Progestogen only Contraception

Transcription

1 Progestogen only Contraception Public Health Commissioned Service delivered by Community Pharmacies Jo Sutton Senior Commissioning Manager Long Term Care, Health and Treatment, Cheshire East Council Dr Sue Walsh and Dr Jo Dennis (SRH clinical leads) East Cheshire NHS Trust

2 Quick Start Contraception Training Event 1. Introduction/Scene set (Jo Sutton) 2. Service information (Jo Sutton) 3. Progestogen Only Contraception/PGD Training (Dr Sue Walsh)

3 Introduction Local Authority commissioned service Pharmacy has vital role in local delivery of accessible services Expansion of suite of sexual health services into community pharmacy setting Building on EHC, C Card, now Quick Start and chlamydia screening Proof already across wide footprint that pharmacies can deliver these services in high quality, consistent fashion Commissioned April 2016 with initial contract expiry date April 2019 (option for two annual extensions)

4 Sexual Health provision in Community Pharmacies EHC 15 pharmacies 54 branches Quick Start Contraception 12 pharmacies 51 branches Chlamydia postal kits year olds 7 pharmacies 28 branches Chlamydia treatment (15 24) 4 pharmacies 21 branches

5 Sexual Health services Fees Emergency Hormonal Contraception Consultation 15 One pack of Levonorgestrel Drug Tariff price plus VAT One pack of Ulipsitral Acetate Drug Tariff price plus VAT Pregnancy test (if clinically indicated) 5 Quick Start Contraception Consultation 15 Per starter pack provided Drug Tariff price plus VAT Chlamydia screening for 15 to 24 year olds Postal testing kit given to 15 to 24 year old 2 per kit Chlamydia treatment consultation (15 to 24) 10 Chlamydia treatment (15 to 24) Drug tariff prices plus VAT

6 Service Requirements Quick Start contraception and chlamydia kit (if contracted) offered following EHC consultation in accordance with PGD Private consultation room Training Safeguarding, Contraception e.g. cppe, NICE Competencies for Healthcare Professionals delivering under PGD, CPD evidenced by DOC PGD signed by each Pharmacist working under PGD (including locums) Record keeping in line with prevailing guidelines Pharmoutcomes template Fraser Guidelines Under 16s

7 POP background Safe, effective (>99% used correctly) hormonal method Few contraindications Some non hormonal benefits Main side effect bleeding irregularities Can be used until age 55yrs

8 Formulation Levornorgestrel 30mcg (Norgeston) Norethisterone 350mcg (Micronor, Noriday) Desogestrel 75 mcg (Cerazette, Cerelle, Zelleta)

9 POP mode of action Increased viscosity cervical mucous Impaired tubal action Thinned endometrium Anovulation with Desogestrel (97%)

10 Risks/Non Contraceptive benefits Breast Cancer risk CVD risk no increase with POP Overall risk of pregnancy reduced but in those that do occur 1:10 risk of ectopic (<1%) Persistent ovarian follicles/cysts Benefit : Alleviate dysmenorrhoea

11 POP side effects Irregular bleeding: common in first 3 months and decreasing with use. After 12 months 50% amenorrhoea or infrequent 50% regular/frequent/prolonged?mood/?libido no evidence of causal relationship

12 POP regime Daily, regular regime, no break Timing important, within 3 hours except desogestrel which is 12 hours Additional precautions 48 hrs if vomiting within 2 hrs taking

13 Efficacy >99 % effective when used consistently 1.55 per 100 woman years /0.41 DSG Enzyme inducing (P45o cytochrome) effects Eg anticonvulsants, need extra precautions and for 28 days after or preferably switch method

14 Missed pills

15 Who for? Medical exclusions Contraindications: UK medical eligibility criteria Hypersensitivity to any of the components of the progestogen only oral contraceptive preparation. Pregnancy or suspected pregnancy. Current or history of ischaemic heart disease or cerebrovascular disease/stroke including transient ischemic attack (TIA). NB UKMEC for additional advice/support

16 Exclusions Past or current history of breast/genital carcinoma. Known or suspected progestogen dependent tumours Any condition that may be affected by the hormones within the POP. Severe liver disease or hepatic cell tumours (Note: Hepatitis is rated 1 in UKMEC 2016). Porphyria.

17 Exclusions: Drug interactions Anyone taking drugs/medications (including prescription, over the counter preparations, herbal, recreational drugs and dietary supplements) that may interact with the progestogen only pill including: Aprepitant, atazanavir, barbiturates, boceprevir, bosentan, carbamazepine, ciclosporin, crizotinib, dabrafenib, efavirenz, elvitegravir, eslicarbazepine, griseofulvin, lamotrigine, nelfinavir, nevirapine, oral anticoagulants, orlistat, oxcarbazepine, perampanel, phenytoin, primidone, rifabutin and rifampicin (rifamycins), ritonavir, rufinamide, selegiline, St John s Wort (Hypericum perforatum), sugammadex, terbinafine, tizanidine, topiramate, ulipristal, vemurafenib, voriconazole.

