This document has been updated since its original release.

PBS listing | Reason for PBS listing | Place in therapy | Safety issues | Dosing issues | Information for patients | Revision History | References

PBS listing

Authority required

For emergency treatment of acute allergic reactions with anaphylaxis:

• when risk and clinical need has been assessed by, or in consultation with a clinical immunologist, allergist, paediatrician or respiratory physician
• after hospital or emergency department discharge for acute allergic anaphylaxis treated by adrenaline.

The authority notes the need for a comprehensive anaphylaxis prevention program and patient action plan. Maximum quantity is one, except for children less than 17 years old, who are eligible for two EpiPens.

Reason for PBS listing

The listing change (August 2006) allows patients to be prescribed an EpiPen immediately after adrenaline treatment in hospital for an episode of anaphylaxis; this ensures that there is no delay between hospital discharge and EpiPen prescription.

Adrenaline autoinjectors were originally listed on the Pharmaceutical Benefits Scheme in December 2000 on the basis of cost effectiveness compared with placebo. Although thought likely to reduce the risk of hospitalisation and death, cost estimates were uncertain because of the unknown size of the ‘at risk’ population, the potential for under-use in emergencies and the high replacement rate due to short shelf life.

Place in therapy

Adrenaline is the appropriate first-line emergency treatment for life-threatening anaphylaxis.¹

Early administration of adrenaline can reduce the risk of hospitalisation and death in people at significant risk of anaphylaxis.²

Surveys show that only 30–50% of patients who have access to an EpiPen in an anaphylactic episode actually use it.^2,3 Ensure that patients are confident about when and how to use the EpiPen:

• Check that patients and carers know how to use the EpiPen and reinforce this at repeat visits. Rehearsal with an EpiPen trainer (a dummy EpiPen without a needle) can help.
• Make sure that patients and carers have an anaphylaxis action plan that shows when and how to use the EpiPen for an anaphylactic reaction. Advise patients and carers that if in doubt, it is better to use the EpiPen; it is more harmful to undertreat anaphylaxis than to overtreat a mild allergic reaction.

Prescribe EpiPen within a comprehensive anaphylaxis management plan

Prescribing an EpiPen is only one part of anaphylaxis management. All patients at risk of allergic anaphylaxis need an overall plan for management of their anaphylaxis (see Box 1). This usually includes:

• referral to an allergy specialist
• identification of triggers
• education on trigger avoidance
• provision of an anaphylaxis action plan
• ongoing follow-up.

If the patient is a child or adolescent it is important that schoolteachers, carers and others who regularly take responsibility for the child are informed about the condition and its management. EpiPen training and anaphylaxis education for teachers and carers is available from First Aid organisations and through some allergy clinics and State Health initiatives. In NSW, Anaphylaxis Guidelines for schools⁴ is available from NSW Health or through the NSW Department of Education and Training.

Box 1: Anaphylaxis Management Plan (ASCIA)⁵

Who should be prescribed an EpiPen?

All patients with a history of allergic anaphylactic reaction should have access to an EpiPen. Patients with a history of generalised allergic reactions but without a previous anaphylactic reaction do not usually need an EpiPen. However a history of generalised allergic reactions and one or more of the risk factors shown in Table 1 warrants consideration of anaphylaxis risk — refer or consult with a specialist allergist or clinical immunologist.

Note the following points.⁵

• Asthma in combination with a history of a generalised allergic reaction increases the risk of anaphylaxis, particularly when there is a food or insect allergy. Most fatal or severe anaphylactic reactions reported have been in people who also had asthma.^6–8 Asthma control is particularly important, as patients with poorly controlled asthma may be less responsive to beta₂ agonists when needed.⁷ However, asthma is not a risk factor for anaphylaxis on its own, and adrenaline is not an emergency treatment for asthma.
• Adolescents and young adults are over-represented in allergy-related anaphylaxis deaths, which less commonly involve children under the age of 5 years.^6–8 This could be due to the greater severity of persisting allergies, the less-controlled environment of teenagers, or lower compliance with carrying adrenaline.
• Nut allergy is a common cause of fatal anaphylaxis^8,9, and exposure can be difficult to avoid. Subsequent episodes may be more severe than the first reaction.

Table 1: Guidelines for prescribing EpiPen (ASCIA*)

*Abbreviated from ASCIA guidelines for EpiPen prescribing⁵

Safety issues

The potential harms of anaphylaxis almost always outweigh the potential harms of giving adrenaline.¹

Advise consumers about adrenaline’s short shelf life, the need to check and record expiry dates, and to replace their EpiPen before expiry.

