Patient Group Direction (Pgd)

LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo)

PATIENT GROUP DIRECTION (PGD) TO SUPPLY FOR INDIVIDUALS TO SELF-ADMINISTER SUBCUTANEOUS MEDROXYPROGESTERONE ACETATE (SAYANA PRESS®) (MPA) INJECTION BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES

Version1.1

Change History

Version and Change details Date Version 1 N/A Version 1.1 Amendments to text highlighted in blue January Revision in light of UKMEC 2016 guidance, 2017 Updated Summary of Product Characteristics (SPC) references To include registered midwives and non-medical prescribers Minor editorial changes

Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD.

This Patient Group Direction (PGD) must only be used by registered nurses/midwives who have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used.

Version No: 1.1 Expiry date: 10.01.2020 Approving Organisation Name:

Approval Committee Name: Reference Number : Date of authorisation: Page 1 of 15 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) TO SUPPLY FOR INDIVIDUALS TO SELF ADMINISTER SUBCUTANEOUS MEDROXYPROGESTERONE ACETATE (Sayana Press®) (MPA) INJECTION 104mg/0.65mL

TABLE OF CONTENTS

CONTENTS PAGE NUMBER

PGD for the supply of subcutaneous 1-14 Medroxyprogesterone Acetate (MPA) injection 104mg

Staff Characteristics 12

Authorisation and Signatures To be added by approving organisation

Individual authorisation to supply Medroxyprogesterone Acetate (MPA) subcutaneous To be added by approving injection 104mg organisation

Approval Committee Name: Reference Number : Date of authorisation: Page 2 of 15

LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) TO SUPPLY FOR INDIVIDUALS TO SELF ADMINISTER SUBCUTANEOUS MEDROXYPROGESTERONE ACETATE (Sayana Press®) (MPA) INJECTION 104mg/0.65mL

DRUG NAME /STRENGTH/FORM: Medroxyprogesterone acetate subcutaneous injection 104mg/0.65mL

CLINICAL CONDITION  Contraception TO WHICH THIS DIRECTION APPLIES INCLUSION CRITERIA  Any individual (menarche to 50 years of age) presenting for contraception and who has no contraindications

EXCLUSION CRITERIA Personal Characteristics & Reproductive History  Known or suspected pregnancy

 Known hypersensitivity to any constituent of the injection

 Individuals under 16 years of age and assessed as not competent using Fraser guidelines

 Individuals 16 years of age and over and assessed as not competent to consent using local safeguarding guidelines

Cardiovascular Disease  Multiple risk factors for cardiovascular disease e.g. smoking, diabetes, hypertension, obesity and dyslipidaemias

 Hypertension with vascular disease

 Current and history of ischaemic heart disease

 Current and history of stroke/transient ischaemic attack

Cancers  Current or past history of breast cancer

 Malignant liver tumour (hepatocellular carcinoma)

Gastro-intestinal conditions

 Severe decompensated cirrhosis

 Benign liver tumour (hepatocellular adenoma)

See next page

EXCLUSION CRITERIA Continued from previous page

Other conditions  Undiagnosed abnormal vaginal bleeding

 Individual wishes to see a doctor

CAUTIONS  Caution in adolescence; MPA may be used as first-line (INCLUDING ANY contraception after all options have been discussed and ACTION TO BE TAKEN) considered unsuitable or unacceptable due to possible effects on bone mineral density

 If individual is under 13 years of age, follow local safeguarding policy

 Interacting medicines – see current BNF on interactions

 Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication of which the nurse/midwife is unsure

ACTION IF EXCLUDED  Refer to appropriate doctor/independent non-medical prescriber  Discuss/offer alternative contraceptive method  Document all actions taken

ACTION IF PATIENT  Refer to appropriate doctor/independent non-medical DECLINES prescriber TREATMENT  Discuss/offer alternative contraceptive method  Record the refusal in the clinical record  Document all actions taken

DRUG DETAILS

NAME, FORM & Medroxyprogesterone Acetate (Sayana Press®) 104 mg in STRENGTH OF 0.65mL Injection (pre-filled) MEDICINE ROUTE/METHOD Subcutaneous The nurse/midwife should advise the individual to follow the manufacturer’s instructions and specifically:

 Shake the syringe/vial vigorously before administration

 Ensure that the full injection is given, the medication should be injected slowly over approximately 5-7seconds with the needle pointing downwards.

