Complex Cases Birmingham 6 th October Dr Nicola Mullin FFSRH FRCOG Consultant in Sexual & Reproductive Health, Chester

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1 Complex Cases Birmingham 6 th October 2018 Dr Nicola Mullin FFSRH FRCOG Consultant in Sexual & Reproductive Health, Chester

2

3 Declaration of interest I have received remuneration for some lectures and support to attend educational meetings from Bayer, MSD and Mylan.

4 Overview Migraine Diabetes Cardiovascular disease Congenital heart disease Gastrointestinal disease HIV Transgender

5 Sources of information UK Medical Eligibility Criteria 2016 Faculty of Sexual and Reproductive Healthcare guidelines: method specific specific populations drug interactions Members Enquiry Service (via FSRH website) BNF and electronic Medicine Compendium

6 Definition of UK Medical Eligibility Criteria categories Category UKMEC 1 UKMEC 2 UKMEC 3 UKMEC 4 Definition A condition for which there is no restriction for the use of the contraceptive method A condition where the advantages of using the method generally outweigh the theoretical or proven risks A condition where theoretical or proven risks usually outweigh the advantages of using the method. Provision of a method requires expert clinical judgement &/or referral to a specialist service since use of the method is not usually recommended unless other more appropriate methods are not available or unacceptable. A condition which represents an unacceptable health risk if the contraceptive method is used.

7 Category 3 conditions Provision of a method to a woman with a category 3 condition requires expert clinical judgement and/or referral to a specialist contraceptive provider, since the use of the method is not usually recommended unless other appropriate methods are not available or not acceptable.

8 UKMEC common misconceptions Misconception #1: If it s UKMEC 1 or 2, I can prescribe it. If it s UKMEC 3 or 4, I can t.

9 UKMEC 2: what is it there for? Jane: 33 years, call centre worker requests COC Smoker (UKMEC 2) BMI 33 (UKMEC 2) Mother had a VTE event aged 49 years (UKMEC 2) Recent episode of superficial thrombophlebitis (UKMEC 2)

10 UKMEC 2: what is it there for? Jane: 33 years, call centre worker requests Nexplanon Smoker (UKMEC 1) BMI 33 (UKMEC 1) Mother had a VTE event aged 49 years (UKMEC 1) Recent episode of superficial thrombophlebitis (UKMEC 1)

11 UKMEC common misconceptions Misconception #2: UKMEC2 + UKMEC2 = UKMEC4

12 UKMEC 2 + UKMEC 2 UKMEC 4 Julie, 33: requests COC Migraine without aura (UKMEC 2) Asymptomatic gallbladder disease (UKMEC 2) CIN 2 (UKMEC 2)

13 UKMEC 2 + UKMEC 2 UKMEC 4 Jane: 33 years, call centre worker requests COC Smoker (UKMEC 2) BMI 33 (UKMEC 2) Mother had a VTE event aged 49 years (UKMEC 2) Recent episode of superficial thrombophlebitis (UKMEC 2)

14 The UKMEC should be used as a guide to safe use of contraception however this should not replace clinical judgement and evaluation in individual situations FSRH Clinical Effectiveness Unit

15 Case 1. Jenny, 32 She has been happy with her contraceptive implant but has recently developed migraine with aura and has been started on Topiramate 50mg bd. What issues does this raise?

16 Implant & Topiramate - issues Can implant remain in situ? Should implant be removed in view of the new onset of migraine? Should the implant be removed as Topiramate will reduce its effectiveness?

