Download 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
Date
Change details
Version 1
N/A
Version 1.1
January
2017
Amendments to text highlighted in blue
Revision in light of UKMEC 2016 guidance,
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
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 1 of 14
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
Medroxyprogesterone Acetate (MPA) injection 104mg
1-14
Staff Characteristics
12
Authorisation and Signatures
To be added by approving
organisation
Individual authorisation to supply
Medroxyprogesterone Acetate (MPA) subcutaneous
injection 104mg
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
To be added by approving
organisation
Expiry date: 10.01.2020
Reference Number :
Page 2 of 14
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
TO WHICH THIS
DIRECTION APPLIES
INCLUSION CRITERIA

Contraception

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
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 3 of 14
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
EXCLUSION CRITERIA
Continued from previous page
Other conditions
 Undiagnosed abnormal vaginal bleeding

Individual wishes to see a doctor
 Caution in adolescence; MPA may be used as first-line
CAUTIONS
(INCLUDING ANY
ACTION TO BE TAKEN)
contraception after all options have been discussed and
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



ACTION IF PATIENT
DECLINES
TREATMENT




Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Refer to appropriate doctor/independent non-medical
prescriber
Discuss/offer alternative contraceptive method
Document all actions taken
Refer to appropriate doctor/independent non-medical
prescriber
Discuss/offer alternative contraceptive method
Record the refusal in the clinical record
Document all actions taken
Expiry date: 10.01.2020
Reference Number :
Page 4 of 14
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 DETAILS
NAME, FORM &
STRENGTH OF
MEDICINE
ROUTE/METHOD
Medroxyprogesterone Acetate (Sayana Press®) 104 mg in
0.65mL Injection (pre-filled)
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
TERMS OF THE
MARKETING
AUTHORISATION
Best practice advice given by the Faculty of Sexual and
Reproductive Healthcare (FSRH) is used for guidance in this
PGD and may vary from the Summary of Product
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

Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
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.
Expiry date: 10.01.2020
Reference Number :
Page 5 of 14
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
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

DURATION OF
TREATMENT
MAXIMUM OR MINIMUM
TREATMENT PERIOD
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
For guidance on changing from one contraceptive
method to another, and when to start after an abortion or
postpartum refer to FSRH guidelines
One injection every 12-14 weeks as long as there is no
contraindication

Minimum 12 weeks

Maximum one year
Expiry date: 10.01.2020
Reference Number :
Page 6 of 14
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
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
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 7 of 14
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
ADVICE TO INDIVIDUAL







Provide a copy of the FPA leaflet on MPA
http://www.fpa.org.uk/contraception-help/contraceptiveinjections


Offer condoms and advise on safer sex practices

FOLLOW UP
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
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


Ensure individual knows what to do if her medical condition
changes in the future
Ensure individual has the contact details of the service
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
Expiry date: 10.01.2020
Reference Number :
Page 8 of 14
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
RECORDS
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
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
Expiry date: 10.01.2020
Reference Number :
Page 9 of 14
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
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/cecceu-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-medicaleligibility-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-andguidance/documents/ceustatementadc0110/
See next page
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 10 of 14
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
Continued from previous page
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:

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/cecceu-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-forresuscitation/

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-andguidance/documents/ceustatementquickstartingafterupa/

Faculty of Sexual and Reproductive Healthcare (2010)
Contraceptive choices for young people.
https://www.fsrh.org/standards-and-guidance/documents/cecceu-guidance-young-people-mar-2010/
Expiry date: 10.01.2020
Reference Number :
Page 11 of 14
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
STAFF CHARACTERISTICS
The named
nurse/midwife
authorised to supply
and/or administer
medications under the
PGD must meet the
following criteria:
THE NURSE/MIDWIFE MUST BE AUTHORISED BY NAME, UNDER
THE CURRENT VERSION OF THIS PGD BEFORE WORKING
ACCORDING TO IT
Registration
Nurses/midwives must be registered with the Nursing and
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-todate 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
Practitioners not listed are not authorised to practise under this PGD.
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 12 of 14
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
PGD DEVELOPMENT GROUP
Date PGD template comes into effect:
Review date
Expiry date:
10.01.2017
31.07.2019 or earlier in the light of significant
changes in best practice
10.01.2020
This template was peer reviewed and ratified by London Contraception and Sexual Health
PGD Working Group:
NAME/ROLE
POSITION
DATE
Independent Nurse Advisor
Project Lead
10.01.2017
Principal Pharmacist
Medicines Information
Projects.
Guy’s and St Thomas’ NHS
Foundation Trust.
10.01.2017
Lead Medical Doctor
Dr Sarah Pillai
Lead Associate Specialist,
Contraception and Sexual
Health Service, Central
London Community
Healthcare NHS Trust
10.01.2017
Lead Pharmacist
Sandra Wolper
Associate Director for
Specialist Pharmacy Service
Hounslow and Richmond NHS
Trust
10.01.2017
Lead Contraception & Sexual Health
Nurse
Lead Nurse
Integrated Sexual Health
Barts Health NHS Trust
10.01.2017
Kathy French
Chair - Working Group
Angela Bussey
Advisor - Working Group
Sandra Bennett
The PGD template is not legally valid until it has had the relevant organisational
approval.
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 13 of 14
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
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
organisation
Signature
Date
Senior doctor
Senior pharmacist
Senior representative of
professional group using
the PGD e.g. Lead
Contraception /Sexual
Health Nurse
Person signing on behalf of
authorising body
e.g. Director of Public
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.
Version No: 1.1
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 10.01.2020
Reference Number :
Page 14 of 14