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 Number of pills Colour Estradiol valerate (mg) Dienogest (mg) 2 dark yellow 3 5 medium red 17 light yellow dark red 1 white

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