Flu and flu vaccinations

Consent, patient safety and delegation for GP practices during the annual winter flu vaccination programme.

  • 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.
  • Special considerations during the pandemic.

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 (see our guide to this topic if you are unsure). Check the status of the adult accompanying the child to be immunised. If it is a grandparent or child minder, ensure someone with parental responsibility has received all relevant information and arranged for another person to consent to the vaccine or provided written authority. Clarify no one with parental responsibility objects to the child receiving the vaccine.

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. 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. Seek legal advice if you are unsure.

Adults

The patient should consent unless you have reason to believe they lack mental capacity to make the decision at that point in time. There is a statutory test with which to assess capacity, set out in the Mental Capacity Act 2005 (MCA) and its accompanying Code of Practice. 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 (LPA) 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, make sure you allow enough time before a vaccination clinic for staff to inform relatives and for any concerns to be discussed and documented.

Delegation

If you delegate flu vaccinations as a GP, you will still be responsible for patients' overall care. You must ensure the healthcare professional concerned has the relevant knowledge, skills and experience, 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. Public Health England 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 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).

Indemnity

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

If a claim arises in NHS practices in England and Wales, then these are covered by the state indemnity scheme. In Northern Ireland and Scotland, the MDU can provide GP members whose HCA staff administer vaccines with indemnity, provided certain safeguards are in place and that our membership department is informed.

It's worth noting that the state indemnity scheme excludes practices vaccinating their own staff. However, providing immunisations to practice staff is included within the benefits of MDU membership for GP members at no additional charge. 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

During the pandemic, due to the increase in numbers of patients who are eligible for a flu vaccine and the need to control infection spread, many practices are running flu clinics offsite, such as in a local hall or car park.

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.

This page was correct at publication on 08/09/2020. Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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