Right patient

Verifying the patient’s identity and the vaccines that they are attending the clinic to receive is a crucial part of the vaccination process. It is important to avoid any confusion when siblings are seen together, as this has been identified as a cause of errors (Lang et al 2014).

Right to give the vaccine

The Immunisation Against Infectious Disease document – commonly referred to as The Green Book – advises that ‘almost all individuals can be safely vaccinated with all vaccines’ (UKHSA 2017). However, although a vaccine may be recommended for a specific age or population group, it would be contraindicated if an individual has a history of a previous anaphylactic reaction to it or to any of its components. Specific vaccines may need to be deferred or avoided in certain patient groups.

Live attenuated vaccines are contraindicated for pregnant women and for patients with immunosuppression caused by an underlying medical condition or treatment. In patients who are immunosuppressed, live vaccine strains, although attenuated, can replicate once administered and may cause an infection that can be extensive, severe or in some cases fatal (Medicines and Healthcare products Regulatory Agency (MHRA) 2016).

In 2016, the MHRA received four reports of neonatal deaths from disseminated BCG or tuberculosis infection after exposure to a tumour necrosis factor-alpha antagonist in utero. As a result, they published an update stating that ‘any infant who has been exposed to immunosuppressive treatment from the mother either in utero during pregnancy or via breastfeeding should have any live attenuated vaccination deferred’ (MHRA 2016). In the same year, notifications were made following the administration of shingles vaccine to older patients with immunosuppression who experienced possible disseminated viral infection caused by the vaccine, prompting a reminder to be aware of the ‘special precautions associated with the shingles vaccine before proceeding with immunisation’ (MHRA 2016). Two reports of fatal adverse reactions to yellow fever vaccines in 2019 led to warnings that ‘yellow fever vaccine is contraindicated in any person who is immunosuppressed’ (MHRA 2019a, 2019b).

An evaluation of newborn screening to identify severe combined immune deficiency has been introduced for babies born in certain regions of England (UKHSA 2021). Although it is important that babies with severe combined immune deficiency are appropriately vaccinated, they should not receive live vaccines such as the BCG and rotavirus. The UKHSA (2021) has published an algorithm for the process of checking for severe combined immune deficiency screening results at the routine eight-week vaccination appointment.

The Complete Routine Immunisation Schedule (UKHSA 2022a) details who should receive vaccines, what diseases these protect against, at what age they should be given, and the site and route of administration. The healthcare practitioner also needs to check that vaccines are not contraindicated for each patient by consulting The Green Book and any patient group directions (UKHSA 2020, 2022c).

Right dose

All vaccinations offered as part of the UK’s routine vaccination programme are presented as a standard dose, usually in a single-use pre-filled device such as a syringe for injection or an applicator for oral or nasal administration. When using such devices, the full dose should be administered and it is unusual for an incorrect dose to be given unless the healthcare practitioner inadvertently administers a partial dose. Some vaccines such as the BCG and COVID-19 vaccines are presented in multi-dose vials and healthcare practitioners must be familiar with the correct dosing schedule for children and adults, as described in the national protocols in The Green Book (UKHSA 2022b) or in patient group directions.

While the administration of a greater than recommended dose will not usually affect the patient’s immune response or their protection against a disease, it may increase the risk of an adverse reaction. When a lower than recommended dose is administered, for example if vaccine leaks out at the injection site during administration, it may be recommended that the dose is repeated as an incomplete dose may not elicit the required immune response. Healthcare practitioners should seek further advice before revaccinating as repeat doses of specific vaccines may not be recommended due to the risk of significant local reaction and because some vaccines, such as the BCG, may lead to keloid scarring. Further information on responding to vaccine errors is included in the vaccine incident guidance published by PHE (2021a).

Right vaccine (and diluent if required)

In Lang et al’s (2014) study, the most common error recorded was the administration of the wrong vaccine, with errors occurring during vaccine selection and preparation. This can occur when there are vaccines in the medical refrigerator with similar packaging, with similar names or with names that share the same first letter.

The Visual Guide to Vaccines poster (UKHSA 2022d) shows images of the vaccines used in the routine vaccination programme in the UK. The images show four vaccines in similar blue and white packaging, four with a name ending in ‘rix’ and two different vaccines that protect against pneumococcal disease with different age indications. There are several influenza vaccines available, also with different age indications. To minimise the risk of the wrong vaccine being selected, Lang et al (2014) suggested separating paediatric and adult vaccines in the fridge and labelling vaccines with a warning to check that the dose is age appropriate.

Some vaccines will require reconstitution. All parts of these vaccines should be correctly reconstituted and only the diluent supplied with the vaccine should be used. An example of such a vaccine is Infanrix hexa, which is given to infants to protect them against six childhood diseases: diphtheria, tetanus, pertussis (whooping cough), polio, Haemophilus influenzae type b and hepatitis B. Failure to use the correct diluent would mean that the infant does not receive protection from Haemophilus influenzae type b as this is contained in the powder component of the Infanrix hexa vaccine.

Right time

Healthcare practitioners must follow the age-based recommendations of the routine vaccination programme, which are informed by several factors, including (UKHSA 2020, 2022b):

To optimise protection against certain diseases, routine vaccines are administered before the age of greatest risk. Although the routine childhood programme begins at eight weeks of age, maternal vaccination provides the unborn baby with protection against disease in the first weeks of life (Campbell et al 2015).

