Flu Vaccination FAQs

Flu Vaccination FAQs

Following publication of the service specification and Patient Group Direction (PGD) this page is currently being updated. The FAQs listed relate to the 2018/19 service; however, further FAQs will continue to be added.

Page last updated: 18th September 2018


Click on a heading below for more information. 

Background and general

Q. Can distance selling pharmacies provide the Flu Vaccination Service?
Yes. A distance selling pharmacy may provide Advanced and Enhanced Services, if any Essential Service which forms part of the Advanced or Enhanced Service is not provided to persons present at the premises. The distance selling pharmacy must fully meet the requirements for the provision of the Flu Vaccination Service, which includes the consultation room requirements.

Q. What insurance should you have for the Flu Vaccination Service?
Advice should be sought from your insurance provider.

Q. Can pharmacies in Wales provide the Advanced Service?
The Advanced Service only applies to England; Community Pharmacy Wales undertakes separate negotiations on Advanced Services which are provided in Wales.

Q. How do contractors inform NHS England that they intend to provide the Advanced Service?
The requirement for contractors to notify NHS England that they intend to provide the service has been removed for 2018/19.

Q. Where can I obtain statistics from previous years on the national pharmacy Flu Vaccination Service?
Information on how many vaccinations have been provided under the national pharmacy Flu Vaccination Service in previous years can be found on the Flu Vaccination – Statistics page.

 

Commissioning

Q. A seasonal Flu Vaccination Service is commissioned locally from community pharmacies in my area (as well as the national Flu Vaccination Service). Will this still be commissioned?
Normally this service is commissioned by NHS England, and the national Flu Vaccination Service replaces any service commissioned by local NHS England teams for the patient groups covered by the national service. Some local NHS England teams may commission a Flu Vaccination Enhanced Service to provide the service to additional groups of patients over and above the Advanced Service target groups.

Q. Will the Flu Vaccination Service be commissioned on an ongoing basis?
The expectation is that this service will be commissioned on an ongoing basis; however, as with any service commissioned by the NHS, it will be necessary to demonstrate that the service is offering value for money and having a positive impact on patient care.

Q. I was an essential small pharmacy, but I now have a replacement LPS contract. Will I be able to provide the Flu Vaccination Advanced Service?
All the services to be provided by an LPS contractor must be agreed between NHS England and the pharmacy and be included in the LPS contract. As the very substantial benefits of pharmacies providing the Flu Vaccination Service are recognised by NHS England – which has agreed this for the standard pharmacy contractual arrangements, PSNC recommend that LPS contractors contact their local NHS England team to propose a contract variation, to include a Flu Vaccination Service.  The location of the ‘essential small pharmacy’ LPS premises often in areas where there are no other healthcare providers could provide a very convenient service for the public who would otherwise be hard to reach.

 

Premises requirements

Q. My pharmacy doesn’t have a consultation room; can I provide the Flu Vaccination Service?
No. Having a consultation room is a prerequisite for provision of the Flu Vaccination Service. The consultation room, which will be used to undertake vaccinations, must comply with the minimum requirements set out below:

  • the consultation room must be clearly designated as an area for confidential consultations;
  • it must be distinct from the general public areas of the pharmacy premises; and
  • it must be a room where both the person receiving services and the pharmacist providing those services are able to sit down together and talk at normal speaking volumes without being overheard by any other person (including pharmacy staff), other than a person whose presence the patient requests or consents to (such as a carer or chaperone).

The consultation room must also meet the General Pharmaceutical Council (GPhC) Standards for Registered Premises.

Q. We are a distance selling pharmacy without a consultation room; can I provide the Flu Vaccination Service to patients in their own homes? 
No. Community pharmacy contractors must have a consultation room that meets the requirements outlined in the service specification, even if they intend to vaccinate off-site only.  

 

Ordering and use of appropriate flu vaccinations

Q. Does the aTIV vaccine (Fluad®) require reconstitution?
No. The aTIV vaccine (Fluad®) does not require reconstitution.

Q. Will GP practices have the same phased delivery of aTIV as community pharmacies?
Yes. GPs and community pharmacies will all receive 40% of their aTIV order in September, 20% in October and 40% in November. 

Q. Will wholesalers be receiving aTIV deliveries?
PSNC has been informed that large wholesalers may be receiving aTIV deliveries; contractors will need to contact wholesalers to enquire about purchasing and delivery timescales.

Q. I have accidentally vaccinated a patient with a vaccine that is not recommended for their age group; what should I do?
Public Health England has advised healthcare practitioners of the process to follow:

  • inform the patient of the error and its potential implications;
    • advise the patient that although the quadrivalent influenza vaccine (QIV) and adjuvanted trivalent influenza vaccine (aTIV) will offer some protection to all age groups, individuals aged 65 years and over (particularly those more than 75 years of age) may not respond as well to the QIV as they would to the aTIV, and individuals aged under 65 years will not benefit from the opportunity to make protection against an additional flu strain if they have been given aTIV;
  • following a discussion about the risks and benefits, advise the patient that they could, if they wish, be given a second dose of the vaccine they should have had;
    • the clear benefit is the additional protection that may be offered by the correct vaccine, but they should be alerted to the potential increased risk of a local or systemic reaction. Although there is no data available on the safety and effectiveness of administering a second flu vaccine shortly after the first in adults, this advice is based on general principles of vaccination, experience of flu revaccination following cold chain and administration incidents and information about the high dose flu vaccine used in the United States (which contains four times the amount of antigen that is in a single dose of QIV or aTIV);
  • if a decision is made to offer the vaccine the patient should have received, it is recommended that this is done as soon as possible after the first dose was given and ideally within a week. This will enable protection to be made as soon as possible. It can, however, still be given if more than a week has elapsed.

This advice also applies to those who have inadvertently been given non-adjuvanted trivalent influenza vaccine (TIV).

Q. Why is aTIV more effective in those aged 65 years and older?
In June 2017, the Joint Committee on Vaccination and Immunisation (JCVI) reviewed the published data that aTIV has higher vaccine immunogenicity and higher effectiveness than non-adjuvanted vaccines in the elderly. (VanBuynder et al., Vaccine 2013, Dominich et al., 2017). Mathematical modelling by PHE indicated that, even under quite conservative estimates of improved effectiveness, aTIV would be highly cost-effective in both the 65-74 and 75 year and over age groups (in press). Given the low influenza vaccine effectiveness seen in the over 65 year olds in seasons dominated by A(H3N2), the JCVI agreed that use of aTIV in those aged 65 years and over would be both more effective and cost-effective than the non adjuvanted vaccines currently in use. JCVI also agreed that the priority for aTIV should be for those aged 75 years and above as this age group appear to derive little benefit from the un-adjuvanted vaccine (JCVI, October 2017). 

Q. Our Fluad® (aTIV) vaccines haven’t arrived yet but a 72 year old patient has walked in and has asked to be vaccinated with another vaccine; can I offer another vaccine?
aTIV is the recommended flu vaccine for people in this age group. This is because aTIV is likely to give better protection against flu. It would therefore be best to wait until you have more supplies of aTIV which will offer the patient the best protection.

Q. Is having Fluad® (aTIV) in November not too late to offer protection?
No. Flu usually starts circulating from December onwards. It can be earlier, but if the vaccination takes place in November, the patient should still benefit from its protective effect. It is better to wait for the vaccine that is most effective for the appropriate age group.

Q. A 68 year old patient has asked if it would be better to have a quadrivalent vaccine (QIV) now because it is in stock, rather than returning later in the season for Fluad® (aTIV). What should I advise?
The aTIV is the recommended flu vaccine for all people aged 65 years and over. This is because the aTIV is likely to give better protection against flu. It would therefore be best to wait until further supplies of aTIV have arrived which are known to offer the best protection for this age group.

Q. People who have their 65th birthday before 31st March 2019 will be eligible for the influenza vaccine so may not be 65 when they are immunised. Which vaccine should they have?
It is appropriate to offer aTIV ‘off label’ to those having their 65th birthday before 31st March 2019 and who are thus eligible to receive influenza vaccine under the current definition of the ‘over 65’ group. Although aTIV is not licensed in those less than 65 years of age ‘off label’ use is an option. The PGD for 2018/19 has included this off label indication.

Q. If aTIV is stronger, does it have more side effects?
There may be some mild reactions to any flu vaccine, but serious side effects are very rare. aTIV is slightly more likely to give a local reaction around the injection site; however, aTIV benefits people aged 65 years and over as it gives a better protection against flu.

Q. Should Fluad® be administered intra-muscularly or subcutaneously?
Fluad® is not licensed for subcutaneous administration, therefore it should be administered intra-muscularly as stated in the PGD.

