The Combined Pill the initial consultation Dr Lisa

The Combined Pill – the initial consultation. Dr Lisa Pickles. GP, Brig Royd Surgery. December 2017.

Overview. The aim of the presentation is to present a checklist of areas to be covered to include: Assessing suitability Examine Teach and inform the patient Prescribe Follow up.

Suitability: indications Contraception Menses Acne/ PCOS

Suitability: right method? Consider other methods/compliance Eg. Long Acting Reversible Contraception (LARC) Other methods already used. Take sexual history.

Suitability: contraindications �Ask re migraine. ? aura

Suitability: contraindications �Drugs : including enzyme inducers eg carbamazepine, OTC and herbal eg St John’s Wort. �CVS risk factors (smoking, obesity – BMI>30 -35, hypertension, DVT, thrombophilia, hyperlipidaemia). Beware multiple risk factors. �Liver disease. �Check past history screen, eg porphyria. �FH – VTE, stroke, CHD, carriers of gene mutations known to increase ca breast risk eg BRAC 1.

Suitability: contraindications And, Check not pregnant.

Suitability: smoker? Ask

Suitability: CI or relative CI? Other medical conditions. UKMEC (UK medical eligibility criteria). See Faculty of Reproductive and Sexual Health Care for tables. https: //www. fsrh. org/standards-andguidance/documents/ukmec-2016 -summary-sheets/ July 2017. Page 5. �UKMEC 1 – unrestricted use eg non migrainous headache (initiation). �UKMEC 2 - benefits generally outweigh risks eg migraine without aura (initiation) �UKMEC 3 - risks generally outweigh benefits eg past (>5 years ago) migraine with aura. �UKMEC 4 - unacceptable health risk and should not be used eg migraine with aura.

UKMEC Quiz.

Suitability: medications(prescribed). see FSRH publication re drug interactions. file: ///C: /Users/GPConnect/Downloads/ceugui dancedruginteractionshormonal. pdf Certain anticonvulsants eg phenytoin, carbamazepine and topiramate are enzyme inducers and reduce serum levels of EE and progesterone in COC. However, EE reduces plasma concentrations of lamotrigine. Possible increased risk of seizures. Consider increasing dose of lamotrigine monotherapy. To avoid toxicity in pill-free week, consider extended regimen. EE may also modestly reduce valproate levels. No interaction between antibiotics and COC, even in short courses.

Suitability: OTC/herbal remedies. St John’s Wort interacts with COC. Specifically ask re other meds/herbal/SJW

Examine. BP BMI

Teach. How to take ( 21 day cycle, PFI 7 days). Note use of mobile phone reminders/apps and ? avoid 1 st thing in morning. Pill is ‘missed’ if > 24 hours late GI upset Never increase PFI. Menses in PFI. Warn initial irregular bleeds common. Works during PFI.

Teach. Remember, tricycling. And why consider this? Non focal migraine/headache in PFI or menorrhagia/dysmenorrhoea or travel And, Tailored pill taking (new pills are unlikely to be 21/7 cycles. Tending to be 24/4 eg. Zoely – 24 active pills, 4 placebo)

Teach – missed pills. What are the rules regarding missed pills ?

Teach – missed pills. GP information. Points for healthcare professionals to understand: �Ovaries are fully suppressed after 7 pills have been taken consecutively. �After 7 day PFI, ovarian activity may be restarting in a few women ie. the achilles heel of pill taking. Need care not to extend this by much. �If pills are missed D 1 -7, this may extend the PFI and emergency contraception may be advised if UPSI has occurred (even if this has been prior to the missed pills in the PFI, sperm can live up to 7 days)

Teach – missed pills. GP information. If pills are missed D 14 -21, ovaries are fully suppressed, so no need for emergency contraception if UPSI has occurred, however, continue onto next pack omitting the break, to avoid extending the PFI. research by WHO has demonstrated that women regularly miss pills during routine pill taking, with less detriment to efficacy than previously thought, but … remember the risks of extending the PFI.

Teach – missed pills. Advice for patients. Current MHRA (Medicines and Healthcare products Regulatory Agency) advice regarding missed pills. 2011 http: //www. mhra. gov. uk/home/groups/spar/documents/websiteresources/con 117375. pdf A missed pill is one taken > 24 hours late. �One missed pill anywhere in the pack will not affect contraceptive cover. Take the last missed pill late, but no need for extra protection. �If 2 or more pills have been missed anywhere in the pack (ie. > 48 hours late), take the last missed pill, c/t pill taking, extra protection for 7 days and omit the break if there are < 7 pills left in the pack.

Teach – missed pills. Advice for patients. MHRA and FSRH advice - continued. � And ‘consider need for emergency contraception’. IT is needed IF: 1. 2 or more pills are missed in the first week and she has had UPSI in the preceding week ( maybe in the PFI). 2. She has UPSI after 2 missed pills and before she has taken the next 7 days of pills consecutively.

Missed pill Quiz.

