NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
SOP prepared by
(full name)
Signature
PURPOSE
SCOPE
GUIDANCE NOTES
Position in pharmacy business
Date of SOP preparation
To ensure that the Community Pharmacy seasonal influenza vaccination Advanced Service is operated in a safe, effective,
systematic and efficient way which complies with the minimum requirements contained in this standard operating procedure (SOP),
the Flu Vaccination Advanced Service Specification and its associated Patient Group Direction (PGD).
This procedure covers the provision of the Community Pharmacy seasonal influenza vaccination Advanced Service at the pharmacy
premises.
 This SOP has been designed to be used within a community pharmacy premises
o The SOP should be tailored, where appropriate, to reflect processes in individual pharmacies
o Changes to the SOP should be considered carefully as some processes are based on legislative requirements or good
practice recommendations
 This SOP should be used in conjunction with the “Community Pharmacy seasonal influenza vaccination Advanced Service
Specification” and the “National Community Pharmacy Flu Vaccination Advanced Service Patient Group Direction (PGD)”
 This SOP is not designed to be used as a legal document; rather it is designed to help community pharmacists adopt best
practices in the administration of the flu vaccination; relevant legislation should be referred to if necessary
 The SOP should be agreed with the superintendent pharmacist /pharmacy owner
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1
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
Preparing for the service
*KEY: P = Pharmacist / PT = Pharmacy Team / SP = Superintendent Pharmacist / PO = Pharmacy Owner
Action / Procedure
1) Undertake and complete appropriate vaccination training
(face-to-face or online refresher), including recognition and
management of anaphylaxis; undertake and complete
appropriate training for working under PGDs for
supply/administration of medicines; ensure you are
competent in the use of PGDs
Who?*
P
Explanation / Guidance / Support


2) Complete and sign the Community Pharmacy Seasonal Flu
Vaccination Advanced Service Declaration of Competence
(DoC)
P

3) Retain a copy of the completed and signed DoC(s) on the
pharmacy premises
SP/PO/P


SP/PO/P


4) Have ready SOPs for handling and storage of vaccines including
management of cold chain, and needlestick injury

Refer to the “Community Pharmacy seasonal influenza vaccination
Advanced Service Specification”, the “National Community Pharmacy
Flu Vaccination Advanced Service PGD” and the Pharmaceutical
Services Negotiating Committee (PSNC) “Briefing 053/15: Guidance
on the seasonal influenza Vaccination Advanced Service” for further
information
Refer to “The National Institute for Health and Care Excellence (NICE)
competency framework for health professionals using patient group
directions”
Requirement under the “Community Pharmacy seasonal influenza
vaccination Advanced Service Specification”
See Appendix 1
Requirement under the “Community Pharmacy seasonal influenza
vaccination Advanced Service Specification”
See Appendix 1
NPA SOPs available for:
o “Needlestick Injury and Biohazard Spillage SOP”
o “ Vaccination services SOP (2015/15): cold chain”
Ensure that these SOPs are up-to-date, have been read and
understood by all members of the pharmacy team, signed, are within
easy access and are implemented as appropriate
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2
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
5) Advise all staff involved in delivering vaccination services to
consider being vaccinated against hepatitis B; provide
adequate information about hepatitis B infection, the vaccine,
risks, benefits, risk associated with accidental needle-stick
injuries and contracting hepatitis B to allow individuals to
make an informed decision
6) Download a copy of the National Community Pharmacy Flu
Vaccination PGD from the NHS England website, read the PGD,
print off a copy of the PGD and complete the ‘Practitioner’
declaration
7) Ensure that the ‘Authorising Manager’ declaration’ is
completed
SP/PO
P

Further information can be found in “Immunisation against infectious
disease, (The Green Book)” Chapter 12

See Appendix 2 for NPA guidance

Ensure that you fully understand the content of the PGD, including
patient eligibility, the inclusion and exclusion criteria and recordkeeping requirements
Completing the ‘Practitioner’ declaration confirms that you have
read and understood the content of the PGD, and that you are willing
and competent to work within the requirements of the PGD
It is up to the pharmacy contractor to determine who the
‘Authorising Manager’ for their organisation is
Where the pharmacist who will be administering the vaccines is also
the superintendent pharmacist / pharmacy owner / pharmacy
contractor, then the authorising manager may be the same individual
as the ‘Practitioner’ pharmacist (however, the signing of both the
‘Practitioner’ declaration’ and the ‘Authorising Manager’ declaration
by the same individual should be avoided wherever possible)
Signing the ‘Authorising Manager’ declaration confirms that the
named ‘Practitioner’ pharmacist has been assessed as competent to
work under the PGD, and that the named pharmacist has the
organisation’s approval to do so
See Appendix 1

