Dr Sarah GatissConsultant 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

• UKMEC 2009 guidance changes from 2005• Essure• Questions

YazQlairaMissed PillsFlexible Pill taking Regimes

COCP: Yaz20mcg EE + 3 mg DrospirenoneNew regime 24/28

Take active Pills for 24 days then 4 day placebos Shorter PFI is more effective

Licensed USA Contraception, acne and PMDD

Benefits Less Dysfunctional Bleeding Less PMS Less Blood loss by 50-60%

COCP: YazInitial efficacy data from USA

3-5 year follow up of new starters or switchers

Prospective recruitment 434 unplanned pregnancies

By March 2008 Pearl Index for 24day regime 0.94 Pearl Index for 21 day regime DRSP/EE 1.5 Pearl Index for 21day regime other COCP 2.22

COCP: QlairaOestradiol Valerate+ DienogestBenefits

More ‘natural’,effective and safe Cycle control like 20mcg LNG Pill Little effect on glucose, lipids, BP, coagulation

factors

Disadvantages New so limited data on VTE / CHD risk etc Need to take all 28 Pills in correct order (EE: Prog) Different Missed Pills rules

Qlaira regime26/2

Maintain stable E2 levels, optimise cycle control, inhibit ovulation

Qlaira packet

Take missed pillTake missed pill• Continue with pack as usualContinue with pack as usual• Use a barrier contraception (e.g. Use a barrier contraception (e.g.

condoms) for the next 9 dayscondoms) for the next 9 days

Missed Pill Advice

Take missed pillTake missed pill• Continue with packet as usual Continue with packet as usual • No additional contraception No additional contraception

necessarynecessary

Start immediately with next packStart immediately with next pack• Use barrier contraception (e.g. Use barrier contraception (e.g.

condoms) for the next 9 dayscondoms) for the next 9 days

Had sex in the 7 days Had sex in the 7 days before forgetting?before forgetting?

Seek advice from your HCPSeek advice from your HCP

YESYES

NONO

day 1-9day 1-9

day 10-17day 10-17

day 18-24day 18-24

day 25-28day 25-28

Missed only Missed only 1 pill (more than 1 pill (more than 12 hours late )12 hours late )

Missed 2 or more Missed 2 or more coloured pills or forgotten coloured pills or forgotten

to start new packto start new pack

YESYES

Check pill number on pack

YESYES

HCP, Healthcare professional

MISSED PILL RULES

Missed PillsMultiple sources of advice

FSRH guidanceSPC- leaflet in box of PillsFPA leafletBNF

ALL DIFFERENT

Conflicting advice leads to confusionInaccurate & inconsistent Pill taking

Missed Pills

MHRA decided not acceptable to have so much conflicting information

New 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 regimeTricycling

3 packets back to back with no break 63 continuous days

Reduce Pill free interval to 3-4 daysReduce bleedingMinimise risk of lengthening break

‘Break at bleed’Take 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 PFI Headaches/ migraines in PFI PMS

Cyclical symptomsEndometriosisPrevious Pill failureWomen’s Choice/ convenience

Alternative ways of delivering combined EE & Progestogen

Nuva RingVaginal Ring

15µg/day EE and 120µg/day Etonogestrel Flexible transparent ring,4mm thick x 54mm diameter Latex free

Use 1 Ring for 3 weeks then 7 day break Can be used with tampons and during SI

Pharmacology Avoids first pass metabolism& GI interference with

absorption Systemic EE is 50% of that of 30µg EE COCP

Efficacy Pearl Index 0.64 ( perfect use) Comparable to COCP

Nuva RingCompliance

>85% of cycles compliant in trialsAcceptibility

Low incidence of Break through bleeding Better than COCP for cycle control >90% trial subjects found easy to insert and remove

Safety Same metabolic and coagulation effects as most

combined methodsStorage

2-8°C before dispensing to patientCost

£27 for 3 rings ( £9 per month)

Failure ratesManagement of bleeding problems

NexplanonSubdermal implantEtonogestrel 68mg released over 3 yearsMost effective method available for womenChange insertion device

New techniqueReduced chance of leaving device in inserter

Change componentBarium SulphateRadio opaque

NexplanonPregnancies

>50% linked with non-insertion 25% with liver enzyme inducers (carbemazepine)

