Contraception Update

Contraception Update Dr Clio Timaeus Clinical Lead/Associate Specialist for Bromley Healthcare Contraception and Reproductive Health Service

Overview • Quick starting contraception • Nuvaring • Qlaira • CHC and antibiotics • Ella-one • Faculty qualifications amnesty

Nuvaring • Flexible transparent ring (54mm diameter; 4mm thick) • Inserted vaginally • Combined hormonal contraception • 15 µg/day ethinyl estradiol (EE) 120 µg/day etonogestrel (ENG) • One ring every 4-week cycle (3 weeks ring in; 1 week ring free)

Useful for • Once monthly dosing – not LARC, but related advantages compared to daily and weekly methods (good for women who want to remain in control of method) • Women who cant settle on a progestogen- only LARC method (usually due to bleeding problems) and choose not to have an IUCD

Useful for • Problems with taking pills/COC: - forgets - changes in time zone - difficulty swallowing pills - nausea on taking pills - absorption problems

Advantages • Monthly dosing • Good cycle control • Rapid return of ovulation (median time 19 days) • Easy to use • High user satisfaction once tried • Low EE dose (15 µg/day) • Avoids oral administration

User satisfaction study • 1492 women tried Nuvaring for 13 cycles: - at baseline 66% said COC preferred method compared to Nuvaring - after 3 Nuvaring cycles 81% said Nuvaring their preferred method • 9/10 women would recommend Nuvaring to a friend Novak A et al. Contraception 2003; 67: 187-194

Can use with: • Tampons • Vaginal thrush treatments • Spermicides • Diarrhoea and vomiting • Antibiotics (but still need extra precautions with liver-inducing enzymes)

Disadvantages • Cost, 3-ring pack costs £27.00 (BNF) • Before dispensing, needs to be stored in a fridge at 2-8 ºC; once dispensed needs to be used within 4 months (so only dispense 1 pack of 3 rings at a time) • Still have to remember to remove and insert each month: www.nuvaring.co.uk for text or e-mail reminders

In practice • Easy to insert – no special technique or position; effective as long as in contact with vaginal mucosa; just ‘shove it in like a tampon’ • Remove by hooking finger round it • Rarely expelled spontaneously (about 0.5% of cycles) – if comes out ok if re-inserted within 3h • Clients and their partners, both seem to be either unaware of or not bothered by it

In practice The Nuvaring is meant to be removed after 3 weeks and a new one inserted after a 7-day ring-free interval, however: - known to be effective for upto 4 weeks if a delay in removing it (un-licensed) - as with COC must not have more than a 7-day hormone-free interval - no reason cant ‘run rings on’ (un-licensed)

Starting schedules • Commence on day one of menstrual cycle or use condoms for at least 7 days • Can commence at the end of the 7-day PFI if changing from the COC without extra precautions • Need extra precautions for at least 7 days if changing from the POP or starting the same day an implant or IUS is removed or contraceptive injection runs out

Qlaira • A COC available since 2009 • A phasic pill – consisting of a 28-day cycle with a quadriphasic dosage regimen and a 2-day placebo phase • The resulting reducing estrogen and increasing progestogen doses are designed to optimise cycle control • First COC to contain estradiol valerate, which is metabolised to estradiol (that also exists naturally in women)

Phasic nature of Qlaira

Disadvantages • Complex regimen • Different (complicated) missed pill rules Therefore need to be a good pill taker and prepared to follow the regimen • Cost (£25.18 for a 3-cycle pack – BNF)

Advantages • Has recently been licensed for heavy menstrual bleeding in women desiring contraception • Dienogest is a highly selective progestogen that produces good suppression of endometrial proliferation

Data from Bayer HealthCare • In 421 women with DUB, including HMB (269 Qlaira; 152 placebo) • 88% reduction in median menstrual loss vs. baseline at 7 cycles, compared to 24% on placebo • Other studies show a 96% reduction for women with an IUS at one year and • 35-43% for women using other COC (un-licensed use)

Potential users • women who have HMB and choose not to have an IUS or who it has proved difficult to fit one in and want to avoid surgery • women who have had problem bleeding (BTB and/or heavy menses) on various COC, as well as with any progestogen-only methods they have tried

Antibiotics and CHC • Still need to use an alternative method unaffected by enzyme-inducing drugs (at the very least good condom use) if using the enzyme-inducing rifamycins (such as rifabutin and rifampicin)

Antibiotics and CHC - No longer advised to use extra precautions (e.g. condoms) when using CHC with antibiotics that are not enzyme-inducers, even if broad spectrum - Only proviso if antibiotics or illness cause significant vomiting and/or diarrhoea