Q. I have accidentally vaccinated a patient subcutaneously with a vaccine that is only licensed for the intramuscular route. Do I need to re-vaccinate them?
No. If vaccines that are only licensed for the intramuscular route are given subcutaneously in error, they do not need to be repeated but the vaccinated individual should be warned of the increased risk of local reactions at the injection site.

Q. Do we need to attach a needle to Fluad® vaccines?
Yes. Due to the increased volume of Fluad® to be produced, the manufacturer will, for the 2018/19 season only, deliver most of the supply in pre-filled syringes (Luer Lock) with a separate needle which will require attachment prior to administration of the vaccine.

From the 2019/20 season onwards, aTIV will be supplied in the more usual presentation of a pre-filled syringe with an attached needle.

Q. I have already ordered a brand of a non-adjuvanted trivalent vaccine; can this be used to vaccinate the 65 or over age category instead of aTIV?
No. Only the adjuvanted trivalent influenza vaccine (Fluad®) can be used to vaccinate those in the o 65 or over age category. The non-adjuvanted influenza vaccine is not one of the recommended vaccines for 2018/19but may be administered where the recommended vaccine choices are unobtainable; please see the PGD for further details.

Q. If a patient is 64 but will be turning 65 during the flu season (i.e. between 1st
September 2018 and 31st March 2019), which vaccination should be administered?
The PGD states that aTIV (Fluad®) may be administered under the PGD to 64 year olds turning 65 years of age by 31st March 2019 in accordance with the recommendations for the national immunisation programme for 2018/19. However, this is an off-label use.

Where a vaccine is recommended off-label, as part of the consent process, pharmacists should consider informing the individual/carer that the vaccine is being offered in accordance with national guidance but that this is outside the product licence.

Service specification and Patient Group Direction

Q. What is the clinical code in table 1 of the service specification?
This is a code used by GP practice IT record systems to record clinical information in a standardised way. There is one coding system currently in use in England and the code for ‘Seasonal influenza vaccination given by pharmacist’ is listed in table 1 for this coding system. The code is also listed on the national GP Practice Notification Form.

Q. What does the service specification mean when it says a contractor should seek to ensure that the service is available throughout the pharmacy’s contracted opening hours?
That wording reflects NHS England’s desire that the service is very accessible for patients and that there is therefore continuity of service provision across the full opening hours of the pharmacy. In previously commissioned local vaccination services, good availability of the service across the week was an aspect of the service that was highly valued by patients. Once a contractor starts to provide the service they must ensure, in so far as is practicable, that the service is available throughout the pharmacy’s core and supplementary opening hours.

Q. The service specification states that the pharmacy contractor should seek to ensure that the service is available throughout the pharmacy’s contracted opening hours – does this mean that locum pharmacists that I book to work in my pharmacy have to be qualified to provide the Flu Vaccination Service?
Wherever practicable, once a contractor starts to provide the service they must ensure, in so far as is practicable, that the service is available throughout the pharmacy’s contracted opening hours. Therefore, contractors should seek to book locum pharmacists who are trained and competent to provide the Flu Vaccination Service.

Q. Does a contractor have to make a ‘prescription register’ entry for each administration of vaccine under the national PGD?
No. The records required to be maintained by the PGD, which are those included in the Flu Vaccination Record Form, made on the date of administration meet the requirements to make records in the Human Medicines Regulations. These records may be kept as a paper record or electronically.

Q. Do pharmacists have to sign a copy of the national PGD?
Yes, pharmacists must sign a copy of the PGD to indicate that they understand the PGD requirements and agree to work under those requirements.

Q. Can the PGD be signed remotely (electronic signature) by the authorising manager, for example, from the pharmacies’ head office for all of their pharmacies?
Yes. It is possible for the PGD to be signed remotely (electronic signature); however, the authorising manager still needs to be able to confirm the pharmacist:

  • is aware of the service specification and requirements for provision of the service;
  • has completed the Declaration of Competence self-assessment framework and has printed and signed the statement of declaration; and
  • has the organisation’s approval to provide the service.

Q. Should a copy of the signed Declaration of Competence (DoC) statement and the signed PGD be kept at the pharmacy for each pharmacist providing the service at the pharmacy?
Yes. The service specification states that the contractor must keep a copy of the completed DoC on the pharmacy premises for each pharmacist providing the service. The DoC statement says a copy of the signed PGD should be attached to the DoC statement.

Q. What is the legal basis for the administration of flu vaccinations in the new Advanced Service?
A national PGD provides the legal authority for supplying the vaccine.

Q. Can pharmacy staff other than a pharmacist administer the vaccine?
No. The flu vaccination is administered under the authority of the national PGD and the associated regulatory requirements mean that products have to be administered by a pharmacist; administration of a parenteral POM cannot be delegated to another person after the supply has been made under a PGD by a pharmacist.

Q. Can a nurse administer the vaccine as part of the service?
No, only a pharmacist can administer the vaccine under the service.

Q. Can a pharmacy technician administer the vaccine?
No. The flu vaccination is administered under the authority of a PGDand the associated regulatory requirements mean that products have to be administered by a pharmacist: administration of a parenteral POM cannot be delegated to another person after the supply has been made under a PGD by a pharmacist.

Q. Can a pharmacist providing the service and qualified as an independent prescriber prescribe the vaccine for patients, rather than using the national PGD?
No. The Advanced Service only uses the national PGDto authorise administration of the vaccine.

Q. Does the national PGD authorise administration of the vaccine for other patients not covered by the NHS eligibility criteria (i.e. as a private service)?
No. If pharmacies wish to provide a private Flu Vaccination Service in addition to the Advanced Service, they need to ensure that another suitable PGD is in place to allow provision of a private service.

Q. Do pharmacists have to send a copy of the signed PGD to NHS England or another organisation?
No. The signed PGDshould be retained in the pharmacy where the pharmacist is administering vaccines.

Q. Can a pharmacy company with multiple pharmacies nominate one authorising manager for all pharmacists signing the PGD, for example, the superintendent pharmacist?
Yes, as it is for the contractor to determine who should be an authorising manager within their organisation.

Q. Who should complete the authorising manager declaration section on the PGD?
It is for the contractor to determine who should be an authorising manager within their organisation. The authorising manager’s role is to confirm the pharmacist:

  • is aware of the service specification and requirements for provision of the service;
  • has completed the Declaration of Competence self-assessment framework and has printed and signed the statement of declaration; and
  • confirm that the pharmacist has the organisation’s approval to provide the service.

In certain circumstances, for example, a community pharmacy where the pharmacist who will administer vaccines is also the superintendent pharmacist or contractor, it may be necessary for the authorising manager to be the same person as the practitioner, though this situation should be avoided wherever possible.

Q. Does the national PGD authorise administration of the flu vaccine via subcutaneous injection?
Yes. Flu vaccines licensed for intramuscular or subcutaneous administration may alternatively be administered by the subcutaneous route. Pharmacists should only administer vaccines via the subcutaneous route if they have been trained to do this and they have made a professional decision that this is the right approach for the individual patient. If a pharmacist is not trained to administer vaccines via the subcutaneous route or if they are uncertain about whether that approach is right for an individual patient, they should refer relevant patients to their GP practice.

Note: Fluarix® Tetra▼ and Fluad® are not licensed for subcutaneous administration so should only be administered intramuscularly under the national PGD.

 

Training requirements (General)

Q. What are the knowledge and skills required in order to provide a vaccination service?
The National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitionersset out the knowledge and skills that healthcare professionals undertaking vaccination services need to have. NHS England has determined that pharmacists providing the Flu Vaccination Service need to attend face-to-face training for both injection technique and basic life support training every three years. This requirement means that a pharmacist who undertook face-to-face training for both injection technique and basic life support in 2016 would not need to undertake face-to-face training until 2019. Pharmacists who last undertook face-to-face training in 2015 would need to undertake face-to-face training in 2018, prior to providing the Flu Vaccination Service.

Q. Do the 2018 National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners contain lots of changes compared to the previous 2005 versions?
No. The revised document contains several updates to the 2005 version, but most of the revisions reflect the expansion of the immuniser workforce beyond doctors and nurses, and the approach that has been taken in recent years to the training of pharmacists and other ‘new’ vaccinators. For example:

  • e-learning courses may provide an effective mechanism through which immunisers can access training. A blended learning approach can be utilised with an e-learning course used alongside face-to-face sessions;
  • foundation training and updates should be tailored to suit the requirements of the immunisers to their specific area of practice and the vaccine(s) that they administer. So, the training of a new immuniser who will only administer one type of vaccine should cover all the topics in the core curriculum, but these should be made context and vaccine specific. With only one vaccine to cover, length of training will be shorter than for those who give a range of different vaccines; and
  • annual update training – face to face updates are likely to be of particular value to those who give or advise on a diverse range of immunisations, e.g. practice nurses. However, it is recognised that for some immunisers in some areas of practice, face-to-face updates may not be feasible, and updating may be best undertaken through self-directed learning. Methods for this may include undertaking the assessment modules of an immunisation e-learning programme and doing/re-doing the necessary modules to refresh knowledge. Practitioners could also read through the ‘Information for healthcare practitioner’ documents on the PHE website, listen to any available webcasts and read recently published articles on immunisation relevant to their area of practice.

