PHE publications gateway number: 2015271
PATIENT GROUP DIRECTION (PGD)
Supply and administration of live attenuated influenza vaccine nasal spray suspension
(Fluenz Tetra®▼or FluMist® Quadrivalent) OR supply only in well-defined local
circumstances.
Children and adolescents aged 2–17 years in accordance with the national flu
immunisation programme
For the supply and administration, or supply only, of live attenuated influenza vaccine (LAIV)
nasal spray suspension (Fluenz Tetra®▼or FluMist® Quadrivalent) by currently registered
nurses, pharmacists or paramedics to children and adolescents aged 2–17 years in
accordance with the national flu immunisation programme for active immunisation against
influenza.
Reference no:
Version no:
Valid from:
Review date:
Expiry date:
LAIV PGD
v03.00
20 October 2015
31 March 2016
31 August 2016
Public Health England has developed this PGD for local authorisation by NHS
England to facilitate delivery of the national immunisation programme.
Those using this PGD must ensure that it is formally authorised and signed by a clinical
governance or patient safety lead, who has designated responsibility for signing PGDs on
behalf of the commissioning NHS England sub-region, so that this document meets legal
requirements for a PGD. THE PGD IS NOT LEGAL OR VALID WITHOUT THIS LOCAL,
FORMAL AUTHORISATION.
Authorising organisations must not alter or amend the body of this document; such action will
invalidate the clinical sign-off with which it is provided.
Operation of this PGD is the responsibility of commissioners and service providers.
THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT
VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT.
Practitioners and organisations must check that they are using the current version of the
PGD. Amendments may become necessary prior to the published expiry date. Current
versions of PHE PGD templates for local authorisation can be found from:
https://www.gov.uk/government/collections/immunisation
Any concerns regarding the content of this PGD should be addressed to:
Immunisation@phe.gov.uk
LAIV PGD v03.00 Valid from: 20/10/2015 Expiry: 31/08/2016
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Change History
Version number
Final version
Final version –
revised
9 September 2013
Version 02.00
Version 03.00
Change details
New PHE Fluenz PGD
Dose Section: Second dose amended from 0.1ml to 0.2ml
Date
1 September 2013
9 September 2013
PHE Fluenz PGD transferred to new PHE PGD template
 Updated for 2015/16 flu programme cohorts
 Included supply only, for subsequent administration
outside the PGD
 Included concomitant administration with other live
vaccines following updated JCVI advice
 Egg allergic children exclusion amended following
updated JCVI advice
 Individuals with asthma requiring systemic or high dose
inhaled corticosteroids excluded following updated JCVI
advice
 Included registered nurse, pharmacist and paramedic
professionals
PHE Fluenz PGD amended to include FluMist®
Quadrivalent presentation and renamed LAIV PGD.
Further information added to section “Written information
to be given to patient or carer” and “Records”
Note: FluMist® Quadrivalent is produced by the same
manufacturer as Fluenz Tetra®▼ and is an identical
product. The MHRA has temporarily allowed the UK
supply of live attenuated influenza vaccine as a licensed
product in FluMist® Quadrivalent packaging.
11 August 2015
20 October 2015
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1. PGD Template Development
This PGD template has been developed by the following on behalf of Public Health England:
Developed by:
Name
Pharmacist
(Lead Author)
Elizabeth Graham
Lead Pharmacist Immunisation
Services, PHE
Signature
Date
20/10/2015
Mary Ramsay
Doctor
Registered Nurse
Consultant Epidemiologist and Head
Immunisation, Hepatitis & Blood
Safety Department, PHE
David Green
Nurse Consultant – Immunisations,
PHE
20/10/2015
20/10/2015
This PGD template has been peer reviewed by the PHE Immunisations PGD Expert Panel in
accordance with PHE Policy for PGD Templates. It has been ratified by PHE Medicines
Management Group and PHE Clinical Governance Group.
Acknowledgements
Name
Dr Richard Pebody
Dr Max Kammerling
Jacqueline Lamberty
Gill Marsh
Lesley McFarlane
Sue Mulvenna
Graham Munslow
Jan MacDonald
Designation
Consultant Medical Epidemiologist, Head of Influenza Surveillance
and Acting Head of Respiratory Diseases, Centre for Infectious
Disease Surveillance and Control
Screening and Immunisations Lead (SIL) – Surrey and Sussex
Medicines Management Adviser – Public Health England
Senior Health Protection Nurse Practitioner, Cheshire &
Merseyside Health Protection Team, Public Health England
Screening and Immunisation Co-ordinator (SIC) NHS England
Leicestershire and Lincolnshire
Pharmacist Lead - NHS England South West
Clinical Screening and Immunisation Manager, NHS England
Lancashire & Greater Manchester / Public Health England.
Group Manager, Access & Information for Medicines & Standards
VRMM, MHRA
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2. Organisational Authorisations
The PGD is not legally valid until it has had the relevant organisational authorisation.
It is the responsibility of the organisation that has legal authority to authorise the PGD, to
ensure that all legal and governance requirements are met. The authorising body accepts
governance responsibility for the appropriate use of the PGD.
INSERT AUTHORISING BODY NAME authorise this PGD for use by the services or
providers listed below:
Authorised for use by the following organisations and/or services
eg All NHS England sub-region commissioned immunisation services
Limitations to authorisation
eg Any local limitations the authorising organisation feels they need to apply in-line with the
way services are commissioned locally. This organisation does not authorise the use of this
PGD by ….
Organisational approval (legal requirement)
Role
Name
Sign
Date
Complete eg NHSE
Governance Lead, Medical
Director
Additional signatories according to locally agreed policy
Role
Name
Sign
Date
Local enquiries regarding the use of this PGD may be directed to…………….
Organisations must add an individual practitioner authorisation sheet or list of authorised
practitioners. This varies according to local policy but this should be a signature list or an
individual agreement as included at the end of this PGD.
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3. Characteristics of Staff
Qualifications and
professional registration
required
Registered professional with one of the following bodies:
 Nurses currently registered with the Nursing and Midwifery
Council (NMC).
 Pharmacists currently registered with the General Pharmaceutical
Council (GPhC).
 Paramedics currently registered with the Health and Care
Professions Council (HCPC).
Additional requirements

