Contraception Update: what s new in 2016? Felicity Young MA BSc (Hons) RMN RGN RM NDFSRH A08 Consultant Nurse for Sexual and Reproductive Healthcare

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1 Contraception Update: what s new in 2016? Felicity Young MA BSc (Hons) RMN RGN RM NDFSRH A08 Consultant Nurse for Sexual and Reproductive Healthcare

2 Declaration of Competing Interests I have not received a fee for this talk today I have not received fees for consulting I have not received research funding I have not been employed by a pharma company I do not hold stocks or shares in any company which might be affected by my talk today I have not received funds reimbursing me for attending a related symposia, or talk

3 Learning Aims Introduction to UKMEC 2016 What s changed? Updates on current methods and choices How can we improve contraception advice and provision? Quick Starting Extended Regimens Exciting new methods in the pipeline! Your questions answered

4 What s the connection?

5 The Ideal Contraceptive Method The one that the person wants Method that works well Minimal negative effects Non-contraceptive benefits Does not interfere with sex Easy to use, minimal person participation Not too expensive

6 Contraceptive Options LARCs Etonogestrel implant Progestogen-only injections Levonorgestrel intrauterine systems Copper intrauterine devices Other methods Natural methods Male & female condoms Diaphragm/Cap Spermicides Oral contraceptives Combined oral contraceptive (COC) Progestogen-only pill (POP) Other combined methods Contraceptive patch Vaginal ring Permanent methods Male & female sterilisation

7 UK MEC 2016

8 Major Changes to UKMEC16 Change of format: LARC, medium, short-term method Removal of split categories Barrier methods, fertility awareness and sterilisation removed (see FSRH method-specific guidelines) Ulipristal acetate included in EHC Malaria, Raynaud s and schistosomiasis removed Obesity, organ transplant, long Q-T syndrome, rheumatoid arthritis included

9 What it does NOT do Does not replace clinical judgement, knowledge and skills Does not recommend or suggest a best method Does not replace a woman s choice Does not describe efficacy Does not provide advice about using method for noncontraceptive uses (e.g. bleeding control)

10 UKMEC16 Categories

11 Quick Starting what are you waiting for? With no current contraception and no risk of pregnancy Following emergency contraception With no current contraception and a risk of pregnancy Consider a bridging method FSRH Switching or Starting Methods of Contraception July 2016 Replaces FSRH Clinical Guidance Quick Starting Contraception 2010 FSRH Quick Starting after UPA September 2015

12 Reasonably certain? No intercourse since normal LMP Correct and consistent use of reliable method of contraception 7 days of LMP 4 weeks postpartum 7 days post-abortion or miscarriage LAM breastfeeding AND - negative pregnancy test AND - asymptomatic

13 Fixed Extended Regimens Seasonique 91 days Seasonale 84 days Lybrel days Available in USA Effective Increased risk of breakthrough bleeding Safety profiles similar to conventional regimens

14 Flexible Extended Regimens - CHC COCP, patch or ring Use continuously >21 days Until BTB for >3 days Then take 4-7 day break

15 Analysis of bleeding/spotting days in the comparative phase with ethinylestradiol 20 μg/drospirenone 3 mg administered as (a) flexiblemib, (b) conventional 28-day and (c) fixed extended regimens (full analysis set) Klipping C et al. J Fam Plann Reprod Health Care 2012;38:73-83 Copyright by the Faculty of Sexual & Reproductive Healthcare of the Royal College of Obstetricians & Gynaecologists. All rights

16 Analysis of cycle length with ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexible management of intracyclical (breakthrough) bleeding (MIB) regimen Klipping C et al. J Fam Plann Reprod Health Care 2012;38:73-83 Copyright by the Faculty of Sexual & Reproductive Healthcare of the Royal College of Obstetricians & Gynaecologists. All rights

17 Sayana Press 104mg/0.65ml medroxyprogesterone acetate Self administered Subcutaneous injection 13 weeks +/- 1 week Annual review in clinic

18 What s in the pipeline? Lisvy Estelle Nesterone gel and ring Intrauterine ball - IUB Ment LNG + tenofovir Microchip

19 Lisvy Transdermal patch Clear Gestodene 60mcg/24 hours Ethinylestradiol 13mcg/24 hours

20 Estetra or Estelle Estretol (E4) Oestrogen produced by the fetal liver 3 rd phase trials with drosperinone Other uses for HRT Better tolerated Neutral effect on liver

21 Nesterone - segesterone acetate Long-acting vaginal ring Used in combination with EE Inserted for 21 days Removed for 7 days 1 ring last a year Refrigeration not required Phase 3 trials in US Transdermal gel Used in combination with estradiol Non-androgenic Better tolerated Fewer side effects Discrete Phase 2 trials in Chile

22 LNG and TFV Vaginal Ring Levonorgestrel 20mcg/24 hours Tenofovir 10mg/24 hours Contraceptive Reduce HIV transmission Reduce HSV transmission Under the woman s control Very early stages of development

23 Intrauterine ball Ocon Copper pearls on memory alloy 3 sizes 5 years duration Thread for removal More acceptable shape Reduced risk of perforation, expulsion and malposition

24 Ment Subdermal implant for men 7α-methyl-19- nortestosterone May be used with DMPA 1 year Suppress/inhibit sperm cell development Does not reduce libido Proof of concept stage

25 Contraceptive Microchip Levonorgestrel 30mcg/24 hours Implant in arm, buttocks or abdomen Switched on and off by the woman: no clinic visits Lasts up to 16 years Pre-clinical trials in US

26 Prescribing off-licence (label) sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy make a clear, accurate, legible record of all medicines prescribed where you are not following common practice, document your reasons for prescribing the medicine. General Medical Council Good Practice in Prescribing Medicines (2008)

27 Current and Common Practice It may not be necessary for clinicians to document every occasion when a contraceptive preparation is prescribed outside the product licence if such use falls within current guidance issued by the Faculty s Clinical Effectiveness Unit (CEU), the Royal College of Obstetricians and Gynaecologists (RCOG) and the National Institute for Health and Clinical Excellence (NICE); these should be regarded as common practice.

28 Nurse Prescribers The Nursing and Midwifery Council (NMC) advises RN or RM independent prescribers may prescribe off-label if they are satisfied that: this better serves the patient s/client s needs, if there is sufficient evidence-base and that they have explained to the patient/client the reasons why medicines are not licensed for their proposed use, and document accordingly. The NMC also states it is acceptable for medicines used outside the terms of the licence to be included in Patient Group Directions (PGDs) when such use is justified by current best clinical practice and the direction clearly describes the status of the product.

29 Any questions?

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