 Inject into the upper anterior thigh or the anterior abdomen, avoiding bony areas or the umbilicus.

 Do not massage the site after the administration of the injection

LEGAL CATEGORY Prescription Only Medicine (POM)

USE OUTSIDE THE Best practice advice given by the Faculty of Sexual and TERMS OF THE Reproductive Healthcare (FSRH) is used for guidance in this MARKETING PGD and may vary from the Summary of Product AUTHORISATION Characteristics (SPC)

This PGD includes unlicensed use by extending the window for administration as follows:

 Supply and administration at 10 weeks

 Supply and administration to 14 weeks

 Supply and administration after five days post partum if not breast feeding

 Supply and administration before six weeks post partum if breast feeding

 For guidance on changing from one contraceptive method to another, and when to start after an abortion or postpartum, refer to FSRH guidelines on switching

methods.

QUANTITY  1-4 pre-filled 0.65 mL injections

DOSAGE/FREQUENCY  104mg in 0.65mL injection (pre-filled injection)

 Start on day 1-5 of the menstrual cycle with no need for additional protection

 MPA can be started at any time after day 5 if it is reasonably certain that the individual is not pregnant. Additional contraception is then required for 7 days after starting

 Starting the MPA after levonorgestrel emergency contraception, additional contraception is required for 7 days

 After the use of ulipristal acetate (UPA), it is recommended that hormonal contraception should not be used for five days, then started/restarted. Extra precautions should then be used for a further 7 days

 A pregnancy test is advised three weeks after any oral emergency contraception- See FSRH statement on UPA Oct 2015

 MPA should be repeated 13 weeks after the last injection. A repeat injection can be given up to 14 weeks after the previous dose with no additional contraceptive precautions

 If required it may be repeated as early as 12 weeks after the last injection

 If the interval from the preceding injection is greater than 14 weeks (13 weeks plus 7 days) for any reason, and unprotected sexual intercourse (UPSI) has occurred, refer to appropriate doctor/independent non-medical prescriber

 For guidance on changing from one contraceptive method to another, and when to start after an abortion or postpartum refer to FSRH guidelines

DURATION OF One injection every 12-14 weeks as long as there is no TREATMENT contraindication

MAXIMUM OR MINIMUM  Minimum 12 weeks Version No: 1.1 Expiry date: 10.01.2020 Approving Organisation Name:

TREATMENT PERIOD

 Maximum one year

SIDE EFFECTS Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information.

This list may not represent all reported side effects of this medicine.

MPA is well tolerated.

Common side effects  Headache  Disturbance of bleeding patterns  Changes in mood  Weight change  Loss of libido  Delay in return to fertility after stopping the medication  Association with a small loss of bone mineral density which is recovered after discontinuation of the injection  Possible weak association between current use of MPA and breast cancer  Weak association between cervical cancer and use of MPA In the event of untoward or unexpected adverse reactions:  If necessary seek appropriate emergency advice and assistance  Document in the individual’s clinical record and inform appropriate doctor/independent non-medical prescriber  Complete incident procedure if adverse reaction is severe (refer to local organisational policy)  Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA). Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at www.yellowcard.mhra.gov.uk. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. Version No: 1.1 Expiry date: 10.01.2020 Approving Organisation Name:

ADVICE TO INDIVIDUAL  Provide Manufacturer’s Patient Information Leaflet (PIL) Explain mode of action, side effects, and benefits of the medicine  Remind individual about need for Human Papilloma Virus (HPV) vaccination and regular cervical smears, where appropriate  Teach individual how to self-administer according to manufacturer’s instructions  Advise individual on safe disposal of sharps according to local policy  Advise individual about need to return for repeat injection if she experiences any difficulty with administration  Women should be re-evaluated periodically as clinically appropriate at least every year to determine if Sayana Press® is still the best option for them  Provide a copy of the FPA leaflet on MPA http://www.fpa.org.uk/contraception-help/contraceptive- injections  Offer condoms and advise on safer sex practices  Ensure individual knows what to do if her medical condition changes in the future  Ensure individual has the contact details of the service

FOLLOW UP  Individual to return to clinic if she has any concerns  Individuals to be re-evaluated at least yearly to determine if Sayana Press is still the best option for them

RECORDS The authorised registered nurse/midwife must ensure the following is documented in the clinical record:  Individual’s name, address and date of birth  GP contact details where appropriate  Attendance date  Reason for attendance  Relevant past and present medical and family history, including drug history  Any known allergy  Relevant examination findings (where appropriate)  Inclusion or exclusion from PGD  A statement that supply and self administration is by using a PGD  Advice given about the medication including side effects, benefits, and when and what to do if any concerns  Details of any adverse drug reactions and what action taken  Record demonstration of how to administer the injection  Any referral arrangements  Any supply outside the terms of the product marketing authorisation  The consent of the individual  If individual is under 13 years of age record action taken.  If individual is under 16 years of age document competency using Fraser guidelines  If individual is 16 years of age and over and not competent, record action taken  Record the name/brand, dose of the medication, quantity supplied  Record batch number and expiry date of medicines supplied according to local policy or national guidelines  Record follow up and/or signposting arrangements  Any other relevant information that was provided to the individual  Name and signature (which may be an electronic signature) of the nurse/midwife supplying the medicine

REFERENCES All references and links correct at time of publication.  Manufacturer’s Summary of Product Characteristics Sayana Press® 104 mg/0.65mL Pfizer Ltd date of last revision July 2016 accessed 20.10.2016 https://www.medicines.org.uk/emc/medicine/27798

 Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press date accessed 03.11.16 http://www.medicinescomplete.com

 National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2 http://www.nice.org.uk/guidance/MPG2

 Faculty of Sexual and Reproductive Healthcare (2013) New Product Review from Clinical Effectiveness Unit. Subcutaneous Depot Medroxyprogesterone Acetate (Sayana Press®) https://www.fsrh.org/standards-and-guidance/documents/cec- ceu-newproductreview-sayana-press-jun-2013/

 Faculty of Sexual and Reproductive Healthcare (2015) Progestogen - only Injectable Contraception http://www.fsrh.org/pdfs/CEUGuidanceProgestogenOnlyInjectabl es.pdf

 Faculty of Sexual and Reproductive Healthcare (2016) UK Medical Eligibility Criteria for Contraceptive Use https://www.fsrh.org/standards-and-guidance/uk-medical- eligibility-criteria-for-contraceptive-use/

 Faculty of Sexual and Reproductive Healthcare (2012) Drug interactions with hormonal contraception http://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormona l.pdf

 Faculty of Sexual and Reproductive Healthcare (2010) Antiepileptic drugs and contraception: CEU statement https://www.fsrh.org/standards-and- guidance/documents/ceustatementadc0110/

See next page Continued from previous page  Faculty of Sexual and Reproductive Healthcare (2013) Update on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives (CEU statement https://www.fsrh.org/standards-and-guidance/documents/cec- ceu-statement-new-art-antiepileptic-interactions-2013/

 Faculty of Sexual and Reproductive Healthcare (2015) Management of problematic bleeding with hormonal contraception http://www.fsrh.org/pdfs/CEUGuidanceProblematicBleedingHor monalContraception.pdf