Q. Where can I undertake training to provide vaccination services?
A range of organisations provide training for pharmacists on vaccination. Some LPCs have arranged training for local pharmacists, so you may want to check with your LPC about the availability of local training. A list of training providers is also available on the PSNC website.

Q. I completed face-to-face training covering injection technique and basic life support last year, but I have been told that unless I vaccinated over a specific number of patients last year I will need to re-do the training again this year. Does this apply to the NHS Advanced Flu Vaccination Service?
No, this does not apply to the NHS Advanced Flu Vaccination Service. NHS England has determined that pharmacists providing the Flu Vaccination Service need to attend face-to-face training for both injection technique and basic life support training every three years, irrespective of how many vaccines are administered each year.

If you are providing private flu vaccinations (not as part of the NHS Advanced Flu Vaccination Service) there may be minimum activity requirements in order for your training to be valid; this should be verified with the private PGD provider.

Q. I completed face-to-face training for both injection technique and basic life support two years ago – do I need to complete face-to-face training again this year?
No. Face-to-face training for both injection technique and basic life support must be completed every three years (previously this training was required every two years).

This requirement means that a pharmacist who undertook face-to-face training for both injection technique and basic life support in 2016 or 2017 would not need to undertake face-to-face training in 2018. The pharmacist would then need to undertake face-to-face training in 2019 in order to continue to provide the service in 2019/20. Pharmacists who last undertook face-to-face training in 2015 would need to undertake face-to-face training in 2018, prior to providing the Flu Vaccination Service 2018/19. 

Q. I completed face-to-face injection technique and basic life support training last year. Do I need to complete online refresher training this year?
No, there is no requirement to complete online refresher training for the national Flu Vaccination Service. Pharmacists may choose to do this or undertake other types of CPD relating to the service, but this is not a mandatory service requirement.

If you are providing private flu vaccinations (not as part of the NHS Advanced Flu Vaccination Service) there may be a requirement to complete online refresher training; this should be verified with the private PGD provider.

Q. There is free flu training available for healthcare professionals on www.e-lfh.org.uk; if I study it and pass the assessments does it count as an online refresher course provided I have had face-to-face training within the last three years?
If the pharmacist has completed their face-to-face training and relevant Declaration of Competence, it is up for them to determine how they wish to do annual update training that meets their needs. This could include, for example, completing a CPPE learning pack, completing online assessments, reading books/articles or watching videos.

There is no stipulated way to do annual update training, but vaccinating pharmacists have a professional obligation to ensure their skills and knowledge are kept up to date.

Q. Is there any other training I should consider?
As well as training specifically on vaccination provision, contractors and pharmacists should consider training for themselves or their team on topics such as consultation skills or first aid, or even marketing or time management, as these may better equip them to provide the service. The core vaccination training will cover matters such as management of allergic reactions and patient consultation.

Q. Does the move to a three year face-to-face training for both injection technique and basic life support match the level of training required for nurses and GPs? 
The move to three yearly face-to-face training is designed to reflect the increased practical experience that many pharmacist vaccinators now have and is better aligned with other professions.  

Nurses, GPs and all registered professionals who provide vaccination services are required to complete annual update training. This update training does not have to be a face-to-face training course provided by an external company; most nurses and GPs receive in-house training every year at little or no additional cost. This does not incur the same level of costs for community pharmacy contractors and pharmacists who previously had to complete external face-to-face training every two years.  

 

Training requirements (Declaration of Competence)

Q. How will contractors determine that their pharmacists have the necessary knowledge and skills to provide the service?
The Declaration of Competence (DoC) approach (developed by the Community Pharmacy Competence Group) is being used to assure contractors that pharmacists have the necessary knowledge and skills to provide the service. A Vaccination services DoC must be used for the Advanced Service; it is available on the CPPE website.

Q. Which vaccination DoC should I use for the Advanced Service?
You must use the Vaccination services DoC; this can be used for the Advanced Service as well as locally commissioned vaccination services.

Q. Once a pharmacist has completed the DoC self-assessment framework and has printed and signed the statement of declaration, is the DoC process complete?
Once both of these documents have been completed and signed, the pharmacist will be able to demonstrate to the contractor that they are working for that they have the necessary knowledge and skills to provide the service. However, it is important to complete step 5 of the DoC process ‘Update your CPPE learning record’. This step confirms that the statement of declaration for Vaccination services has been signed.

Q. Since the requirement for face-to-face training for both injection technique and basic life support now needs to be completed every three years (previously this training was required every two years), will the DoC requirement also change to every three years so the requirements can be synchronised?
No. The Declaration of Competence process remains unchanged; this needs to be completed every two years. 

Q. Since there is a new DoC for the Flu Vaccination Service (Vaccination services), is the DoC I completed last year still valid?
Yes. Pharmacists must review their DoC every two years; there is no need for all pharmacists to immediately complete the new single Vaccination DoC unless they have not previously completed a DoC for flu vaccination or they are due to review their DoC. 

Q. If I am a pharmacist with a registered address in Wales or Scotland, but I will be working in an English community pharmacy providing the service, how can I access the DoC on the CPPE website?
Pharmacy professionals on the borders who work in England but live in Scotland or Wales can make a request to CPPE for their practice location to be changed on their database (telephone 0161 778 4000 or email info@cppe.ac.uk). This will allow the pharmacist access to learning and assessments plus the DoC. Every six months CPPE will automatically check if they still practise in England.

Q. The Vaccination services DoC provides a list of recommended learning and assessments; should all of these be completed?
This is a decision that needs to be made by the individual pharmacist. A pharmacist is personally responsible for keeping their knowledge and skills up to date and relevant to their roles and responsibilities. Working through the DoC system provides a pharmacist with the opportunity to reflect on their current competencies and identify and meet their learning and assessment needs.

The list of recommended learning and assessments will help pharmacists to fill any gaps in their knowledge or competence in order to provide the Flu Vaccination Service.

Q. If a pharmacist has completed an independent prescribing course, does this mean they meet the Consultation Skills for Pharmacy Practice: Practice Standards for England, and can complete the core competency section in the Vaccination services DoC?
The wording in the core competency within DoC states that pharmacy professionals should be actively working towards the Practice Standards. This is because developing consultation skills is an ongoing process throughout the career of every pharmacy professional. The independent prescribing course will have provided a pharmacist with an element of training on consultation skills to support them in working towards the Practice Standards; however, it would be down to the individual pharmacist to download the Consultation Skills for Pharmacy Practice: Practice Standards for England to see whether they feel the training they have undertaken has sufficiently supported them or whether further learning would be beneficial. If a pharmacist feels they meet the standards and have a good understanding of consultation skills due to the learning they have undertaken, they should attempt the consultation skills e-assessment, which will help assess their skills in this area and provide reassurance of competency.

Q. Is it a requirement to have accessed, but not necessarily completed the Consultation Skills for Pharmacy Practice: e-assessment to be able to provide the Advanced Flu Vaccination Service?
Pharmacists are not required to have completed the Consultation Skills for Pharmacy Practice: e-assessment before completing the Vaccination services DoC; they are required to meet or be actively working towards the Consultation Skills for Pharmacy Practice Standards for England.

If you confirm that you are actively working towards the standards, you are declaring that you are undertaking the relevant learning and CPD to meet the standards. It is expected that you will have accessed the standards and associated learning to meet this requirement and that you will complete the assessment within 12 months of signing the DoC statement.

As a pharmacy professional, you should continuously seek to develop your consultation skills throughout your career and, therefore, this topic should regularly feature in your CPD plan. To access the assessment, go to the CPPE website. If you have not yet completed the assessment, you should be able to provide evidence of the consultation skills learning you have undertaken.

Q. I signed the statement of declaration for the NHS seasonal influenza vaccination ADVANCED DoC last year, do I need to sign it again this year as it has been updated?
No. The statement of declaration will remain valid from the date it was signed for two years.

Q. Do pharmacists need to complete the safeguarding and consultation skills e-assessment every two years when reviewing their DoC?
This is a decision that needs to be made by the individual pharmacist. A pharmacist is personally responsible for keeping their knowledge and skills up to date and relevant to their roles and responsibilities.  There are regular developments in practice in particular with regard to Safeguarding which require pharmacists to ensure they are aware of new developments in this area.

The pharmacist should reflect on their current competencies and decide whether further learning is required.

It is also important to note that Consultation Skills for Pharmacy Practice is not a ‘tick box’ exercise. As a pharmacy professional, you should continuously seek to develop your consultation skills throughout your career and, therefore, this topic should regularly feature in your CPD plan.

