From 1st October 2017, the Human Medicines (Amendment) Regulations 2017 has allowed schools in the UK to buy adrenaline auto-injector devices (known as AAIs) without a prescription to use in an emergency on children who are at risk of a severe allergic reaction (known as anaphylaxis) but whose own device is not available or not working. This could be because their AAI(s) are broken, or out-of-date, for example.
Our helpline and information team have answered frequently asked questions we have received through our national helpline from school nurses and school staff about spare pens in schools and The Human Medicines (Amendment) Regulations 2017. Links to guidance for schools and our top tips and advice are below.
The Human Medicines (Amendment) Regulations 2017 and available guidanceDoes the change in legislation apply to all schools? E.g. nursery schools, primary and secondary schools, independent schools?
The change in legislation applies to local authority maintained nurseries, primary, secondary and special schools, academies, pupil referral units and independent schools in England, Scotland and Wales. In Northern Ireland this applies to grant aided schools and independent schools as defined in the Education and Libraries (NI) Order 1986. The ‘Human Medicines (Amendment) (No. 2) Regulations 2014’ defined what the term ‘school’ means. This definition can be found here.
The Department of Health has released non-statutory guidance called ‘Guidance on the use of adrenaline auto-injectors in schools’ which explains good practice which schools in England should observe when using spare AAIs and can use to develop their own protocol or policies.
This guidance does not apply to schools in Scotland, Wales and Northern Ireland. This is because devolved administrations have responsibility for issuing their own guidance. However, the principles in the English guidance are universal and based on recognised good practice.
Any policies developed in reference to ‘Guidance on the use of adrenaline auto-injectors in schools’ must also be in line with statutory guidance which sets out what schools and local authorities must do to comply with the law, called ‘Supporting pupils at school with medical conditions‘.
The Scottish Government published ‘Guidance on Healthcare Needs in Schools‘ in December 2017 which is a guidance document for NHS Boards, education authorities and schools about supporting children and young people with healthcare needs in schools.
This guidance replaces the previous guidance on the administration of medicines in schools, which was published in 2001.
The document ‘Guidance on the use of emergency adrenaline auto-injectors in schools in Wales‘ is available on the Welsh Government’s Learning Wales website. The guidance applies to maintained nurseries, primary, secondary and special schools, pupil referral units (PRUs) and independent schools in Wales. A Welsh version is available here.
The guidance from the Department of Health in England has been adapted for Northern Ireland by the Department of Health, in partnership with the Department of Education, and should be read as an addendum to ‘Supporting Pupils with Medication Needs’.
The document ‘Guidance for use of AAIs in schools in Northern Ireland 2017’Guidance on the use of adrenaline-auto injectors (AAIs) in schools in Northern Ireland is available on the Department for Education, Northern Ireland website.
Obtaining, storing, administering and disposing spare adrenaline auto-injector(s)How can my school purchase adrenaline auto-injector(s)?
The DOH Guidance on the use of adrenaline auto-injectors in schools 2017 sets out that schools can purchase AAIs from a pharmaceutical supplier, such as a local pharmacy, without a prescription, provided the general advice relating to these transactions are observed: i.e. small quantities on an occasional basis and the school does not intend to profit from it. A supplier will need a request signed by the principal or head teacher stating:
- the name of the school
- the purpose why the AAI(s) is/are required
- the total number of AAIs required
Pharmacies are not required to provide AAI(s) free of charge to schools, your school must pay for them as a retail item. The retail price is circa £35 and your local pharmacy may add a small handling charge.
We are aware that some schools are being charged substantially more than this. Please contact the Helpline on 01252 542029 or email [email protected] if you have concerns regarding the cost of AAIs.
The adrenaline injectors prescribed in the UK at present are EpiPen® and Jext®.
Emerade devices in all doses (150mcg, 300mcg and 500mcg) have been recalled and are not currently available. Please see our Latest News pages for updates on adrenaline auto-injector availability here.
The decision as to how many AAIs and what brands to purchase will depend on the individual circumstances within your school. However, the Department of Health guidance advises:
“Where all pupils are prescribed the same device, the school should obtain the same brand for the spare AAI. If two or more brands are currently held by the school, the school may wish to purchase the brand most commonly prescribed to its pupils.”
The place where the adrenaline is administered is the same for all three injectors; Emerade®, EpiPen® and Jext® are injected into the muscle in the front quarter of the outer thigh. However, there is some variation in operating each AAI and training on each device should be given to all school staff who might be required to administer adrenaline in an emergency.
You can also obtain trainer pens containing no needle or adrenaline from the manufacturers. More details about supplier websites and administering adrenaline are in our Factsheet.
Schools should ensure that all AAI devices – including those belonging to a younger child, and any spare AAI in the Emergency kit – are kept in a safe and suitably central location: for example, the school office or staffroom to which all staff have access at all times, but in which the AAI is out of the reach and sight of children.
They must not be locked away in a cupboard or an office where access is restricted. AAI(s) must be accessible and available for use at all times, and not located more than 5 minutes away from where they may be needed.