17 UKMEC Headache & hormonal methods Headaches CHC POP DMPA IMP I C a). Non-migrainous (mild or severe) b). Migraine I C i). Without aura, age <35 yrs ii). Without aura, age >35 yrs iii). With aura, at any age c). Past history of migraine with aura at any age

18 Migraine without aura Tell me about your headaches? Visual symptoms can be difficult to interpret AURA is NOT bilateral symptoms that occur with headache: dark floaters bilateral blurred vision photophobia PIN for diagnosing migraine without aura with ID-Migraine Photophobia Impairment Nausea MacGregor A. Diagnosing Migraine. J Fam Plan Reprod Healthcare, 2016,42(4)

19 Migraine with aura Occurs (5-60mins) before the headache & typically lasts min Often both eyes, loss of vision & bright zig zag becoming C shaped, scotoma (bright white spot) Tingling one side face, tongue, speech affected, one arm, rarely one leg Tip from Dr MacGregor, City of London Migraine Clinic people with true aura always use a hand beside their head to describe their PRE-headache eye symptoms

20 Migraine & stroke risk Risk of stroke increased in assoc with migraine with aura, COC use increases that risk 2-4x Risk of stroke increases with age, BP, smoking. Schurks M et al. Migraine and cardiovascular disease: systematic review and meta-analysis. BMJ 2009;339:b3914

21 Headache - management Type of headache Action Prescribe Migraine with aura STOP CHC, consider P-only or hormone free contraception Classical migraine During pillactive weeks Reduce oestrogen 20 mcg EE COC or POP During pill-free weeks Try extended cycle routine Tension headache Reassure Encourage perseverance Lifestyle advice eg reduce caffeine, regular bedtime Analgesia

22 Drug interactions with hormonal contraception FSRH CEU guidance 2017 Online drug interaction checker

23 Types of drug effect metabolism Decrease contraceptive efficacy (enzyme inducers) Antiepiletics Carbamazepine, Phenytoin, Primidone, Topiramate Antibacterials Rifabutin, Rifampicin Antiretrovirals Ritonivir, Efavirenz, Nevirapine Antidepressants St Johns Wort Others Modafinil (students), Bosentan, Aprepitant

24 Types of drug effect metabolism Enzyme inhibiting drugs that may increase hormone levels Antibacterials Erythromycin Antifungals Fluconazole, Ketoconazole, Itraconazole Antiretrovirals Atazanir Immunosuppressants Tacrolimus NSAIDS Etoricoxib Statins Atorvastatin, Rosuvastatin Vasodilators Sitaxentan sodium

25 Case 2. Sarah, 26 Had renal transplant 5 years ago Taking Tacrolimus, Alfacalcidol & sodium bicarb Using Depo-provera for 12 months Has been recommended implant Renal team want to create a dialysis access in her arm and have asked for the implant to be inserted in another location.

26 Sarah Can Nexplanon be inserted in another part of the body? Inner thigh? Lower abdomen? Would this render it as off label use?

27 UKMEC & organ transplant Organ transplant a) Complicated: graft failure (acute or chronic) rejections, cardiac allograft, vasculopathy b) Uncomplicated Cu-IUD LNG-IUS IMP DMPA POP CHC I C I C Evidence: no comparative studies have examined IUC use amongst transplant patients. Four case reports show inconsistent results of beneficial effects & contraceptive failures

28 Case 3. Lorna, 40 She is thinking about changing from POP to the injection. There is no medical history of note but there is a family history of diabetes & heart disease. Her BP is 140/85, BMI is 37. She smokes 5 cigarettes per day. She has a bicornuate uterus. What are her contraceptive options?

29 Voting question: which statement is false? 1. She should be encouraged to stay on POP 2. Depo-provera will make her gain weight 3. Depo-provera is UKMEC 3 4. Combined hormonal methods should be avoided 5. Intrauterine contraception is not suitable for her 6. Nexplanon is UKMEC 3

30 UKMEC: Cardiovascular disease Multiple risk factors for CVD: smoking, diabetes, hypertension, obesity & dyslipidaemias IUD UKMEC 1 IUS/IMP/POP UKMEC 2 DMPA/CHC UKMEC 3

31 UKMEC & multiple risk factors for cardiovascular disease multiple risk factors for cardiovascular disease (smoking, diabetes, BP, obesity, dyslipidaemias Cu- IUD LNG- IUS IMP DMPA POP CHC UKMEC 4 conditions: CHC with BP>140/90 mmhg, vascular disease, current & history of ischaemic heart disease or stroke