 

Training requirements (Supervised clinical practice)

Q. I have heard that the 2018 National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners include a new requirement for supervised clinical practice following training. Is that correct?
A period of supervised clinical practice is recommended, but this is not a new requirement – this was also recommended in the 2005 documents.

Q. Who does the recommendation for a period of supervised clinical practice apply to?
The document states that those new to immunisation should receive comprehensive foundation immunisation training, either through a face to face taught course or a blended approach of both e-learning and a face to face taught course. New immunisers should also have a period of supervised practice and support with a registered healthcare practitioner who is experienced, up to date and competent in immunisation.

Q. Does the recommendation for a period of supervised clinical practice apply to pharmacists who have previously been trained to vaccinate?
If you have vaccinated patients in the past and consider yourself to be an experienced vaccinator, supervised practice would only be required if you feel it would benefit your professional practice, for example, if a long duration of time has passed since you last vaccinated patients.

Q. I am a pharmacist who is commencing immunisation training for the first time, so I can provide the Flu Vaccination Advanced Service. What are the steps I need to take?
If you are a new vaccinator we recommend the following steps:

  1. Complete your core training (face to face and any other learning directed by your training provider);
  2. Complete the Vaccination Services Declaration of Competence (DoC) on the CPPE website;
  3. Undertake a period of supervised practice with a registered healthcare practitioner who is experienced, up to date and competent in immunisation; then
  4. Should any additional training need be identified during your supervised practice, undertake the further training and then review your DoC.

Q. What is the idea behind undertaking a period of supervised practice?
In addition to acquiring knowledge through a theoretical taught course, practitioners need to develop clinical skills in immunisation and apply their knowledge in practice. A period of supervised practice will allow acquisition and observation of clinical skills and application of knowledge to practice when the practitioner is new to immunisation.

Q. What happens during a period of supervised practice?
Before starting to give immunisations, it is recommended that all new immunisers should spend time with an experienced registered practitioner, such as an experienced pharmacist immuniser, who has undertaken training that meets the national minimum standards and is experienced in advising about immunisation and giving vaccines. The new immuniser should have the opportunity in these sessions to observe and discuss relevant issues with the experienced practitioner.

Those new to their role in immunisation should also demonstrate an appropriate standard of practice to their supervisor. This supervised practice should be structured and robust and follow a clear, comprehensive checklist so each step of the consultation is considered. A competency checklist such as that written by PHE and the Royal College or Nursing (see Appendix A of the National Minimum Standards and Core Curriculum for Immunisation Training for Registered Healthcare Practitioners) should be used for formal assessment and sign-off of the practitioner’s clinical competency in immunisation. A copy of the completed checklist should be retained in the practitioner’s personnel file.

Q. How long should a period of supervised clinical practice be?
PHE advise that there is no agreement or evidence as to how many times supervised practice should occur, but both the supervisor and new practitioner need to feel confident that the practitioner has the necessary skills and knowledge to advise on and/or administer vaccines. If the practitioner administers a range of different vaccines to patients of different ages, their supervisor should ensure this is considered and they should be given the opportunity to observe and also be assessed on this range.

Q. Are there any qualifications which apply to the experienced healthcare practitioner?
The supervisor does not require a formal teaching and assessing qualification but should be competent in immunisation and have the ability to make an assessment of a new immuniser’s knowledge and skills. One of the supervisor’s key roles is to go through the assessment document with the new immuniser and assure themselves that the new immuniser has the appropriate level of knowledge and skill to undertake their role in immunisation.

Q. Can another pharmacist act as the experienced healthcare practitioner within a period of supervised clinical practice?
Yes, as long as the pharmacist is competent in immunisation and has the ability to make an assessment of a new immuniser’s knowledge and skills.

Q. How can a period of supervised clinical practice be arranged?
There are several ways a supervision session could be arranged, for example:

  • At the point of arranging face-to-face immunisation training, trainees could enquire whether the training provider could arrange such a session;
  • New immunisers could speak to the pharmacy contractor they work for to enquire whether they could arrange a supervised session with an experienced immuniser, within the same organisation; or
  • New immunisers could contact local pharmacist colleagues, who are experienced immunisers, and ask them whether they would be willing to supervise a session within their pharmacy.

Promoting the service to patients

Q. I want to develop my own promotional materials for the Flu Vaccination Service, am I allowed to do this?
Yes; however, contractors must ensure they comply with the requirements of the Terms of Service relating to promotion of services funded by the NHS and If the NHS logo is used in materials related to the service, this must comply with the guidelines for use of the NHS identity by community pharmacies.

The Flu Vaccination – promoting the service to patients page on the PSNC website provides links to resources from PSNC, Public Health England, NHS Employers and vaccine manufacturers, which contractors can use if they do not want to develop their own materials.

Q. Can a contractor provide a patient with any kind of free gift if they have a vaccination under the Advanced Service?
No. The Terms of Service state that a pharmacy must not offer any gift or reward to any person as an inducement to receive any Advanced Service.

Q. Will pharmacies be sent promotional materials? 
Pharmacy teams may receive promotional materials from their LPC or other local organisations. PSNC promotional materials will not be sent to pharmacies but are freely available to download from psnc.org.uk/flu 

 

Eligible patient groups

Q. If a patient was previously eligible for a flu vaccine but is currently no longer in a risk group, can they still receive a vaccine?
Some patients may have been eligible for a vaccine under the Flu Vaccination Service during previous flu seasons whilst in an at risk group but may no longer be in that group. Examples could include women who were pregnant during the last flu season but are no longer pregnant or patients who were taking regular inhaled steroids during last flu season but are no longer taking them.

Providing that these patients are not in any other risk group as detailed in Annex A of the service specification they would not be eligible for a flu vaccination this year under the Flu Vaccination Service.

Q. At what stage of pregnancy should pregnant women be offered the flu vaccine?
All pregnant women should be offered an inactivated influenza vaccine whilst pregnant, regardless of their stage of pregnancy. Studies have demonstrated that pregnant women can safely receive influenza vaccine during pregnancy and that infants also receive some protection from maternal antibodies because of their mother having the vaccination whilst pregnant.

Q. Can the flu vaccine be given to women who are breastfeeding?
Yes. The flu vaccine can be given to breastfeeding women; however, ‘breastfeeding women’ is not an eligible group for the Flu Vaccination Service. Breastfeeding women would only be entitled to a free flu vaccination if they fall into an eligible group listed in Annex A of the service specification.

Q. If a patient has already received a seasonal flu vaccine this year (e.g. in January 2018), do they still need a vaccine during this flu season (e.g. September 2018 – March 2019)?
Yes. If the patient received the vaccine produced for the 2017/18 season, then they will still need a dose of the vaccine produced for the 2018/19 season as the vaccine for 2018/19 contains different strains from the previous year.

In addition, the protection gained from flu vaccine is thought to last for one season only so those eligible to receive the vaccine are recommended to have it every year to ensure on-going protection.

Q. Can a homeless person have a flu vaccination?
A homeless person can have a flu vaccination if they fall into one of the eligible groups for the Flu Vaccination Service. Contractors should also consider the following:

  • The homeless person would need to come into the pharmacy for their vaccine, this couldn’t be provided at another location as the only off-site vaccinations that are allowed are those for people living in long-stay residential care homes, other long-stay care facilities or in a patient’s own home (where the pharmacy has an existing clinical relationship with the patient);
  • No fixed abode (NFA) can be written on the consent and record form in the patient’s address section;
  • If a homeless person is registered with a GP practice, notification would need to be sent to the GP practice if appropriate providing as much identifying information as the pharmacy can provide to allow the GP practice to match the information to the relevant person (some areas have specific homeless patient services to allow GP registration and some encourage registration at regular GP practices); and
  • If a homeless person is not registered with a GP, it will not be possible for the notification to be sent to a GP practice, but the service can still be provided to the person.

Q. A patient has requested a flu vaccination, but they seem generally unwell; can they receive the vaccine?
Vaccination may be postponed in those who are acutely unwell until they have fully recovered. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to the adverse effects of the vaccine.

Q. Can immunosuppressed patients have the flu vaccine?
Yes, the inactivated influenza vaccine can be safely given to immunosuppressed individuals though they may have a sub optimal response to the vaccine. Individuals may be immunosuppressed because of a medical condition or because of medical therapy that they are taking. As these patients are at risk of increased morbidity and mortality if they develop influenza they should be offered the vaccine. Immunosuppression may continue for a number of months following completion of treatment. If there is any uncertainty regarding an individual’s level of immunosuppression, further advice should be taken from their consultant.

Q. Can patients taking steroids have the inactivated flu vaccine?
Yes, patients taking steroids can be safely vaccinated with inactivated flu vaccine. As systemic steroids at a dose equivalent to prednisolone 20mg or more per day are considered to be immunosuppressive, patients taking steroids are at risk of serious illness if they develop flu and so should be vaccinated. Patients that are receiving high-dose steroids may be immunosuppressed for at least 3 months after cessation of treatment.

