Flu Vaccination FAQs

Flu Vaccination FAQs

This page contains Frequently Asked Questions (FAQs) on the Flu Vaccination Advanced Service (last updated on 14th September 2017).


Click on a heading below for more information. 

Background and general

Q.How many vaccinations were provided under the national Flu Vaccination Service in 2016/17?
Community pharmacists in England provided 950,765 flu vaccinations to patients under the national NHS Flu Vaccination Service in 2016/17.

Q.How many pharmacies provided flu vaccinations in 2016/17?
The number of community pharmacies who provided the national NHS Flu Vaccination Service in 2015/16 was 8,451 (71.2% of all community pharmacies in England).

Q.How many pharmacies provided flu vaccinations in previous years?
The number of community pharmacies who provided the national NHS Flu Vaccination Service in 2015/16 was 7,195 (60.9% of all community pharmacies in England).To assess the prevalence of local flu vaccination commissioning in 2014/15 (before the national service was commissioned), PSNC conducted a survey of LPCs early in 2015 and found that:

  • almost 90% of LPCs had a local pharmacy Flu Vaccination Service commissioned during the 2014/15 season;
  • pharmacy flu vaccination services were commissioned by 21 of the 25 NHS England Area Teams (now known as local NHS England teams); and
  • more than 5,000 community pharmacy contractors signed up to the services, and in some areas 84% of those signed up were active vaccination providers.

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 two 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. Can distance selling pharmacies provide the Flu Vaccination Service?
Yes. A distance selling pharmacy may provide Advanced and Enhanced Services, as long as 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. 

Commissioning and service requirements

Q. How do contractors inform NHS England that they intend to provide the Advanced Service?
Contractors must notify NHS England that they intend to provide the service via a declaration on the NHS BSA website. This must be done each year prior to provision of the service.

 If the form is not completed before provision of the service, claims for payment will not be accepted by the NHS BSA.

The electronic form on the NHS BSA website asks for the Pharmacy Organisation Code; this is the ODS or F code for the pharmacy that is used on the end of month submission to the Pricing Authority. If the form is incorrectly completed it may result in non-payment for the service.

Q. Does the notification of NHS England of a pharmacy contractor’s intention to start providing the service (via the form on the NHS BSA website) need to be undertaken for each pharmacy a contractor owns?
Yes. The notification may be undertaken centrally by one person on behalf of the contractor, but a notification needs to be made for each individual pharmacy that will be providing the service.

Q. Does the notification to NHS England of intent to provide the service have to be made for each pharmacist that will provide the service?
No. The notification is only required for each pharmacy.

Q. A seasonal Flu Vaccination Service is already commissioned from community pharmacies in my area. What will happen to that service?
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 are commissioning 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 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.

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

Patient Group Direction (PGD)

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 and Consent 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. Does the national PGD authorise administration of the vaccine via subcutaneous injection?
Yes. The PGD does cover the subcutaneous injection route; this is to be used for people with bleeding disorders. 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.

Q. If my patient has a bleeding disorder or is taking oral anticoagulants, do I need to take any special precautions when giving them their flu vaccine?
If the patient is eligible to receive the vaccine then they should be offered it at the earliest opportunity. The vaccine should be administered by deep subcutaneous injection to individuals with bleeding disorders to minimise the risk of bruising or bleeding.

In contrast, most patients on stable anticoagulant therapy can receive influenza vaccine by intramuscular injection, for example, individuals on warfarin who are up-to-date with their scheduled INR testing where their latest INR was in the therapeutic range.

For other patients at risk of bleeding, most influenza vaccines are licensed for administration by either the intramuscular or subcutaneous routes. Recommendations for subcutaneous vaccine administration for patients on anticoagulants are based on the theoretical risk of haematoma. There is a lack of primary source evidence to support the hypothesis that the subcutaneous route of vaccination is any safer than the intramuscular route in people taking anticoagulants and the subcutaneous route can itself be associated with an increase in localised reactions.

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 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 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 PGD to 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 PGD should 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. 

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.

Out of pharmacy vaccination

Q. Can I administer flu vaccinations at premises other than the pharmacy premises?
If a pharmacy receives a request from a long-stay residential care home or other long-stay care facility to vaccinate a resident/patient away from the pharmacy premises and approval is given by the local NHS England team then a contractor can provide vaccinations at a suitable location within the care home or care facility (contractors must follow the protocols set out in Annex C of the service specification). However, the service does not allow pharmacists to provide off-site vaccinations for any other group of patients at any other premises.

Q. Would people living in supported accommodation such as sheltered accommodation be eligible for an off-site flu vaccination?
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’ and would therefore not be eligible for an off-site flu vaccination. However, they may be eligible for an NHS flu vaccination if they fall into one of the other eligible groups for the Advanced Service and if so, could have a flu vaccination at the pharmacy.

