Community Pharmacy Seasonal Influenza Vaccination Service (PGD & PSD) 2021-22
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Community Pharmacy Seasonal Influenza
Vaccination Service (PGD & PSD)
2021-22
A Community Pharmacy Enhanced Service
Authors
Name Role
Adam Mackridge Strategic Lead for Community Pharmacy (BCUHB)
Date Approved
Community Pharmacy Wales 24 June 2021
National Extended Services
10 June 2021
Management Board
Key dates
Date activated: September 2021
Date to be reviewed: April 2022
This document describes the specification and standards pertaining to the provision of the
seasonal influenza vaccination enhanced service. This document does not constitute a Service
Level Agreement (SLA) although the provisions within the document may be contained within any
SLA between a Local Health Board and pharmacy contractor for the provision of the service.Version history
Version Changes from previous version Date
1 Pilot specification 1 Sep 2020
2 Update to include option to vaccinate under a patient specific direction 24 Jun 2021
INTERPRETATION
In this document:
Local Health Board or (Health Board) means the Local Health Board established under
section 11 of the National Health Service (Wales) Act 2006 (local health boards) in
whose area the service is provided.
Patient means any person in receipt of the service;
Patient Specific Direction (PSD) means a written direction to supply and administer
medicines to one or more named patient(s), which the prescriber has assessed on an
individual basis.1
Pharmacist means a person registered in Part 1 or 4 of the Register of pharmacists
and pharmacy technicians maintained under article 19(2) of the Pharmacy Order
2010 or in the register maintained under Articles 6 and 9 of the Pharmacy (Northern
Ireland) Order 1976.
Pharmacy means a listed premises under regulation 10 (preparation and
maintenance of pharmaceutical lists) at which pharmaceutical services are provided
by an NHS pharmacist pursuant to arrangements made to section 80 of the 2006 Act.
Pharmacy contractor (or contractor) means a person lawfully conducting a retail
pharmacy business.
Vaccinator means an accredited pharmacist (operating under a PGD or PSD), or
accredited pharmacy technician / pre-reg foundation pharmacy student (operating
under a PSD)
1
Further information on Patient Specific Directions is available here https://www.sps.nhs.uk/articles/questions-about-patient-
specific-directions-psd/
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 2 of 14Part A
1. SERVICE AIM
1.1. To provide influenza immunisation for those patients in nationally and locally
agreed at-risk groups. This is to support the wider provision of influenza
immunisation and increase the proportion of at risk individuals who receive
immunisation. Immunisation of those patients most likely to have a serious or
complicated illness should they develop influenza will help to reduce morbidity
and mortality.
2. SERVICE OUTCOMES
2.1. An increase in the number and location of sites providing influenza
immunisation;
2.2. Increased immunisation uptake rates in identified target groups;
2.3. At risk patients, particularly those in hard to reach groups, receive influenza
immunisation;
2.4. Improved convenience for patients.
3. SERVICE OUTLINE
3.1. The pharmacist shall identify patients who fall within nationally and locally
agreed target groups for seasonal influenza immunisation in accordance with
the guidance provided by the Welsh Government in the Welsh Health Circular,
or any additional guidance issued by the health board or specified in the Patient
Group Direction (PGD) for this service;
3.2. The pharmacy contractor shall promote influenza immunisation to patients
identified under 3.1 including providing information (which may be verbal or
written) regarding the availability of influenza vaccination from their GP and
from the pharmacy;
3.3. Where patients indicate that they have booked an appointment with their GP
for vaccination, they should be encouraged to keep this appointment.
