WHICH PILL? - selecting the right pill for the user

WHICH PILL? - selecting the right pill for the user

Combined hormonal contraception Dr Caroline Marfleet Consultant in Sexual and Reproductive Healthcare Colchester Hospital University Foundation Trust Nov 2016 2010 50th anniversary of the pill ENOVID 75mcg mestranol + 5mgm norethynodrel Approved for use as a contraceptive in 1960 Approved for use in Japan in 1999 1961 1st case of Pulmonary embolus in Suffolk, England 1960-2016 Dose of EE has

New, more specific progestogens OCs containing Oestradiol as valerate/hemihydrate New methods of delivery of CHC patches, rings Better knowledge and clinical evidence! Improved QOL and better health for women Use of the OCP Most commonly used method of contraception for women in UK Used by 1 million women in 1969 Used by 3 and a quarter million women in 2000 Use decreases with age 2/3 of women use ocp age 20-24 11% of women use ocp in late 40s FPA Fact sheet 2007 2016 3 methods of delivery of combined hormonal

contraception UK Medical Eligibility Criteria UK MEC 1 a condition for which there is no restriction for the use of the contraceptive method UK MEC 2 a condition where the advantages of using the method generally outweigh the theoretical or proven risks UK MEC 3 - a condition where the theoretical or proven risks usually outweigh the advantages of using the method UK MEC 4 a condition, which represents an unacceptable health risk if the contraceptive method is used Prior to the 1st prescription: A clinical history should be taken to include: Medical conditions (past & present) incl migraine & risk factors for cardiovascular disease eg smoking; previous VTE; hyperlipidaemia Drug use (prescription, non-prescription & herbal)

Family history VTE; stroke; arterial disease; breast cancer; diabetes; other BP should be documented Height, weight & BMI should be documented WHICH CHC? Types of OCPs combined and progestogen-only Ethinyl oestradiol and progestogens Oestradiol valerate /hemihydrate(body-identical oestrogen) and progestogen Routes of administration -pill.patch, ring Risks and benefits to individuals Side effects relating to oestrogens/progestogens Which pill and managing side effects COC Progestogen ladder Cyproterone 35 mcg EE

Drospirenone Gestodene Desogestrel Dianette Levonorgestre l Cilest 30 mcg EE Yasmin Femodene 20 mcg

EE Eloine (Yaz) Femodette Mercilon POP Norgestimate Marvelon Cerazette Norethisteron e Brevinor Mic 30

Loestrin 30 Loestrin 20 Norgeston Micronor Androgenicity series Norethisterone Levonorgestrel Gestodene Desogestrel Drospirenone Cyproterone acetate Choice of COCP by progestogen More oestrogen dominant Drospirenone Norgestimate

Gestodene Desogestrel Less oestrogen dominant Levonorgestrel group Norethisterone group Which COC? Oestrogen dominant COCs Cilest Marvelon Femodene Dianette Yasmin Progestogen dominant COCs Microgynon 30 Loestrin 30 Side effects

Oestrogenic Progestogenic Nausea Bloating

Weight gain (water retention) Vaginal discharge (no infection) Breast enlargement/tenderness Some headaches Chloasma Photosensitivity Acne Greasy hair Hirsutism Weight gain (increased appetite) Depression Loss of libido Vaginal dryness Recommendations for choosing oral contraception Woman

COC POP Symptom free, < 18 30 mcg EE + LNG DSG 30 mcg Symptom free, 18-35 30 mcg EE + LNG DSG 30 mcg Symptom free, > 35 20 mcg EE + GSD or DSG 30 mcg EE + LNG

Traditional or DSG 30 mcg Acne/hirsutism Severe 30 mcg EE + CYP None Mod 30 mcg EE + DRSP Mild 30 mcg EE + GSD or DSG or DRSP PMS/mood changes/fluid retention 30 mcg EE + DRSP extended regimen None HMB Choose age appropriate COC

as extended regimen or E2V + Dienogest None Migraine w/out aura/headaches Potential drug interactions DSG 30 mcg See CEU Guidance FSRH Nuvaring vaginal ring A flexible transparent ring of ethylene vinyl acetate with an outer diameter of 54 mm and cross-sectional diameter of 4 mm One size for all! Combined hormonal

contraceptive vaginal ring containing 2.7 mg ethinylestradiol and 11.7 mg etonorgestrel It has the lowest oestrogen content of any combined hormonal contraceptive Ingredients - Nuvaring Every 24 hours the device releases: 15 mcg EE 120 mcg ENG The hormones are absorbed into the rich supply of blood vessels within the vagina and enter the general circulation, avoiding the first-pass metabolism by the liver