SP/PO/P




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3
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
Delivering the service
*KEY: P = Pharmacist / PT = Pharmacy Team / SP = Superintendent Pharmacist / PO = Pharmacy Owner
Action / Procedure
Who?*
1) Ensure that the working area in the consultation room is
cleaned and disinfected (if necessary) and is presentable
for the patient
2) Take the following steps:
 Remove the flu vaccine from the fridge about ten
minutes before administration
 Ensure a tray containing at least two in-date
adrenaline 1:1000 injections (for example, ampoules
(with relevant needles and syringes) OR two autoinjectors each of different strengths) are within reach
and readily available in case of an emergency (and a
resuscitation mask, if available)
 If there is insufficient or no stock of adrenaline 1:1000
available in the pharmacy, DO NOT administer any
vaccines
 In another tray ensure you have the flu vaccine and
cotton wool ready
 Check the sharps bin is within easy reach
 Make sure other members of the pharmacy team are
available / within earshot
3) When the patient arrives for their appointment, direct
patient to the consultation room
P
P
Explanation / Guidance / Support







PT


Vaccine should be at room temperature before administration
All necessary equipment should be placed nearby including sharps bins
and access to adrenaline is readily available in case of an emergency
If there is insufficient or no stock of adrenaline 1:1000 in the pharmacy,
defer the appointment until you have sufficient stock of adrenaline in
stock, or refer the patient to another service provider
Refer to Chapter 8 “Immunisation against infectious disease, (The Green
Book)” for management of adverse reactions following vaccination
Refer to the NPA SOP “Needlestick Injury and Biohazard Spillage SOP”
Any patient concerns should be addressed prior to vaccination
In the case of an emergency, staff may need to be summoned, for
example, to call for an ambulance
Refer to the “Community Pharmacy seasonal influenza vaccination
Advanced Service Specification” and the “General Pharmaceutical Council
(GPhC) Standards for Registered Premises” for details on premises
requirements
This is to ensure patient confidentiality and privacy is maintained
throughout the service provision
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4
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
4) Assess patient eligibility to receive the flu vaccination
under the NHS Advanced Service — patient must be aged
18 years or over to be eligible for this service
P



5) Discuss background of the flu vaccine, possible side effects
of the vaccine and potential for anaphylactic reaction(s)
P


6) Ensure that the Flu Vaccination Record and Consent Form
are completed by the patient
P





Refer to Annex A of the “Community Pharmacy seasonal influenza
vaccination Advanced Service Specification” for patients who are eligible
to receive the flu vaccination under the Advanced Service
The Summary of Product Characteristics (SPC) for each vaccine and the
contraindications listed in the “National Community Pharmacy Flu
Vaccination Advanced Service PGD” should also be referred to when
assessing patient suitability for receiving the vaccine
The service should only be provided to those that are eligible —users of
the Community Pharmacy Flu Vaccination Advanced Service PGD should
be aware that they only have permission to immunise certain eligible
groups that they are commissioned to immunise
Provide the relevant patient information leaflet (PIL) for the flu vaccine to
the patient to read through and discuss with the pharmacist if required
Advise patients about the action(s) which may need to be taken in the
event of an adverse event and in the management of side effects
If the patient is unsuitable for vaccination under the “Community
Pharmacy seasonal influenza vaccination Advanced Service Specification”
, explain why and refer them to their local GP surgery (or if the pharmacy
offers a private flu PGD service, this can be offered to the patient as an
option)
The patient must sign the consent form prior to vaccination, without
exception; if patient consent is not given, the service cannot proceed
The consent covers the sharing of information with the patient’s GP
practice and NHS England for the purpose of post payment verification
The Flu Vaccination Record form should be reviewed to confirm patient
suitability for vaccination
Each patient is required to complete a consent form before the vaccine
can be administered — the consent form is part of the national Flu
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5
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
Vaccination Record and Consent Form (Annex D of the “Community
Pharmacy seasonal influenza vaccination Advanced Service Specification”)
7) Explain to the patient what will happen during the
vaccination and how long it is likely to take including
waiting time afterwards
8) Remove the vaccine from its packaging and check that it is
not frozen or contains particles
P