Community Pharmacy vaccination should only be offered in these instances if
the patient reports that they would have difficulty in attending a GP
appointment;
3.4. The pharmacy contractor will offer influenza immunisation at the pharmacy, or
off-site venue, administered to patients identified in accordance with 3.1. by:
3.4.1 an accredited pharmacist under the authority of a Patient Group
Direction (PGD), or
3.4.2 an accredited pharmacist, pharmacy technician, or pre-reg
foundation pharmacist under the delegated authority of a Patient
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 3 of 14Specific Direction (PSD), following individual clinical assessment of
each patient by an independent prescriber;
3.5. Where Choose Pharmacy is used as the clinical record, the vaccinator shall
ensure the patient has been provided with a copy of the Choose Pharmacy
Information Governance leaflet. Where other system(s) are used, equivalent
information will be provided to the patient. The patient must provide informed
verbal consent to continue with the consultation and vaccination service prior
to administering influenza immunisation and to sharing relevant information
with the person with whom the patient is registered for general medical services
and NHS Wales. In line with normal practice, where the patient is not known to
them, the vaccinator must take reasonable steps to ensure the identity of the
patient;
3.6. The vaccinator shall maintain a complete and contemporaneous clinical record
of service provision utilising the Choose Pharmacy application for vaccinations
provided by a pharmacist under the PGD or PSD. For vaccinations provided by
pharmacy technicians or pre-reg foundation pharmacists under the PSD, an
alternative clinical record system should be used, with records being retained
in line with Department of Health guidance for clinical records. Such alternative
clinical record system must be auditable and contain, as a minimum, the
following information:
3.6.1. Patient Details
▪ Patient Reference Number (not NHS number)
▪ Gender
▪ Date of birth
▪ Postcode
▪ Eligibility (all reasons)
▪ Care Home (if applicable)
▪ Referral
3.6.2. Vaccination Details
▪ Date and time of vaccination
▪ Name of vaccine
▪ Batch Number
3.6.3. Other information
▪ Whether the patient had a flu jab last year and relevant
details of this
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 4 of 14▪ Whether the patient has been offered an appointment with
their GP
▪ Whether the patient was unable to attend the appointment
with their GP
▪ Why the patient choose to have a vaccination at the
pharmacy
3.7. Where the clinical record system is unavailable because of technical issues, a
paper copy of the record may be used to ensure continued service provision
(for example using the paper Choose Pharmacy template), but must be added
to the clinical record system as soon as is practicable when available;
3.8. The vaccinator shall administer influenza immunisation, where clinically
indicated, to patients in accordance with 3.1 and the requirements described
in:
3.8.1. the PGD, provided by the commissioning health board, or
3.8.2. a PSD that has been signed by an appropriate prescriber who has
individually assessed the suitability of the patient for vaccination;
3.9. Where any patient presenting at the pharmacy cannot receive the influenza
immunisation from the pharmacy for reason of ineligibility (e.g. they are not
one of the agreed target groups, they do not meet the inclusion criteria set out
in the PGD, or they meet any of the exclusion criteria set out in the PGD) the
patient should be referred to their GP or a non-NHS influenza vaccination
service as appropriate for further advice;
3.10. Where any patient presenting at the pharmacy cannot receive the influenza
immunisation from the pharmacy for reason of service unavailability (e.g. there
is no accredited pharmacist available) the patient should be invited to re-attend
at the next available time at which the service will be available from the
pharmacy, be advised of another pharmacy providing the service or be referred
to their GP for further advice;
3.11. Using the “Seasonal Flu Vaccination” letter generated by the Choose Pharmacy
application, or equivalent if using an alternative system, the vaccinator will
provide details of patients receiving influenza immunisation through the service
to the person with whom the patient is registered for general medical services
as soon as is practical and in any case not later than 5 working days after
the patient has been vaccinated. Where a copies of the consultation record
are able to be electronically transmitted to the patient’s GP via the Choose
Pharmacy application (eSummaries) the eSummary may be sent in preference
to the paper record.
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 5 of 143.11.1 In areas where health board staff are included in the PGD for the
service, a paper copy should be provided to health board staff
members receiving the vaccination (such individuals are also eligible
to be vaccinated under a PSD in line with the other requirements set
out in this document).