Each Nuvaring is used for one monthly cycle It stay in the vagina for 3 weeks and is then removed for a 1 week ring-free interval The 7 days without Nuvaring allows for a withdrawal bleed No daily pill taking; low dose; avoids 1st pass effect; low incidence of BTB or adverse effects; latex free Evra - contraceptive patch

Daily dose 20mcg EE + 150 mcg Norelgestromin (similar to Cilest) Levels sufficient to inhibit ovulation for at least 7 days Contraindications similar to COCs Efficacy similar to triphasic COC (overall PI 1.24) Probable reduced efficacy in women > 90 Kg BTB more common in 1st 2 cycles than COC Additional contraception advised for women on enzyme inducers Additional contraception advised for women on antibiotics (except Tetracycline) SPC Suitable for women with absorption problems, who are forgetful or have difficulty swallowing pills Non contraceptive health benefits of oral contraceptives

Endometriosis; dysmenorrhoea and ovulatory pain Menorrhagia; Fe deficiency anaemia; fibroids Endometrial and ovarian cancer; colon cancer Acne; hirsutism; symptoms of PCOS Functional ovarian cysts; PID; benign breast disease; rheumatoid arthritis PMS RCGP study - women in the UK who have ever used the oral contraceptive pill are less likely to die from any cause, including all cancers and heart disease, compared with never users Reasons to stop immediately Serious neurological effects (prolonged headache,

getting worse) Partial or complete loss of vision Sudden disturbance of hearing or other perceptual disorders Dysphasia 1st epileptic seizure or weakness, motor disturbance or numbness affecting one side or part of body Sudden chest pain Sudden breathlessness

Haemoptysis Severe pain in one calf Hepatitis, jaundice, enlarged liver Severe depression BP > 100/160 Detection of a risk factor (UKMEC) Risks and Benefits Potential harms & benefits of CHC Rate per 1000 women not using in non smokers CHC RR with CHC use in non smokers RISKS Coronary artery disease 1500

V small inc risk Ischaemic stroke 100 2 fold inc risk VTE 5 3 fold inc risk with LNG, NET; 5 fold inc risk with DSG and GSD Breast cancer 1 in 9 will develop at some time Any inc risk likely to be small and to vary with age. No inc risk above

background 10 yrs after stopping Cervical cancer 11 Small inc after 5 yrs and 2 fold inc after 10 yrs Ovarian cancer 22 Halving of risk lasting for > 15 yrs Endometrial cancer 15 Halving of risk lasting for > 15 yrs

BENEFITS Risk of VTE per 200,000 wy (absolute risk) European Pharmacovigilance working party 2011 (MHRA) International working party Berlin 2009 (FSRH) Women not using COC 5-10 40-50 Women using COCs with LNG or NET 20

Women using COCs with DSG or GSD 40 90-100 Pregnant women 60 290 COCs and risk of VTE

BMI and smoking are significant risk factors Smoking doubles the risk BMI 30-35 doubles the risk BMI > 35 has a 4-6 fold increased risk BMI 30-34= UKMEC 2 BMI > 35 = UKMEC 3 Smoking age < 25 yrs UKMEC 2 Smoking age > 35 yrs UKMEC 3 (<15/day) or UKMEC 4 (> 15 day) Migraine and thrombotic stroke risk Age 20 2/100.00 Age 20+COC + migraine 10/100,000

Age 20+COC + migraine + cigarettes 60/100,000 Age 40 20/100,000 Age 40+ migraine 56/100,000 Age 20+COC + migraine 100/100,000 Qlaira COC containing estradiol valerate (E2V) and dienogest (DNG) E2V Estradiol (E2 = natural oestrogen)