Pertussis, influenza and COVID-19 vaccines recommended for pregnant women are to protect the woman herself, to protect the unborn baby as it develops passive immunity from the transfer of maternal antibodies, and to protect the infant from transmission of infection from the mother following birth. Maternal vaccinations should be administered at the recommended stage of pregnancy. It is recommended that pregnant women are vaccinated against COVID-19 as soon as possible (UKHSA 2022e), while an influenza vaccine can be administered at any stage of pregnancy and the pertussis vaccine is recommended from 16 weeks of pregnancy (NHS 2019a, 2019b). Delaying vaccination leaves the pregnant woman at risk of infection and may compromise the passive immunity given to the infant if it is born before optimal transfer of maternal antibodies has taken place.

Some of the vaccines in the routine programme require a series of doses with recommended intervals between them. This is to enable a primary response to develop so that future doses stimulate the immune system to produce a secondary response. Administering a vaccine with less than the recommended interval from the previous dose may lead to a reduced response to the vaccine. Booster doses should also be given at the correct intervals to ensure optimal and long-lasting protection (PHE 2021a).

It is important to ensure that a vaccine is used before it reaches its expiry date, which is usually determined by adding the shelf-life period to the date of manufacture. Although it is unlikely that a vaccine would lose all potency on reaching its expiry date, revaccination may be recommended for a patient if an expired dose was inadvertently administered to them. Since most vaccines tend to have a shelf life of a few years, those that have reached their expiry date will have had a prolonged time in storage and may be more vulnerable to degradation (PHE 2021a).

Right route

A vaccine can be administered via the intramuscular (IM), subcutaneous, intradermal, oral or intranasal route. If administered via an incorrect route, the vaccine may not elicit an optimal immune response. If vaccines containing adjuvants are administered subcutaneously, there may be an increased risk of a local reaction or formation of a granuloma at the injection site (Plotkin et al 2008).

All injected vaccines given as part of the routine vaccination programme are recommended to be given via the IM route, so healthcare practitioners should check the site of administration and the needle length before administration (Plotkin et al 2008, UKHSA 2022a).

A Cochrane review by Beirne et al (2018) explored the effect of needle size and gauge on immune response to a vaccine, pain experienced during the vaccination procedure and occurrence of reactions after vaccination. The authors advised that ‘choosing an appropriate length and gauge of a needle may be important to ensure that a vaccine is delivered to the appropriate site and produces the maximum immune response while causing the least possible harm’. They concluded that for IM injections, using 25mm needles (23G or 25G) ‘probably reduces the occurrence of local reactions while achieving a comparable immune response to 25G 16mm needles’ (Beirne et al 2018).

Right site

A full assessment of the area that the vaccine will be administered into should be conducted to find the anatomical markers that will help to identify the correct injection site. The deltoid muscle in the upper arm is the recommended site for those over the age of one year because this muscle is usually sufficiently developed by this age. If there is insufficient muscle mass at the site of the deltoid then an alternative site, such as the anterolateral aspect of the thigh, may be used. The recommended site for infants under the age of one year is the vastus lateralis muscle in the anterolateral aspect of the thigh.

Using the correct technique and landmarking the injection site for the administration of an IM injection can optimise the response to the vaccine and help to avoid bruising, shoulder injury, pain and reduced range of motion at the joint (Bancsi et al 2018). If the vaccine is administered at the wrong site, then a more severe or prolonged reaction may be experienced (Plotkin et al 2008).

Occasionally, there may be challenges accessing the correct site for vaccination, for example when vaccinating an infant in a hip spica cast. It may be possible for vaccines to be administered when the infant’s cast is being changed, or a window could be cut in the cast for the injection and then reapplied. If that is not possible and vaccines are administered in the deltoid muscle, consideration will need to be given to the needle size, the location of the radial nerve (since it is more superficial in infants), and the injection technique. If more than two vaccines are to be administered into a single muscle, a gap between injection sites of 2.5cm is recommended to enable vaccine identification in the event of a local reaction (Australian Government Department of Health 2021).

Right documentation

Vaccines are prescription-only medicines and a legal framework for their supply and administration is required to be in place. This may be in the form of an individual prescription, a patient-specific direction, patient group directions or a national protocol.

National patient group directions templates are published for vaccines recommended as part of the national vaccination programme. These documents require local sign-off by an appropriate authorising person before use. They contain full details of the vaccine and outline inclusion and exclusion criteria for each of them. Assessing patients against the exclusion criteria in the patient group directions should identify those who are not eligible to receive the vaccine and those with clinical contraindications.

Once administered, details of the vaccination should be carefully and accurately recorded in the digital clinical care system using the correct codes and in the personal child health record (the red book). This can help to avoid duplicate doses being administered, identify the cause of any local reaction that may occur and facilitate patient identification in the event of a product batch recall.

All patients should be informed about expected reactions following vaccination, advised on actions to take if they have any concerns, and receive or be signposted to further information. Information for healthcare practitioners and leaflets for patients and parents are available to download at: www.gov.uk/government/collections/immunisation.

Any adverse events following vaccination should be documented and can be reported by patients or healthcare practitioners via the MHRA’s (2021a) Yellow Card scheme. Side effects are usually mild and quickly resolve but rarer serious effects, such as anaphylaxis, may require hospital treatment and would mean that future doses of the same vaccine are contraindicated. The COVID-19 Yellow Card reporting site (coronavirus-yellowcard.mhra.gov.uk) should be used to report any side effects from COVID-19 vaccination (MHRA 2021b).