3.12. The vaccinator will offer a user-friendly, non-judgmental, patient-centred and
confidential service.
3.13. Where vaccines are provided under a Patient Specific Direction:
3.13.1 the pharmacist must be annotated as an independent prescriber and
have individually assessed the patient for suitability of vaccination
prior to including their name on the patient specific direction;
3.13.2 for the purposes of this service, a pharmacist (including the
prescriber), pharmacy technician or pre-reg foundation pharmacist
may administer the vaccine, but the clinical responsibility for the
appropriateness of the vaccination rests with the prescribing
pharmacist;
3.13.3 the prescribing pharmacist must be present when vaccines are
administered under a PSD;
3.13.4 the prescribing pharmacist must be satisfied that the person to whom
the administration is delegated under the PSD has the qualifications,
experience, knowledge, and skills to provide the care or treatment
involved;
3.13.5 the PSD must include all of the information required in law and in line
with current best practice guidance – see:
https://www.sps.nhs.uk/articles/questions-about-patient-specific-
directions-psd/
3.13.6 a copy of the PSD must be retained in the pharmacy in line with the
Department of Health guidance available here:
https://digital.nhs.uk/data-and-information/looking-after-
information/data-security-and-information-governance/codes-of-
practice-for-handling-information-in-health-and-care/records-
management-code-of-practice-for-health-and-social-care-2016
4. PROVIDER RESPONSIBILITIES
Contractors
4.1. Contractors wishing to provide the service shall apply to their Local Health
Board;
On-site provision
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 6 of 144.2. Within the pharmacy, the contractor shall ensure that the service is only
provided from an area in the pharmacy which:
4.2.1. is a clearly designated area for provision of services which is distinct
from the general public areas of the pharmacy; unless the pharmacy
is closed to other members of the public, in which case the service
may be provided from any part of the pharmacy providing conditions
4.2.2 to 4.2.7 continue to be met;
4.2.2. is an area where both the patient receiving the service and the
vaccinator can sit down together and talk at normal speaking volumes
whilst maintaining an appropriate level of confidentiality from other
visitors to the pharmacy or any other person, including pharmacy
staff;
4.2.3. is an area which ensures the dignity and privacy of the patient is
maintained;
4.2.4. is of an appropriate size and layout to facilitate the carrying out
vaccination in accordance with accepted standards of safe
immunisation practice including the management of any potential
adverse effect, including provision of basic life support and
anaphylaxis management;
4.2.5. has suitable facilities to ensure adequate hand hygiene can be
maintained;
4.2.6. has suitable arrangements in place with their Local Health Board for
the safe disposal of sharps and clinical waste;
4.2.7. allows access to the Choose Pharmacy application, or alternative
electronic system, to enable contemporaneous record keeping using
the seasonal influenza vaccination module. Paper records may be kept
temporarily should the system be unavailable due to technical fault
etc. but the electronic record must be updated as soon as is
practicable.
Off-site provision (see appendix 1)
Contractors may provide the service “off-site” to eligible patients. In such cases the
service must be provided from an area which:
4.2.8. allows both the patient receiving the service and the vaccinator to sit
down together and talk at normal speaking volumes whilst
maintaining an appropriate level of confidentiality from other visitors
to the off-site premises or by any other person, including pharmacy
staff or staff at the off-site premises;
4.2.9. ensures the dignity and privacy of the patient is maintained;
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 7 of 144.2.10. is of an appropriate size and layout to facilitate vaccination in
accordance with accepted standards of safe immunisation practice
including the management of any potential adverse effect, including
provision of basic life support and anaphylaxis management;
4.2.11. has suitable facilities to ensure adequate hand hygiene can be
maintained;
4.2.12. has suitable arrangements in place for the safe disposal of sharps and
clinical waste;
4.2.13. allows the keeping of temporary, confidential and contemporaneous
paper records to enable updating of the electronic choose pharmacy
record as soon as is practically possible and before the end of the next
working day, or afford remote access to the Choose Pharmacy
application, or other clinical record system.