Teach – start. Usually day 1 - 5 start (works straight away). Can be any day of cycle (takes 7 days to work) if ‘reasonably certain that patient not pregnant’. Ref: Quickstart. FSRH. https: //www. fsrh. org/standardsand-guidance/documents/fsrh-clinical-guidance-quickstarting-contraception-april-2017/

Teach - start Postpartum – not BF, day 21 (works straight away). Later if happy not pregnant(works after 7 days). - BF after 6 weeks (new) - If risk factor for VTE after 6 weeks (eg. immobility, BMI>30, post PPH, transfusion, LCSC, eclampsia or smoking) Within 7 days of TOP or miscarriage (works straight away). https: //www. fsrh. org/standards-andguidance/documents/contraception-after-pregnancyexecutive-summary-document/

Teach – switching from other method. If preceding method is anovulatory, then can start COC straight away with no need for extra protection. So, Other COC – start at end of current pack, no break, no extra protection Depo, Implant, Cerazette - start straight away if used correctly/before runs out. No extra protection

Teach – switching from other method. However, if previous method doesn’t suppress ovulation: IUD – up to D 5 of menses, no extra protection. Any other time of cycle, extra protection 7 days. Retain IUD for 7 days. Older POP or IUS – start straight away (if used correctly). Extra protection 7 d. Retain IUS for 7 days. Ref: FSRH switching document. file: ///C: /Users/GPConnect/Downloads/switching-

Inform- efficacy > 99% if taken properly.

Inform- sexual health. Safer sex/condoms also. Consider chlamydia screening (CHLASP) if age 16 -25.

Inform-side effects. – what would you mention?

Inform-side effects. I mention: Weight gain. No effect. May be some appetite stimulation? Initial irregular bleeding. Should settle, so don’t stop COC if it happens. Headaches. Report migraine immediately. Other ‘hormonal’/non harmful effects eg. Bloating, nausea, moody, sore breasts, skin changes. May settle. Minor. Not harmful.

Inform-risks What would you mention?

Inform. I mention small increased (relative)risk of the following (bearing in mind that for most women of contraception age that the actual risk of all of these conditions is very small anyway, hence also low absolute risk):

Inform-risks VTE. Advise re symptoms of DVT or PE (as per MHRA advice Jan 2014. Includes a check list). Stroke (and maybe, MI – beware multiple risk factors) Ca cervix Ca breast : possibly slight increased risk. RR 1. 24 current users. Resolves after 10 years off COC. Discuss w pt. But remember genetic mutations eg. BRAC 1.

Inform-VTE risk per 10, 000 women yrs. (FSRH Nov 2014) -Not on CHC 2 - 2 nd generation pill- LNG, norethisterone COC eg microgynon 5 -7 - 3 rd generation pill- desogestrel, gestodene or drospirenone COC eg femodene or yasmin 9 -12 -Etonogestrel ring or norelgestromin patch 6 -12 In pregnancy Immediate post partum period 29 300 -400

Inform-benefits Reduced risk of ca ovary ca endometrium (both halved, lasts for 15 years) and, possibly, colorectal ca. (also, reduced menorrhagia, dysmenorrhoea and PMS)

Prescribe – which preparation? Ist line is 2 nd generation , monophasic, norethisterone or levonorgestrel containing, 30 mcg EE pill eg microgynon 30 Rationale: -not phasic (simple to take). -lower VTE risk than 3 rd gen pills. -equal efficacy to 20 mcg pill, but less unscheduled bleeding.

Prescribe – which preparation. 2 nd line is 3 rd generation pill. Newer progesterones, fewer SE, ? heart disease friendly (not proven) : gestodene (femodene) desogestrel (marvelon), norgestimate (cilest) Note: 3 rd generation pills are acceptable, however, for 1 st line use if wished because ACTUAL risk of VTE is still very small

Prescribe – which preparation? Note: - marvelon and femodene. Good cycle control, well tolerated, relatively acne friendly (mercilon and femodette are the 20 mcg versions if OE 2 side effects) - cilest. Sold as relatively acne friendly. - Loestrin 30 ( a 2 nd generation pill) - Not usually used. Evidence of reduced efficacy of this compared with other pills.

Prescribe- which preparation? Other options: Dianette* (co-cyprindiol)/Yasmin – good for acne treatment. Former licensed for treatment of moderate/ severe acne (after topical rx and systemic antibx have been tried) and should not be used solely for contraception- and latter, for acne treatment and as a contraceptive. Stop dianette once acne (or hirsutism) controlled. Change to other acne friendly pill. Can have repeat courses of dianette. * 2013 PRAC study by EMA ( European medicines agency) suggests 1. 5 -2 x increased VTE risk of cyproterone containing CHC compared with LNG CHCs. Suggests VTE still rare, remain vigilant and evaluate continued need for treatment periodically.

Prescribe- which preparation? Phasic pills eg. logynon. Varying dose in 2 or 3 steps throughout the 21 days. Need to be in correct order, more complicated. Good for cycle control. ED pills. 21 active and 7 dummy pills (or newer, 24/4). Qlaira. Different oestrogen (oestradiol valerate rather than ethinyloestradiol). Complicated quadriphasic/26 day regime. Marketed as more ‘natural’ – is same oestrogen as used in HRT. Zoely also contains oestradiol valerate – but is monophasic, 24/4 version. Eloine/Daylette – 20 mcg version of Yasmin, in 24/4 cycles.