Must be authorised by name as an approved practitioner under
the current terms of this Patient Group Direction before working
to it.

Must have undertaken appropriate training for working under
PGDs for supply/administration of medicines.

Must be competent in the use of PGDs (see NICE Competency
framework for health professionals using patient group
directions).

Must be familiar with the vaccine product and alert to changes in
Summary of Product Characteristics, Immunisation Against
Infectious Disease (“The Green Book”), and national and local
immunisation programmes.

Must have undertaken training appropriate to this PGD as
required by local policy and in line with the National Minimum
Standards for Immunisation Training (2005).

Must be competent to undertake immunisation and to discuss
issues related to immunisation.

Must be competent in the handling and storage of vaccines, and
management of the “cold chain”.

Must be competent in the recognition and management of
anaphylaxis.

Have access to the Patient Group Direction and associated
online resources.

Should fulfil any additional requirements defined by local policy.
THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER
THE CURRENT VERSION OF THIS PGD BEFORE WORKING
ACCORDING TO IT.
Continued training
requirements

Practitioners must ensure they are up to date with relevant issues
and clinical skills relating to immunisation and management of
anaphylaxis, with evidence of appropriate Continued Professional
Development (CPD).

Practitioners should be constantly alert to any subsequent
recommendations from Public Health England and/or NHS
England and other sources of medicines information.
Note: The most current national recommendations should be
followed but a Patient Specific Direction (PSD) may be required
to administer the vaccine in line with updated recommendations
that are outside the criteria specified in this PGD.
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4. Clinical condition or situation to which this PGD applies.
Clinical condition or
situation to which this
PGD applies
LAIV is indicated for the active immunisation of children and
adolescents aged 2 to 17 years (inclusive) for the prevention of
influenza infection, in line with the recommendations given in
Chapter 19 of Immunisation Against Infectious Disease: The Green
Book, the Flu Plan and the annual flu letter.
Criteria for inclusion
This PGD includes vaccination of children and adolescents for
whom LAIV is indicated across the 2015/16 national influenza
immunisation programme. Users of this PGD should note that
where they are commissioned to immunise certain groups this
PGD does not constitute permission to offer LAIV beyond the
groups they are commissioned to immunise.
1. Children and Adolescents in Clinical Risk Groups
 Children and adolescents aged 2 to 17 years (up to their 18th
birthday) who are in a clinical risk group category listed in
Chapter 19 of “The Green Book” - LAIV is the influenza vaccine of
choice, unless it is clinically contraindicated, because LAIV
provides greater protection for children than inactivated influenza
vaccine.
2. Children eligible for vaccination with LAIV in accordance
with national recommendations for 2015/16:
 Children aged two, three, and four years on 31 August 2015 (i.e.
date of birth on or after 1 September 2010 and on or before 31
August 2013)
 Children of school years 1 and 2 age (i.e. five to seven year olds
with a date of birth between 1 September 2008 and on or before
31 August 2010)
o Some children in years 1 and 2 might be outside of these
date ranges (eg if a child has been accelerated or held back
a year). It is acceptable to offer and deliver immunisations to
these children with their class peers under this PGD