Antibiotics and CHC - World Health Organisation Medical Eligibility Criteria for Contraceptive Use (WHOMEC, 2009/10) - US Medical Eligibility Criteria for Contraceptive Use (USMEC, 2010) - FSRH Clinical Effectiveness Unit (CEU) - (UK Medical Eligibility Criteria for Contraceptive Use, UKMEC 2009)

Antibiotics and CHC • WHOMEC states that there is intermediate level evidence that the contraceptive effectiveness of COCs is not affected by co-administration of most broad-spectrum antibiotics and advises no restriction on use (WHOMEC Category 1) of CHC with antibiotics

Antibiotics and CHC • FSRH CEU Clinical Guidance – Drug Interactions with Hormonal Contraception (January 2011) • On web-site: www.fsrh.org.uk - as are UKMEC guidelines 2009

ellaOne • New (2009) oral post coital/emergency contraceptive • 30mg ulipristal acetate (one tablet to be taken as soon as possible after UPSI) • Prescription only (i.e. no direct provision available by pharmacists)

Levonelle is a progestogen (1500 µg levenorgestrel) • ellaOne is a selective progesterone modulator, i.e. acts on the progesterone receptor (tissue-selective) but is not a progestogen Both primarily work by inhibiting/delaying ovulation, but may also effect endometrium – inhibiting implantation if fertilisation has occured

Levonelle licensed for use up to 72 hours post UPSI, but in practice used up to 120 hours (supported by FSRH) • ellaOne licensed for use up to 120 hours post UPSI

ellaOne appears to be marginally more effective than Levonelle, this superior efficacy increasing the longer the time since UPSI • Would need to treat about 120 women with ellaOne rather than Levonelle to prevent one pregnancy • If the client wants the most effective method available to prevent pregnancy, she should have a copper IUD fitted (which can be removed at the next menses or kept as a long term method)

ellaOne concerns • Effects of ellaOne on any subsequent pregnancy or current pregnancy unknown • May reduce the efficacy of any ongoing hormonal contraception use or any hormonal contraception started immediate;y after its use

Costs from current BNF • Levonelle 1500 - £5.20 • Levonelle OneStep - £13.83 • ellOne - £16.95

Bromley Contraception &RH service don’t provide ellaOne • We issue Levonelle 1500 up to 120 hours post UPSI (and will also consider more than once in a cycle and more than 120 hours post UPSI if before the earliest expected date of ovulation – Dr only) • Always offer emergency Cu-IUD fit as an alternative if fit parameters – not necessarily at same visit (when give Levonelle as well) • Dedicated LARC clinics on Tuesday a.m. and Thursday p.m. and can also usually fit on a Monday and Thursday evening

Faculty of Sexual and Reproductive Healthcare qualification amnesty • Until 31st July 2011 • For people who have already held the qualification in the past and continue to utilise the relevant skills, but for whatever reason have not re-certified, or experienced IUCD/implant fitters and removers • Diploma (DFSRH) – necessary for LoC • LoC SDI (sub-dermal implants) • LoC IUT (intrauterine techniques)

Diploma (DFSRH) • Experienced practitioner currently providing contraceptive and sexual healthcare • Previously held DFSRH/DFFP or JCC • Completed 15 hours of relevant CPD in last 5 years (meetings/reading/discussions/audit/etc) • Above to include completion of module 8 (Contraceptive Methods) of the e-SRH programme on www.e-lfh.org.uk website (1-2 hours of updating)

LoC IUT (intra-uterine techniques) • Experienced IUCD fitters, who have not re-certified or never obtained qualification • Have the Diploma (DFSRH) • Self-certify to fitting at least 12 devices per year and to be auditing results • Have 2 fittings observed by a Faculty Registerd Trainer or a GP trainer who holds LoC IUT • Have completed module 18 (IUTs) of e-SRH on e-learning for healthcare website

LoC SDI (sub-dermal implants) • Experienced in SDIs, but - not re-certified or - originally trained in a non-Faculty LoC programme as did not have DFSRH • Need DFSRH now to take advantage of amnesty • Provide details of original training and if >5 years ago complete module 17 (SDIs) of e-lfh • Received Nexplanon training/updating • Self-certify doing at least 6 procedures a year (at least one a removal and one an insertion)

e-learning for Healthcare (e-lfh) • Free to everyone working in NHS • Can access with GMC number – need to register • http://www.e-lfh.org.uk/projects/e-srh/index.html • http://registration.elfh.org.uk/UserRegistration/RegistrationForm.aspx?pid=18 • Access the e-SRH package (sexual and reproductive health); different to SRH overview in GP training package • www.fsrh.org

Contraception Update