrawal bleed at the end of the pack or beginning of the new pack, the possibility of pregnancy should be considered.

    *The outer delivery catheter is 1mm in diameter allowing it to be placed through a 5fr operating channel of any commercially available hysteroscope.Normal control Xray after 3 months.