In addition to the provisions outlined above the contractor should ensure there are
appropriate procedures in place to enable safe transfer of vaccines (including
maintenance of the cold chain), patient records and clinical waste and sharps
between the pharmacy and the premises where the service is provided. This should
have regard to:
4.2.14. Safe transport and storage that meets the requirements of the
Summary of Product Characteristics for the vaccines used;
4.2.15. Safe transport and storage of sharps and clinical waste including
compliance with any relevant regulation;
4.2.16. Secure and confidential transport and storage of patient clinical
records and procedures to ensure that consent is documented and
records maintained in line with this service specification. “Off-site”
movements of patient records should be included in the contractor’s
Information Governance policy.
Out of hours provision
To facilitate the provision of “flu clinics” by pharmacy contractors, the service may
be provided in the pharmacy or off-site, outside of normal pharmacy opening hours.
In all cases, the standards for service provision remain as laid out in this document.
General provisions
4.3 The contractor should inform local GP practices as soon as possible that they
intend to provide the Flu Vaccination service during the relevant season;
4.4. The contractor shall ensure that all records of vaccinations provided are kept
safely and securely;
4.5. The contractor shall ensure that vaccinators have indemnity insurance covering
their role in the provision of the service;
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 8 of 144.6. All support staff shall be fully informed and suitably trained in relation to their
involvement in the service, which may include the provision of any part of the
service provided on behalf of an accredited pharmacist, if they are competent
and it is legal for them to do so. For the purpose of this agreement, staff shall
include any person or persons employed or engaged by the contractor, to
provide any part of the service;
4.7. The contractor shall have awareness of, and ensure the service is provided in
accordance with any relevant nationally agreed standards, this will specifically
include, but not be limited to, having in place procedures for dealing with needle
stick injuries, syncope and resuscitation;
4.8. The contractor shall ensure that all standards required by the General
Pharmaceutical Council, so far as they relate to pharmacy owners and
superintendent pharmacists, are met;
4.9. The contractor shall ensure that, prior to entering into any agreement to
provide the service, they are satisfactorily complying with his or her obligation
under Schedule 5 part 2 to the National Health Service (Pharmaceutical
Services) (Wales) Regulations 2020 to provide pharmaceutical essential
services and have a system of clinical governance that is acceptable;
4.10. The contractor shall notify the relevant Local Health Board, of circumstances
that result in the temporary unavailability of the service for any period that
would preclude patients from access to any supply due to them in that period;
4.11. The contractor shall ensure that any publicity material not directly supplied by
the health board or Public Heath Wales states that the service is “funded by
NHS Wales”;
4.12. The contractor shall participate in any reasonable review of the service required
by the Local Health Board;
4.13. The contractor shall ensure that the service is provided only by vaccinators
who:
4.13.1. Meet the requirements of the Health Education and Improvement
Wales (HEIW) National Enhanced Service Accreditation (NESA)
Process and the HIEW accreditation for the provision of the influenza
immunisation service 2021/22; and
4.13.2. Have either:
previously completed a face-to-face Basic Life Support competence
assessment with an HEIW recognised provider, and have maintained
competence through completing an approved online refresher course
at least once every 12 months since the last face to face competence
assessment (route not permitted in BCUHB);
Or
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 9 of 14completed a face-to-face Basic Life Support competence assessment
with an HEIW recognised provider in the previous 12 months; and
4.13.3. Have their names included in the All Wales Pharmacy Database for the
service (where operating under the PGD); and
4.13.4. Have been offered vaccination against hepatitis B; and
4.13.5. Have a NADEX account that enables access to the Choose Pharmacy
application, or have access to an appropriate mechanism to maintain
clinical records; and
4.13.6. Have successfully completed an enhanced Disclosure and Barring
Service check; and
4.13.7. Have signed the PGD agreement form issued for the service by the
Local Health Board, or are operating under a PSD.
