Frequently asked questions (FAQs)

The Medical and Health Care Products Regulatory Agency (MHRA) has provided advice on this. It states:

'People who have been prescribed an adrenaline auto-injector because of the risk of anaphylaxis should carry two with them at all times for emergency, on-the-spot use. After every use of an adrenaline auto-injector, an ambulance should be called (even if symptoms are improving), the individual should lie down with their legs raised and, if at all possible, should not be left alone’

Further details (accessed 14 June 2024)

14 July 2024

Auto-injectors are primarily for self use by patients who are at risk of an anaphylactic reaction. They should be prescribed on an individual basis by a specialist in allergy. These guidelines are aimed at healthcare professionals in a variety of settings. We have not specifically recommended auto-injectors for use by this group for several reasons:

• Auto-injectors are relatively expensive with a limited shelf life compared with the cost of an ampoule of adrenaline and syringe and needle. Anaphylactic reactions are uncommon. Most auto-injectors purchased for the healthcare setting will not be used.
  
  
• Auto-injectors come with standard length needle which may not be long enough to give intramuscular adrenaline for some patients.
  
  
• Most healthcare staff likely to deal with an anaphylactic reaction in the healthcare setting should have the skills to draw up adrenaline and give an intramuscular injection of adrenaline.
  

 Ultimately it is a local decision whether a healthcare setting opts to use auto-injectors instead of adrenaline ampoules. If there is no other form of adrenaline available it would be appropriate for a healthcare professional to use an adrenaline auto-injector for the treatment of an anaphylactic reaction.

All patients with a suspected or proven anaphylactic reaction should be offered the opportunity to be reviewed in an allergy clinic. Emergency departments should liaise with their nearest allergy clinic to ensure that there is local guidance in place for the further care of these patients. Issues that will need to be addressed in follow-up include:

• Confirmation of the diagnosis.
   
• Investigation of possible causes of the anaphylactic reaction. 
   
• Advice on future prevention strategies including advice on emergency management. 
   
• Education for the patient.

The BSACI website shows locations and contact details for allergy clinics.

Response from George Rylance (Chairman, Paediatric Formulary Committee, BNF for Children):

The editors of BNF publications review prescribing information as it emerges; in the light of this information, advice from experts in the field, and the Joint Formulary and Paediatric Formulary Committees, amendments to the BNF and BNF for children (BNFC) are made.

The BNF is published twice yearly, in September and March, and BNFC is published once a year in July. It is important for the treatment of anaphylaxis to be as clear as possible, so it is likely that the advice in the next edition of the BNF or BNFC will be amended in line with this guideline.

Prescribing doses from either this guideline or the BNF or BNFC is justifiable at this time, but using doses in this guideline seems the more appropriate. 

Anaphylaxis in children under 6 months of age is very uncommon. In the rare circumstances an auto-injector is considered to be necessary, it would be appropriate to prescribe and recommend for use one containing 150 micrograms adrenaline. This should be prescribed only by a specialist.

There is no legal problem in any person administering adrenaline that is either prescribed for a specific person or in administering adrenaline to an unknown person in such a life saving situation (through specific exemptions in the medicines act). However the nurse involved must work within the Nursing & Midwifery Council (NMC) standards, and must therefore be competent in being able to recognise the anaphylactic reaction and administer adrenaline using an auto-injector. Therefore it would be sensible for trusts/employers to ensure that such a provision is included in their first aid or anaphylaxis guidelines.

There is no legal problem in any person administering adrenaline that is either prescribed for a specific person or administering adrenaline to an unknown person in such a life saving situation (through specific exemptions in the medicines act). However the first aider involved must be competent in being able to recognise the anaphylactic reaction and administer adrenaline using an auto-injector. First aiders must ensure that they work within the guidelines of the first aid training organisation that issued their qualification and their employer.

The Health & Safety Executive also provides guidance.

As at 25 January 2024 this stated:

"Medicines legislation restricts the administration of injectable medicines. Unless self administered, they may only be administered by or in accordance with the instructions of a doctor (e.g., by a nurse). However, in the case of adrenaline there is an exemption to this restriction which means in an emergency, a suitably trained lay person is permitted to administer it by injection for the purpose of saving life. The use of an Epipen to treat anaphylactic shock falls into this category. Therefore, first aiders may administer an Epipen if they are dealing with a life threatening emergency in a casualty who has been prescribed and is in possession of an Epipen and where the first aider is trained to use it." 

