Yes.

In the event of an emergency, anyone can administer adrenaline to a specified maximum dosage (e.g. through an AAI) for the purpose of saving a life.

A severe allergic reaction inducing or potentially inducing anaphylaxis will fall into this category. This exemption is specifically set out in law through Regulation 238 of The Human Medicines Regulations 2012 which states that the prohibitions on administrating prescription medicines “does not apply to the administration of a prescription only medicine specified in Schedule 19 where this is for the purpose of saving life in an emergency.”

Adrenaline in the form of“1:1000 up to 1mg for intramuscular use in anaphylaxis” as used in the Anaphylaxis Kitt AAIs is a Schedule 19 medicine. Although a person suffering a reaction could administer their own AAI (and they may prefer to do so if they are able), legally there is no ban on someone else assisting in this process or doing it completely for them. AAIs are designed to give a single fixed dose of adrenaline by someone who is not medically trained.

Notwithstanding this, it is advisable to provide basic training to one or more people within your organisation to identify the signs of anaphylaxis and how to use an AAI. This helps ensure the most effective use of an AAI in an emergency situation, maximising the prospects of a positive outcome. Readily accessible and unlimited online training is provided by Kitt Medical as part of the Anaphylaxis Kitt service. The frequency of training is not specifically mandated in law with the HSE using terms such as refreshing at “suitable intervals”.

Training needs should be assessed based on business need and reviewed whenever anything changes (e.g. staff moves) and on an at least annual basis.

For more information on this (directly from the MHRA clarification document), please click here.

Yes.

Hesitation around using adrenaline pens is a huge problem. As leading allergy Professor Adam Fox says, “It's not harmful at all. It's a very, very safe drug. If you suspect that anything severe is happening - that's the time to get on and give it (adrenaline). And the great thing is, is that as well as being really safe, it's extremely effective. So even if it wasn't that bad a reaction, then you're still going to feel a lot better a lot quicker as a consequence of using it.” (Click here to watch our full interview).

Therefore, based on the current evidence, the benefit of using appropriate doses of intramuscular adrenaline far exceeds the risk in an allergic emergency.

Yes.

As a result of the Human Medicines (Amendment) Regulations 2017 schools have been permitted to buy AAI devices without a prescription, for emergency use in children who are at risk of anaphylaxis but their own device is not available or not working (e.g. because it is broken, or out-of-date).

For more information on this, click here.

Yes.

Severe anaphylaxis is a time-critical situation: delays in administering adrenaline have been associated with fatal reactions. All AAI devices – including those prescribed to the pupil themselves, as well as any spare AAI(s) – must:

- Be accessible at all times, in a safe and suitably central location e.g. school office or staffroom.

- NOT be locked away in a cupboard or kept in an office where access is restricted.

AAIs should not be located more than 5 minutes away from where they may be needed. This is especially important to consider in larger schools, e.g. how far is the central dining area, to the playground?

Spare AAI devices in the emergency kit should be kept separate from any AAIs prescribed to pupils and clearly labelled as such. In general, AAIs should be kept at room temperature (in line with manufacturer’s guidelines), away from direct sunlight and extremes of temperature. They should not be stored in a refrigerator.

For more info on guidance on the use of adrenaline auto-injectors in schools, click here.

We designed Kitt specifically to store your school’s spare set of adrenaline auto-injectors safely in accessible locations. Click here to enquire with us today to find out more.

Yes.

The Department of Health has stated that it is reasonable for ALL staff to:

- Be trained to recognise the signs and symptoms of an allergic reaction (understanding the rapidity with which anaphylaxis can progress to a life-threatening reaction, and that anaphylaxis may occur with or without prior mild symptoms such as skin rash);

- Be aware of how to access the AAI and appreciate the need to administer adrenaline without delay as soon as anaphylaxis occurs (before the patient might reach a state of collapse, after which it may be too late for the adrenaline to be effective);

- Be aware of the anaphylaxis policy and allergy register;

For more information on this (directly from the MHRA guidance), please click here.

We include a CPD-accredited online training course with every Anaphylaxis Kitt subscription, covering information on allergies and anaphylaxis including symptom recognition and treatment procedures, accessible to all staff.

Click here to enquire with us today to find out more.

Yes & No.

It is up to individual organisation to decide when it is best to obtain consent for use of an AAI. The most appropriate time is probably when an individual healthcare plan is agreed. Consent should be updated annually or when there are any changes to the treatment plan.