Q. When I seek consent from NHS England 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 seeking consent from the local NHS England team. The request form sent to NHS England requires the contractor to declare that they have undertaken this already, so it is imperative that this is undertaken before the declaration is completed.

Q. How long will the local NHS England team take to respond to a request to vaccinate people off-site who are living in a long-stay residential care home or other long-stay care facility?
NHS England should provide the pharmacy contractor with a response to vaccinate people off-site who are living in a long-stay residential care home or other long-stay care facility within five working days of receiving the request (if for clinical reasons approval is needed more quickly that must be arranged locally).

Q. Can I administer flu vaccinations at individual patient’s homes (not care homes) or at workplaces?
No, that is not currently permitted.  

Eligible patient groups

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 as a result 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 are not eligible for the community pharmacy Advanced Flu Vaccination Service unless in a clinical risk group.

Q. If a patient has already received a seasonal flu vaccine this year (e.g. in January 2017), do they still need a vaccine during this flu season (e.g. September 2017 – March 2018)?
Yes. If the patient received the vaccine produced for the 2016/17 season then they will still need a dose of the vaccine produced for the 2017/18 season as the vaccine for 2017/18 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 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 NHS community pharmacy Advanced 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 specification and 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 community pharmacy Advanced 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. Are front line medical staff an eligible group for flu vaccination under the community pharmacy Advanced Flu Vaccination Service?
No. Employers may wish to offer front line medical staff flu vaccinations as part of their occupational health arrangements, but this cannot be undertaken as part of the Advanced Flu Vaccination Service.  If a front line medical 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.

Locally commissioned services for front line medical staff or a private flu service can be offered if available.

Q. Which carers are eligible for a flu vaccination under the community pharmacy Advanced Flu Vaccination Service?
Carers are eligible if they are aged 18 or over and are in receipt of a carer’s allowance, or if they are the main carer of an older or disabled person whose welfare may be at risk if the carer falls ill.

Q. Are paid care workers eligible for vaccination under the Flu Vaccination Service?
No. Care workers who are paid to provide care to people (for example, in their own homes or in care homes) are not eligible for vaccination under the Flu Vaccination Service; however, they are likely to be eligible for flu vaccination as a result of their job. In this case the provision of flu vaccination would be an occupational health responsibility which should be funded by the person’s employer. Community pharmacies may be able to provide such a service under a private PGD.

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 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.

 

Practicalities of service provision

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.

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. 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. 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. 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 specification does state that a pharmacy 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. 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 to 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.

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

Q. Can any brand of flu vaccine be used for the Flu Vaccination Service?
No. Public Health England’s annual flu letter contains more information about which vaccines to use and who supplies them for the NHS Flu Vaccination Service. Please note, the community pharmacy NHS Flu Vaccination Service does not include the intradermal vaccine (Intanza) or the nasal spray (Fluenz Tetra).

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.

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 NHS Flu Vaccination Service when providing the service from the pharmacy and also when providing the service from long-stay residential care homes or other long-stay care facilities.

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 (see page 26).

At the time of writing, there is a global shortage of adult hepatitis B vaccines affecting the UK supply. If pharmacists have not already been vaccinated against hepatitis B, they are unlikely to be able to get vaccinated due to the shortage of vaccines. Pharmacists will therefore need to consider the risks before deciding if they wish to offer the service without being vaccinated.

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. 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. 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.

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. 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 take into account 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. If a carer consents for me to notify their GP practice that they are a carer after they’ve received a flu vaccination at the pharmacy, how should I notify them?
If a patient has consented for you to notify their GP practice (verbal consent is acceptable), a note can be added to the paper GP notification form to say that the patient is a carer. If the pharmacy is using an nhs.net email address, a note can be included in the body of the email informing the GP practice that the patient is a carer and if PharmOutcomes or Sonar Informatics is being used then a note can be added to the additional comments box.

Q. What are the clinical codes in table 1 of the service specification?
They are codes used by GP practice IT record systems to record clinical information in a standardised way. There are three coding systems currently in use in England and the codes for ‘Seasonal influenza vaccination given by pharmacist’ are listed in table 1 for each of these coding systems. The codes are also listed on the national GP Practice Notification Form.

Q. Can patients with egg allergy have the inactivated flu vaccine?
Inactivated influenza vaccines may contain traces of egg such as ovalbumin. Adults with egg allergy can be immunised in any setting using an inactivated flu vaccine with an ovalbumin content less than 0.12 microgram/ml (equivalent to <0.06microgram for the 0.5ml dose).

There is no ovalbumin-free vaccine available for the 2017/18 flu season. A list of all flu vaccines for the 2017/18 season and their ovalbumin content is available in the document: Influenza vaccines for the 2017/2018 influenza season.