No, you should give adrenaline intravenously only if the patient is in cardiac arrest. There is a fundamental difference in the response to adrenaline when given to a patient with a spontaneous circulation compared with when it is given in cardiac arrest. In the patient with a spontaneous circulation, intravenous adrenaline can cause excessive hypertension, tachycardia and arrhythmias - this is why this route should be used only by someone with experience in titrating adrenaline to produce an appropriate haemodynamic response. In cardiac arrest, intravenous adrenaline is given to increase the coronary perfusion pressure achieved during CPR - under these circumstances absorption from an intramuscular injection would be too unreliable.

Once cardiac arrest occurs it is important to ensure expert help is coming and start cardiopulmonary resuscitation (CPR) immediately. Good quality CPR with minimal interruption for other interventions improves the chances of survival from cardiac arrest. Once cardiac arrest has occurred intramuscular adrenaline is not beneficial and attempts to give it may interrupt CPR. Absorption of adrenaline given by intramuscular injection will not be reliable once cardiac arrest has occurred. Advanced life support according to current guidelines should start as soon as possible.

Current advanced life support guidelines.

Allergic rashes alone are relatively common and often respond to an oral dose of antihistamine (e.g., chlorphenamine). Some patients are also prescribed a steroid by their doctor. If the patient has or is developing life threatening airway, breathing or circulation problems other treatments including adrenaline are necessary.

Auto-injectors are recommended primarily for use by laypeople for self administration. Guidance for their use must allow a greater degree of safety in terms of dose and recommended dosing interval. There is little science on which to base a recommendation for the dosing interval. The recommendation of 5 minutes is pragmatic and based on the personal experience of those who use adrenaline in their regular practice. Waiting for 10-15 minutes for a response before giving a further dose may be excessive in a patient with life-threatening airway, breathing or circulation problems caused by an anaphylactic reaction.

The intramuscular doses we recommend are for healthcare staff who rarely deal with paediatric emergencies. The doses have been chosen because they are easy to draw up and administer and are within the safe acceptable dose ranges for the particular age groups.

We have provided doses on a weight basis for IV adrenaline for use by specialists only. Some specialists working in critical care settings may wish to administer more precise doses based on a patient’s weight. These guidelines do not preclude this.

The Department of Health guidance on this issue does not state a specific time (see Green Book 2006 guidance) but does not recommend long periods of observation. The risk of severe life-threatening reactions after immunisation is extremely small. This rate in the UK (approximately one per million vaccine doses) is similar to that reported from other countries (Bohlke K, Davis RL, Marcy SM, Braun MM, DeStefano F, Black SB, et al. Risk of anaphylaxis after vaccination of children and adolescents.Pediatrics 2003;112(4):815-20).

Based on the information available a short period of observation (5-10 minutes) should be used to detect immediate problems. Patients (and carers) should be provided with advice on possible local and systemic reactions and what to do if they occur.

Immunisation against infectious disease. The Green Book 2006, Department of Health states:

[Chapter 4, Immunisation procedures]:

“Recipients of any vaccine should be observed for immediate ADRs. There is no evidence to support the practice of keeping patients under longer observation in the surgery.”

[Chapter 8, Vaccine safety and the management of adverse events following immunisation]:

“Onset of anaphylaxis is rapid, typically within minutes, and its clinical course is unpredictable with variable severity and clinical features. Due to the unpredictable nature of anaphylactic reactions it is not possible to define a particular time period over which all individuals should be observed following immunisation to ensure they do not develop anaphylaxis.”       

No, you don’t need to be carrying hydrocortisone and chlorphenamine. These drugs can be administered when the patient arrives in hospital. Adrenaline is the mainstay of treatment for an anaphylactic reaction.