The patient may be in a hurry and unable to stay in the pharmacy for the
required period (15 minutes) after the vaccine is administered
P

Frozen vaccines or those that have suspended particles within them may
have become denatured and unstable leading to loss of potency and this
could cause a possible increase in adverse reactions
The freezing of vaccines may also cause hairline cracks in the container
which could allow for microbial contamination of the vaccine
SPC’s are available from : www.medicines.org.uk/emc/
Vaccines should be shaken well to ensure suspension is homogeneously
mixed before administration

9) Check the appearance of the vaccine against the Summary
of Product Characteristics (SPC) of the particular brand of
vaccine you are using
10) Flick/tap the top of the vaccine gently to expel any air
bubbles
11) Ensure you wash and dry your hands prior to
administering the vaccine
P


P
P


Please refer to the NPA SOPs on “Vaccination Services SOP (2015/16):
hand hygiene”
This should be carried out both before and after each patient is
vaccinated
12) Check which arm the patient wishes to have the vaccine
administered in to
P

Local tenderness at the injection site, for example, pain, swelling or
redness can occur; patients may prefer to have the vaccine administered
in a particular arm
13) Ask the patient to roll up their sleeves so that there is
enough of the deltoid area exposed on the upper arm
P


Ensure you maintain the patient’s respect and confidentiality at all times
Consider having a chaperone policy in place
14) Clean the skin with water if visibly soiled
P

If the skin appears clean there is no need for further cleaning or
disinfection
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6
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
15) Ask the patient to place their arm down by their side in a
relaxed manner
16) Put on gloves, if using, and administer the vaccine using
the appropriate vaccination technique
P
P


17) Dispose of the used syringe promptly into the sharps bin
without re-sheathing / re-capping the needle
P



Vaccinate patient according to the guidance outlined in Chapter 4
“Immunisation against infectious disease, (The Green Book)” and
according to the practical training you have undertaken
Check the allergy status of the patient before using gloves; patients may
be allergic to latex; consider using hypoallergenic gloves if needed
Refer to the NPA SOP “Needlestick Injury and Biohazard Spillage SOP”
Refer to Chapter 4 “Immunisation against infectious disease, (The Green
Book)”
Equipment used for immunisation, including used syringes should be
disposed by sealing in a puncture-resistant ‘sharps’ bin, according to local
authority regulations and guidance from the Department of Health in the
“Health Technical Memorandum 07-01: Safe management of healthcare
waste”
18) Apply cotton wool to the vaccination site and instruct the
patient to hold in place if there is any bleeding at the
injection site
19) Remove cotton wool once bleeding has stopped and apply
a plaster if necessary, or if requested by the patient
20) Dispose of the gloves (if used) and cotton wool in the
clinical waste container
21) Ensure you wash and dry your hands after administering
the vaccine
P

Occasionally the hypodermic needle may catch a small blood vessel, and
you or the patient may notice a small drop of blood; this is not serious
P

Be aware that some patients may be allergic to plaster adhesive
P

Ensure appropriate arrangements for waste management are in place
P

22) Complete relevant paperwork; make a record of the type
of vaccine, vaccine name, batch number, expiry date, dose
administered, site used, date, your name and signature
P

Please refer to the NPA SOP on “Vaccination Services SOP (2015/16): hand
hygiene”
The list of records that must be kept are contained in the “National
Community Pharmacy Flu Vaccination Advanced Service PGD”
All records of individuals receiving the flu vaccination under the “National
Community Pharmacy Flu Vaccination Advanced Service PGD” need to be

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NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)



23) Whilst completing documentation, observe the patient for
15 minutes for signs of adverse reactions / anaphylaxis
P


24) While they are being observed, ask the patient to
complete a patient questionnaire (Annex E of the
“Community Pharmacy seasonal influenza vaccination
Advanced Service Specification”)
P
25) Make a contemporaneous note on the Patient Medication
Record (PMR)
26) After 15 minutes, check the patient’s arm for signs of
adverse local reactions
P