DNG offers good suppression of endometrial proliferation The first and only COC to deliver E2 The first product in the UK to contain DNG Regimen 26/2 Maintain stable E2 levels, optimise cycle control, inhibit ovulation oestrogen dominant increasing progestogenic activity oestrogen only Summary - Qlaira Clinical studies of E2V/DNG demonstrate Relatively stable oestrogen levels throughout the

menstrual cycle Effective inhibition of ovulation Effective contraception Good bleeding profile shorter, lighter bleeding and fewer bleeding/spotting days compared with monophasic EE/LNG An absence of all bleeding or spotting occurred in 15.4% of cycles No discontinuations due to bleeding disorders Qlaira practical use Reduced margin for pill taking errors Uses body identical oestrogen - low dose estradiol Reduction in bleeding Now has European licence for HMB in women who also require contraception

Antiandrogenic effects Preservation of positive effects of oestrogens Only 2 days hormone-free interval probable reduction in unwanted effects compared to 21/7 formulations Missed Pill Advice - Qlaira Missed 2 or more coloured pills or forgotten to start new pack Seek advice from your HCP YES YES day 1-9 Had sex in the 7 days before forgetting? NO

Missed only 1 pill (more than 12 hours late ) day 10-17 Take missed pill Continue with pack as usual Use a barrier contraception (e.g. condoms) for the next 9 days day 18-24 Start immediately with next pack Use barrier contraception (e.g. condoms) for the next 9 days YES Check pill number on pack

day 25-28 HCP, Healthcare professional Take missed pill Continue with packet as usual No additional contraception necessary Zoely 24 active pills/ 4 placebo pills no PFI 1.5 mg estradiol (as hemi hydrate) + Nomegestrol acetate 2.5 mg (NOMAC) NOMAC has a strong affinity for progesterone receptor, strong antigonadotrophic activity, mild antiandrogenic activity Shorter/lighter WTB, higher incidence of absent WTB Acne improvement Efficacy comparable to COC (Yasmin ethinylestradiol, drospirenone) Faculty of SRH

Statement from CEU May 2013 Tailored regimens for use of combined hormonal contraception Type of regimen Suggested regimen CHC-free interval Extended use Tricycling 7 days taken after finishing 3rd packet, 3rd ring or 9th patch Shortened hormone-free interval

3 weeks of CHC use 4 days taken after each packet of pills, each ring or 3rd patch Extended with shortened interval Method used continuously until BTB occurs for 3-4 days 4 day interval Extended use with regular interval Method used continuously until BTB occurs for 3-4 days

7 day interval FSRH Clinical Guidance Combined Hormonal Contraception Oct 2011 NEW! missed pill guidelines If one pill missed (>24 hrs & up to 48 hrs late) Take the missed pill asap and continue pill taking as normal EC not usually required NEW! missed pill guidelines If 2 or more pills have been missed (> 48 hrs late) Take the most recent pill asap and continue pill-taking as normal Use condoms or abstain from SI until 7 consecutive pills have been taken EC may be required if pills missed in 1st week and UPSI occurred in PFI or in 1st week If pills missed in 2nd week EC not indicated if 7 pills have been taken consecutively

If pills are missed in week 3 omit the PFI CEU 2011 Drug interactions and hormonal contraception Additional precautions NO longer required when using nonenzyme inducing antibiotics with CHC All women on enzyme inducing drugs should be advised to use methods unaffected by those drugs Cu-IUD; IUS; Injectables CHC not recommended in women on Lamotrigine monotherapy (inc risk of seizures) UPA not recommended while using enzyme inducers or within 28 days UPA not recommended while breast feeding UPA may reduce efficacy of other hormonal contraception - so abstinence for 5 days and then additional contraception for 7 days (pill, ring, patch, implant, injectable); 9 days (Qlaira); 2 days POP Quick starting contraception!!! Criteria for excluding pregnancy: No SI since last menses Is correctly and consistently using a reliable method

Is within 7 days of onset of menses Is within 4 weeks postpartum and not breast feeding Is fully or nearly fully breast feeding, amenorrhoeic and < 6 months postpartum Conclusion - 2016 In 2016, more choice than ever before! Different combinations, doses and delivery systems may be associated with different effects Choice of hormonal contraception can be tailored based on the patients previous experience and risk profile Appropriate contraception can offer significant health benefits to women and improve QOL Appropriate counselling is vital to encourage continuation

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