Q. When should patients having chemotherapy have their flu vaccine?
Patients receiving chemotherapy should receive their vaccine at the earliest opportunity. For individuals due to commence immunosuppressive treatments, inactivated vaccines should ideally be administered at least two weeks before commencement. In some cases, this will not be possible and therefore vaccination may be carried out at any time.

Q. If an individual has had confirmed influenza recently and they are in an at risk group should they still have the vaccine?
Yes, anyone eligible to receive the vaccine should still have it even if they have had confirmed influenza, either recently or in the past. Having the vaccine will help to protect against other circulating strains. The inactivated flu vaccine can be given at any time following recovery providing there are no contraindications to vaccination.

Q. I am unsure whether a patient is eligible to receive a vaccine under the Flu Vaccination Service because their condition is not specifically mentioned as being part of an eligible group in the service specification. What is the best way to proceed?
Pharmacists will need to make a clinical decision as to whether an individual patient falls into an eligible group based on the information in the service specificationand consider that eligible groups offered the flu vaccination are those that are most at risk of the complications of flu.  If a pharmacist is unsure if a patient is eligible for an NHS flu vaccination, the patient should be referred to their GP.

Q. Can children receive a flu vaccination under the Flu Vaccination Service?
No. The NHS Advanced Flu Vaccination Service is for patients aged 18 years and over who fall into an eligible group; it does not cover children.

Q. Should pharmacy teams check with the patient’s GP practice if the patient has already had a flu vaccination? 
In most cases the patient will be able to verify if they have received a flu vaccination at their GP practice; however, if the patient is unsure then the GP practice should be contacted to confirm whether they have already been vaccinated or not to prevent the risk of the patient being vaccinated twice. This is especially important for patients who fall into vulnerable groups such as those with dementia who may not remember if they have been vaccinated or not.

Q. Can children (2-17 years) be vaccinated under the national service if they are allergic to Fluenz Tetra nasal vaccine?
No.

Q. Should pharmacy teams verify the eligibility of patients requesting flu vaccination under the service?
In many circumstances pharmacy teams will know the patients who are requesting vaccination under the service and they will therefore be able to determine whether a patient falls within an eligible group as a result of the knowledge of the patient and their patient medication record. There will, however, be circumstances where the patient is not known to the pharmacy team. In that case it will be necessary for the pharmacist to talk to the patient and to use their professional judgement to determine whether the patient falls within an eligible group. As part of the service patients must sign a form which contains a declaration that the information they have given in relation to the service is correct and complete.

Q. Are all people with asthma (aged 18 years or over) eligible for an NHS flu vaccination under the national Flu Vaccination Service?
No. People with asthma are entitled to an NHS flu vaccination if they have asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission as stated in the service specification. Therefore, patients who are only prescribed a short-acting β2 agonist, for example, salbutamol to manage their asthma are not entitled to an NHS flu vaccination unless they fall into another eligible group.

Q. Are pharmacy team members an eligible group for flu vaccination within the Advanced Service?
No. Employers may wish to offer pharmacy staff flu vaccinations as part of their occupational health arrangements, but this cannot be undertaken as part of the Advanced Service. If a pharmacy team member is eligible for an NHS flu vaccination and falls into one of the eligible patient groups for the Advanced Service, they would be able to use the service at the pharmacy.

Q. What should I do if a patient requests a vaccination, but they are not eligible under the Advanced Service?
If a patient is not eligible for vaccination under the Advanced Service, but they are eligible for an NHS vaccination (for example, a child in a clinical risk group), they should be referred to their GP practice. If a patient is not eligible for vaccination at NHS expense by any healthcare provider, the patient could be offered a private vaccination service (if the pharmacy has appropriate arrangements in place to provide such a service).

Q. Can a vaccination be provided to a patient in an eligible group who is registered with an NHS GP practice and lives elsewhere in England or one of the other home countries, for example, Scotland?
Yes. There are no geographical restrictions placed on provision of the service to eligible patients registered with an NHS GP practice.

Q. Is a patient with epilepsy eligible for an NHS flu vaccination under the national Flu Vaccination Service?
No. Epilepsy is not considered a high-risk group for flu; therefore, patients with epilepsy are not entitled to an NHS flu vaccination unless they fall into another eligible group.

Q. Do patients with HIV need to stop their antiretroviral treatment for two weeks after immunisation and not be immunised until 48 hours after stopping the antivirals?
No. The HIV Pharmacy Association of the UK has advised that there is no interaction between the influenza vaccine and antiretrovirals used to treat or prevent HIV infection and recommend that it is safe to give patients on antiretroviral therapy the influenza vaccine without compromising either the vaccine or the patient’s HIV treatment.

Q. Are all workers working within registered care home and domiciliary care organisations eligible to receive the Flu Vaccination Advanced Service?
No. Only those workers directly involved in the care of vulnerable patients/clients are eligible. A worker that has no direct contact with a patient/client is not eligible. For example, a member of catering staff that serves food to patient/clients would not be considered eligible.

Q. If a person presenting is a social care worker but is also eligible to receive the Flu Vaccination Advanced Service at the community pharmacy because they are part of an ‘at risk’ group, under which risk category should they be recorded?
The person presenting should be recorded under their ‘at risk’ group for their eligibility for the Flu Vaccination Advanced Service.

Q. If a patient has a bleeding disorder or is taking oral anticoagulants, do I need to take any special precautions when giving them their flu vaccine?
Information on providing a flu vaccination to a patient who has a bleeding disorder or is taking oral anticoagulants is available in the PGD.

Q. The PGD states that I can vaccinate patients on stable anticoagulation therapy (including patients on warfarin who are up-to-date with their scheduled INR testing and whose latest INR was below the upper threshold of their therapeutic range) via the intramuscular route using a 23G or finer needle. Does the PGD allow the administration of Fluad, which has a 25G needle, on such patients?
Yes. The 25G needle, which is the size of needle that Fluad is supplied with, is finer than the 23G needle (the higher the gauge, the finer the needle) and therefore acceptable to use when vaccinating patients on stable anticoagulation therapy.

Q. Can patients with neurological deterioration receive a flu vaccination?
The presence of a neurological condition is not a contraindication to immunisation but if there is evidence of current neurological deterioration, deferral of vaccination may be considered to avoid incorrect attribution of any change in the underlying condition. The risk of deferring the vaccine should be balanced against the risk of flu and vaccination should be promptly given once the diagnosis and/or the expected course of the condition becomes clear.

This precaution does not apply to individuals with a chronic neurological condition who should be offered vaccine.

Q. Which care home and domiciliary care workers are eligible for the Flu Vaccination Advanced Service?
Health and social care staff who are eligible for the Flu Vaccination Service are those aged 18 years and over, employed by a registered residential care/nursing home, registered domiciliary care provider or a voluntary managed hospice provider who are directly involved in the care of vulnerable patients/clients who are at increased risk from exposure to influenza. Vulnerable means those patients/clients in a clinical risk group for flu or aged 65 years and over, are eligible to be vaccinated by community pharmacies.

 

Identifying carers

Q. The 60-second pharmacy flu chat, which can be used to engage with someone who you think is a carer, suggests that pharmacists should offer to mention to a carer’s GP practice that they are a carer when they send the flu vaccination notification form to the practice. Why is it important for the GP practice to know that a person is a carer?
If the carer’s GP practice is aware that they are a carer, they can ‘tag’ their medical records so that everyone in the practice team will know that they are a carer. Some practices may then offer the carer more flexible appointments (or home visits if the carer struggles to attend appointments). GPs and other healthcare workers at the practice will also be able to consider the particular stresses and strains that being a carer might have on the person’s health. If the carer becomes seriously unwell and is no longer able to provide care, it’s important that the practice is aware that the person is a carer so that alternative support can be put back in place for the person they look after as well.

The 60-second pharmacy flu chat can be accessed on the Identifying carers eligible for a flu vaccination page.

Q. Is there a definition of carers who are eligible for the Flu Vaccination Service?
The Carer’s Trust defines a carer as anyone who cares, unpaid, for a friend or family member who due to illness, disability, a mental health problem or an addiction cannot cope without their support. Unpaid carers may or may not be receiving Carer’s Allowance.

A paid carer is someone that is employed to care for a patient and support their individual needs. Paid carers can work in a variety of settings, including residential homes, nursing homes or at home with the patient.   

Q. Does a social care worker need to provide evidence that they work within a relevant organisation?
Yes. A hospice worker should present evidence that they are eligible to be vaccinated under the Flu Vaccination Service – they should have been told by their employer to bring some evidence with them. The types of appropriate evidence accepted could be an ID badge or payslip from their place of work. A letter on the employer’s letterhead would also be acceptable evidence. As with all patients who present for a vaccination, it’s up to the pharmacy to decide if they are satisfied that the patient is eligible under the Advanced Service.