Pharmacists providing the service, or issuing PSDs
4.14. Pharmacists shall ensure that they meet the requirements set out in 4.13
above;
4.15. Pharmacists shall sign a copy of the PGD agreement form at each pharmacy
premises where they provide the service, unless they are only providing
vaccines under their own authority as a prescriber;
4.16. Pharmacists providing the service will have indemnity insurance covering the
provision of the service.
Pharmacy technicians and pre-reg foundation pharmacists providing the
service under a PSD
4.17. Pharmacy technicians and pre-reg foundation pharmacists shall ensure that
they meet the requirements set out in 4.13 above;
4.18. Pharmacy technicians providing the service will have indemnity insurance
covering the provision of the service.
5. LOCAL HEALTH BOARD RESPONSIBILITIES
5.1. Local Health Boards, or their authorised officers, shall determine the fees and
allowances payable in respect of the service;
5.2. The Local Health Board shall enter into a Service SLA with all pharmacies
commissioned to provide the service. The format of the SLA may be determined
locally but its content shall not contain additional requirements over and above
the provisions of this specification;
5.3. The Local Health Board, or its authorised officer, shall provide details of
services, this will include any relevant telephone numbers, to which providers
can signpost patients requiring further assistance. The Local Health Board will
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 10 of 14also have in place reasonable measures to ensure that pharmacies and other
stakeholders are aware of local service provision;
5.4. The Local Health Board will put in place appropriate arrangements to
communicate the service to the target population;
5.5. The Local Health Board, or its authorised officer, shall ensure that procedures
are in place to facilitate effective communication and referral between providers
and appropriate local NHS services;
5.6. The Local Health Board, or its authorised officer, shall support the resolution of
difficulties so far as they relate to issues within the control of the Local Health
Board;
5.7. The Local Health Board, or its authorised officer, shall support the handling of
any complaints or issues relating to the service so far as they relate to issues
within the control of the Local Health Board;
5.8. The Local Health Board will make available a PGD for the provision of the
service.
6. WELSH GOVERNMENT RESPONSIBILITIES
6.1. The Welsh Government shall make provision for the Choose Pharmacy
application or any replacement mechanism to be available to each pharmacy
providing the service;
6.2. The Welsh Government shall make provision for the details of each pharmacy
providing the service to be included in the All Wales Pharmacy Database;
6.3. The Welsh Government shall make provision for the details of each pharmacist,
approved to provide the service, to be included in the All Wales Pharmacy
Database and shall ensure reasonable access for contractors wishing to verify
the accreditation of pharmacist;
6.4. The Welsh Government shall make provision for the fees and allowances
payable for provision of the service to be published in the Drug Tariff;
6.5. The Welsh Government shall make provision for an appropriate level of service
performance information to be available to, the contractor, Local Health Boards
and other organisations of NHS Wales (e.g. Public Health Wales NHS Trust),
and to Community Pharmacy Wales;
6.6. The Welsh Government will develop a list of approved training providers that
can be used to support this service;
6.7. The Welsh Government will make available a template PGD for the provision of
the service.