EpiPen should be stored below 25°C and protected from light. In hotter areas of Australia where this may be difficult, a portable cooler could be used. Refrigeration is not advised, as the effect on stability is not certain. Regular checking for discolouration can help detect decay of the adrenaline, but this is not an absolute indicator if recommended temperatures are exceeded.

Incorrect administration may result in accidental injury; training should reduce this risk.

Adverse Drug Reactions

Few adverse reactions have been reported with the use of EpiPen auto-injectors. Transient pallor, tremor, anxiety, palpitations or other cardiovascular effects, headache and nausea have been experienced. ^10–12

Report suspected adverse reactions to the Adverse Drug Reactions Advisory Committee (ADRAC) online or by using the 'Blue Card' distributed with Australian Prescriber. For information about reporting adverse drug reactions, see the Therapeutic Goods Administration website.

Dosing issues

The EpiPen auto-injector is available as EpiPen Jr (150 micrograms) and EpiPen (300 micrograms). It should be administered as an intramuscular injection into the anterolateral thigh. Injection into the buttocks is not recommended because of the greater chance of injecting into fat rather than muscle, while injecting into the extremities (hands, feet, face) may stop blood flow to these areas.

Box 2: EpiPen doses recommended by ASCIA

Note: The EpiPen product information suggests EpiPen Jr for children 15–30 kg, and EpiPen for those above 30 kg.^11,12 However, the above doses are consistent with routine intramuscular dosing schedules.

Information for patients

• Advise patients to seek medical treatment immediately in the case of a severe allergic reaction; further adrenaline or other follow-up may be needed even if the EpiPen is used.
• EpiPens tend to be under-used in emergencies, even when one is available.² Teach patients how to use EpiPen and reinforce training when needed (poor recall of correct use is common).^2,3 EpiPen trainers are dummy models without a needle, which can be used to practice the correct use of the EpiPen.
• Ensure that all patients have an emergency action plan (see Box 1). Advise that, if in doubt in an emergency, it is safer to use adrenaline than to have an anaphylactic reaction. Action plan proformas are available from the ASCIA website www.allergy.org.au.

ASCIA has a range of publications about allergies and anaphylaxis for consumers on its website: www.allergy.org.au.

Revision history

Updated August 2006: PBS listing change to allow prescribing immediately following hospital treatment with adrenaline for anaphylaxis, without the need for patient or prescriber consultation with a clinical immunologist, allergist, paediatrician or respiratory physician.

Updated May 2004: PBS listing change to allow prescribing by or in consultation with respiratory physicians or paediatricians in addition to clinical immunologists or allergists.

First released: 1 December 2003

References

1. Australian Medicines Handbook. Adelaide: Australian Medicines Handbook Pty Ltd, 2006.
2. Gold MS, Sainsbury R. First aid anaphylaxis management in children who were prescribed an epinephrine autoinjector device (EpiPen). J Allergy Clin Immunol 2000;106:171–6. [PubMed]
3. Mullins RJ. Anaphylaxis: risk factors for recurrence. Clin Exp Allergy 2003;33:1033–40. [PubMed]
4. NSW Health. Anaphylaxis guidelines for schools. Sydney: NSW Department of Health and NSW Department of Education and Training. http://www.health.nsw.gov.au/pubs/a/pdf/anaphylaxis.pdf (accessed 26 June 2006).
5. Australasian Society of Clinical Immunology and Allergy (ASCIA). Guidelines for EpiPen prescription. 2004. http://www.allergy.org.au/anaphylaxis/epipen_guidelines.htm (accessed 26 June 2006).
6. Macdougall CF, Cant AJ, Colver AF. How dangerous is food allergy in childhood? The incidence of severe and fatal allergic reactions across the UK and Ireland. Arch Dis Child 2002;86:236–9. [PubMed]
7. Pumphrey RS. Lessons for management of anaphylaxis from a study of fatal reactions. Clin Exp Allergy 2000;30:1144–50. [PubMed]
8. Bock SA, Munoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol 2001;107:191–3. [PubMed]
9. Sampson HA, Mendelson L, Rosen JP. Fatal and near-fatal anaphylactic reactions to food in children and adolescents. N Engl J Med 1992;327:380–4. [PubMed]
10. Simons FE, Chan ES, Gu X, Simons KJ. Epinephrine for the out-of-hospital (first-aid) treatment of anaphylaxis in infants: is the ampule/syringe/needle method practical? J Allergy Clin Immunol 2001;108:1040–4. [PubMed]
11. CSL Limited. EpiPen Jr. Product Information, 11 April 2005.
12. CSL Limited. EpiPen. Product Information, 11 April 2005.