 Faculty of Sexual and Reproductive Healthcare (2016) Service Standard for Resuscitation in Sexual Health Services https://www.fsrh.org/news/updated-service-standards-for- resuscitation/

 Faculty of Sexual and Reproductive Healthcare (2010) CEU: Quick starting contraception http://www.fsrh.org/pdfs/CEUGuidanceQuickStartingContracepti on.pdf

 Faculty of Sexual and Reproductive Healthcare (2015) CEU Statement: Quick-starting hormonal contraception after use of ulipristal acetate https://www.fsrh.org/standards-and- guidance/documents/ceustatementquickstartingafterupa/

 Faculty of Sexual and Reproductive Healthcare (2010) Contraceptive choices for young people. https://www.fsrh.org/standards-and-guidance/documents/cec- ceu-guidance-young-people-mar-2010/

STAFF CHARACTERISTICS The named THE NURSE/MIDWIFE MUST BE AUTHORISED BY NAME, UNDER nurse/midwife THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT authorised to supply and/or administer medications under the Registration PGD must meet the Nurses/midwives must be registered with the Nursing and following criteria: Midwifery Council (NMC)

Education/training, qualifications and competencies Nurses/midwives must satisfy the following criteria:  Qualification in contraception/sexual health (university modules/FSRH). Note- an introduction to contraception is not sufficient  Has had training in the use of PGDs  Has had training which enables the nurse/midwife to make a clinical assessment in order to establish the contraceptive need and supply the medication according to this PGD.  Has undertaken the competency training appropriate to this PGD.  Is competent in the assessment of individuals using Fraser guidelines  Has undergone regular training and updating in safeguarding children and vulnerable adults  Has undergone regular updating in basic life support and anaphylaxis Maintenance of competencies  The nurse/midwife should ensure she/he is aware of any changes to the recommendations for the medication.  It is the responsibility of the nurse/midwife to keep up-to- date with continuing professional development and take part in audit of clinical records on a regular basis  The nurse/midwife should be familiar with current FSRH guidelines on progestogen-only injectable contraception

An up to date list and signatures of registered practitioners who are authorised to practise under this PGD is kept in by Version No: 1.1 Expiry date: 10.01.2020 Approving Organisation Name:

Practitioners not listed are not authorised to practise under this PGD.

PGD DEVELOPMENT GROUP

Date PGD template comes into effect: 10.01.2017 Review date 31.07.2019 or earlier in the light of significant changes in best practice Expiry date: 10.01.2020

This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group:

NAME/ROLE POSITION DATE

Kathy French Independent Nurse Advisor 10.01.2017 Project Lead Chair - Working Group

Angela Bussey Principal Pharmacist 10.01.2017 Medicines Information Advisor - Working Group Projects. Guy’s and St Thomas’ NHS Foundation Trust. Lead Medical Doctor Lead Associate Specialist, 10.01.2017 Dr Sarah Pillai Contraception and Sexual Health Service, Central London Community Healthcare NHS Trust Lead Pharmacist Associate Director for 10.01.2017 Sandra Wolper Specialist Pharmacy Service Hounslow and Richmond NHS Trust

Lead Contraception & Sexual Health Lead Nurse 10.01.2017 Nurse Integrated Sexual Health Sandra Bennett Barts Health NHS Trust

The PGD template is not legally valid until it has had the relevant organisational approval.

ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS

The PGD is not legally valid until it has had the relevant organisational authorisations. To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the authorising organisation. Complete details below or use format agreed according to local policy.

Name Job title and Signature Date organisation Senior doctor Senior pharmacist Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse Person signing on behalf of e.g. Director of Public authorising body Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust.

It is the responsibility of the authorising organisation to ensure that all legal and governance requirements are met.

To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement.

PGDs do not remove inherent professional obligations or accountability. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD.

ORGANISATIONS MAY ALSO ADD:  Local training and competency assessment documentation.  Other supporting local guidance or information.  Links to local PGD Policy and other supporting guidance.