Dispensing practices are urged to talk to patients aged 65 and over (75 and over in Scotland) to ensure patients understand the unique nature of the 2018/19 flu vaccination programme and are able to receive the correct vaccination for their age group.
To support practices, the DDA has produced a flu vaccination poster, detailing the availability of pneumococcal, shingles and flu vaccinations from the GP practice.
In this year’s flu programme, for the first time two vaccinations are being recommended for adults:
- For all over-65s: Fluad (Seqirus), which is an adjuvanted trivalent vaccine (aTIV)
- For 18-64 year olds: the quadrivalent vaccine (QIV).
NHS England guidance also sets out a three-phased prioritisation approach to vaccinating patients aged 65 years and over:
- First priority should be given to those aged 75 years and over or those in a care home.
- Second priority should be given to those aged 65-74 years in a clinical risk group.
- Third priority should be given to those aged 65-74 years NOT in a clinical risk group.
Practices and pharmacies will receive a phased delivery of stock of aTIV: 40 per cent of their order in September; 20 per cent in October; and 40 per cent in November. Contractors should have been contacted by Seqirus in August, to inform them of their exact delivery dates and quantities.
GPs and pharmacies that have temporarily run out of aTIV are advised by NHS England to ask patients to return for vaccination when stocks become available. If a patient requires urgent vaccination, they should be referred to an alternative contractor with stock.
GPs with a permanent shortage of aTIV should contact their CCG. They should also work closely with local pharmacies to direct patients to contractors that have aTIV in stock and that are able to vaccinate patients. In this circumstance, the practice issuing prescriptions for aTIV would not be appropriate.
Exceptional use of QIV for patients 65 years and over is only clinically appropriate if there is no locally accessible supply of aTIV, and no further supplies are expected. This is only likely to occur in late November. The patient should be informed that the vaccine is not one nationally recommended for them, has a possible lower efficacy, why it is being offered instead of the recommended vaccine and why it may still offer protection against seasonal flu or attenuate the progression of the infection should they get it. The discussion should be documented in the patient’s record. Further information on consent to immunisation is available in The Green Book.
The GP service specification details that for payment purposes, practices should ensure that the correct dosage is administered as clinically appropriate.
The pharmacy service specification is clear that pharmacy contractors participating in the service will not be reimbursed or remunerated for vaccines administered to patients outside of the eligibility criteria set out in the service specification.
In a briefing to pharmacists, PSNC advises that the NHS England Patient Group Direction sets out the recommended vaccine choice for the two cohorts of patients. If a contractor seeks reimbursement for vaccine other than the recommended vaccine choice, NHS England may make enquiries to understand how the evidence of clinical efficacy of aTIV and QIV was taken into account and how the clinical judgement to use the relevant vaccines was reached.
Where an appropriate clinical justification cannot be provided, NHS England may seek to take action against a contractor for breach of the terms of service for failing to provide the service and exercise their professional judgement consistent with standards generally accepted in the pharmaceutical profession.
Off-label use of Fluad: Fluad is licensed for administration to individuals aged 65 years and over. It may be administered off-label under the national PGD to 64-year-olds turning 65 years of age by 31st March 2019 in accordance with the recommendations for the national influenza immunisation programme for 2018/19. Where a vaccine is recommended off-label, as part of the consent process, practices should consider informing the patient/carer that the vaccine is being offered in accordance with national guidance but that this is outside the product licence. If this advice is provided, it should be documented in the patient’s record.
Welsh GPs are asked to:
- Prioritise aTIV available during September and October for those aged 75 years and over and those aged between 65 years and 74 years who are in a clinical risk group.
- Offer those aged 65 to 74 years not in a clinical risk group the choice of waiting for aTIV to become available at a later date or the option to have a quadrivalent influenza vaccine (QIV) immediately
View the communication
- Use of Fluad is recommended in over-75s only.
- Flu vaccines are centrally supplied in restricted quantities as per England, and maximum order restrictions apply
- NHS Scotland has produced a flu vaccination algorithm
Egg allergy: Patients with an egg allergy 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 QIV with an ovalbumin content less than 0.12 micrograms/ml (0.06 micrograms in a 0.5 ml dose).
Side effects: Fluad is slightly more likely to give a local reaction around the injection site. Fever, malaise, shivering are also common. Further information on side effects can be found in the Summary of Product Characteristics
Presentation: For the 2018/19 season only, most Fluad will be supplied in a pre-filled syringe (Luer Lock) with a separate needle which will require attachment prior to administration of the vaccine. From the 2019/20 season onwards, Fluad will be supplied in the more usual presentation of a pre-filled syringe with an attached needle.