In larger schools, it may be prudent to locate a kit near the central dining area and another near the playground as more than one kit may be needed.
In line with the recommendation from the Commission on Human Medicines the school’s spare AAI should only be used on pupils known to be at risk of anaphylaxis and for whom both medical authorisation and written parental consent for use of the spare AAI has been provided. The school’s spare AAI can be administered to a pupil whose own prescribed AAI cannot be administered correctly without delay.
In line with good clinical practice all pupils who are prescribed an AAI(s) should have an appropriate management plan. The pupil’s allergy management plan should incorporate both medical authorisation and parental consent for the use of the school’s spare AAI(s) and a copy should be shared with the pupil’s school. The BSACI have templates which can be used for this purpose, which can be downloaded at www.sparepensinschools.uk or the BSACI website.
If a child is having anaphylaxis but does not have a plan with medical authorisation and parental consent, schools should immediately call 999 and seek advice. If spare AAIs are available, mention this to the call handler/emergency medical dispatcher, as they can authorise use of the spare AAI if appropriate.
Any member of staff may volunteer to take on this role. In many schools, it would be appropriate for there to be multiple designated members of staff who can administer an AAI to avoid any delay in treatment and ensure cover when staff are on leave.
Schools should ensure staff have appropriate training and support, relevant to their level of responsibility. The statutory guidance “Supporting pupils with medical conditions at school” requires governing bodies to ensure that staff supporting children with a medical condition should have appropriate knowledge, and where necessary, support.
The Department of Health has indicated it would be reasonable for ALL staff to:
- be trained to recognise the range of signs and symptoms of an allergic reaction
- understand the rapidity with which anaphylaxis can progress to a life-threatening reaction, and that anaphylaxis may occur with prior mild (e.g. skin) symptoms
- 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
- be aware of how to check if a pupil is on the register of pupils at risk of anaphylaxis
- be aware of how to access the AAI
- be aware of who the designated members of staff are, and the policy on how to access their help
You can also obtain trainer pens containing no needle or adrenaline from the manufactures. More details about supplier websites and administering adrenaline are in our Factsheets.
Once an AAI has been used it cannot be reused and must be disposed of according to manufacturer’s guidelines. Used AAIs can be given to the ambulance paramedics on arrival or can be disposed of in a pre-ordered sharps bin for collection by the local council.
The spare AAI is a spare or back up device and not a replacement for a pupil’s own medication.
This is emphasised in the Department of Health guidance, which states:
“Children at risk of anaphylaxis should have their prescribed AAI(s) at school for use in an emergency. The MHRA recommends that those prescribed AAIs should carry TWO devices at all times, as some people can require more than one dose of adrenaline and the AAI device can be used wrongly or occasionally misfire.
Depending on their level of understanding and competence, children and particularly teenagers should carry their AAI(s) on their person at all times or they should be quickly and easily accessible at all times. If the AAI(s) are not carried by the pupil, then they should be kept in a central place in a box marked clearly with the pupil’s name but NOT locked in a cupboard or an office where access is restricted.
It is not uncommon for schools (often primary schools) to request a pupil’s AAI(s) are left in school to avoid the situation where a pupil or their family forgets to bring the AAI(s) to school each day. Where this occurs, the pupil must still have access to an AAI when travelling to and from school.”
Current advice from the Medicines and Healthcare products Regulatory Agency “Adrenaline auto-injector advice for patients” recommends that people with allergies and their carers should carry two adrenaline auto-injectors at all times, especially if they also have allergic asthma as they are at increased risk of experiencing a severe anaphylactic reaction.
The Anaphylaxis Campaign support the MHRA guidance. We actively campaign for people to be prescribed two AAIs and firmly recommend that once prescribed they should always be kept with the patient so they have access to them at all times. The reasoning behind two devices always being available is in case one is broken or misfires, or a second injection is needed before emergency help arrives.
After school clubs and out of school activitiesCan after school clubs, such as girl guides or scouts, get adrenaline auto-injector(s) with this legislation change?
Where clubs occurs on school premises as part of official school activities, they can have access to the school’s spare AAI(s).
The change in legislation does not apply to other circumstances, and children at risk of anaphylaxis should have their own prescribed AAI(s) with them, in the event of a reaction.
Schools should conduct a risk-assessment for any pupil at risk of anaphylaxis taking part in a school trip off school premises, in much the same way as they already do so with regards to safe-guarding.
Pupils at risk of anaphylaxis should have their AAI(s) with them, and there should be staff trained to administer AAI(s) in an emergency. Schools may wish to consider whether it may be appropriate, under some circumstances, to take spare AAI(s) obtained for emergency use on some trips.
Our FREE online anaphylaxis training course AllergyWise for Schools is designed to ensure that key staff in schools are fully aware of the signs and symptoms of anaphylaxis, how to provide emergency treatment and the implications for management of severely allergic children from Key Stages 1 to 5 in an education setting. Find out more and register here.