Know which patient groups are eligible for the flu vaccine.
Obtain consent from the patient or someone with legal responsibility.
Follow GMC guidance when delegating vaccinations.
Keep accurate records of all flu vaccinations.

The annual flu programme

The UK has an annual vaccination programme to protect vulnerable patients from flu and reduce pressure on the NHS each winter.

Letters announcing the programme are sent to general practices, community pharmacies and other NHS organisations each year. The letter sets out:

which patient groups are included in the programme that year
a GP practice checklist
details of vaccine names, age restrictions and suppliers
how to submit uptake data.

Information and updates on the programme for England are available online and similar schemes operate in Scotland, Wales and Northern Ireland.

You can also find detailed guidance on the types of flu virus and vaccination in the immunisation section (chapter 19) of the Green Book.

Obtaining consent

Young children

Obtain authority from someone with parental responsibility (read our guide on this topic if you're unsure).

Check the status of the adult accompanying the child being immunised; if they are a grandparent or child minder, check that someone with parental responsibility knows the child has been brought, has received all relevant information, and agrees for the vaccination to be given.

Older children

Older children can consent if they are mature enough to understand all the necessary information, retain it, weigh it up and communicate their decision.

In England and Wales, if a competent child refuses consent, you should weigh the potential benefits of the vaccine against the harm caused by seeking to override their wishes, getting legal advice if you're unsure.

If you're in Scotland or Northern Ireland and feel it might be appropriate to override the wishes of a child under 16 who has capacity, then you should seek legal advice.

Adults

Adult patients should be asked for their consent to receive the vaccine.

If there is any doubt about a patient's mental capacity to consent to vaccination at the time it's needed, it will need to be assessed. Our guide on assessing capacity has more information.

If the assessment is finely balanced, seek specific medico-legal advice. Record the capacity assessment and decision in the patient's records.

If a patient lacks capacity, you need to act in their best interests. You should:

consider whether they are likely to regain capacity and the decision can be postponed
involve the patient as much as possible and take into account any wishes they may have previously expressed
discuss the matter with those close to the patient or anyone appointed with lasting power of attorney – such as an LPA for health and welfare (England and Wales) or a welfare attorney (Scotland) – and seek advice if there is a disagreement
seek advice on whether restraint is justified if the patient resists vaccination. This should only be used to prevent harm to the patient or others and must be the minimum amount necessary to achieve the vaccination.

If you're responsible for delivering vaccination programmes in settings where a number of patients could lack capacity, such as a nursing home or residential home, make sure you allow enough time before a vaccination clinic for staff to inform relatives and for any necessary assessments of capacity and discussions of best interests to take place, and for any concerns to be discussed and documented.

Intractable disputes about best interests may need to be taken to the Court of Protection (Court of Session in Scotland) for a decision, so get advice promptly if you encounter difficult cases.

Delegation

If you delegate flu vaccinations as a GP, you will still be accountable for the overall management of the patient. You must be confident the colleague you delegate to has the necessary knowledge, skills and training, in line with GMC guidance.

Nurses

Nurses can carry out the mass administration of vaccinations through a Patient Group Direction (PGD). This allows licensed medicines to be supplied or administered by a named health professional to a group of patients who meet the criteria defined in the PGD. They are responsible for selecting appropriate patients and for obtaining the consent or parental authority.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the use of PGDs. The UK Health Security Agency (UKHSA) has also produced PGD templates to support national immunisation programmes.

Healthcare assistants

Subject to the right safeguards, practices can ensure the efficient running of the flu vaccination programme by involving trained staff, such as healthcare assistants (HCAs).

HCAs can only administer flu vaccinations under a Patient Specific Direction (PSD). This is an instruction from a GP or independent nurse prescriber to supply and/or administer medicine directly to a named patient or several named patients. The prescriber is responsible for assessing the patient(s).

For more information, read our separate article on healthcare assistants and flu vaccinations.

Indemnity

GP members can come to the MDU for advice and support with complaints, disciplinary investigations, adverse incidents or other issues related to HCA vaccinations.

In England and Wales, clinical negligence claims arising from NHS vaccination work fall under the state indemnity scheme. In Northern Ireland and Scotland, the MDU can provide indemnity for GP members whose HCA staff administer vaccines, as long as certain safeguards are in place and our membership department is informed.

Staff vaccinations

It's worth noting that the state indemnity scheme excludes practices vaccinating their own staff.

But many members find it easier to make sure staff are appropriately vaccinated if they offer vaccinations, such as flu or hepatitis B, within the practice. Indemnity for this work is included within the benefits of MDU membership for GPs.

GPs and other clinical staff providing these vaccinations should follow normal procedures for unregistered patients. This includes assessing each staff member's suitability for the vaccine (such as checking for contraindications), obtaining consent, recording the vaccination, and informing the staff member's registered GP.

It is important that all GP partners have their own indemnity in place in respect of their potential vicarious liability for such services.

Offsite clinics

A number of practices run vaccination clinics offsite, such as in a local hall.

The CQC has issued guidance, with examples, explaining when further application to them or notification is required. Offsite clinics need special consideration as the same facilities won't be available as they would be in the practice itself. You will need to consider issues such as:

whether the staff carrying out the vaccinations will have access to the patients' clinical records
how records will be kept if there is no access to the electronic record
how you will protect a patient's dignity if they were to become unwell and how and where they would be treated
the need to have relevant equipment, medication and skilled and competent staff immediately available to provide necessary care to patients if required.

Patient safety

These actions should help you ensure the safety of patients during the annual vaccination programme.

Have a practice protocol covering the storage and administration of vaccines and a named lead to oversee the vaccination programme.
Ensure your practice can identify at-risk patients who are eligible to receive the vaccine and follow up patients who do not attend.
Check the records and take a history from the patient to confirm the vaccine is not contraindicated, eg, they have had a previous anaphylactic reaction to any component.
Follow latest guidance on which vaccine to use, including which are suitable for children and how to treat patients who cannot have the live vaccine. Beware of the potential for confusion between different brands.
When seeking consent or parental authority, give details of the procedure, set out the risks and possible side-effects and explain any alternatives.
Check the product licence and ensure all vaccinations are recorded accurately, including the vaccine name, product name, batch number and expiry date, dose, date, vaccination site and the name of the vaccinator.
If something goes wrong, tell the patient or their representative, apologise and explain the steps you will take to arrange appropriate treatment and follow-up.
Report adverse reactions and other problems with vaccines to the MHRA using the Yellow Card scheme.

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