Transcript Whats new 2011 - Northern Deanery

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
• UKMEC 2009 guidance changes from 2005
• Essure
• Questions
Yaz
Qlaira
Missed Pills
Flexible Pill taking Regimes
COCP: Yaz
 20mcg EE + 3 mg Drospirenone
 New 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: Yaz
 Initial 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
Pearl Index for 21 day regime DRSP/EE
Pearl Index for 21day regime other COCP
0.94
1.5
2.22
COCP: Qlaira
 Oestradiol Valerate+ Dienogest
 Benefits



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 regime
 26/2
 Maintain stable E2 levels, optimise cycle control,
inhibit ovulation
DNG
E2V
Day
Phase
3mg
2mg
3mg
1
2
1
2mg
3
4
5
2a
6
7
8
1mg Placebo
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
2b
3
4
Qlaira packet
Missed Pill Advice
Missed 2 or more
coloured pills or forgotten
to start new pack
Seek advice from your HCP
YES
YES
day 1-9
Had sex in the 7 days
before forgetting?
NO
Missed only
1 pill (more than
12 hours late )
day 10-17
Take missed pill
• Continue with pack as usual
• Use a barrier contraception (e.g.
condoms) for the next 9 days
day 18-24
Start immediately with next pack
• Use barrier contraception (e.g.
condoms) for the next 9 days
YES Check pill
number
on pack
day 25-28
HCP, Healthcare professional
Take missed pill
• Continue with packet as usual
• No additional contraception
necessary
MISSED PILL RULES
Missed Pills
 Multiple sources of advice
 FSRH guidance
 SPC- leaflet in box of Pills
 FPA leaflet
 BNF
 ALL DIFFERENT
 Conflicting advice leads to confusion
 Inaccurate & inconsistent Pill taking
Missed Pills
 MHRA decided not acceptable to have so much
conflicting information
 New set of missed Pill rules
 Not dependant on dose
 NB separate rules for
 QLAIRA-Quadraphasic Pill –use SPC
 Cerazette
 Progestogen only Pills
Missed Pill Rules
CEU- May13th 2011
 1 missed Pill
( >24 hrs late or PFI lengthened by 1 day)
 Take Pill as soon as remember
 Continue rest of pack
 No additional contraception needed
 Have 7 day break as normal
Missed Pill Rules
CEU- May13th 2011
 2 missed Pills ( or PFI lengthened by 2 days)
 Take Pill as soon as remember
 Continue rest of pack
 Use additional contraception for 7 days
 EC if 2 pills are in first week of packet
 No break if less than 7 Pills left in packet
FLEXIBLE PILL TAKING REGIMES
COCP :Flexible regime
 Tricycling
 3 packets back to back with no break
 63 continuous days
 Reduce Pill free interval to 3-4 days
 Reduce bleeding
 Minimise risk of lengthening break
 ‘Break at bleed’
 Take Pills continuously until break through bleed occurs
 Break 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 symptoms
 Endometriosis
 Previous Pill failure
 Women’s Choice/ convenience
Alternative ways of delivering combined EE & Progestogen
Nuva Ring
 Vaginal 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 Ring
 Compliance

>85% of cycles compliant in trials
 Acceptibility



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
methods
 Storage

2-8°C before dispensing to patient
 Cost

£27 for 3 rings ( £9 per month)
Failure rates
Management of bleeding problems
Nexplanon
 Subdermal implant
 Etonogestrel 68mg released over 3 years
 Most effective method available for women
 Change insertion device
 New technique
 Reduced chance of leaving device in inserter
 Change component
 Barium Sulphate
 Radio opaque
Nexplanon
 Pregnancies


>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 Patterns
 Median number of days bleeding /spotting in LARC
No
method
Implanon
IUS
16
14
12
10
8
6
4
2
0
DMPA
users over 3 months
Irregular Bleeding PatternsManagement Options
 Pre-insertion/fitting/injection Counselling
 Progestogen Injection

