‘Flu season’ is a well-established annual occurrence in primary care services, with a range of practitioners administering vaccinations against the flu virus, including district and community nurses, practice nurses, GPs and pharmacists.
Influenza is a common and infectious virus, far more severe than the common cold. According to the University of Oxford Vaccine Knowledge Project (2020), complications from influenza lead to tens of thousands of hospital stays and an average of more than 600 deaths a year in the UK. Several unpleasant symptoms can present in a case of influenza (Box 1).
Mahase (2020) highlights the concerns raised by GPs to cope with the 2020-2021 winter demand for flu vaccinations, with up to 30 million people included in the expansion of what will be the most comprehensive flu vaccination programme in national history (Public Health England (PHE), 2020a).
To expand capacity to vaccinate, the Department of Health and Social Care (2020) held a public consultation to extend the remit of the current workforce, including nursing associates and operating department practitioners, as well as paramedics, midwives and physiotherapists; this proposal was broadly supported. Mahase (2020), however, advises caution, warning that the additional workforce would require training to meet expected patient safety standards.
This extension of practice has already occurred in the other home nations. Pharmacies in Scotland can give flu vaccinations for the first time to meet increased demand. Practitioners need to be eligible to administer the vaccine in accordance with Patient Group Directions (PGDs) and employer prescribing frameworks.
Mathew (2020) argues that the flu vaccination programme will be one of the most important preventive exercises that will be undertaken in this pandemic and a failure to receive government help could leave primary care overwhelmed.
It is interesting to note, however, that the World Health Organization (WHO) (2020) has reported that cases influenza have reduced considerably this year compared with previous years, possibly due to mandatory social distancing and stricter hygiene protocols in connection with the current SARS-CoV-2 precautions.
The vaccine
Those eligible will be offered a vaccine most effective for them, depending on age and inclusion criteria recognising their potential vulnerability, such as patients with a long-term condition. Adults aged 65 years and over will receive the adjuvanted trivalent vaccine due to its increased effectiveness in older people as shown in Table 1.
| Age Group | Recommended vaccine | Live vaccine? | Types of flu strains protected | Reason for recommendation |
|---|---|---|---|---|
| Children aged 6 months to 2 years | Egg-grown quadrivalent vaccine (QIVe) | No | 4 | Live attenuated influenza vaccine (LAIV) is not suitable for children aged under 2 years |
| Children aged 2–17 years | LAiV | Yes | 4 | Nasal vaccine helps to reduce spread of flu virus in children |
| Adults aged 18–64 years | Quadrivalent influenza vaccine (QIV): Egg-grown (QIVe) Cell-based (QIVc) | No | 4 | Quadrivalent vaccines protect against four types of flu strain |
| Adults aged 65 or over | Adjuvanted trivalent influenza vaccine (aTIV) | No | 4 | ‘Adjuvant’ is added to the vaccine to make it more effective in older people |
This vaccination is the best protection available against an often unpredictable virus that can cause both unpleasant illness and death. Studies have shown that the flu vaccine will help prevent individuals getting the flu, although it will not be effective against all flu viruses (NHS website, 2020). However, evidence shows (PHE, 2018) that the 2017-2018 seasonal influenza vaccine was effective in only 12.2% in at-risk groups aged 18-64 years and just 10.1% in those aged 65 or over.
The benefits of avoiding or reducing the effects of the flu are not the only potential benefits of the vaccine. The results of a Danish observational study (Modin et al, 2018) showed a 20% reduction in mortality for patients with heart failure who were vaccinated, which reduced the risk of decompensation caused by influenza to the decreased circulatory reserve, particularly in frail and elderly patients.
No vaccine offers 100% protection and a proportion of individuals may still become infected—it is a common misconception among the general public that vaccination provides total protection.
Inactivated vaccines are used with individuals aged over 18 years, and a first injection without prior exposure to the antigen will produce a primary antibody response. Antibodies may persist for months or years and, even if detectable antibody count falls, individuals may still be protected (PHE, 2018). Haralambieva et al (2015) cautioned that there is considerable evidence that immune responses substantially decline with age. In the case of influenza, further seasonal reinforcement doses are used to boost immunity and provide longer term protection.