 Primary school-aged children in areas that participated in primary
school pilots in 2014/15
 Children and adolescents aged 2 to 17 years (up to their 18th
birthday) who are household contacts of immunocompromised
individuals, i.e. individuals who expect to share living
accommodation on most days over the winter and therefore for
whom continuing close contact is unavoidable. (See exclusion for
contacts of severely immunocompromised individuals).
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Criteria for exclusion1
 Children and infants under 2 years of age
 Adults aged 18 years and over
 Patients for whom no valid consent has been received
In addition LAIV should NOT be given to:
 Individuals with a confirmed anaphylactic reaction to a previous
dose of influenza vaccine.
 Individuals with a confirmed anaphylactic reaction to any
component of LAIV, except egg proteins.
 Individuals with severe anaphylaxis to egg which has previously
required intensive care.
 Individuals with severe asthma, for example children who have
taken oral steroids in the past 14 days or are currently taking a high
dose of an inhaled steroid – budesonide >800 micrograms/day or
equivalent (eg fluticasone >500 micrograms/day) – such children
should only be given LAIV on the advice of their specialist. As
these children are a defined risk group for influenza, those who
cannot receive LAIV should receive an inactivated influenza
vaccine.
 Individuals receiving salicylate therapy (other than topical treatment
of localised conditions). This is because of the association of
Reye’s syndrome with salicylates and wild-type influenza infection.
 Individuals with unrepaired craniofacial malformations.
 Pregnant teenagers. See Actions if excluded below.
Note: There is no need to specifically test eligible girls for
pregnancy or to advise avoidance of pregnancy in those who have
been recently vaccinated.
 Individuals who are clinically severely immunodeficient due to
conditions or immunosuppressive therapy such as:
o acute and chronic leukaemias
o lymphoma
o HIV infection not on highly active antiretroviral therapy
(HAART)
o cellular immune deficiencies
o high dose corticosteroids (prednisolone at least 2mg/kg/day for
a week or 1mg/kg/day for a month or equivalent)
 Individuals for whom close contact with very severely
immunocompromised patients (eg bone marrow transplant patients
requiring isolation) is likely or unavoidable (for example, household
members). However, appropriate alternative inactivated influenza
vaccines should be considered.
LAIV is not contraindicated for use in children or adolescents with
stable HIV infection receiving antiretroviral therapy; or who are
receiving topical corticosteroids, standard dose inhaled
corticosteroids, low-dose systemic corticosteroids or those receiving
corticosteroids as replacement therapy, eg for adrenal insufficiency or
low-dose immunosuppressive therapy. This PGD may be used for
these individuals.
Criteria for exclusion
(continued over page)
In other cases of immunosuppression, the vaccine may be considered
– but this is not within the remit of this PGD. In such cases, the
individual’s General Practitioner (GP) should issue a Patient Specific
Direction (PSD) or administer the vaccine themselves. As with all
1
Exclusion under this Patient Group Direction does not necessarily mean the medication is contraindicated, but
it would be outside its remit and another form of authorisation will be required
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Page 7 of 16
Criteria for exclusion
(continued)
complex cases, it is good practice to involve the individual’s specialist
clinician in the decision whether to vaccinate. See Chapter 6 of “The
Green Book” for further guidance.
Temporary Exclusion