Hydrocortisone and chlorphenamine are not first line drugs for the treatment of an anaphylactic reaction. The key steps are using an ABCDE approach to recognising the patient is having an anaphylactic reaction, calling for help early and administrating intramuscular adrenaline. The risk of an anaphylactic reaction after immunisations and vaccinations is very small. Considering these facts, it is not necessary to carry these drugs.

It is important to make sure you can access a telephone easily to summon an ambulance to take your patient to hospital.

Immunisation against infectious disease. The Green Book 2006, Department of Health states:

[Chapter 8, Vaccine safety and the management of adverse events following immunisation]:

“An anaphylaxis pack normally contains two ampoules of adrenaline (epinephrine) 1:1000, four 23G needles and four graduated 1 ml syringes, and Laerdal or equivalent masks suitable for children and adults. Packs should be checked regularly to ensure the contents are within their expiry dates. Chlorphenamine (chlorpheniramine) and hydrocortisone are not first-line treatments and do not need to be included in the pack.”

The Resuscitation Council (UK) has taken advice from several sources. A PGD is not required for anyone (whether they are a healthcare professional or not) to give intramuscular adrenaline for the purpose of saving a life in an emergency. 

The Statutory Instrument (SI) is 1997 The Prescription Only Medicines (Human Use) Order no 1830. It can be found on the website www.legislation.gov.uk (formerly at HMSO). This Statutory Instrument amends the main Statutory Instrument on prescribing which is the Medicines (Products other than veterinary drugs)(prescription only) order 1983 Statutory Instrument;

Article 7 of the 1997 SI states:

"The restriction imposed by s58 (2)(b) (restriction on administration) shall not apply to the administration to human beings of any of the following medicinal products for parenteral administration: Adrenaline injection 1 in 1000 (1 mg in 1mL), Atropine sulphate injection, Chlorpheniramine [chlorphenamine] injection, Cobalt edetate injection, Dextrose injection strong BPC, Diphenhydramine injection, Glucagon injection, Hydrocortisone injection, Mepyramine injection, Promethazine hydrochloride injection, Snake venom antiserum, Sodium nitrate injection, Sodium thiosulphate injection, Sterile pralidoxime. Where the administration is for the purpose of saving life in an emergency".

The impact of this article is that where parenteral administration is being used (this is defined as administration by breach of the skin or mucous membrane), and it is for an emergency to save life, then s.58(2)(b) does not apply. This section states that no administration shall take place unless it is by an appropriate practitioner or a person acting in accordance with the directions of an appropriate practitioner.

Also the Medicines, Ethics and Practice guide for pharmacists and pharmacy technicians, issued by the Royal Pharmaceutical Society of Great Britain (updated July 2007), states that intramuscular adrenaline injection (1 in 1000) is exempt from requiring a prescription when given for the purpose of saving a life in an emergency. This is also based on article 7 of the prescription-only medicines (POM) order.

This means that any nurse, teacher, parent, etc can administer adrenaline (or any of the other named drugs) if the purpose is to save life, without needing permission from an authorised prescriber. If they do this, they will not commit an unlawful act under the Medicines Act 1968. It is only for adrenaline that a dosage is stated. This means that for dosages of adrenaline over 1mg in 1mL, the directions of a prescriber are needed if it is not being given by a prescriber.

PGDs are only valid for the NHS, defence medical service, police custody, independent sector clinics or hospitals that are registered with the Healthcare Commission.

Some Trusts may still wish to have a PGD in place as a framework to guide local practice and training needs. This is their choice as they are the ones who are vicariously liable for their practitioners. It is important that trained staff are not put in the position that they feel they cannot give adrenaline for anaphylaxis because they think they are “not covered” for this.

Further information is available on the national Patient Group Directions website.

There are now two versions of the algorithm available on this website:

1. The initial treatment of anaphylactic reactions. This covers the initial steps and includes guidance on the use of intramuscular (IM) adrenaline. This will be useful for most healthcare staff who are expected to recognise and treat an anaphylactic reaction whilst awaiting expert help. Second line treatments such as the use of hydrocortisone and chlorphenamine are also not included.
   
   
2. The anaphylaxis algorithm. This is the more detailed algorithm and includes information about both IM and IV adrenaline, intravenous fluids, and second line drugs (hydrocortisone and chlorphenamine).

