Download patient group direction (pgd)

LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD)
FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE
(Depo Provera®)(DMPA) INJECTION by registered nurses
in Sexual and Reproductive Health services
Version Number 1.2
Change History
Version and
Date
Change details
1.2
New template.
Updated SPC/BNF/NICE and other references
Amendments in line with FSRH guidelines (2015)
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 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: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date: 18.5.2018
Reference Number :
Page 1 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
TABLE OF CONTENTS
CONTENTS
PAGE NUMBER
PGD for the supply and administration of
intramuscular Medroxyprogesterone Acetate (DMPA)
injection 150mg/mL
Pages
Staff Characteristics
Page
Authorisation and Signatures
12
To be added by approving
organisation
Individual authorisation to supply and administer
Medroxyprogesterone Acetate (DMPA) injection
150mg/mL using this PGD
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
1-14
To be added by approving
organisation
Expiry date:18.5.2018
Reference Number :
Page 2 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
DRUG NAME /STRENGTH/FORM: Medroxyprogesterone acetate (DMPA) injection
150mg/mL
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. older age
group, smoking, diabetes, hypertension and obesity

Hypertension with vascular disease

Current and history of ischaemic heart disease

Current and history of stroke/transient ischaemic attack

Diabetes with end organ disease
Cancers
 Current or past history of breast cancer

Benign liver tumour

Malignant liver tumour (hepatoma)
Gastro-intestinal conditions
 Severe decompensated cirrhosis
See next page
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 3 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
EXCLUSION CRITERIA
Continued from previous page
Other conditions
 Systemic Lupus Erythematosus (SLE) with positive or
unknown anti-phospholipid antibodies
CAUTIONS
(INCLUDING ANY
ACTION TO BE TAKEN)

Systemic Lupus Erythematosus (SLE) with severe
thrombocytopenia if starting DMPA

Undiagnosed abnormal vaginal bleeding

Individual wishes to see a doctor

If individual is under 13 years of age, follow local safeguarding
policy
Interacting medicines – see current BNF on interactions


Ensure emergency drugs and equipment, including adrenaline
are available for the treatment of anaphylaxis and
emergencies according to local policy

Caution in adolescence; guidance from the Medicines
Health Regulatory Authority (MHRA) states that individuals
under 18 years of age should only be offered this method of
contraception if other methods are unsuitable, due to the
potential effect on bone mineral density

Discuss with appropriate doctor/independent nurse prescriber
any medical condition or medication of which the nurse is
unsure
ACTION IF EXCLUDED



Refer to appropriate doctor/independent nurse prescriber
Discuss /offer alternative contraceptive method
Document all actions taken
ACTION IF PATIENT
DECLINES
TREATMENT

Record the refusal in the clinical record and document all
other actions
Refer to appropriate doctor/independent nurse prescriber
where required
Discuss/offer alternative contraceptive method


Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 4 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
DRUG DETAILS
NAME, FORM &
STRENGTH OF
MEDICINE
ROUTE/METHOD
Medroxyprogesterone Acetate (Depo Provera®) 150 mg in 1 mL
Injection (vial/pre-filled syringe)
Intramuscular
 Shake the syringe/vial vigorously before administration
(SPC)

Deep intramuscular injection into the gluteal (preferred) or
deltoid muscle

Do not massage the site after the administration of the
injection
LEGAL CATEGORY
Prescription Only Medicine
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
FSRH (2010) guidance on Contraceptive choices for young
people and FSRH guidance on Progestogen-only injectable
contraception (2015)- see reference section
QUANTITY
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:

1 mL injection
Expiry date:18.5.2018
Reference Number :
Page 5 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
DOSAGE/FREQUENCY

150mg in 1mL injection (vial/pre-filled syringe)

Start on day 1-5 of the menstrual cycle with no need for
additional protection

DMPA can be started at any time as quick start 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 DMPA as quick start after levonorgestrel
emergency contraception, additional contraception is
required for 7 days. If started after ulipristal acetate
emergency contraception, 14 days of additional
precautions are required. A pregnancy test is advised 21
days after UPSI in either circumstance

DMPA 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 10 weeks after
the last injection

If it is more than 14 weeks since the last DMPA and UPSI
has occurred, refer/discuss with appropriate doctor
/independent nurse prescriber
For guidance on changing from one contraceptive method to
another, and when to start after an abortion/miscarriage or post
partum, refer to the appropriate doctor/independent nurse
prescriber/FSRH guidelines on switching methods.
DURATION OF
TREATMENT
Contraceptive cover is maintained for 14 weeks after injection
and repeat doses may be given after an interval of 10-14 weeks
under this PGD, as long as no contraindication to use of DMPA
MAXIMUM OR MINIMUM
TREATMENT PERIOD
Minimum ten weeks
Maximum fourteen weeks
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 6 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
SIDE EFFECTS
Any drug may produce
unwanted or unexpected
adverse reactions.
Detection and recording of
these is of vital
importance. Patients
should be actively
encouraged to report any
suspected adverse
reaction, particularly to
black triangle medicines.
This list may not represent all reported side effects of this
medicine.
DMPA 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 current use of DMPA and
breast cancer

Weak association between cervical cancer and use of
DMPA
Refer to current Summary of Product Characteristics (SPC) of
relevant product and current British National Formulary (BNF)
for full list and further information.
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 nurse 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: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 7 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
ADVICE TO INDIVIDUAL