PSNC has provided a template that pharmacies can give to local care provider organisations for them to add to their letterhead and provide to staff.

Off-site vaccinations

Q. Can I administer flu vaccinations at an individual patient’s home?
Yes. This is permitted where it is requested by the patient and where pharmacy services have previously been provided to the patient.

Q. Do I need to obtain consent from the local NHS England team before vaccinating a patient in their own home?
No. Contractors do not need to obtain consent before vaccinating a patient in their own home. However, before providing any off-site vaccinations (i.e. in a patients’ homes or long-stay care home or long-stay residential facility), contractors should send a completed copy of the ‘Notification of intent to provide off-site NHS flu vaccinations’ form (available in Annex C of the service specification) to the local NHS England team. No acknowledgment of the receipt of the form is required by the contractor before they provide an off-site vaccination.

Q. A patient has requested a flu vaccination in their own home; do I need to let the patient’s GP know before I vaccinate the patient?
No. If a pharmacist is vaccinating a patient in their own home they do not need to notify the patient’s GP before vaccinating the patient (however, if a patient is in a care home, the patient’s GP must be notified prior to vaccinating the patient).

Q. When I notify NHS England that I intend to vaccinate patients in a care home, do I first need to inform the patients’ GP practices that the pharmacy has been asked to undertake the vaccinations?
Yes.  The requirements in Annex C of the service specification includes the need to contact each patient’s GP practice prior to notifying from the local NHS England team. The notification form sent to NHS England requires the contractor to declare that they will ensure this action is completed for each care home, so it is imperative that this is undertaken.

Q. Can community pharmacies provide vaccinations to social care workers or hospice workers at their place of work?
No. Flu vaccinations must be administered to care home, domiciliary care and hospice care workers at the community pharmacy premises. There is no provision within the service specification to vaccinate at their place of work.

Q. Can we provide other services to patients in their homes at the same time as the Flu Vaccination Service, such as MURs?
This may be possible, but contractors must ensure they follow the requirements in the service specification for each service they intend to carry out. For example,in order to conduct off-site MURs, contractors must have permission from the local NHS England team.  

Q. Is there an additional payment for vaccinations administered off-site?
No. Off-site vaccinations are paid at the same rate as vaccinations administered in the pharmacy.

Q. Can I administer flu vaccinations at premises other than the pharmacy?
Yes. Contractors can provide flu vaccinations in a long-stay residential care home, long-stay care facility or at a patient’s own home (where the pharmacy has an existing clinical relationship with the patient, for example, pharmacy services have previously been provided to the patient. However, before undertaking any off-site vaccinations, contractors must submit a completed copy of the ‘Notification of intent to provide off-site NHS flu vaccination’ form (see Annex C of the service specification) to the local NHS England team.

Q. Does the request to vaccinate a patient in their own home need to come from the patient or could a pharmacy offer this to a patient?
The service specification states that contractors can undertake vaccinations in the patient’s home, where the service is requested by the patient.

Q. Do all patients who receive their vaccination off-site have to be asked to complete the patient questionnaire following their vaccination?
Yes. Patients should be encouraged to complete the questionnaire, but they have the right to refuse to do so.

Q. Would people living in supported accommodation such as sheltered accommodation fall into the ‘people living in long-stay residential care homes or other long-stay care facilities’?
No. People living in supported accommodation such as sheltered accommodation would not fall under the eligible group ‘people living in long-stay residential care homes or other long-stay care facilities’.

Q. Can patients living in sheltered accommodation receive an off-site flu vaccination?
Yes, if the patient falls into one of the eligible groups as listed in Annex A of the service specification they can receive an off-site vaccination if they live in sheltered accommodation as this is their place of residence.

Q. Can I administer flu vaccinations at a person’s place of work?
No. The only off-site vaccinations that can be carried out are those at a patient’s home or for patients living in long-stay residential care homes or other long-stay care facilities.

Q. Are health and social care staff working in sheltered housing accommodation, for example, warden controlled flats, eligible to receive the Flu Vaccination Advanced Service?
No. Sheltered housing providers are not regulated by the Care Quality Commission and are therefore not required to be registered, so their staff do not fall within the definition set out in the service specification. However, if a registered domiciliary care provider has staff that attend sheltered housing accommodation to support patients, then these staff will be eligible for the Flu Vaccination Service.

Q. Are health and social care staff working in extra-care housing (also called assisted living) eligible to receive the Flu Vaccination Advanced Service?
Yes. Unlike sheltered housing, extra care housing is regulated by the Care Quality Commission. Therefore, if staff are directly involved in the care of vulnerable patients/clients who are at increased risk from exposure to influenza these staff would be eligible for the Flu Vaccination Service.

Extra-care housing (also called assisted living) offers more support than sheltered housing, but still allows clients to live independently. Clients live in a self-contained flat, with their own front door, but meals may be provided. Personal care and support services are generally available on-site 24 hours a day. Some extra care housing is available to buy or rent privately and some is available from the local council following a needs assessment. This type of housing isn’t available in all areas.

 

Practicalities of service provision

Q. Will my pharmacy need to be registered with the Care Quality Commission (CQC) to provide the service?
No. The CQC does not regulate community pharmacies in relation to the provision of pharmaceutical services (including administration of vaccines); that is the role of the General Pharmaceutical Council.

Q. What should I do if a patient has inadvertently been given a second dose of inactivated flu vaccine?
It is not harmful to have extra doses of the inactivated flu vaccine. Any adverse reaction to an extra dose is likely to be similar to those commonly seen after a scheduled dose of flu vaccine such as local redness/pain at the injection site, malaise etc. The patient should be offered reassurance and local systems reviewed to prevent this happening again.

Q. Can the inactivated flu vaccine be given at the same time as immunoglobulins and other vaccines?
Yes, the inactivated influenza vaccine can be given safely and effectively at the same time as, or at any interval before or after, any immunoglobulin or other vaccine (whether live or inactivated). The vaccines should be given at separate sites, preferably in different limbs but if given in the same limb, they should be given at least 2.5cm apart and the site of each should be recorded in the patient’s record. Because of the increased risk of local reaction following aTIV, Fluad® should be administered in a separate limb to any other vaccines that need to be given at the same time.

Q. Do you need to expel the air bubble in a pre-filled syringe before administering the flu vaccine?
No, you shouldn’t get rid of the air bubble unless specifically stated in the vaccine SPC. To try to expel it risks accidently expelling some of the vaccine and therefore not giving the patient the full dose. The air bubble is also there for a reason – the air injected into the muscle forms an airlock preventing the medication seeping out along the needle tract into subcutaneous tissue and onto the skin. The small bolus of air injected following administration of the vaccine clears the needle and prevents a localised reaction to the vaccination.

Q. What should I do if there is a power failure to the fridge containing the flu vaccines?
You should refer to the Vaccine incident guidance document and the vaccine product’s Summary of Product Characteristics. Further advice should be obtained from your local screening and immunisation team (members of local NHS England teams).

Q. Do I need to notify anyone if I am unable to provide the service over the full hours for any reason?
No. However, the service specificationdoes state that a contractor should seek to ensure that the service is available throughout the pharmacy’s contracted opening hours therefore we would recommend you document the reasons why the service could not be provided over the full opening hours of the pharmacy. This means if NHS England query why you have not been able to provide the service on certain days or times, you have the reasons documented.

Q. Can a pharmacy buy vaccines direct from the manufacturer?
Yes.

Q. Do patients who are not exempt from prescription charges have to pay a prescription charge for the flu vaccination that is administered as part of the service?
No.

Q. Is it mandatory for a pharmacy to have a Standard Operating Procedure (SOP) for the service?
Yes. Template SOPs are available from a number of organisations, including the National Pharmacy Association (please note NPA login required).

Q. Will we need to have a needle stick injury procedure?
Pharmacies should have a needle stick injury procedure in place and all staff involved in the provision of the service should be aware of the contents of the procedure. Template needle stick injury procedures are available from a number of organisations, including the National Pharmacy Association(please note NPA login required).

Q. Do contractors have to arrange their own clinical waste disposal service to dispose of waste resulting from the NHS Flu Vaccination Service?
Yes. Contractors have to arrange their own clinical waste disposal service to dispose of waste resulting from the Flu Vaccination Service when providing the service from the pharmacy and also when providing the service from long-stay residential care homes, other long-stay care facilities and patients’ homes.

Q. Should staff involved in the provision of the service be offered hepatitis B vaccination?
Yes. PHE’s advice in the Green Book is that hepatitis B vaccination is recommended for healthcare workers who may have direct contact with patients’ blood, blood-stained body fluids or tissues. This includes any staff who are at risk of injury from blood contaminated sharp instruments. The Health and Safety Executive guidance on blood borne viruses provides further advice on this issue.

