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

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Contraception Update

Dr Clio TimaeusClinical Lead/Associate Specialist for

Bromley Healthcare Contraception and Reproductive Health Service

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Overview

• Quick starting contraception

• Nuvaring

• Qlaira

• CHC and antibiotics

• Ella-one

• Faculty qualifications amnesty

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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)

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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

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Useful for

• Problems with taking pills/COC:

- forgets

- changes in time zone

- difficulty swallowing pills

- nausea on taking pills

- absorption problems

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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

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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

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Can use with:

• Tampons

• Vaginal thrush treatments

• Spermicides

• Diarrhoea and vomiting

• Antibiotics

(but still need extra precautions with liver-inducing enzymes)

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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

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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

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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)

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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

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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)

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Phasic nature of QlairaNumber of pills

Colour Estradiol valerate (mg)

Dienogest (mg)

2 dark yellow 3 0

5 medium red 2 2

17 light yellow 2 3

2 dark red 1 0

2 white 0 0

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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)

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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

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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)

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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

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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)

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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

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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)

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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

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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

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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)

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• 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

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• 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

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• 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)

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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

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Costs from current BNF

• Levonelle 1500 - £5.20

• Levonelle OneStep - £13.83

• ellOne - £16.95

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• 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

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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)

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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)

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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

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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)

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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/R

egistrationForm.aspx?pid=18• Access the e-SRH package (sexual and

reproductive health); different to SRH overview in GP training package

• www.fsrh.org