Prescribe-patch/ring If compliance is a problem, consider: Combined contraceptive patch , Evra (apply weekly x 3, then patch free week). There is a 48 hour ‘window’ in which to remember patch application Combined contraceptive ring, Nuvaring (insert vaginally, leave in situ for 3 weeks, then remove for 1 week). It can be left in for up to 4 weeks before efficacy may be lost. LARC

My pill choices 1 st microgynon If acne – Yasmin If ‘hormone’ SE eg. moody – femodene or marvelon If headaches – 20 mcg pill eg. femodette, daylette - if persists, then tricycle If poor cycle control – 3 rd generation eg femodene or marvelon. – phasic eg logynon If >40 – 20 mcg pill eg. femodette, daylette (or ? Zoely 24/4 – oestradiol valerate. Same E as in HRT), or POP. ( ref: my summary sheet)

Leaflet. Issue FPA leaflet. Or online, http: //www. fpa. org. uk/sites/default/files/thecombined-pill-your-guide. pdf Other, eg. patient. info

Follow up. Prescription for 3 months. Is free from chemist. Consider issuing condoms/CHLASP testing. See nurse for FU if all is well. See GP if any problems. Note: plan for FU may be different at other practices!

Fraser Guidelines. If the patient is under 16 and unaccompanied, be happy that the patient fulfills the criteria. Remember to encourage her to involve a parent in her decision. And ensure that she is having consensual sex, not being coerced. Record in the notes. Safeguarding. (see below for full guidelines)

Fraser Guidelines. �The young person will understand the professional’s advice. �The young person cannot be persuaded to inform their parents. �The young person is likely to begin, or continue having, sexual intercourse with or without contraceptive treatment. �Unless the young person receives contraceptive treatment, their physical or mental health, or both, is likely to suffer. �The young person’s best interests require them to receive contraceptive advice or treatment with or without parental consent.

Young patients. Have parents got access to records? Consider changing password.

Summary/checklist COC - new start 1. Indication – menses, contraception, PCOS/acne. 2. Consider other methods eg LARC/suitability /previous methods used/sexual history. 3. Contraindications – focal migraine, DVT, other eg active liver disease, ca breast, pregnant. -FH: BRAC 1, DVT, stroke (relative CI) -check history screen for rarer entries eg. Porphyria. - other drugs inc. OTC eg. St John’s Wort. 4. Smoker? 5. Check BP and BMI. 6. Teach – 21 days on, 7 days off (pill free interval) - missed pills (>24 hours late), GI upset, enzyme inducers. - never increase PFI. - timing, usually D 1 start, works straight away (remember Quickstart, 7 d extra precns) -remember mobile phone reminder /app to aid compliance, ? Not 1 st thing if young. 7. Efficacy - > 99% when taken properly. 8. Safer sex advice/condoms/sexual history.

Summary/checklist – contd. 9. SE – initial irregular bleeding - reassure re weight. - headaches (need to report migraine) - other ‘hormonal’/minor eg mastalgia, moody, bloating, nausea, acne. 10. Risks – small actual numbers. VTE (check knows symptoms), ca cervix, ca breast, stroke. 11. Benefits – ca ovary, ca endometrium. - improved periods. - good contraceptive. 12. Issue prescription and ? condoms. Initially 3 months’ supply. If all well, 12 months after that. 13. Give FPA leaflet (or signpost online). 14. Follow up. Inform re need to be seen in 3 months for next prescription. Also, advise that the prescription is free. 15. Fraser Guideline. If under 16 ensure that she fits the criteria and record in the notes. Safeguarding. 16. Offer chlamydia screening (CHLASP programme) if aged 16 -25. 17. Check if parents have online records access.

Project to consider Draw up own auto-consultation at your practices if not already available.

References. � Faculty of Sexual and Reproductive Healthcare (FSRH). www. fsrh. org. uk Go to Publications on the site, many useful documents inc. COC – First prescription, CEU guidance: missed pills, quickstart contraception, switching methods, drug interactions w hormonal contraception, emergency contraception, contraception post pregnancy and UKMEC summary sheets MHRA update Feb 2014 following letter to GPs January 2014 (link to this) with checklist. https: //www. gov. uk/drug-safety-update/combined-hormonalcontraceptives-and-venous-thromboembolism-review-confirms-risk-is-small FSRH statement from CEU: 1. Feb 2014 in response to MHRA re VTE and 2. Nov 2014 FSRH VTE and hormonal contraception statement. http: //www. fsrh. org/pages/Clinical_Guidance_2. asp Family Planning Association (FPA). www. fpa. org. uk � Other GP education sites, eg GP notebook, CKS, patient. info � Other patient information sites eg. CKS and patient. info � This presentation will be found on the Pennine website for a few weeks! www. pennine-gp-training. co. uk

And finally…Training videos: You. Tube. Search: Matt Smith 1. Simulated consultation of 1 st pill prescription in detail. 18 minutes long. Includes the steps in this presentation May need to split the consultation if short of time. 2. And 10 minute consultation 1 st pill prescription. Practice for CSA.