Cautions including any
relevant action to be
taken
Acute febrile illness – postpone administration until completely
recovered
Heavy nasal congestion may impede delivery of the vaccine to
the nasopharyngeal mucosa – postpone administration
Wheezing in the past 72 hours or those who have increased their
use of bronchodilators in the previous 72 hours – postpone
administration and if their condition has not improved after a
further 72 hours then, to avoid delaying protection in this high risk
group, these children should be offered an inactivated influenza
vaccine.
Treatment with influenza antiviral agents in the last 48 hours –
postpone administration until 48 hours following the cessation of
treatment with influenza antiviral agents.
Individuals who have immunosuppression and HIV infection may not
make a full antibody response. Consideration should be given to the
influenza vaccination of household contacts of immunocompromised
individuals.
There is a potential for transmission of live attenuated influenza virus
to immunocompromised contacts for one to two weeks following
vaccination. Where close contact with severely immunocompromised
patients is likely or unavoidable, appropriate alternative inactivated
influenza vaccines should be considered.
Action to be taken if the
patient or carer declines
treatment
Informed consent, from the patient or a person legally able to act on
the patient’s behalf, must be obtained for each administration.
Advise parent/carer about the protective effects of the vaccine, the
risks of infection and potential complications.
Document advice given and decision reached.
In a GP practice setting, inform or refer to the GP or prescriber as
appropriate.
Action to be taken if the
patient is excluded
Where individuals are excluded and are in a routine cohort with no
clinical risk factors, no further action will be required.
Patients temporarily excluded may be offered LAIV at a later date. In
case of postponement arrange a future date for vaccination.
Patients with clinical risk factors should be considered for inactivated
influenza vaccine.
All pregnant teenagers should be offered inactivated influenza
vaccine.
Vaccination with inactivated influenza vaccine should be considered in
most patients with immunosuppression.
(continued over page)
Children and adolescents with a history of severe anaphylaxis to egg
which has required intensive care, and who require protection against
flu because they are in a clinical risk group, should be referred to
specialists for immunisation in hospital.
Seek appropriate advice from the local Screening and Immunisation
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Action to be taken if the
patient is excluded
Team, a Consultant in Health Protection or individual’s clinician, as a
PSD may be indicated.
(continued )
The risk to the individual of not being immunised must be taken into
account.
Document reason for exclusion and any action taken in the individual’s
clinical records.
In a GP practice setting, inform or refer to the GP or a prescriber as
appropriate.
Arrangements for
referral for medical
advice
As per local policy
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5. Description of Treatment
Name, strength &
formulation of drug
Fluenz Tetra®▼ nasal spray suspension (0.2 ml) in pre-filled nasal
applicator (Influenza vaccine, live attenuated).
OR
FluMist® Quadrivalent nasal spray suspension (0.2 ml) in pre-filled
nasal applicator (influenza vaccine, live attenuated).
Legal category
Prescription Only Medicine (POM).
Black triangle
Yes.
Off-label use
LAIV Summary of Product Characteristics includes a contraindication
for patients with a hypersensitivity to egg or egg proteins. However,
JCVI has advised that, except for those with severe anaphylaxis to egg
which has previously required intensive care, children with an egg
allergy can be safely vaccinated with LAIV in any setting.
LAIV Summary of Product Characteristics states “For children who
have not previously been vaccinated against seasonal influenza, a
second dose should be given after an interval of at least 4 weeks.”
However, JCVI has advised that children aged two years to under nine
years of age who are not in a clinical risk group, only require a single
dose of live attenuated influenza vaccine irrespective of whether they
have received influenza vaccine previously.
Route / method of
administration
LAIV is given intranasally.
LAIV must NOT be injected.
Instructions for administration of the vaccine by the registered
practitioner:
Administration under this
PGD must be directly by