32 UKMEC & Obesity Obesity CHC All other methods a). BMI > kg/m b). BMI >35 kg/m No upper limit, depends on other risk factors

33 Bariatric surgery Bariatric surgical procedures involving a malaborptive component have potential to decrease effectiveness of oral contraception. May be made worse by long term diarrhoea and/or vomiting Adjustable gastric band may be ok Jejuno-ileal bypass - some conflicting pharmacokinetic evidence on effectiveness

34 Types of surgery: Restrictive or Malabsorptive Gastric band: restrictive Gastric bypass (Roux-en-y): malabsorptive Sleeve gastrectomy: restrictive

35 CEU Contraception and obesity guideline due to be published soon FSRH CEU Statement: Contraception for women with eating disorders, 2018

36 Depo-provera: effect on weight Appears to be assoc with weight gain, esp in women <18 with BMI >30 [B] Women who gain more than 5% baseline weight in first 6 months, likely to continue gaining weight [C] No increased risk of pregnancy in women with BMI>40 [B] FSRH Guidance Progestogen-only injectables. Dec 2014, updated March 2015

37 Weight changes when using DMPA 60 Pooled results from 3 Contraception Studies (N=1516) % % % 0 Lost >2.2kg N= Remained within 2.2kg N=763 Gained >2.3kg N=572

38

39 Case 4. Emily 18 year old with jejunostomy and is taking Cerazette. Is contraceptive cover an issue? British Society of Gastroenterology jejunostomy leads to accelerated gastric emptying accelerated intestinal transit less time for digestion & absorption of drugs & nutrients FSRH CEU = risk of malabsorption so avoid oral contraception

40 Case 5. Helen, 21 Young woman with eating disorder and laxative abuse since age 14 Hospitalised twice, currently BMI 16 Has anxiety, depression and OCD Lives at home and has boyfriend

41 Voting question: what contraceptive method should be avoided for a young woman with 1. Condoms 2. Combined pill 3. Sayana Press 4. IUD 5. IUS 6. Nexplanon 7. Combined patch an eating disorder?

42 Case 5. Helen Young women with eating disorder and laxative abuse. Concerns: severity of diarrhoea on efficacy of oral contraception Is timing of taking laxatives relevant Is re-absorption of EE metabolites from large bowel affecting patch or ring safety of DMPA FSRH CEU non-oral contraception recommended & DMPA not suitable

43 Case 6. Louise 27 She was diagnosed with insulin dependant diabetes age 7. BMI 28, normal BP. She struggles to control her diabetes. In the past she had to have an IUS removed under GA following a partial perforation. What would you advise?

44 Voting question: what contraceptive method would be most suitable for Louise? 1. Combined hormonal method 2. Progestogen-only pills 3. Nexplanon 4. Injection 5. IUD 6. IUS 7. Any method can be used 8. One she is happy with

45 Voting question: regarding hormonal contraception and diabetes which statement is false? 1. COC use has limited effect on daily insulin requirements 2. COC has no effect on long term control or progression to retinopathy 3. Development of non-insulin dependant diabetes after gestational diabetes is not increased by use of COC 4. COC is UKMEC 4 if neuropathy or vascular disease if present

46 UKMEC and Diabetes Diabetes Cu-IUD LNG-IUS IMP DMPA POP CHC a) History of gestational disease b) Non-vascular disease (i) Non-insulin dependant (ii) Insulin dependant c) Nephropathy/ retinopathy/ neuropathy d) Other vascular disease

47 Case 7.Susie, 21 She needs contraception and is requesting an IUD because of unacceptable bleeding on POP. She had a Fontans operation as a child. She is still seen annually in a young adult cardiac clinic What do you do?

