New flu vaccines were introduced this season, following concerns over the effectiveness of flu immunisation over the past couple of years. The JCVI updated their guidance to recommend a quadrivalent flu vaccine (QIV) for 18-64 year olds at risk, and an adjuvanted trivalent vaccine (aTIV) for those 65 and over.
However, supply issues of the new vaccine have presented problems for practices across the country who have been unable to supply the new jab.
What are the issues with aTIV and QIV vaccine supplies?
Pulse reported back in June that practices had been told they would receive their stock of aTIV in a phased manner over three months – with 40% delivered in September, 20% in October and 40% in November – raising concerns they may run out of supplies between deliveries and have to turn patients away.
The latest updated advice from NHS England says the manufacturer of aTIV, Seqirus, has confirmed there is sufficient availability of the vaccine to meet anticipated demand.
However, according to NHS England some practices and community pharmacies did not meet the deadline for ordering, and in some places demand has exceeded supply.
The UK’s main supplier of QIV, Sanofi Pasteur, was also hit by a manufacturing issue earlier this year, including problems with packaging, which delayed deliveries to around 1,000 GP practices by two weeks. However, Sanofi said deliveries of QIV should have been received by the end of September, and no delivery issues have been highlighted by its main rival Mylan.
What do we do if our aTIV supplies do not arrive in time for flu clinics?
If more supplies are expected, the practice should rebook patients for their jab for when the stocks arrive.
Dr David Bailey, the BMA GPs committee (GPC) dispensing and pharmacy policy lead, says practices should make sure to notify the patient of the delay and information about the prevalence of flu.
If there are no more supplies expected, then practices should try to secure stocks from other providers, or recommend the patient goes elsewhere.
If there is no local supply, and no further supplies expected, then NHS England has said it would be ‘clinically appropriate to offer QIV’ to eligible patients. It will likely still give ‘important protection’.
How can we secure the supplies of aTIV from other providers?
If the practice has run out or expects to run out, then there are a number of options.
The first is to check with the supplier of the vaccines if there is any additional stock available. NHS England recently announced that a further 400,000 vaccines will be available. However, this will go to practices on Seqirus’ waiting list.
The second is to direct patients to a pharmacy that may have supply.
The third option is to transfer flu vaccines between providers, which is possible due to the newly relaxed guidelines.
How do we arrange transfer of vaccine from a local pharmacy or practice?
NHS England says its regional teams and public health commissioning teams, including SITs, are working with CCGs to coordinate local plans to fill gaps.
CCGs have a lead for seasonal flu, who will be coordinating the flu programme in the area to ensure access to the aTIV vaccine. Practices should contact this lead to try to work out a solution.
How can we ensure vaccine transfer is appropriate?
Normally, medication can only be passed between providers if a wholesaler licence exists, although community pharmacies are able to transfer medicines under specific circumstances. However, the Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed it would not prevent the redistribution of stocks amid supply issues, as long as certain measures were adhered to:
- The surgery holding the excess stock must give an assurance that the vaccine has been held properly in the correct temperature controlled conditions.
- There must be confirmed record keeping of temperature monitoring.
- The surgery that requests the aTIV must be able to verify the assurances given.
- The vaccine should be transported appropriately under the right conditions.
GPC clinical and prescribing lead, Dr Andrew Green, says he doubts there will be significant volumes of vaccine going spare, but suggested if there were, that practices should collect them personally ‘to ensure safe transit’.
When should we direct patients to an alternative provider?
If the practice’s supply has run out of aTIV and there is no more stock expected, or the wait would be an unreasonable amount of time, patients should then be directed to another provider.
In practice, this means directing patients to a pharmacy for vaccination on the NHS.
A BMA spokeswoman tells Pulse they are still in the process of drafting guidance for GPs on this. However due to the regulation change it is more likely that practices will be able to secure aTIV stock via transfer from a different practice, rather than sending patients away.
Can we give an elderly person the QIV flu vaccine?
In exceptional circumstances, people 65 years and older can be offered QIV. However, it should be the last option if aTIV is not available in the local area, and is highly unlikely to become available.
Will we still be reimbursed if we administer the QIV jab to an elderly patient?
Practices will only be paid if they give the clinically appropriate vaccine, says Dr Green. They must therefore demonstrate that there was no practical way for the patient to receive aTIV, such as lack of local supply.
Will we be compensated for lost dispensing fees due to supply problems?
No. Dr Green says NHS Engalnd will only pay for work that has been done, and not reimburse any lost income caused by supply problems.
What if our QIV orders do not turn up in time for flu clinics?
In this circumstance, a dispute should be raised with the supplier for potential loss of income, as some patients will go elsewhere, says Dr Bailey.
However, as long as patients are informed and the delay is considered reasonable, then it is ‘perfectly permissible’ to simply rebook the appointment.
Public Health England. Inactivated influenza vaccine information for health care practitioners. September 2018