the registered health
professional named in
section 7.
If the PGD is used for
“supply only”, subsequent
self-administration or
administration by another
healthcare worker is
outside the remit of this
PGD and should be in
well-defined local
circumstances covered by
protocols and training.
Single application in each nostril of 0.1ml
The patient can breathe normally during vaccine administration and
there is no need to actively inhale or sniff.
LAIV is for intranasal application only.
Remove
protective tip
cap.
Do not remove
the dosedivider
With the patient
upright, position
the applicator
and depress as
rapidly as
possible
Pinch and
remove the
dose-divider
clip from the
plunger
Administer the
remaining
vaccine into
the other
nostril
The Summary of Product Characteristics for Fluenz Tetra®▼ provides
further guidance on administration.
http://www.medicines.org.uk/emc/medicine/25084
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Page 10 of 16
Dose and frequency of
administration
Single dose of 0.2ml of LAIV administered as 0.1ml in each nostril.
Children in Clinical Risk Groups
Children aged 2 to less than 9 years who are in a clinical risk group
category listed in Chapter 19 of the “The Green Book” and who have
not received influenza vaccine before, should receive a second dose of
LAIV at least 4 weeks after the first dose.
Second dose of 0.2ml of LAIV administered as 0.1ml in each nostril.
Duration of treatment
See section on Dose.
Quantity to be supplied /
administered
0.2ml dose to be administered.
OR
0.2ml LAIV supplied for immediate self-administration or administration
by an appropriately trained healthcare support worker (HCSW) within
the clinic setting.
Note: The act of administration by anyone other than the registered
professional named in Section 7 is outside the remit of this PGD and
should be in well-defined local circumstances covered by protocols
and training.
Children aged 2 years to less than 9 years old and in a clinical
risk category
This dose (0.2ml) should be repeated after a 4 week interval.
Supplies
Live attenuated influenza vaccine has been purchased centrally for
children aged 2 years to less than 17 years in the annual routine
cohorts and for children aged 2 years to less than 18 years in clinical
risk groups. These vaccines should be ordered as per the usual
mechanisms for the routine childhood immunisation programme.
Storage
Store in a refrigerator at +2°C to +8°C.
Store in original packaging in order to protect from light.
Do not freeze.
Before use, the vaccine may be taken out of the refrigerator, without
being replaced, for a maximum period of 12 hours at a temperature not
above 25°C. If the vaccine has not been used after this 12-hour period,
it should be disposed of.
Disposal
Equipment used for immunisation, including used vials, ampoules, or
partially discharged vaccines in an applicator, should be disposed of at
the end of a session by sealing in a proper, puncture-resistant ‘sharps’
box, according to local authority regulations and guidance in the
technical memorandum 07-01 (Department of Health, 2013).
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Drug interactions2
There is a potential for influenza antiviral agents to lower the
effectiveness of the LAIV. Therefore, influenza antiviral agents and
LAIV should not be administered concomitantly.
LAIV should be delayed until 48 hours following the cessation of
treatment with influenza antiviral agents.
Administration of influenza antiviral agents within the two weeks
following administration of LAIV may adversely affect the effectiveness
of the vaccine.
Children and adolescents younger than 18 years of age: Do not
administer LAIV if receiving salicylate therapy and do not use
salicylates for 4 weeks after vaccination.
LAIV can be given at the same time as other live or inactivated
vaccines. Although it was previously recommended that, where
vaccines cannot be administered simultaneously, a four-week interval
should be observed between live viral vaccines, JCVI have advised
that no specific intervals need to be observed between the live
attenuated intranasal influenza vaccine and other live vaccines (see
Chapter 6 of “The Green Book”).
Identification and
management of adverse
reactions2
The most common adverse reactions observed after administration of
LAIV are decreased appetite, headache, nasal congestion,
rhinorrhoea, malaise. Less common reactions include myalgia and
pyrexia and uncommon reactions include hypersensitivity reactions,
epistaxis and rash.
A detailed list of adverse reactions associated with LAIV is available in