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 11 of 147. CONFIDENTIALITY AND DATA PROTECTION The Provider will ensure that no-one shall, whether during or after their appointment, disclose or allow to be disclosed to any person (except on a confidential basis to their professional advisers) any information of a confidential nature acquired by the Provider or any other individual in the course of carrying out their duties under this Agreement, except as may be required by law or as directed by the Commissioner. The Provider must protect personal data in accordance with the provisions and principles of Data Protection Act and the Confidentiality: NHS Wales Code of Practice, and must ensure that all staff that have access to such data are informed of, and comply with this requirement. The Provider shall at all times ensure that appropriate technical and organizational security measures shall be taken against unauthorised or unlawful processing of personal data and against accidental loss or destruction of, or damage to, personal data. The Provider must be aware that the any information held by the Welsh Government, Local Health Boards or their authorised officers, may be subject to disclosure under the Freedom of Information Act. 8. AUTHORISED OFFICERS For the purpose of the service the Welsh Government and Local Health Boards shall inform the provider immediately, in writing, of the details of any officer authorised to act on its behalf. Any notice, information or communication given by the authorised officer shall be deemed to have been given by the Welsh Government or Local Health Board as the case may be. 9. REVIEW VARIATION AND TERMINATION The service specification shall be reviewed at least annually. Variation to the service specification, Competency and Training Frameworks and the Choose Pharmacy application can only be made with the agreement of the Welsh Government and only following consultation with Community Pharmacy Wales. Contractors will be notified of any variations to the service specification in writing. No variation to the specification will be made until 90 days after that notice is received. Providers, as signatories to the SLA, may cease to provide the service by giving notice in writing to the Local Health Board. In the event of such notice the service will be terminated 90 days after that notice is received. BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 12 of 14
10. CLAIMS, FEES AND ALLOWANCES
10.1. The contractor shall receive a professional fee on each occasion a flu vaccine is
administered in the course of the service. Fees will be published in the Drug
Tariff;
10.2. The contractor shall receive reimbursement for the cost of any flu vaccination
administered in the course of the service;
10.3. Contractors shall submit claims for any vaccinations administered by a
pharmacist using the Choose Pharmacy application
10.4 Claims for vaccinations administered by a pharmacy technician or pre-reg
foundation pharmacist under a PSD will be submitted via NECAF;
10.5. Fees and allowances shall be paid monthly in arrears;
10.6. Claims for payment shall be subject to Local Health Board arrangements for
Post Payment Verification;
10.7. Fees for the provision of the service are based on the requirements of the
Community Pharmacy National Enhanced Services Competency and Training
Framework.
11. DOCUMENTATION
All records shall be made for the service via the NHS Choose Pharmacy application
or other approved clinical record management system. Paper documentation for use
when the service is unavailable is available from the Local Health Board.
BCUHB Seasonal Influenza Vaccination Service (PGD and PSD) 2021/22 Page 13 of 14Appendix 1: Providing vaccination off premises or in an area within the
pharmacy outside the consultation room
When providing vaccination services away from the pharmacy premises, or in an
alternative location to the consultation room, it is important that the pharmacist
considered the information governance, infection prevention and control, and clinical
governance measures that are needed to ensure the safe and effective running of
the service.
The below checklist is provided as guidance to help with this process and any
contractors using these flexibilities would be expected to be able to provide, on
request, written evidence of the steps taken to address each of these items.
• Appropriate transportation arrangements to maintain the vaccine cold chain
are in place which uses a validated cool box with maximum/minimum
thermometers.
• Immunisation will be carried out by a pharmacist (or other permitted
vaccinator) meeting the relevant NHS accreditation requirements.
• Appropriate hygiene and infection prevention measures will be in place to
enable sanitisation / cleaning of hands between every patient.
• Appropriate personal protective equipment will be available
• Immunisation will take place in an appropriate area where the patient can sit
down and confidentiality can be maintained.
• A suitable area will be available for patients to be observed following
vaccination, where required.
• Appropriate arrangements are in place for clinical record documentation
including mechanisms to maintain confidentiality and ensure prompt
transmission of information regarding vaccination to the patient’s GP
• Appropriate arrangements for the management of anaphylaxis will be in place,
including adrenaline and emergency telephone access.
• Appropriate arrangements for the management of clinical waste will be in place
(including transportation back to the pharmacy).
• Suitable indemnity arrangements will be in place.
• Information is provided to the patients GP in a timely fashion
• Choose Pharmacy flu vaccination records are updated on the same or the next
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