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, …