Mandatory flu vaccinations and their effectiveness
The topic of mandatory flu vaccinations for employees remains controversial. In 2019, England's then chief medical officer Alison Davies suggested that it should be a contractual duty, an opinion shared by Sir Bruce Keogh, medical director of NHS England (Brocklehurst, 2018). Uptake figures showed that in 2019, 70.3% of all eligible frontline staff had received a flu vaccination, only a slight increase on the previous year. In Scotland, this fell to 40% for all NHS workers (Brocklehurst, 2018). The implications of enforcing employees contractually to receive an immunisation could potentially generate confrontation and protest. McCartney (2018) advised that it would be a mistake to make this mandatory, warning that flu vaccinations may not be greatly beneficial and forcing staff to receive an annual vaccine of uncertain effectiveness would be a concern.
The case of US company Essential Health was discussed by Dyer (2017): the company, fired 69 of its 14 000 employees who failed to be vaccinated or provide an exemption request form. This resulted 1 year later, in 2017, in compliance reaching 99.5%.
PHE (2017) showed that the effectiveness of the influenza vaccination in 18 to 65-year-olds was 41% in 2016-2017 in England. Further evidence from the University of Oxford Vaccine Knowledge Project (2020) suggested that in 2016-17, the inactivated flu vaccine did not work at all for people aged over 65 years, which resulted in an adjuvant (MF59) being introduced for the 2018-2019 season. MF59's main ingredient is squalene oil, which it is found only in Flaud, the inactivated targeted vaccine for adults aged 65 years and over. Yang et al's (2020) systematic review supported the benefits of the MF59 adjuvant in over-65s and advised that this could improve protection in the future for what is universally recognised as a vulnerable age group.
According to Blackmore (2018) the benefits of vaccination outweigh those of not having it, stating that there is little evidence to demonstrate any negative effects from being vaccinated. Blackmore (2018) also proposed a ‘presumed consent’ system similar to organ donation, enabling staff to opt out. Thomas et al (2016) suggested that benefits are best seen for staff working in care homes, showing lower death rates and health service use for home care staff who are vaccinated.
Making staff vaccinations mandatory for influenza will continue to pose ethical and legal challenges. However, the lack of objective and valid evidence, particularly for people aged under 65 years may continue to prevent staff being persuaded to agree to annual vaccinations. Mounier-Jack et al's (2020) qualitative study suggested that a more positive culture favouring non-coercion will yield greater staff adherence.
Practitioner requirements
PHE (2020b) has recently published its influenza Patient Group Direction (PGD) to which all practitioners must adhere. Only registered professionals, with the exception of nursing associates, are allowed to legally supply and administer under a PGD and they include:
Practitioners must have undertaken appropriate training relevant to the supply/administration of medicines, as well as shown demonstrable competence in immunisation, management of the ‘cold chain’ (see next section) and ability to recognise and manage anaphylaxis. Despite the pressures faced by primary care services throughout the current COVID-19 pandemic, staff must not feel pressured to undertake any procedure or skill they do not feel confident in delivering.
Practice for registered professionals across different specialties is governed by codes of conduct that include recognition of one's limitations and the need to practise safely. This is especially important when considering inclusion and exclusion criteria for eligible patients. Because the medication falls under a PGD, practitioners are responsible for ensuring the patient receiving the vaccine undergoes an appropriate assessment. If a patient falls outside PGD criteria, a Patient Specific Direction (PSD) will need to be obtained from an appropriate prescriber to administer in line with any updated recommendations (PHE, 2020b). Exclusion criteria for vaccination include individuals who:
The presence of a minor infection is not a contraindication, although practitioners often err on the side of caution and delay until the patient is feeling well. Practitioners need to gain informed consent from patients or from someone legally able to act on their behalf for each administration. A discussion should take place advising the patient or legally responsible person of any risks of not receiving the vaccine.
The ‘cold chain’
The ‘cold chain’ is a term used to define expectation for the storage of certain products requiring refrigeration or their need to be stored at an optimum temperature. Guidelines from the National Institute for Health and Care Excellence (NICE) (2020) advise that this is between +2°C and +8°C. Best practice will also involve the vaccines being stored in the original product packaging, so that batch numbers and expiry dates can be retained.