18 Quick starting Faculty CEU supports POP after EC if woman likely to continue to be at risk of pregnancy or unlikely to return PT after 3 weeks after last UPSI Extra precautions 48 hrs after LNG, 9 days after UPA

19 POP PGD:Learning Objectives Be familiar with the content of the local PGD Be able to gather and interpret relevant information as required by the PGD to then give appropriate advice Be clear about medico legal issues involved in providing POP via a PGD Be competent to provide POP appropriately via a PGD Be competent to refer clients where necessary

20 PGDs A PGD is a written instructions for the supply or administration of medicines to groups of patients who may not be individually identified before presentation for treatment Supply and administration of medicines under PGD should be reserved for those limited situations where this offers an advantage for patient care (without compromising patient safety) Consistent with appropriate professional relationships and accountability.

21 PGD for POP Clinical indication Patient group for inclusion Contraindications Exclusion criteria Cautions / Special considerations (eg, drug interactions) Action to be taken if woman is excluded from the PGD Action if woman declines treatment after initial counselling Legal status & brand names Route, dose and repeated dose instruction Adverse effects Patient information & advice Record keeping

22 Inclusions Prevention of pregnancy in females of child bearing age, who are aged 13 years or over. Informed consent obtained. Suitability assessed by taking/updating history Quick start issue in women attending for Emergency Contraception who request ongoing contraception and following discussion choose to use the POP Note: Woman must understand the method of contraception, missed pills routine, be aware of emergency contraception and how to obtain it, and aware of the possible need for condom use and possible side effects of the product.

23 Who is able to be treated. o Under 16 year olds are included provided they meet the criteria of the Fraser Guidelines on consent to medical treatment. A risk assessment should be undertaken to ensure the child is not at risk of harm. If a risk is identified, a referral to social services should be made o In addition, if patient is under 13 years of age a referral to social services should be made in line with the Child Protection Procedures of the Commissioning Organisation

24 Ectopic pregnancy/cysts Although symptoms of ectopic pregnancy should be watched for history of ectopic pregnancy need not be considered a contraindication to use of this contraceptive method. Vaginal bleeding and abdominal pain are typical symptoms of an ectopic pregnancy. Women reporting these symptoms should be evaluated. Norgeston SPC states that if there is a history of ectopic pregnancy or one fallopian tube is missing the use of Norgeston should be carefully considered. Norgeston SPC states that persistent functional ovarian cysts may occur, most are asymptomatic and resolve spontaneously although may cause pelvic pain or dyspareunia.

25 Action if excluded/declines Pathway Refer if appropriate Document findings and action taken in patient s record Advise patient of possible consequences of declining treatment and of alternative sources of treatment Document decline and advice given in patient s record Offer alternative treatment where appropriate and inform referrer.

26 Brand names/formulas, doses Norethisterone 350micrograms tablets Micronor /Noriday 28 tablet pack Levonorgestrel 30micrograms tablets Norgeston 35 tablet pack Desogestrel 75micrograms tablets Cerazette / Cerelle /Zelleta /Aizea 28 tablet pack

27 Patient information One tablet daily every day without a break, within 3 hours (12 hours for Cerazette, Cerelle, Zelleta, Aizea ) at the same time each day. Every day preparations. Commence the next pack the day after finishing the first pack. Missed pill chart as earlier

28 Advice to patient (1) Explain treatment and course of action Discuss side effects and administration The woman must seek medical advice if they experience any hypersensitivity reaction Potential health risks and benefits of the method Drug interactions always check with prescriber or pharmacist. An alternative contraceptive method is recommended during and for at least 4 weeks after treatment with an enzyme inducing drug

29 Advice to patient (2) Additional contraceptive precautions are not required during or after courses of antibiotics that do not induce liver enzymes. Vomiting or diarrhoea additional precautions for duration of illness and 48 hours following should be observed If any adverse symptoms occur advise woman to seek medical advice that day Ensure the manufacturers patient information leaflet (PIL) is in the box prior to issue

30 Advice to patient (3) Barrier protection to protect against sexually transmitted infections if appropriate If cervical cytology is due advise to make an appointment with appropriate practitioner Diet and exercise advice for BMI outside of normal range if applicable Current Family Planning Association (FPA) leaflets on POP and Emergency Contraception to be discussed and given to woman.

31 Record keeping (1) Record that valid informed consent was given Name of patient, address, date of birth, current contact number and GP Past and present medical history including medicine history and any allergies Signature, / e signature designation and printed name of member of staff who supplied the medicine Date of issue Name of medicine and dose, strength form and quantity supplied Manufacturer of medicine / brand, batch number and expiry date Advice given both verbal and written Advice given for interacting medicines, conditions and side effects Advice given if excluded or declines treatment Record how the patient s central record or GP surgery record will be updated (where the woman gives permission)

32 Record keeping (2) Any leaflet supplied Any use outside Product Licence Special instructions (e.g. if additional contraception is required for a specific period of time) Fraser rule competence document if under 16 years of age or record valid parent/guardian consent Clinic contact details issued for follow up All records should be clear, legible and contemporaneous. The information should be recorded in the patient record as per local documentation requirements. A computer or manual record of all individuals receiving treatment under this PGD should also be kept for audit purposes

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