48 Voting question: what would you do for Susie? 1. Offer her Nexplanon 2. Offer her Depo-provera 3. Advise her to double her POP 4. Arrange to fit an IUD yourself straight away because she must avoid pregnancy 5. Write to her cardiologist for more information 6. Refer her to your local gynaecologist

49 Valvular & congenital heart disease Virchow s triad stasis, endothelial injury, hyper viscosity increases risk clot formation Impaired cardiac function/dilated heart chamber or arrhythmia increases risk stasis Closure of cardiac defect in last 6/12 or mechanical valve increases risk thrombus formation Cyanotic defect assoc with hyper viscosity because of increased erthrocytosis

50 FSRH CEU Contraceptive choices for women with cardiac disease Proactive approach during teenage years Avoid combined hormonal methods Limited data about assoc POP and VTE, could use desogestrel pill while seeking advice (not with enzyme inducers) IUD/IUS risk vaso-vagal reaction, hospital setting, don't need prophylactic antibiotics Anticoagulants not CI, experienced clinician

51 Susie - management Wikipedia: procedure for children who possess only a single functional ventricle, either due to lack of a heart valve, abnormal pumping, or complex congenital defect Write to her GP and her cardiac team Offer bridging contraception NOT suitable for IUD fitting in community clinic/surgery

52 Case 8. Lamia 38 year old Thai woman has had HIV for 20 years. She takes Atripla (efavirenz, emtricitadine, tenofovir) & her viral load is undetectable. She has noticeable chloasma on her cheeks and forehead which started with her last pregnancy.

53 Voting question: What's the most suitable contraception for Lamia? 1. Combined hormonal methods 2. POP 3. Depo-provera 4. IUD 5. IUS 6. Condoms 7. Sterilisation

54 HIV BHIVA/BASHH/FSRH Guideline for the sexual and reproductive health of people living HIV, DMPA/IUD/IUS ok Women with HIV infections often have co-morbidities that may influence their choice of contraception.

55 Drug interactions

56 HIV diagnosed prevalence rate / 1,000 aged 15-59: Cheshire West and Chester: 1.12/1000 England: 2.31/1000 HIV late diagnoses: Cheshire West and Chester: 48.3% England: 40.1%

57 90:90:90 target

58

59 Case 9. Jo 42 year old trans man attended for a cervical smear. He had recently had unprotected anal with ejaculation on his external genitals. What do you do for him?

60 Voting question: which statement is false? 1. Trans men and non-binary (assigned female) people can t take levonorgestrel or UPA because these drugs interfere with testosterone 2. Cu-IUDs are safe but may cause unacceptable bleeding 3. Combined hormonal methods will counteract testosterone masculinising effects 4. Testosterone is not contraceptive 5. IUS and Depo-provera may have benefit of amenorrhea

61 FSRH CEU statement: Contraceptive choices & sexual health for Transgender & Non-binary people, 2017 People assigned female at birth should be advised of all methods they are medically eligible for Cervical screening Consider HPV vaccination plus condoms Hepatitis A and B vaccination Availability of PREP/PEPSE Testosterone is not contraceptive (teratogenic) Unscheduled bleeding w hormonal contraception

62 Thank you for listening.

63 Safe prescribing of combined pill two essential requisites for safe prescribing: Evidence-guided prescribing of the Pill. Hannaford & Webb 1996 Careful personal & family history, with particular attention to CVS risk factors Accurate measurement of BP

64 VTE risk of COC: Statement from CEU Non contraceptive users & not pregnant Risk if VTE per 10,000 women years Oral contraceptive users Pregnancy 29 2 Immediate postpartum period Heinemann LAJ, Dinger JC. Contraception 2007;75: Dinger JC et al. Contraception 2007;75: Heit JA et al. Annals of Internal medicine 2005;143:

65 Raynauds disease Raynauds disease/phenomenon: expert opinion from UK rheumatologists was that UKMEC 2009 classification was unhelpful/ no longer appropriate since the risks associated with Raynauds disease relate to the underlying disease process rather than the condition itself.

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