Like adults, young people (aged 16 or 17) are presumed to have sufficient capacity to decide on their own medical treatment, unless there's significant evidence to suggest otherwise. Children under the age of 16 can consent to their own treatment if they're believed to have enough intelligence, competence and understanding to appreciate what's involved in their treatment fully. Otherwise, someone with parental responsibility can consent for them.

If a pupil is experiencing anaphylaxis but does not have the required authorisation/consent for a spare adrenaline pen to be used (perhaps they weren’t even previously aware they had an allergy), a trained staff member who believes it to be a life-threatening scenario can act accordingly and use a spare adrenaline pen from the Kitt (Always call 999 in an emergency).

Yes.

Schools have a legal duty to make arrangements for pupils with medical conditions (including those with food allergies) under the Children and Families Act 2014. This requirement is supported by the statutory guidance Supporting pupils at school with medical conditions (linked here). All pupils with medical conditions – including food allergies – should have an Individual Healthcare Plan agreed between the parents and the school. This is particularly important where an adrenaline auto-injector (AAI) has been prescribed for use in emergencies.

The Department of Health recommends that schools keep a register of pupils to whom the spare AAI(s) can be administered. Schools may find it helpful to keep this list in the Emergency Anaphylaxis kit, in which case it is vital to ensure the list is kept up-to-date.

The school’s policy should include a procedure for allowing a quick check of the Allergy register as part of initiating the emergency response (this should NEVER delay treatment!). This does not need to be undertaken by the designated member of staff, but the register should be easily accessible. Alternatively, allowing pupils to keep their AAI(s) with them allows for confirmation of consent without the need to check the register.

AAIs are a prescription-only medicine (POM). This means that people with a serious allergy will often have one or more AAIs prescribed to them by their medical professional and it is not possible for individuals to purchase AAIs without such a prescription. For example, they are not available ‘over the counter’ in a pharmacy.

There are exemptions from the restrictions on the sale/supply of POMs, including AAIs, contained in Schedule 17 of the Human Medicines Regulations 2012. Specifically, allowing POMs to be sold or supplied to someone operating an occupational health scheme (OHS) in response to an order in writing signed by a doctor or a registered nurse, or sold or supplied to a school.

As such, our Anaphylaxis Kitt service can only be purchased in the UK by registered schools and qualifying businesses with an occupational health scheme (OHS) available. This OHS could be an internal company OH physician/nurse, or a third-party provider you have available to the business (e.g. Health Assured).

Although your OHS status should always be checked, unfortunately the limits of the legal exemption on supply of AAIs often means smaller independent businesses and groups such as scouts often do not qualify.

We are unable to supply AAIs to anyone who cannot evidence OHS status and we have no discretion on this decision.

Occupational Health schemes come in all shapes and sizes, and there are many different companies that can provide different services.

We recommend getting in touch with Health Assured to discuss OH for your business.

In England and Wales, there is no legal requirement on an individual/bystander to intervene in an emergency situation (sometimes called a ‘good Samaritan’ provision). This does not apply to those who have an express duty to do so through their employment such as medical professionals. If a bystander does intervene, the law does not encourage legal action against people who have attempted to assist in an emergency, whether through criminal or civil law.

The HSE provides guidance on the legal risk of providing first aid care stating that “it is very unlikely that any action would be taken against a first-aider who was using the first-aid training they have received.”

In civil law, for example where first aid given was alleged to be negligent, the risk is also limited. Courts have determined that once a decision to assist is made, the person giving aid must ensure that they act “reasonably” and not cause more harm than if the patient/person in difficulty had not been rescued.

However, there is also specific legislation designed to make sure people are not deterred from providing help through the fear of potential legal liability. Specifically, the Social Action, Responsibility and Heroism Act 2015 states that when a court considers a negligence claim or breach of duty, it must consider whether the person was acting “for the benefit of society or any of its members” or whether a person “demonstrated a predominantly responsible approach towards protecting the safety or interests of others” or the person was “acting heroically by intervening in an emergency to assist an individual in danger”.

As such, considering (1) the potential consequences of anaphylaxis; (2) the recognised need for urgent medical intervention; (3) the low risk of adrenaline; and (4) the legal protections available, the risk of legal liability to an individual who administers an AAI in a medical emergency (and especially when in accordance with Kitt Medical training and guidance) is low.