ASCIA Guidelines - Adrenaline (Epinephrine) Autoinjector Prescription

Proforma - Script Examples

Examples of documents that can be used to handle requests for adrenaline autoinjectors (EpiPen, EpiPen Jr) on PBS Authority prescription

docxRequest for adrenaline autoinjectors (EpiPen, EpiPen Jr)28.09 KB 

When accessing the PBS website http://www.pbs.gov.au/medicine/item/8698T it is important that prescribers are aware that they have to click on “Note” on the top left hand side of the webpage, to access the following information:
The auto-injector should be provided in the framework of a comprehensive anaphylaxis prevention program and an emergency action plan including training in recognition of the symptoms of anaphylaxis and the use of the auto-injector device. 
Note - Authority approvals will be limited to a maximum quantity of 2 auto-injectors at any one time.
Note - No applications for repeats will be authorised.

The following document has been updated to emphasise the importance of not walking patients who are experiencing anaphylaxis, to address dose issues for infants and pregnant women and to incorporate the word 'epinephrine', which is a new TGA requirement.

pdfASCIA Guidelines - adrenaline autoinjector prescription 2019147.8 KB

Introduction 

The aim of these guidelines is to outline the appropriate prescription of adrenaline (epinephrine) autoinjectors for use in non-medical settings for the emergency/first aid treatment of potentially life-threatening severe allergic reactions (anaphylaxis).

Adrenaline autoinjectors are used to treat severe symptoms, reduce the risk of serious morbidity (e.g. cerebrovascular damage) and prevent fatalities due to anaphylaxis.

Adrenaline rapidly reverses the effects of anaphylaxis and should be considered the emergency medication for anaphylaxis. Adrenaline autoinjectors:

Adrenaline ampoules and syringes are not considered by ASCIA to be suitable for non-medical settings such as schools, early childhood education/care centres and workplaces. 

These guidelines consider currently available evidence on the:

Adrenaline autoinjector prescription is recommended for patients with:

Adrenaline autoinjector prescription is sometimes recommended for patients with a history of a generalised allergic reaction, with one or more of the following additional risk factors:  

This list is not comprehensive and if there is a concern, patients should be referred to a clinical immunology/allergy specialist for assessment.

These factors should be considered when deciding whether an adrenaline autoinjector is prescribed, as they are known risk factors for more severe or fatal allergic reactions.

Adrenaline autoinjector prescription is not normally recommended as follows:

Adrenaline autoinjector dose recommendations

The following dosage recommendations are based on expert opinion regarding recommended dose for weight and clinical trials of injected adrenaline in children, which is currently at variance with the product information leaflet. Adrenaline autoinjectors available in Australia and New Zealand include EpiPen Jr (0.15 mg) and EpiPen (0.3 mg).

Children over 20 kg and adults

Adrenaline autoinjector 0.3 mg (e.g. EpiPen) is recommended for adults and children over 20 kg.

Children 7.5-20 kg

Adrenaline autoinjector 0.15 mg (e.g. EpiPen Jr) is recommended for children between 7.5 and 20 kg. Whilst the previous weight guide for a 0.15mg adrenaline autoinjector device was for 10-20 kg, health professionals who have made a considered assessment of an infant who weighs 7.5 kg-10 kg, may prescribe a 0.15mg device. Use of a 0.15mg device for treatment of infants weighing 7.5 kg or more should pose less risks than using adrenaline ampoules and syringes, particularly when used without medical training.

Children less than 7.5 kg

Adrenaline autoinjectors are not usually recommended for children less than 7.5 kg as the risk of fatal anaphylaxis in children this age is very low. While the ‘optimal’ dose of adrenaline is unknown there is a risk that the lower dose adrenaline autoinjector could provide a significant overdose.

ASCIA does not recommend the use of adrenaline ampoules and syringes for children less than 7.5 kg as they are inappropriate for non-medical settings (e.g. early childhood education/care centres). Even if they are administered by ‘trained’ non-medical personnel (e.g. parents) there may be a risk of a serious dosing error.

If there is a concern regarding the requirement for an adrenaline autoinjector for an infant under 7.5 kg, patients should be referred to a clinical immunology/allergy specialist for assessment. The issues should be discussed with the parents based on a risk assessment. Where it is felt that it is essential for emergency adrenaline to be prescribed for a child less than 7.5 kg, the risk of administering a ‘fixed’ overdose via a 0.15mg device is considered to be lower than the risk of a dose error with an adrenaline ampoule and syringe.

Number of devices to be prescribed

EpiPen (and its generic equivalent) is:

Two devices per prescription are routinely recommended. This allows one device to be with the patient (or for parental use at home for younger children), and one device to be available for use at the early childhood education/care centre or school. Additional devices (if desired) may be purchased privately without prescription in Australia, since more than two devices at a time are not PBS subsidised in Australia. There is currently no Pharmac subsidy for adrenaline autoinjectors in New Zealand therefore all devices need to be purchased privately.

In adults and older high school students, two devices are strongly recommended in those with:

Anaphylaxis Management Plan

An adrenaline autoinjector should only be prescribed within the context of a comprehensive Anaphylaxis Management Plan that includes the following:

1. Referral to a clinical immunology/allergy specialist

Review by a clinical immunology/allergy specialist should occur to:

2. Identification of anaphylaxis trigger(s)

This should include a comprehensive history, clinical examination, appropriate use and interpretation of allergy testing and under some circumstances, deliberate challenge to prove or disprove allergy.

3. Education on the avoidance of trigger(s)

This is particularly important with food allergy induced anaphylaxis.

4. Provision of an ASCIA Action Plan for Anaphylaxis (emergency response plan)

This documents the following;

ASCIA Action Plans for Anaphylaxis are available from www.allergy.org.au  and contain electronic fields to allow online completion of patient information. The Action Plan must be signed by the prescribing doctor. 

5. Appropriate follow-up 

Yearly review by a patient’s medical practitioner (normally their GP) should occur to:

Definitions

Anaphylaxis

OR

Symptoms/signs of respiratory/cardiovascular involvement include:

Respiratory
Difficult/noisy breathing 
Swelling of tongue
Swelling/tightness in throat 
Difficulty talking and/or hoarse voice 
Wheeze or sudden persistent cough

Cardiovascular:
Persistent dizziness or collapse
Pale and floppy (in young children)
Hypotension
Loss of vision

Generalised allergic reaction

A generalised allergic reaction is a characterised by one or more symptoms or signs of skin and/or
gastrointestinal tract involvement without respiratory and/or cardiovascular involvement:

Skin: 
Generalised pruritus 
Generalised Urticaria/erythema 
Angioedema 

Gastrointestinal:
Abdominal pain
Vomiting
Loose stools

Note: While vomiting and abdominal pain are common features of mild to moderate allergic reactions to food, they are signs of a severe allergic reaction to insect stings and tick bites.

© ASCIA 2019

ASCIA is the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand.

ASCIA resources are based on published literature and expert review, however, they are not intended to replace medical advice. The content of ASCIA resources is not influenced by any commercial organisations.

For more information go to www.allergy.org.au

To donate to immunology/allergy research go to www.allergyimmunology.org.au

Content updated March 2020