If a pharmacist refuses a hepatitis B vaccination, contractors should make a record of this, so they can demonstrate that the pharmacist was offered a vaccination.

Q. Can patients with an egg allergy have the inactivated flu vaccine?
There is no ovalbumin-free vaccine available for the 2018/19 flu season. Inactivated influenza vaccines may contain traces of egg such as ovalbumin. The ovalbumin content of the flu vaccines for the 2018/19 season will be made available on the PHE Annual flu programme webpage.

With the exception of those individuals with a severe anaphylaxis to egg which has previously required intensive care, patients with less severe egg allergy can be immunised in any setting using an inactivated influenza vaccine with an ovalbumin content less than 0.12 micrograms/ml (equivalent to 0.06 micrograms in a 0.5 ml dose).

Public Health England has published Influenza vaccine: ovalbumin content which lists the ovalbumin content of flu vaccines available in England for the 2018/19 flu vaccination season.

Q. Can patients with an egg allergy have the Fluad® vaccine?
The aTIV vaccine, Fluad®, contains more than the recommended ovalbumin content for patients with egg allergy (each 0.5ml dose contains less than or equal to 0.2μg ovalbumin). Patients aged 65 years and over with an egg allergy should therefore be given a quadrivalent vaccine with an ovalbumin content less than 0.12 micrograms/ml (0.06 micrograms in a 0.5 ml dose).

Q. Can patients who have had a previous anaphylaxis reaction to egg have the inactivated flu vaccine?
Adults with severe anaphylaxis to egg that have previously required intensive care should be referred to specialists for immunisation in hospital. If there is any uncertainty about the cause of an anaphylactic reaction, the patient should be advised to consult with an immunologist.

Further information about egg allergy and the inactivated influenza vaccine can be found in the Influenza chapter 19 of the Green Book.

Q. There is a shortage of adrenaline auto-injectors and we do not have enough stock; how do we proceed if we want to provide the Flu Vaccination Service?
There is currently a national supply shortage of AAIs which has an impact on patients and contractors who wish to provide the Flu Vaccination Service. Many wholesalers have therefore restricted supplies of AAIs to ensure it is available for those in immediate need and maintain a sustainable supply. NHS Improvement has issued a letter encouraging community pharmacy contractors to consider using adrenaline ampoules instead of AAIs as all healthcare professionals providing services where anaphylaxis treatment may be required, including but not exclusive to the Flu Vaccination Service, should have the competency to draw up and administer adrenaline from ampoules with a normal syringe and needle.

Q. Will my pharmacy be sent paperwork for the Flu Vaccination Service or do I need to download this from the PSNC website?
Contractors will not be sent paperwork for the Flu Vaccination Service. Paperwork can be downloaded from the PSNC website and the paper claim form can be downloaded from the NHS BSA website (if contractors decide to claim using the paper claim form rather than claiming online).

Q. What would normally be contained in an anaphylaxis pack?
The Green Book states that an anaphylaxis pack normally contains two ampoules of adrenaline (epinephrine) 1:1000, four 23G needles and four graduated 1ml syringes, and Laerdal or equivalent masks suitable for children and adults. The mask for children would only be required if the pharmacy is providing a vaccination service to children; the Advanced Service does not include the vaccination of children.

Q. Can I use an adrenaline auto-injector to treat anaphylaxis?
The Green Book states that auto-injectors for self-administration of adrenaline should not be used as a substitute for a proper anaphylaxis pack (see above). However, if an adrenaline auto-injector is the only available adrenaline preparation when treating anaphylaxis, health care providers should use it.

Q. If a pharmacist administers adrenaline in an emergency to treat anaphylaxis, is a PGD required to authorise the administration?
No.  Regulation 238 of the Human Medicines Regulations 2012 allows adrenaline to be administered by anyone for the purpose of saving life in an emergency.

Q. How long should a patient be observed for following receiving the flu vaccination to ensure they do not have an anaphylaxis reaction?
The Green Book states in the Anaphylaxis section in Chapter 8 Vaccine safety and the management of adverse events following immunisation (Page 57-58) ‘Onset of anaphylaxis is rapid, typically within minutes, and its clinical course is unpredictable with variable severity and clinical features.

Due to the unpredictable nature of anaphylactic reactions it is not possible to define a particular time period over which all individuals should be observed following immunisation to ensure they do not develop anaphylaxis.’

Q. What should I do if a patient requests or is eligible for another vaccination, for example, a pneumococcal vaccine?
Unless the pharmacy is commissioned at a local level to provide additional vaccinations, the patient should be referred to their GP practice.

Q. What are the storage requirements for vaccines?
Vaccines should be stored in line with the requirements set out by their manufacturer in the Summary of Product Characteristics. The National Patient Safety Agency issued an alert in 2010 giving guidance on vaccine cold storage for all healthcare providers, including community pharmacies.

Q. What records should I make if a patient has an adverse reaction to a vaccine?
A record of any adverse reaction from a flu vaccine and any treatment administered or advised should be made by the pharmacy. Where the adverse reaction is deemed to be clinically significant by the pharmacist, this information may also be shared with the patient’s GP (subject to the patient consenting to this). Pharmacists may also wish to consider reporting adverse reactions via the Yellow Card scheme.

Record keeping and data requirements

Q. Must patient consent be recorded in writing?
Yes. The national consent form must be completed and then the patient must sign this. A record of the consent may also be maintained on an electronic record, for example, within the Sonar or PharmOutcomes systems, if such a system is available in your pharmacy. Such systems may allow you to print out a completed copy of the consent form for the patient to sign.

Q. Do I need to get written patient consent each time a patient has a flu vaccination? For example, if the patient had a flu vaccination at the pharmacy during the 2017/18 flu season, do I need to get written consent again for the 2018/19 flu season?
Yes, written consent would need to be obtained each time a patient has an MUR. The General Pharmaceutical Council’s publication Guidance on Consentstates ‘Getting consent is an ongoing process between you and the patient. Consent cannot be presumed just because it was given on a previous occasion’.

Q. How long should consent forms be retained by the pharmacy?
NHS England has advised that consent forms should be retained for an appropriate period of time but for the purposes of post-payment verification, the forms should be kept for a minimum of two years after the vaccination takes place. As contractors are the data controller it is for each contractor to determine what the appropriate length of time is, beyond two years.

Specialist Pharmacy Service has published a document called Retention of Pharmacy Records, which recommends that all patient consent forms relating to any Advanced Service or Enhanced Service are kept for six complete tax years.

Q. Will we need to report vaccinations to GPs or to a national reporting system or both?
National paperwork has been developed to allow the notification of the patient’s GP practice of the administration of the vaccine. If IT systems are available that allow the notification of a patient’s GP practice to take place electronically, these may be used. Notifying the patient’s GP practice is an important service requirement, as is the case for locally commissioned vaccination services.

Q. If a web-based platform such as Sonar or PharmOutcomes is available in my area for the Flu Vaccination Service, do I have to use it?
PSNC would strongly encourage the use of web-based platforms, such as Sonar or PharmOutcomes if they are available in your area as this means that the local NHS England team and/or the LPC will be able to access local data to monitor uptake of the service. It also means the GP notification form may be able to be sent electronically, taking away the need to print out a GP notification form and deliver or fax to the GP surgery.

Q. If we are using PharmOutcomes or Sonar to notify GP practices that a patient has been vaccinated, is it sufficient to only keep electronic records of the vaccination, provided we have obtained written consent?
Yes.

Q. Will NHS England provide IT support for recording provision of the service?
No national IT support will be provided by NHS England to support provision of the service. Many local NHS England teams have got or are putting in place IT support for the service. If at a local level, IT systems are available that allow the notification of a patient’s GP practice to take place electronically, these may be used.

Q.Can I vaccinate a person with a learning disability who is unable to understand the consent form?
No. If the patient does not have capacity to provide informed consent, they must be referred to their GP for vaccination.

Patient questionnaire

Q. Will the patient questionnaire still be used in 2018/19?
Yes. NHS England will still require patients to be asked to complete the surveys in 2018/19 and there is a NHS England IT platform for contractors to use to support collation and submission of the data.

Q. Is it a requirement to upload all questionnaire results electronically if captured via paper?
When patient questionnaires are completed on paper, contractors should utilise the functionality available on the IT platform to submit patients’ responses to the questionnaire.

Q. Do all patients have to be asked to complete the patient questionnaire following their vaccination?
Yes. Patients should be encouraged to complete the questionnaire, but they have the right to refuse to do so.

Q. What does the NHS England patient questionnaire IT platform support contractors and patients to do?
The IT platform supports a number of functions, including allowing patients to complete the questionnaire online and allowing pharmacy teams to collate the results of completed paper questionnaires returned to them by patients. Patients can also access and complete the questionnaire via a QR code if the patient has a smart phone with a QR code reader App installed on it.