P


27) Keep all paperwork in the designated folder for recordkeeping purposes
P

kept according with local policy for auditing purposes
Pharmacists should keep proper records of the treatment on the relevant
forms; records made should be legible and contemporaneous
Refer to Chapter 4 “Immunisation against infectious disease, (The Green
Book)”
it is important that the correct brand of vaccine, batch number and site at
which each vaccine is administered is accurately recorded
Onset of anaphylaxis in a patient typically occurs within minutes of the
patient being vaccinated therefore patients should be observed following
vaccination
Patients and healthcare professionals are advised to report serious
adverse reactions using The Yellow Card Scheme and in particular those
vaccines that have a black triangle symbol (▼ )
Guidance on processing completed questionnaires will be issued
separately as stated in the “Community Pharmacy seasonal influenza
vaccination Advanced Service Specification”
Completed questionnaires should be collected for analysis
Refer to Chapter 8 “Immunisation against infectious disease, (The Green
Book)” for management of adverse reactions following vaccination
The patient many need a cold compress against the affected area and/or
treatment with simple analgesia if any adverse effects are observed
All records of individuals receiving the flu vaccination under the
“National Community Pharmacy Flu Vaccination Advanced Service PGD”
need to be kept according with local policy for auditing purposes and to
ensure the ongoing service is delivered effectively
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8
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
28) Refer patients who are eligible for other vaccinations to
their GP practice for these vaccinations
29) Send a record of the vaccination to the patient’s GP to
allow clinical follow- up and to avoid duplicate vaccination
P

P



30) Ensure working area is cleaned and disinfected (if
necessary) and is presentable and ready for the next
patient
The pharmacy may administer these additional vaccinations if they are
contracted to do so under the terms of a Local Enhanced Service
Notification of vaccination must be sent to the patient’s GP practice on
the same day vaccination occurs or the following working day via post,
hand delivery, fax, or secure email—if notification to the GP practice
occurs via hardcopy, the national GP Practice Notification Form must be
used( Annex B of the “Community Pharmacy seasonal influenza
vaccination Advanced Service Specification”)
NHS England has not been able to put in place a national IT solution to
support the notification of the patient’s GP of a patient’s vaccination
status.
In some areas, Local Pharmaceutical Committee’s (LPCs) and local NHS
England teams have been able to arrange IT support for this service;
contact your LPC to find out if there is a system in place to notify GP’s
using online systems
P
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NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
Staff declaration
IMPORTANT: The following declaration must be made by all members of the pharmacy team involved in delivering vaccination services.
Declaration: I have read and understood this SOP and agree to implement the procedures set out in it when required.
Date
Full name
Qualification
GPhC number,
where relevant
Signature
10
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NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
Appendix 1: Responsibilities of Superintendent Pharmacists/Pharmacy Owners
Pharmacy
eligibility to
provide the
service and
payment
arrangements







Authorising
Manager


Service
availability


Ensure that the pharmacy is providing all Essential Services satisfactorily and is compliant with the Clinical Governance requirements
of the Community Pharmacy Contractual Framework
Prior to carrying out the NHS Community Pharmacy flu vaccination Advanced Service, declare through the NHS Business Services
Authority (NHSBSA) website that pharmacists who will be administering the NHS flu vaccinations, and the pharmacy premises where
vaccinations will be administered, meet the required standards provided in the “Community Pharmacy seasonal influenza vaccination
Advanced Service Specification”
If you cease to provide the NHS Community Pharmacy flu vaccination Advanced Service through your pharmacy, the NHSBSA must be
notified within one week of ceasing service provision
In order to claim for providing the service, complete the “Community Pharmacy Seasonal Influenza Vaccination Advanced Service”
claim form and submit this to the NHSBSA along with your FP34C each month; this claim form can be found on the NHSBSA website
Ensure that a consultation room which meets the requirements set out in the “Community Pharmacy seasonal influenza vaccination
Advanced Service Specification” and “General Pharmaceutical Council (GPhC) Standards for Registered Premises” is available in the
pharmacy
Ensure appropriate arrangements for clinical and sharps waste management are in place; ensure all members of the pharmacy team
are trained appropriately and are aware of the risks associated with the handling and disposal of clinical and sharps waste; ensure that
measures are in place to minimise those risks
Ensure that a SOP to minimise risk of and how to manage needlestick injuries is in place and implemented as necessary (refer to NPA
resources “Needlestick Injury and Biohazard Spillage SOP”)
The Authorising Manager of the pharmacy must give authorisation on
behalf of the organisation they represent for the pharmacist who has signed the “National Community Pharmacy Flu Vaccination
Advanced Service PGD”
By signing the PGD, the Authorising Manager confirms that the pharmacist
is competent to work under this PGD and they have the organisational approval to do so
Ensure that the service is available and accessible throughout the contracted opening hours of the pharmacy; this includes core and
supplementary opening hours
Ensure all pharmacists working throughout the opening hours of the pharmacy (including locums and relief pharmacists) are trained
and competent to deliver the service
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11
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)