the Summary of Product Characteristics for this vaccine, which is
available from the electronic Medicines Compendium website:
www.medicines.org.uk
Reporting procedure of
adverse reactions
As LAIV is black triangle, any suspected adverse reactions should be
reported via the National Reporting System to the Medicines and
Healthcare products Regulatory Agency (MHRA) using the Yellow
Card reporting scheme on: http://yellowcard.mhra.gov.uk
Any adverse reaction to the vaccine should be documented in the
indvidual’s record and the individual’s GP should be informed.
Written information to
be given to patient or
carer
Supply marketing authorisation holder's patient information leaflet
(PIL) provided with the vaccine.
Patient advice / follow
up treatment
Inform patient/carer of possible side effects and their management.
(continued over page)
2
Note: The Fluenz Tetra®▼ PIL should be provided as this contains
the relevant patient information in accordance with UK licensing of the
administered product. FluMist® Quadrivalent will be supplied with
supplemental Fluenz Tetra®▼ PILs. The FluMist® Quadrivalent
prescribing information intended for the US market can be discarded.
The parent/carer should be advised to seek medical advice in the
event of a severe adverse reaction.
When applicable, advise parent/carer when the subsequent dose is
due.
Refer to British National Formulary (BNF) and Summary of Product Characteristics (SPC) for complete list
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Page 12 of 16
Patient advice / follow
up treatment
(continued)
Vaccine recipients should be informed that LAIV has the potential for
transmission to immunocompromised contacts. Vaccine recipients
should attempt to avoid, whenever possible, close association with
severely immunocompromised individuals (eg bone marrow transplant
recipients requiring isolation) for 1-2 weeks following vaccination.
If the PGD is used for supply only, advise the patient/carer the process
they need to follow for subsequent administration eg. refer immediately
to appropriately trained HCSW within the clinic setting.
When administration is postponed advise the patient when to return for
vaccination.
Special considerations /
additional information
As with most vaccines, appropriate medical treatment and supervision
should always be readily available in case of an anaphylactic event
following the administration of LAIV.
Immediate access to adrenaline (epinephrine) 1 in 1000 injection and
access to a telephone.
Minor illnesses without fever or systemic upset are NOT valid reasons
to postpone immunisation. If an individual is acutely unwell,
immunisation may be postponed until they have fully recovered. This is
to avoid confusing the differential diagnosis of any acute illness by
wrongly attributing signs or symptoms to adverse effects of the vaccine.
JCVI has advised that, except for those with severe anaphylaxis to egg
which has previously required intensive care, children with an egg
allergy can be safely vaccinated with LAIV in any setting (including
primary care and schools).
Individuals on high dose inhaled corticosteroids are excluded from this
PGD, due to the severity of their respiratory disease, and LAIV should
only be given on the advice of their specialist. Individuals on high dose
inhaled corticosteroids are not excluded for reasons of
immunosuppression.
Exposure of healthcare professionals
Very severely immunosuppressed individuals should not administer
live attenuated influenza vaccine. Other healthcare workers who have
less severe immunosuppression or are pregnant, should follow normal
clinical practice to avoid inhaling the vaccine and ensure that they
themselves are appropriately vaccinated.
If the PGD is used for supply only for subsequent administration by an
appropriately trained HCSW, the registered practitioner named in
Section 7 of this PGD must supply the vaccine to the patient/carer. The
HCSW cannot supply the medicine.
Records
(continued over page)
Record:
 That valid informed consent was given
 Name of patient, address, date of birth and GP with whom the
individual is registered
 Name of immuniser
 Name and brand of vaccine (Note: as there is no specific code for
FluMist® Quadrivalent brand on clinical systems this should be
recorded using the generic option “Influenza vaccine (live
attenuated)”)
 Date of administration or supply
 Dose, form and route of administration of vaccine
 Quantity administered or supplied
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Records
(continued)