Q. Can patients who have had confirmed anaphylaxis 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.

There is no ovalbumin-free vaccine available for the 2017/18 flu season. A list of all flu vaccines for the 2017/18 season and their ovalbumin content is available in the document: Influenza vaccines for the 2017/2018 influenza season. Further information about egg allergy and the inactivated influenza vaccine can be found in the Influenza chapter 19 of the Green Book.

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 or other long-stay care facilities;
  • 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.

Data recording and reporting

Q. How will I record and claim payment for vaccinations I have administered?
National paperwork has been developed to allow the recording of patient consent, the clinical record of vaccination and 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. Payment claims will be made using a form which will be sent to the NHS BSA.

Q. Is there national paperwork/forms for the service?
Yes. National paperwork has been developed to allow the recording of patient consent, the clinical record of vaccination and notification of the patient’s GP practice of the administration of the vaccine.

Q. Must patient consent be recorded in writing?
Yes. The national record and 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 record and consent form for the patient to sign.

Q. How long should Flu Vaccination Record and Consent Forms be retained by the pharmacy?
NHS England has advised that consent forms should be retained for an appropriate period of time. As contractors are the data controller it is for each contractor to determine what the appropriate length of time is. However, 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 can be sent electronically, taking away the need to print out a GP notification form and deliver or fax to the GP surgery.

Q. Will NHS England provide IT support for recording and claiming for 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.

Training and competency requirements

Q. What are the knowledge and skills required in order to provide a vaccination service?
The National Minimum Standards for Immunisation Training and the associated Core Curriculum for Immunisation Training set 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 two 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 in 2017. Assuming the service continues to be commissioned in 2018, the pharmacist would then need to undertake face-to-face training in 2018 in order to continue to provide the service. Pharmacists who last undertook face-to-face training in 2015 would need to undertake face-to-face training in 2017, prior to providing the Flu Vaccination Service.

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 two 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 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. 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. 

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. An existing DoC for vaccination services has been edited for use in 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 NHS seasonal influenza vaccination ADVANCED DoC, not the Immunisation (NOT ADVANCED Flu service) DoC.

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 the NHS seasonal influenza vaccination ADVANCED has been signed.

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. I completed the DoC process last year and will be completing face-to-face injection technique and basic life support training this year. Do I need to complete the DoC process again?
The DoC process needs to be completed every two years so it would not need to be completed again this year. However, we would suggest that pharmacists consider completing the DoC process again as by doing this it will mean a pharmacist’s face-to-face training and completion of the DoC process can then be completed together every two years, rather than having to do training one year and completion of the DoC process the next.

Q. The NHS seasonal influenza vaccination ADVANCED 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 NHS seasonal influenza vaccination ADVANCED DoC?
The wording in the core competency within DoC states that pharmacy professionals should be 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 NHS seasonal influenza vaccination ADVANCED DoC system; 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 Declaration of Competence 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. It is however good practice to align the statement of declaration with practical training and also review the documentation each year i.e. Patient Group Direction and service specification.

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 make a decision on 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. To access the assessment, go to the CPPE website.

 

Funding and payment claims

Q. How do I claim payment for provision of the service?
Contractors must complete the Flu vaccination claim form 2017/18 at the end of each month and submit this to the Pricing Authority with their script bundle submission.

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 (provided I have sent them before 5th April 2018)?
Claims should be sent in the months they correspond to; otherwise contractors are at risk of not getting paid.

Q. Will the Pricing Authority accept claims for a few months after the service finishes?
No. Payment claims for those vaccinations administered during March 2017 must be submitted to the NHS BSA by 5th April 2018 in line with the FP34C process. Late claims will not be processed and contractors will not receive payment for vaccinations claimed for.

Q. Will my pharmacy be sent paperwork for the Flu Vaccination Service or do I need to download this from the PSNC website?
The forms will need to be downloaded from the PSNC or NHS BSA (for the claim form) websites.

Q. Can I make claims for payment via PharmOutcomes or Sonar instead of using the claim form and sending it to the Pricing Authority?
No.

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. 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. 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).

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?
The service specification states that the claim form should be submitted each month to claim payment for the service therefore contractors may not get paid if they do not submit their form each month. If contractors choose to submit their form quarterly, they should be aware that the final quarterly claim must be made by 5th April in the same year in line with the FP34C process. Claims after this date will not be processed, therefore contractors will not get paid for any late submissions.

 

Patient questionnaire

Q. Will the patient questionnaire still be used in 2017/18?
Yes. NHS England will still require patients to be asked to complete the surveys in 2017/18 and there will be an 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 will 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 will also be able to 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. I have uploaded the patient questionnaire results that were captured via paper to the IT platform; what do I now do with the paper questionnaires?
If 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.

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