FOLLOW UP
Version No: 1.2
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
Advise individual about need to return for repeat injection
Remind individual about need for Human Papilloma Virus
(HPV) vaccination and regular cervical smears, where
appropriate
Individual to return to clinic if she has any concerns
Review in thirteen weeks
Review and evaluate use of the method after two years of
use
Expiry date:18.5.2018
Reference Number :
Page 8 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
RECORDS
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
The authorised registered nurse 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 or 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
 Any referral arrangements
 Any administration outside the terms of the product licence
 The consent of the individual
 If individual is under 13 years of age record action taken.
 If individual is under16 years of age document competency
using Fraser guidelines
 If individual is 16 years of age and over not competent,
record action taken
 Record the name/brand, dose of the medication, quantity
supplied and site of injection
 Record batch number and expiry date 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 supplying or administering the medicine
Expiry date:18.5.2018
Reference Number :
Page 9 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
REFERENCES

Manufacturer’s Summary of Product Characteristics
Depo-Provera 150 mg/ml Pfizer Ltd
https://www.medicines.org.uk/emc/medicine/11121 23.03.2015

Joint Formulary Committee. British National Formulary (online)
London: BMJ Group and Pharmaceutical Press
<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 (2015)
Progestogen - only Injectable Contraception
http://www.fsrh.org/pdfs/CEUGuidanceProgestogenOnlyInjectabl
es.pdf

Faculty of Sexual and Reproductive Healthcare (2010.) UK
Medical Eligibility Criteria for Contraceptive Use
http://www.fsrh.org/pages/Clinical_Guidance_1.asp

Faculty of Sexual and Reproductive Healthcare (2011) Drug
interactions with hormonal contraception
https://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormon
al.pdf

Faculty of Sexual and Reproductive Healthcare (2010)
Antiepileptic drugs and contraception: CEU statement January
2010 http://www.fsrh.org/pdfs/CEUStatementADC0110.pdf

Faculty of Sexual and Reproductive Healthcare (2013) Update
on newer antiepileptic and antiretroviral drugs and interactions
with hormonal contraceptives (CEU statement
http://www.fsrh.org/pdfs/CEUstatementUpdateNewerAntiepilepti
cAntiretroviralDrugs.pdf

Faculty of Sexual and Reproductive Healthcare (2004)
Statement on MHRA Guidance on Depo-Provera
http://www.fsrh.org/pdfs/archive/CEUstatementDepoProveraYou
ngPeople.pdf
See next page
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 10 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
Continued from previous page
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:

Faculty of Sexual and Reproductive Healthcare (2009)
Management of unscheduled bleeding in women using hormonal
contraception
http://www.fsrh.org/pdfs/UnscheduledBleedingMay09.pdf

Faculty of Sexual and Reproductive Healthcare (2010) Service
Standard for Resuscitation in Sexual Health Services
http://www.fsrh.org/pdfs/ServiceStandardsResuscitation.pdf

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 (2010)
Contraceptive choices for Young people.
http://www.fsrh.org/pdfs/ceuGuidanceYoungPeople2010.pdf
Expiry date:18.5.2018
Reference Number :
Page 11 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
STAFF CHARACTERISTICS
The named nurse
authorised to supply
and/or administer
medications under the
PGD must meet the
following criteria:
THE NURSE MUST BE AUTHORISED BY NAME, UNDER THE
CURRENT VERSION OF THIS PGD BEFORE WORKING
ACCORDING TO IT
Registration
Nurses must be registered with the Nursing and Midwifery
Council (NMC)
Education/training, qualifications and competencies
Nurses 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 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 should ensure she/he is aware of any changes to
the recommendations for the medication.

It is the responsibility of the nurse to keep up-to-date with
continuing professional development and take part in audit
of clinical records on a regular basis

The nurse 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: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 12 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
PGD DEVELOPMENT GROUP
Date PGD template comes into effect:
Review date
Expiry date:
18/05/2015
30/11/2017 or earlier in the light of significant
changes in best practice
18/05/2018
This template was peer reviewed and ratified by London Contraception and Sexual Health
PGD Working Group:
NAME/ROLE
POSITION
DATE
Independent Nurse Advisor
SRHC, Project Lead
18/05/2015
Principal Pharmacist
Medicines Information
Projects.
Guy’s and St Thomas’ NHS
Foundation Trust.
18/05/2015
Lead Medical Doctor
Dr Sarah Pillai
Lead Associate Specialist,
Contraception and Sexual
Health Service, Central
London Community
Healthcare NHS Trust
18/05/2015
Lead Pharmacist
Sandra Wolper
Associate Director for
Specialist Pharmacy Service
Hounslow and Richmond NHS
Trust
18/05/2015
Lead Contraception & Sexual Health
Nurse
Lead Nurse
Integrated Sexual Health
Barts Health NHS Trust
18/05/2015
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.
See next page
Version No: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 13 of 14
LONDON CONTRACEPTION AND SEXUAL HEALTH
PATIENT GROUP DIRECTION (PGD) TEMPLATE
(add organisational logo)
PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF
INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION
150mg/mL
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: 1.2
Approving Organisation Name:
Approval Committee Name:
Date of authorisation:
Expiry date:18.5.2018
Reference Number :
Page 14 of 14