Batch number and expiry date
Advice given; including advice given if excluded or declines
immunisation
Details of any adverse drug reactions and actions taken
Record whether supplied only or supplied and administered via
Patient Group Direction (PGD).
Records should be signed and dated (or password controlled
immunisers record on e-records).
All records should be clear, legible and contemporaneous.
It is important that vaccinations given either at a general practice or
elsewhere (for example, at schools or community pharmacies) are
recorded on appropriate health records for the individual (using the
appropriate clinical code). If given elsewhere, a record of vaccination
should be returned to the patient’s general practice to allow clinical
follow up and to avoid duplicate vaccination.
The local Child Health Information Systems team (Child Health
Records Department) must be notified using the appropriate
documentation/pathway.
A record of all individuals receiving treatment under this Patient Group
Direction should also be kept for audit purposes in accordance with
local policy.
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6. Key References
Key references
 Chapter 19 of Immunisation Against Infectious Disease: The Green
Book. Updated 28 August 2015.
https://www.gov.uk/government/publications/influenza-the-greenbook-chapter-19
 Collection: Annual Flu Programme.
https://www.gov.uk/government/collections/annual-flu-programme
 Flu Plan: Winter 2015 to 2016. Published 27 March 2015
https://www.gov.uk/government/publications/flu-plan-2015-to-2016
 The national flu immunisation programme 2015 to 2016: supporting
letter. Published 27 March 2015
https://www.gov.uk/government/uploads/system/uploads/attachment
_data/file/418428/Annual_flu_letter_24_03_15__FINALv3_para9.pdf
 Fluenz Tetra®▼ Summary of Product Characteristics. 3 September
2015
http://www.medicines.org.uk/emc/medicine/29112
 FluMist® Quadrivalent Prescribing Information. August 2015.
https://www.medimmune.com/docs/default-source/pdfs/flumist-uspi-2015.pdf?sfvrsn=4
 Revised recommendations for administering more than 1 live
vaccine. 24 April 2015.
https://www.gov.uk/government/publications/revisedrecommendations-for-administering-more-than-1-live-vaccine
General
 PHE Immunisation Collection. Updated 22 June 2015
https://www.gov.uk/government/collections/immunisation
 British National Formulary (BNF) and British National Formulary for
Children (BNF-C) www.BNF.org
https://www.evidence.nhs.uk/formulary/bnf/current/14immunological-products-and-vaccines/144-vaccines-andantisera/influenza-vaccines/influenza-vaccines/tetravalent-seasonalinfluenza-vaccine-for-intranasal-use/fluenz-tetra
 National Minimum Standards for Immunisation Training (2005)
https://www.gov.uk/government/publications/immunisation-trainingnational-minimum-standards
 NICE Medicines Practice Guideline 2 (MPG2): Patient Group
Directions
https://www.nice.org.uk/guidance/mpg2
 NICE MPG2 Patient group directions: competency framework for
health professionals using patient group directions
https://www.nice.org.uk/guidance/mpg2/resources/competencyframework-for-health-professionals-using-patient-group-directions60468733
 Immunisation knowledge and skills competence assessment tool.
Royal College of Nursing (RCN) 2015.
http://www.rcn.org.uk/__data/assets/pdf_file/0011/641918/RCN_PH
E_immunisation_TOOL_2015_WEB.pdf
 Health Technical Memorandum 07-01: Safe Management of
Healthcare Waste. Department of Health 20 March 2013
https://www.gov.uk/government/publications/guidance-on-the-safemanagement-of-healthcare-waste
LAIV PGD v03.00 Valid from: 20/10/2015 Expiry: 31/08/2016
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7. Individual Practitioner Authorisation Sheet
BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU
AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT
PATIENT GROUP DIRECTIONS DO NOT REMOVE INHERENT PROFESSIONAL
OBLIGATIONS OR ACCOUNTABILITY
IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY
WITHIN THE BOUNDS OF THEIR OWN COMPETENCE
Practitioner
I confirm that I have read and understood the content of this Patient Group
Direction and that I am willing and competent to work to it within my professional
code of conduct
Signed……………………………….………………………….…..Date……….….…………....
Name
(Print)…………….…………..………….………………………………………….…….............
Designation……………………………………………………………….…..………………......
Authorising Manager
Manager to give authorisation on behalf of INSERT NAME OF ORGANISATION for the
named Health Care Professional who has signed the PGD
Signed…………………………………….………………………. Date………………………..........
Name (Print)………………………..…………………………………….……………..………..........
Designation………………………………………………………………..…………….…….............
Note to Authorising Manager
By signing above you are confirming that you have assessed the staff member as
competent to work under this PGD and that they have the organisational approval to do so
You must give this signed PGD to each Authorised Practitioner as it shows their
authorisation to use the PGD
LAIV PGD v03.00 Valid from: 20/10/2015 Expiry: 31/08/2016
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