Training
requirements



Service
promotion





Ensure that the service is accessible by all eligible patients without prejudice; the service should be delivered in an appropriate
manner, sensitive to the needs of the service users
Ensure that pharmacists providing the NHS community pharmacy flu vaccination Advanced Service are competent to do so
Ensure that each pharmacist can demonstrate that they have the necessary knowledge and skills to provide the service safely and
effectively
Ensure that each pharmacist has printed off, completed and signed the community pharmacy seasonal flu vaccination Advanced
Service Declaration of Competence (DoC)
Keep a signed copy of the DoC completed by each pharmacist employed/engaged by your organisation to deliver this service
Ensure that staff are appropriately trained and aware of the risks involved with handling and disposal of clinical and sharps waste
Ensure that a SOP to minimise risk of and how to manage needlestick injuries is in place and implemented as necessary
If developing promotional and marketing material to promote the service, ensure they comply with the requirements of the Terms of
Service of NHS pharmacists relating to promotion of services funded by the NHS
If using the NHS logo, ensure that the guidelines for use of the NHS identity by community pharmacies are complied with
Appendix 2: Hepatitis B — NPA guidance



Once the individuals have made a decision, consider the following:
o Those who choose to get vaccinated should give signed consent to get the vaccine (or booster) and
o Those who choose not to receive the hepatitis B vaccine (or have the booster) should also sign a statement declaring their understanding of the
risks associated with their unvaccinated status (or inadequate immune status) to hepatitis B
Record all these consents/declarations so there is a complete record of vaccinated and non-vaccinated individuals providing professional/clinical
services in your pharmacy/organisation
For individuals who choose NOT to get vaccinated (including not receiving a booster), decide whether such individuals should be undertaking the
relevant professional/clinical services; this can have implications both from a Professional Indemnity and/or your Employer’s Liability Insurance
perspective
Members and Customers who are insured through the NPA Insurance Ltd for professional indemnity purposes will be covered against any potential third
party liability which may arise; for example, in the unlikely event that a claim is made by a patient who alleges that they have contracted hepatitis B from a
member of staff. However it is expected that this guidance will have been followed.
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12
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
NPA resources
The following resources to support NPA Members in the provision of the national flu vaccination Advanced Service are available to download from the NPA
website (login required):

Hand hygiene SOP

Flu information pack 2015/16: vaccine information

Dealing with needlestick injuries and biohazard spillages SOP

Flu information pack 2015/16: vaccine ordering and

Cold chain SOP
availability

Cold chain products date checking matrix

Flu information pack 2015/16: pharmacy staff guide

Cold chain products drug alert log

Flu information pack 2015/16: guidance
References and further reading





Department of Health:
o ‘Immunisation against infectious disease, (The Green Book)’, Chapter 4 and 8
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Human Medicines Regulations 2012:
o
Regulation 233:
http://www.legislation.gov.uk/uksi/2012/1916/regulation/233/made
o
Schedule 16:
http://www.legislation.gov.uk/uksi/2012/1916/schedule/16/made
NICE Guidelines MPG2: PGDs
o
https://www.nice.org.uk/guidance/mpg2
NHS PGDs website for information and guidance
o
http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/
Pharmaceutical Services Negotiating Committee(PSNC):
o
National Community Pharmacy Flu Vaccination Advanced Service Patient Group Direction
(PGD)
http://psnc.org.uk/services-commissioning/advanced-services/flu-vaccination-service/flu-vaccination-service-spec-and-pgd/
o
Community Pharmacy seasonal influenza vaccination Advanced Service Specification
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13
NHS Community Pharmacy Flu Vaccination Advanced Service SOP (2015/16)
http://psnc.org.uk/services-commissioning/advanced-services/flu-vaccination-service/flu-vaccination-service-spec-and-pgd/
Disclaimer: The information published is, to the best of our knowledge, correct at the time of publication. However, no responsibility will be accepted for
any consequences of decisions made using this information.
14
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Direct Dial: 01727 891 800 Email: pharmacyservices@npa.co.uk Online: www.npa.co.uk