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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
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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 • UKMEC 2009 guidance changes from 2005 • Essure • Questions
COMBINED ORAL CONTRACEPTION 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 0.94 • Pearl Index for 21 day regime DRSP/EE 1.5 • Pearl Index for 21day regime other COCP 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
Start immediately with next pack • Use barrier contraception (e.g. condoms) for the next 9 days Missed Pill Advice Missed 2 or more coloured pills or forgotten to start new pack Seek advice from your HCP YES YES Had sex in the 7 days before forgetting? day 1-9 NO • Take missed pill • Continue with pack as usual • Use a barrier contraception (e.g. condoms) for the next 9 days day 10-17 Missed only 1 pill (more than 12 hours late ) Check pill number on pack YES day 18-24 • Take missed pill • Continue with packet as usual • No additional contraception necessary day 25-28 HCP, Healthcare professional
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 RulesCEU- 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 RulesCEU- 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
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
NUVARING 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)
Nexplanon 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 users over 3 months
Irregular Bleeding Patterns-Management 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
FACULTY GUIDANCE 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
FACULTY GUIDANCE 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 RECENT CHANGES UKMEC 1 Unrestricted Use UKMEC2 Benefits outweigh Risks UKMEC 3 Risks outweigh Benefits UKMEC4 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 • Cirrhosis
UKMEC New changes- Liver disease • Liver tumours
UKMEC New changes- SLE • SLE
UKMEC New changes • Lamotrigine • CHC (UKMEC 3) • All other methods (UKMEC 1) • Broad spectrum Antibiotics • All methods ( UKMEC 1) • Antiretroviral therapy
Essure • Permanent contraception • Implant placed into each tube which involves an occlusion • Hysteroscopic approach • Without General Anesthesia • No scar, no incision