Pregnancy rate 0.049/100 implants fitted 0.01/100 true method failure

New insertion Site Inner 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

02468

10121416

DM

PA IUS

Impl

anon

No

met

hod

Irregular Bleeding Patterns-Management OptionsPre-insertion/fitting/injection CounsellingProgestogen Injection

Shorten interval to 8/52 until amenorrhoeicIUS / Nexplanon

Change earlier is bleeding starts in final year of useDrug treatments

COCP cyclically for 2-3 months NSAIDs/ Mefanamic Acid( little evidence) Doxycycline (little evidence) NET 5mg tds for 3 weeks for 2-3 cycles

Problems Recurrence 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 acceptable

Follow-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 method

Do 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 antibiotics

EVIDENCE in line with World Health OrganisationUS Medical eligibility Criteria for Contraceptive

Use

Drug interactions- AntibioticsEVIDENCE

Several studies show no decrease in EE levels with antibiotic use

Small non randomised trials no effect on pharmacokinectocs of EE/ progestogen when used with tetracyclinc/amoxicillin/doxycycline

Small non randomised trials failed to show that ampicillin has any effect on gonadotrophin conc or progesterone levels in women using >30µg COCP

Small 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 levels

Methods unaffected IUCDIUSInjectable progestogen

Drug interactions-Enzyme inducersCombined Pill

Change method(or long term 2 x50µg COC)Patch/ Ring

Change method(2Patches/ 2Rings not recommended)POP/Nexplanon

Change methodPOEC- Levonelle

Use 3mg LNG asapUllipristal Acetate- EllaOne

Ella One contraindicatedUse IUCD if enzyme-inducers in last 28days

Drug interactions- no longer includedWarfarin

Increase or decrease of anticoagulant effect with hormonal contraception

Lack of consistant evidence therefore no longer included

GriseofulvinNot a clinically important enzyme inducer

LanzoprazoleNo 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 intervalProgestogens

Levels of some progestogens may be reducedMay increase levels of LamotrigineNeed more evidence (still UKMEC1 for PO

methods)

UKMEC 1 Unrestricted UseUKMEC2 Benefits outweigh RisksUKMEC 3 Risks outweigh BenefitsUKMEC4 Contraindicated

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 disease

Decreasing or undetectable levels All methods (UKMEC 1)

Persistant elevated βhcg levels/malignant disease All 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 -I

CHC-C

POP DMPA Implant

IUCD

IUS

Hepatitis A

3/4 2 2 1 1 1 1

Carrier 1 1 1 1 1 1 1

Current 1 1 1 1 1 1 1

CHC -I

CHC-C

POP DMPA Implant IUCD

IUS

Mild 1 1 1 1 1 1 1

Severe 4 3 3 3 3 1 3

UKMEC New changes- Liver diseaseLiver tumours

CHC POP DMPA Implant IUCD IUS

Focal nodular type

2 2 2 2 1 2

Hepatocellular Adenoma

4 3 3 3 1 3

Malignant Liver Ca

4 3 3 3 1 3

UKMEC New changes- SLESLE

CHC POP DMPA-I DMPA-C

Implant

IUCD-I IUCD-C IUS

Positive antibodies

4 3 3 3 3 1 1 3

Severe Thrombocytopenia

2 2 3 2 2 3 2 2

Immunosuppressive treatment

2 2 2 2 2 2 1 2

None of the above

2 2 2 2 2 1 1 2

UKMEC New changesLamotrigine

CHC (UKMEC 3)All other methods (UKMEC 1)

Broad spectrum AntibioticsAll methods ( UKMEC 1)

Antiretroviral therapy

CHC POP DMPA

NEX IUD -I

IUD-C

IUS-I IUS-C

NRTI 1 1 1 1 2/3 2 2/3 2

NNRTI

2 2 1 2 2/3 2 2/3 2

RBPI 3 3 1 2 2/3 2 2/3 2

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 / Sterilization Impossibility to use another contraception Contraindication to laparoscopyContraindication to general anaesthesia

Contraindications• Uncertain patient• Pregnancy or suspected pregnancy • Immediate post-partum and post termination (< 6

weeks)• Infection• Unexplained bleeding• Corticosteroids 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 305

Tip of the implant

Black mark

Gold Ring

Implant details

Dynamic expanding outer coils in Nitinol

PET Fibers

Expanded diameter : 1,8 mmTotal lenght : 3,75 cm

Stainless 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

12

3

4

Ultrasound

Hysterosalpingography

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

ConclusionPatient 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,

…