Vaccines may lose their effectiveness if not stored correctly. Storage outside the recommended manufacturer temperature range, even during transport, can increase the speed of loss of potency, which is irreversible (PHE, 2019). If vaccines were to be used after being incorrectly stored and temperature controlled, they are no longer within the terms of the product licence and a violation of the manufacturer's guidance.
Community teams can benefit from having nominated, responsible individuals who order, receive and ensure correct care of vaccines. Other good practice includes rotating stored vaccine stocks, so that expiry dates can be monitored, designating areas where staff know the location of fridges will be and ensuring the vaccines are quality checked and counted daily, including a review of the refrigerator thermometer. Any failure in the cold chain needs immediate escalation to line managers and adherence to local protocols. Vaccines should be removed immediately and clearly quarantined, until a rapid assessment has taken place to form an action plan to assess their potential for clinical use (PHE, 2019).
Consent
Individuals aged 18 years and over are adults and must consent to any treatment. Although the patient may have had the vaccine or treatment before, ensuring that consent is still valid is essential. The NMC (2018)Code provides nurses with clear expectations of accountability, and failure to obtain or seek appropriate consent could leave the professional vulnerable to legal action. Where patients are unable to give consent, their GP, in consultation with relatives, or those with a health-specific lasting power of attorney (LPA), can make the decision to administer the vaccine, as long as the risks of administration do not pose potential for harm (PHE, 2019).
Administration
Safety checks should be performed to ensure the vaccine is safe to give. Practitioners should ensure the vaccine has not passed its expiry date and ensure the cold chain has not been broken. The practitioner should also check that the vial septum is clean and not damaged in any way.
The vaccine should be administered by intramuscular injection, preferably into the deltoid region of the upper arm and care taken to avoid injury. Caution is advised with patients experiencing coagulation difficulties such as haemophilia or thrombocytopenia that may be poorly controlled (NICE, 2020). Patients with bleeding disorders can be vaccinated intramuscularly, if authorised by a doctor familiar with the risks associated with the patient.
The deep subcutaneous route is advised in patients where risks have been identified; however, PHE (2019) guidance advises that there is a lack of evidence that administration via this route is any safer for patients taking anticoagulants, with potential associated risks with localised reactions. For patients on anticoagulants needle size should be considered, as well as gentle pressure to the injection site post procedure.
Immunisations should not be given into the gluteus maximus because this could cause sciatic nerve damage and pose a risk of injecting the vaccine into fatty tissue rather than muscle (PHE, 2019).
If the skin is clean, no further cleansing is necessary. Skin that is visibly dirty or soiled will need to be washed with warm, soapy water prior to injection (PHE, 2019). Needle choice is not usually an issue for the staff administering the vaccine, because flu vaccines are already often prepared with a 23 or 25 gauge needle (PHE, 2020b). However, with morbidly obese patients a risk assessment may need to be carried out by a qualified practitioner to determine whether another administration method is needed.
Immunisations into the deltoid muscle should be given at a 90° angle with the skin stretched, not bunched. No aspiration is required once the needle is in the muscle. If the patient requires a deep subcutaneous injection, this should be done at a 45° angle with the skin bunched, in contrast to the intramuscular technique.
After administering the vaccine, the patient should be monitored for any adverse drug reactions. Pain, swelling and redness at the injection site should be reported, as well as fever, tiredness/lethargy, headache and myalgia (PHE, 2019; NICE, 2020). Most often, these symptoms disappear after 1-2 days without treatment, with some patients often misconceiving this as ‘getting the flu’ after being vaccinated. Practitioners should observe the patient prior to their departure after vaccination for any indications of anaphylaxis, bronchospasm and urticaria (PHE, 2019). If anaphylaxis were to occur, staff should have adrenaline available and follow NICE (2020) national guidelines for the management of acute anaphylaxis; these guidelines reinforce the need for staff to be trained and competent in its management before administering any medications.
To ensure accountability and transparency, details of the consultation with the patient should be documented accurately. PHE (2018) advises that the following are recorded:
Information can be recorded either electronically or handwritten. Most GP surgeries and community teams use a method of electronic recording, often using the primary patient record on SystmOne or EMIS. Practitioners should ensure that the information provided is accurate, clear and concise as per NMC (2018) expectations and in compliance with local information governance guidelines.