Post on 11-Jan-2016
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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,
…