Shorten interval to 8/52 until amenorrhoeic
 IUS / Nexplanon

Change earlier is bleeding starts in final year of use
 Drug 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 start
 If 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 licence
 If method of choice is not available use bridging
method- COCP, POP or Injectable Progestogen
 IUCD can be used if meet EC criteria
 IUS insertion should be delayed until pregnancy
excluded
Quick start
 If 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 weeks
 Use may be out of licence
Quick start
 Starting hormonal contraception after POEC
(eg Levonelle)
 Advise condom use or abstainance for
 7 days for COCP, Nexplanon, Injectable Progestogen
 2days for POP
 9days for Qlaira
Quick start
 Starting hormonal contraception after Ullipristal
(EllaOne)
 Advise condom use or abstainance for an extra week
 14 days for COCP, Nexplanon, Injectable Progestogen
 9 days for POP
 16 days for Qlaira
Pregnancy after quickstart
 If pregnancy is diagnosed after quick starting
contraception
 Stop or remove method
 Do not remove IU contraceptives
 after 12 weeks gestation
 if threads not visible
Drug interactions
Drug interactions- Antibiotics
 CEU no longer advises that additional precautions are
required when using CHC with non-enzyme inducing
antibiotics
 EVIDENCE in line with
 World Health Organisation
 US Medical eligibility Criteria for Contraceptive Use
Drug interactions- Antibiotics
 EVIDENCE
 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 inducers
 Rifampicin-like drugs are enzyme inducers and are the only
antibiotics that have been shown to reduce EE levels
 Methods unaffected
 IUCD
 IUS
 Injectable progestogen
Drug interactions-Enzyme inducers
 Combined Pill
 Change method(or long term 2 x50µg COC)
 Patch/ Ring
 Change method(2Patches/ 2Rings not recommended)
 POP/Nexplanon
 Change method
 POEC- Levonelle
 Use 3mg LNG asap
 Ullipristal Acetate- EllaOne
 Ella One contraindicated
 Use IUCD if enzyme-inducers in last 28days
Drug interactions- no longer included
 Warfarin
 Increase or decrease of anticoagulant effect with
hormonal contraception
 Lack of consistant evidence therefore no longer
included
 Griseofulvin
 Not a clinically important enzyme inducer
 Lanzoprazole
 No longer listed as an enzyme inducer
Drug interactions- Lamotrigine
 CHC not recommended in women on Lamotrigine
monotherapy ( UKMEC3)
 Risk of reduced seizure control
 Potential for toxicity in the CHC free interval
 Progestogens
 Levels of some progestogens may be reduced
 May increase levels of Lamotrigine
 Need more evidence (still UKMEC1 for PO methods)
UKMEC 1
UKMEC2
UKMEC 3
UKMEC4
Unrestricted Use
Benefits outweigh Risks
Risks outweigh Benefits
Contraindicated
UKMEC New changes
 Obesity
 >30-34kg/m2 BMI UKMEC 2 for CHC
 > 35kg/m2 BMI UKMEC 3 for CHC
 Previous >40kg/m2 UKMEC4no longer included
 Current VTE On anticoagulants
 CHC UKMEC 4
 All other methods UKMEC 2
 Previously UKMEC 3 except POP
UKMEC New changes
 Gestational 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 disease
 Hepatitis
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
 Cirrhosis
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 disease
 Liver 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- SLE
 SLE
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 changes
 Lamotrigine
 CHC
(UKMEC 3)
 All other methods
(UKMEC 1)
 Broad spectrum Antibiotics
 All 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
Essure
 Permanent contraception
 Implant placed into each tube which involves an
occlusion
 Hysteroscopic approach
 Without General Anesthesia
 No scar, no incision
Mechanism of action
OCCLUSION after benign
inflammatory reaction into the intra
mural part of the uterus
Indications
 Permanent contraception / Sterilization
 Impossibility to use another contraception
 Contraindication to laparoscopy
 Contraindication 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
Black mark
Tip of the implant
Gold Ring
Implant details
Stainless steel
316L inner coil
PET Fibers
Dynamic expanding outer coils in
Nitinol
Total lenght : 3,75 cm
Expanded diameter : 1,8 mm
Procedure
THE 3 MONTHS CHECK
 Essential
 The contraception must be used until the validation of
the success of the procedure by the surgeon
 There are 3 possibilities
 Standard x-ray
 Ultrasound
 Hysterosalpinogramm
X-RAY
1
2
3
4
Ultrasound
Hysterosalpingography
HSG : 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 friends
 More than 250 publications worldwide
 96.9% of placement success rate
 No pregnancies in the 800 patients in the clinical trial
after 5 years of follow-up
 Gold standard in Netherlands, France, Finland, …