Q. Once I have uploaded the patient questionnaire results that were captured via paper to the IT platform; what do I do with the paper questionnaires?
Once the information has been uploaded on to the IT platform, the questionnaires can be disposed of; there is no requirement to retain the paper questionnaires.

Communicating with GP practices

Q. My local GP practices are very resistant to pharmacy services; how will I recruit patients for flu vaccinations?
Collaborative working with local GP practices is an aim that all pharmacy teams will share, but it is possible that the national commissioning of flu vaccinations from community pharmacies may result in tensions with local GP practices. The commissioning of the national Flu Vaccination Service over the past three years and with the majority of local NHS England teams commissioning a Flu Vaccination Service from community pharmacies during the 2014/15 season may already have exposed these issues.

Community pharmacies will be able to proactively offer flu vaccination to eligible patients alongside dispensing and other services such as Medicines Use Reviews and the New Medicine Service, and whilst GP support for this would be helpful and should be encouraged, it is not necessary in order to successfully provide the service. PSNC will be working nationally to try to ease any tensions with GPs.

Q. Does the patient’s GP practice always need to be informed of the vaccination administered to their patient?
Yes. The requirement is that a notification of the vaccination is sent to the patient’s GP practice on the same day the vaccine is administered or on the following working day. If a patient is eligible for a vaccination, but is not registered with a GP practice, it will not be possible for the GP notification to be undertaken by the pharmacy, but the service can be provided to the patient.

Q. A local GP practice is communicating incorrect information to their patients about the community pharmacy Flu Vaccination Service. What should I do?
Talk to the practice manager at the GP practice to raise your concerns and try to get them to correct any misleading information that is being provided to patients. You should also let your LPC know about the matter and agree with them whether they or you will notify the local NHS England team about the issue.

Q. Does a GP practice need to know the site of a flu vaccination?
The national GP Practice Notification Form does not include this information. Some GP practices have requested this information from pharmacies, stating that they require this to be recorded in the event that a patient reports an adverse reaction to the vaccine. If in the future this information is required by the GP practice to provide clinical care to the patient, they could ask the patient about the site of the vaccination or if the patient cannot recall this information, the GP practice could request that information from the community pharmacy.

Q. Does a GP practice need to know the manufacturer, batch number and expiry date of flu vaccines administered by a community pharmacy?
The national GP Practice Notification Form does not include this information. Some GP practices have requested this information from pharmacies, stating that they require this to be recorded in their records to allow them to contact patients if there is a drug recall for a specific batch of vaccines. If a drug recall does take place it would be the responsibility of the community pharmacy to identify whether they had vaccinated any patients using the recalled vaccine. The pharmacy would then follow the instructions provided in the recall notice, including contacting patients where this is necessary. That action would not be the responsibility of the patient’s GP practice if they had not administered the vaccine.

 

Claiming payment

Q. Has the claiming process for the Flu Vaccination Advanced Service changed for the 2018/19 Flu Vaccination Service?
Yes. This year contractors have the option of claiming payment for the Flu Vaccination Service either via the paper claim form or via a new digital service.

Further information on the claims process can be found on the Flu Vaccination – claiming payment page.

Q. Can I make claims for payment via PharmOutcomes or Sonar?
No.

Q. If I send my claims form to the NHS BSA a month later than the flu vaccines were administered, will I still get paid?
Yes. Claims for payments for the Flu Vaccination Service should be made monthly; however, claims will be accepted by the NHS BSA within six months of administration of the vaccination, in accordance with the usual Drug Tariff claims process.

Q. Will NHS BSA accept claims for a few months after the service finishes?
Claims will be accepted by the NHS BSA within six months of administration of the vaccination, in accordance with the usual Drug Tariff claims process. Later claims will not be processed.

Q. Can we alternative between sending our flu claims using the paper claim form one month and the NHS BSA webform another month?
Yes, however contractors must ensure that only one claims submission is sent each month. Submitting an electronic claim via the NHS BSA webform as well as a paper claim form for the same month will be identified by NHS BSA and will need to be clarified with the pharmacy before they can be processed. This could result in payment delays.

Q. Can I submit the community pharmacy seasonal influenza vaccination advanced service claim form to NHS BSA each quarter to claim payment for the service?
Claims for payments for the Flu Vaccination Service should be made monthly; however, claims will be accepted by the NHS BSA within six months of administration of the vaccination, in accordance with the usual Drug Tariff claims process.

Q. If a pharmacy does not have a premises-shared NHSmail address, will they receive the submissions URL (to claim for payment using the digital service) to their NHS BSA-registered email address?
No. The unique URL to the electronic flu claim webform can only be accessed using a premises-shared NHSmail pharmacy email addresses. The unique link for each pharmacy will automatically be sent to each premises-shared NHSmail account every month.

Other e-mail addresses cannot be used to receive the unique link to the NHS BSA flu claim web-form. Therefore, if the pharmacy does not have a premises-shared NHSmail address they will not be able to use the digital service and will need to claim using the paper claim form and submit this with their FP34C submission document and prescription bundle each month.

Q. If we submitted our claim using the digital service do we also need to submit a paper claim at the end of the month?
No. If you have completed an online claim submission, do not send a paper claim form in with your FP34C and prescription bundle for that month. Duplicate entries will be identified by NHS BSA and will require further investigation, which could delay your payment.

The NHS BSA will be running checks each month for any contractors sending a digital and paper submission. In the event this does occur, the NHS BSA will contact the contractor for clarification and to advise contractors not to do this.

Q. What happens if I make an error when I use the digital service and realise after I’ve submitted my claim?
If you submit incorrect information and need to make an amendment to your claim, you should contact the NHSBSA helpdesk by phone on 0300 330 1349 or email nhsbsa.prescriptionservices@nhsbsa.nhs.uk before the 15th of the following month.

Q. If you use the digital service to claim for payment is that is all I need to do to receive payment?
Yes.

Q. What happens if someone clicks on the URL twice – does the second response overwrite the first?
Validation has been built into the application so there is no risk of duplicate claims being sent for the same month digitally. If the first claim has been sent successfully a further attempt to use the same link again will not be possible.

Q. I understand that an email will be sent to the premises-shared NHSmail once a claim has been submitted using the digital service; what information is included in the email?
The email will contain the date and time of the claim, the number of each flu vaccination claimed for, the name of the person submitting the claim and details of who to contact if incorrect information was submitted in the claim.

 Management information report

Q. If I use the digital service to claim for the Flu Vaccination Service will my head office be able to view what I have claimed for?
Yes, a head office will be able to view this if they request a management information report from NHS BSA. The report can be requested for an individual pharmacy or for all pharmacies in a payment group.

Q. How do I request a monthly management information report to see what my pharmacies have claimed for?
Requests for a monthly report should be sent to the project helpdesk at nhsbsa.mys@nhs.net, stating the ODS code (or ODS codes if the request is for more than one pharmacy) and the job title of the person requesting the report.  For head offices of multiples, the Y Code should also be provided.

A report will be produced for those pharmacies within the organisation that have submitted a digital flu claim (if will not include information on pharmacies who have claimed using the paper claim form).

A single initial request can be submitted to the NHS BSA for a recurring monthly report for all pharmacies who claim using the digital service.

Q. When will the monthly management information report be available?
Each month’s report is expected to be available towards the end of the following month, for example, the September report would be available mid to late October.

Q. What will the management information report show?
The management information report will show claim details for all pharmacies under the head office Y Code. This will include pharmacy details, volumes claimed for each flu vaccine, claim timestamp and the name of the person submitted the claim.

Please note, it will not include information on pharmacies who have claimed using the paper claim form.

Funding

Q. Where is the money for the Flu Vaccination Service coming from?
The cost of the service and the vaccines administered is being funded from NHS England’s budgets.

Q. Do pharmacies have to pay for disposal of clinical waste associated with the service?
Yes. The funding agreed for the service recognises the cost of a clinical waste disposal service which contractors will need to put in place.

Q. Will the NHS cover set up costs for the Flu Vaccination Service?
Set up costs that contractors incur will not be separately funded, but they have been considered in the setting of the fees for provision of the service.

Q. Who pays for occupational health services for pharmacy employees, such as provision of hepatitis B vaccinations?
Provision of occupational health services is a responsibility of employers (contractors).

Flu vaccination service statistics

Q. How many vaccinations were provided under the national Flu Vaccination Service in 2017/18?
Community pharmacists in England provided 1,344,462 flu vaccinations to patients under the national NHS Flu Vaccination Service in 2017/18.

Q. How many pharmacies in England provided flu vaccinations in 2017/18?
The number of community pharmacies who provided the national NHS Flu Vaccination Service in 2017/18 was 8,987 (77.1% of all community pharmacies in England).

Return to the flu vaccination hub page



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