We have deliberately not provided too much detail on IV adrenaline in the algorithm. We expect most clinicians to use IM adrenaline for the reasons given in the guideline (section 5.2, page 21). The small proportion of healthcare staff who are experienced in the use of IV adrenaline, e.g., anaesthetists, intensivists, will know how to give IV adrenaline already. Those who do not know how to give IV adrenaline should use the IM route for adrenaline and get experienced help (see also FAQ 9.)

The anaphylaxis algorithm includes both the IV and IM doses for adrenaline and they are clearly different. One problem is that individuals have given the larger IM dose of adrenaline by the IV route by mistake. The inclusion of both IM and IV doses for adrenaline in the algorithm does make it clear that the doses for IM and IV adrenaline are different.

A standard blue needle (25 mm and 23 G) should be used to inject intramuscular adrenaline.

The best site for an intramuscular injection of adrenaline for the treatment of an anaphylactic reaction is the anterolateral aspect of the middle third of the thigh. The needle needs to be long enough to ensure that the adrenaline is injected into muscle. The current Resuscitation Council UK guidance states that a 25 mm length needle is best and suitable for all ages (see Appendix 2).

In the UK, a standard blue needle (25 mm and 23 G) is therefore best. In obese patients a longer needle may be needed (38 mm length).

The standard orange needle that is most commonly available in the UK is only 16 mm in length. This shorter length needle can result in injecting the adrenaline subcutaneously. A 25 mm length orange needle is less commonly available.

Anaphylaxis after immunisation is very rare - less than 1 in a million immunisations. Oxygen should be given to a patient having an anaphylactic reaction as soon as it is available. Based on a risk assessment oxygen would not be routinely needed by nurses to enable them to administer immunisations in the community. Nurses who administer immunisations should be able to access help from the ambulance service in an emergency.

The “Green Book” provides guidance on  what is required for the “anaphylaxis pack”.

Immunisation against infectious disease. The Green Book 2006, Department of Health states:

[Chapter 8, Vaccine safety and the management of adverse events following immunisation]: 

“An anaphylaxis pack normally contains two ampoules of adrenaline (epinephrine) 1:1000, four 23G needles and four graduated 1 ml syringes, and Laerdal or equivalent masks suitable for children and adults. Packs should be checked regularly to ensure the contents are within their expiry dates. Chlorphenamine (chlorpheniramine) and hydrocortisone are not first-line treatments and do not need to be included in the pack."

Individuals who require training to use an auto-injector include those who have to carry an auto-injector for self-use and those who may have to treat a person with anaphylaxis using an auto-injector e.g. parents, carers and teachers.

There is no statutory legal requirement in the UK deeming who is suitably trained to train others. However any trainer has an obligation under common law to ensure they are competent to train others. The Resuscitation Council (UK) recommends that those who train others in treating anaphylaxis and the use of adrenaline auto-injectors should be appropriately qualified.

Trainers should be skilled in teaching others, and be able to demonstrate competency in teaching others how to recognise and treat anaphylaxis including the use of an adrenaline auto-injector. The following groups are suggested as trainers: doctors, nurses, resuscitation officers, registered paramedics, statutory ambulance service trainers, voluntary aid society and voluntary rescue organisation trainers, and other individuals such as accredited first aid trainers. This list is not exhaustive.

Whilst there is no prescriptive course programme, training for trainers should be based on current Resuscitation Council (UK) recommendations. Trainers should also be familiar with the current legislation which applies to their client group.

All those who prescribe adrenaline auto-injectors must ensure that individuals who carry an auto-injector receive training in its use. There is more than one available brand of auto-injector so training will need to be tailored accordingly.

Adrenaline auto-injectors are not intuitive and everyone who attends training needs to be shown how to use the device and also be given an opportunity to practise using a training device. Anaphylaxis training should also include avoidance of allergens, the early recognition of symptoms and crisis management which would include when to administer emergency treatment, and how to care for the patient whilst waiting for emergency services to arrive.

The decision whether to use Emerade adrenaline auto-injector, another brand of auto-injector, or an ampoule, needle and syringe is a local decision. The decision should factor in the ease of implementation and the likelihood of anaphylaxis.