Flu Vaccination FAQs

This page contains Frequently Asked Questions (FAQs) on the Flu Vaccination Advanced Service (last updated on 31stAugust 2015).

Background and General

Q. How many pharmacies currently provide flu vaccinations?
To assess the prevalence of local flu vaccination commissioning in 2014/15PSNC conducted a survey of LPCs early in 2015 and found that:

·  Almost 90% of Local Pharmaceutical Committees (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; and

·  More than 5,000 pharmacy contractors signed up to the services, and in some areas 84% of those signed up were active vaccination providers.

Q. Whycouldn’twe have more notice of the flu vaccination service?
PSNC fully understands the need for contractors to have good notice of changes to the Community Pharmacy Contractual Framework (CPCF) and this is regularly communicated to the NHS in our negotiations. NHS England wished to commission this service from community pharmacies in order to create additional NHS capacity and to improve vaccination rates during the winter period. As a consequence of this the timelines to implement the service are shorter than would be ideal, but as flu vaccinations are currently commissioned from a great many pharmacy contractors at a local level, this should ease implementation. As the service is an Advanced service contractors have the choice as to whether they provide it.

Q. My local GP practices are very resistant to pharmacy services; how will I recruit patients for flu vaccination?
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 majority of local NHS England teams commissioned a flu vaccination service from community pharmacy during the 2014/15 season and this prior local commissioning 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 MUR and NMS 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 pharmacies in Wales provide the new Advanced service?
The new Advanced service only applies to England; Community Pharmacy Wales undertakes separate negotiations on Advanced services which are provided in Wales.

Timescales for implementation

Q. When will the service commence?
Community pharmacies will be commissioned to provide seasonal flu vaccinations to eligible adult patients, starting from September 2015. PSNC, NHS Employers and NHS England anticipatethat the exact date of commencement will be at the start of September, but implementation of the service requires regulatory changes and the timing of such changes can be impacted on by external events outside the control of any of the organisations.

Q. Will the service commence on 1st September 2015?
PSNC, NHS Employer, DH, Public Health England and NHS England are all working to get the arrangements for the service in place for the start of September, but implementation of the service requires regulatory changes and the timing of such changes can be impacted on by external events outside the control of any of the organisations. Further details on the start date will be provided as they become available. In most previous years, supplies of flu vaccines have not started to be delivered by manufacturers and wholesalers until the middle of September.

Q. When will the service specification be published?
PSNC, NHS Employers and NHS England have agreed the wording of the service specification and this is now going through NHS England’s internal governance procedures. It will be published once it has successfully passed through theinternal governance procedures. The service specification will also inform the amendment of the Secretary of State Directions which provide the regulatory framework for the Advanced Services.

Commissioning and service requirements

Q. How will pharmacy contractors inform NHS England that they intend to provide the Advanced Service?
Pharmacy contractors will notify NHS England that they intend to provide the service via a declaration on the NHS BSA website.Further information on this matter will be provided on this website as soon as possible.

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 will replace any service commissioned by local NHS England teams.Some 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 and some are implementing a service to cover the period prior to the Advanced Service commencing.

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. The existing evidence on locally commissioned flu vaccination services is however very strong and PSNC anticipates that this will also be the case for the national flu vaccination service.

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 Englandand 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, PSNCrecommend that LPS contractors contact their local NHS England teamto 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 (GPhC).

Patient Group Direction (PGD)

Q. What will be the legal basis for the provision of flu vaccinations in the new Advanced service?
A Patient Group Direction (PGD) will form the legal basis for supplying the vaccine. A template PGD has been developedby Public Health England (PHE) and this will be used as the basis for the PGD for the Advanced Service.

Q. When will the national PGD be published?
PHE have published a template PGD and this will be used as the basis for the PGD for the Advanced Service.

Q. Can pharmacy staff other than a pharmacist administer the vaccine?
No. The flu vaccination will be 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 apharmacist.

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 will only use the national PGD to authorise administration of the vaccine.

Q. Will the PGD authorise administration of the vaccine via sub-cutaneous injection?
The template PGD published by PHE does cover the sub-cutaneous injection route; this is to be used (where the vaccine is licensed for this route of administration) for people with bleeding disorders.

Q. Will 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 will need to ensure that another suitable PGD is in place to allow provision of a private service.

Premises requirements

Q. My pharmacydoesn’thave a consultation room; can I provide the Flu Vaccination Service?
No. Having a consultation room which meets the existing requirements for provision of MUR/NMS is a prerequisite for provision of the flu vaccination service.

Eligible patient groups

Q. Arepaid 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 (e.g. 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 providesuch a service).

Practicalities of service provision

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.

Q. Will pharmacies have to arrangetheir ownclinical waste disposal service to dispose of waste resulting from the Flu Vaccination Service?
Yes.

Q. Should staff involved in the provision of the service be offered Hepatitis B vaccination?
Yes. PHE’s advice in the Green Book is thatHepatitis B vaccination is recommended forhealthcare workers who may have direct contact withpatients’ blood, blood-stained body fluids or tissues. This includes any staff who are at risk of injury from blood contaminatedsharp instruments. The Health and Safety Executive guidance on blood borne viruses provides further advice on this issue (see page 26).

Q. Can a pharmacy technician administer the vaccine?
No.The flu vaccination will be 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 apharmacist.

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, andLaerdal 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 asubstitute for a proper anaphylaxis pack (see above). However, if an adrenaline autoinjector,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. Can a pharmacy contractor provide a patient with any kind of free giftif they have a vaccination under the Advanced Service?
No. The Terms of Servicestate that a pharmacy must not offer any gift or reward to any person as an inducement toreceive any Advanced Service.

Q. What should I do if a patient requests or is eligible for another vaccination, e.g. 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.

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. Will there be 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, informed by the paperwork developed in 2013 for the ‘winter pressures’ toolkit. The paperworkwill be published as soon as it has been approved by NHS England’s internal governance process.