This year is the first year that the adjuvanted trivalent flu vaccine (aTIV) has been recommended and it should be used in patients aged over-65.
Previous NHS England guidance said that the aTIV vaccines will be delivered in three batches, with 40% delivered in September, 20% in October and 40% in November. NHS England's guidance and the flu letter have advised that phasing invitations for particular groups to tie in with these deliveries may be necessary.
This new guidance says that where practices have ordered sufficient aTIV for their local population aged 65 years and over, they should follow the above recommendations.
However, while the manufacturers Sequiris has confirmed that there is sufficient availability of the vaccine to meet anticipated demand this winter, there have been reports of problems with vaccine orders and some practices and pharmacies may not have enough stock to meet demand.
If this is the case the Medicines and Healthcare Products Regulatory Agency (MHRA) has said supplies of the adjuvanted trivalent flu vaccine (aTIV) can be shared between GP practices and pharmacies to ‘ensure that the sufficient stock of vaccine is distributed to reflect actual demand’.
Normally, medication can only be passed between providers where a wholesaler licence exists. However, the MHRA has confirmed that it does not want to ‘prevent supply’ and that clinicians will now be ‘able, and expected, to work with other surgeries and pharmacies to safely move vaccine stock between locations’ in cases where providers face ‘short supply’ or ‘no supply’ of the aTIV vaccine.
The MHRA has warned that vaccines can only be transferred between locations under the following circumstances:
- The surgery that is holding the excess stock can give an assurance that the vaccine has been held properly in the correct temperature controlled conditions.
- Confirmed record keeping of temperature monitoring is available.
- The surgery that requests the aTIV is able to verify the assurances given.
- The vaccine can be transported appropriately under the right conditions.
Guidance on this is available in Chapter 3 of the Green Book ‘Storage, distribution and disposal of vaccines’. Practices intending to supply vaccine or receive vaccine should follow the recommendations in this.
Steps to take
NHS England's guidance says the following actions should happen in local areas.
- NHS England regional teams will coordinate local plans for aTIV deliveries if gaps in availability are identified.
- All practices should have assessed whether their confirmed order total is likely to meet demand this year, based on historical uptake. They should provide this information to their CCG.
- CCGs should be working with LMCs and local pharmacy committees to ensure all over-65s have access to an aTIV vaccine.
- Practices who have not been able to order aTIV vaccines should work closely with local pharmacies to direct people to where vaccines are available locally. They should not issue prescriptions for aTIV.
Can you provide the QIV vaccine?
- The quadrivalent inactivated vaccine (QIV), which is recommended for those under 65 in at-risk groups, can be offered to over-65s 'in exceptional circumstances'.
- If aTIV is not available then the first step is to signpost them to another provider where it is available.
- The guidance says that it would only be 'clinically appropriate' to give patients the QIV if there is no accessible aTIV supply and no further supplies are expected. Any decision to do this should be made on a case-by-case basis taking into account an individual’s personal circumstances. The reason for electing to give QIV should be documented by the clinician.
- The guidance says that if you offer QIV to individuals who would benefit from the more appropriate aTIV, when gaining consent for immunisation, clinicians should ensure they inform the individual the vaccine is not one nationally recommended for them. They should explain the possible lower efficacy of the vaccine being offered to them, 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 individual’s records.
What has the BMA said?
GPC clinical and prescribing lead Andrew Green told GPonline: ‘It would be very unfortunate if patients were to miss out on effective flu vaccination due to lack of supplies if vaccines were available elsewhere, and this is welcome guidance to allow some flexibility in distribution.
‘However, any practices using this mechanism must be careful to follow it in its entirety in order to ensure that their arrangements will stand scrutiny.’