Today’s correspondent says:

ASCIA had updated its guidelines for the management of anaphylaxis a few years ago such that patients over 20kg should be administered a 500µg dose if using an autoinjector, and repeat after 5 minutes if no improvements. I note that Poisons and Therapeutic Goods Regulation 2008 Appendix C only authorised the possession and use of autoinjectors containing no more than 300µg.

Does it mean that a trained lay person or workplace (eg. school) can only carry and use the 150µg and/or the 300µg autoinjectors but not 500µg, for use to assist people showing signs/symptoms of anaphylaxis without having a valid prescription, even though relevant first aid training that was undertaken by the first aider may have been updated to suggest the use of 500µg in accordance with the ASCIA guidelines?

Considering only the 500µg autoinjectors (assuming the standing authorisation does not apply to the 500µg device), are the following considered to be a valid authority to use the drug by a trained lay person (ignoring the legalities of being in possession of the drug):

1. another identical autoinjector or its packaging with the typical label from the pharmacy displaying the patient’s name, drug name, dose, administration instructions, prescriber and date? What if the date on the label is quite old?

2. a red anaphylaxis action plan with the patient’s name and the doctor’s signature (which does not specify the dose)? Does it imply any appropriate dose per the guidelines can be used? Suppose the doctor prescribed a 300µg Anapen which the adult patient forgot to carry (the plan would just say Anapen with instructions for Anapen, and suppose the patient is not able to state the pen prescribed is 300µg), could a first aider use a 500µg pen? (Ignoring any protection for good Samaritans/volunteers/)

3. does a recently used 500µg autoinjector prescribed to the patient imply a 2nd dose can be administered from another device after 5 minutes and the patient is still showing signs and symptoms (in accordance with guidelines)?

What if the first aider has never undertaken any formal training on anaphylaxis management and was relying on the instructions on the personalised and signed red action plan? The generic yellow ASCIA first aid plan for anaphylaxis?

I assume ASCIA is the Australasian Society of Clinical Immunology and Allergy.

My first thought is to comment on the suggestion ‘relevant first aid training that was undertaken by the first aider may have been updated to suggest the use of 500µg in accordance with the ASCIA guidelines’.  I’ve done first aid training and apart from the fact that there is a child and an adult version, I could not have told you the dosage administered. I do wonder what difference it makes if there’s a 500µg injector – are there different side effects? Contra-indications? I think its optimistic (but happy to be corrected) to think that first aid training focussed on the dosage in an autoinjector. Because it’s an auto-injector there is little need to discuss or know the dosage that will be injected.

Putting that aside, I can return to the questions. The first question was about the Poisons and Therapeutic Goods Regulation 2008 Appendix C. Clause 13 says:

A person is authorised to possess and use adrenaline if–

(a) if the person requires the adrenaline for use in connection with the carrying out of anaphylaxis first aid, and

(b) the adrenaline is contained in single use automatic injectors that have been filled by the manufacturer and that deliver no more than 0.3 milligrams of adrenaline each, and

(c) the person holds a current first aid certificate issued after completion of a first aid course approved by the WorkCover Authority as referred to in regulations made under the Occupational Health and Safety Act 2000, and the person has received training on the symptoms and first aid management of anaphylaxis from–

(i) a first aid training organisation approved by the WorkCover Authority, or

(ii) any other organisation approved by the Secretary for the purposes of clause 18(5)(b)(ii) of this Regulation.

0.3 milligrams is the same as 300 micrograms or 300µg.

I have previously discussed issues with respect to sub-paragraph (c) and the fact that OHS Act is no longer in force and the WorkCover Authority no longer exists or approves first aid certificates  (see Use of methoxyflurane in first aid – Part 2 (March 16, 2019)) so I won’t revisit those issues.

The question was:

Does it mean that a trained lay person or workplace (eg. school) can only carry and use the 150µg and/or the 300µg autoinjectors but not 500µg, for use to assist people showing signs/symptoms of anaphylaxis without having a valid prescription, even though relevant first aid training that was undertaken by the first aider may have been updated to suggest the use of 500µg in accordance with the ASCIA guidelines?

Yes, that is what the Poisons and Therapeutic Goods Regulation 2008 (NSW) Appendix C cl 13 means. Subparagraph (b) refers to an autoinjector that will ‘deliver no more than 0.3 milligrams of adrenaline each’. That means a person with the relevant training can carry and use an EpiPen that delivers a 300µg, not a 500µg dose.  

With respect to the numbered questions, a first aider in NSW can go to a pharmacist and buy a 300µg autoinjector to carry in their first-aid kit and could administer that drug to anyone who needed it (Poisons and Therapeutic Goods Regulation 2008 (NSW) Appendix C cl 13).

With respect to question (1), if someone is having an anaphylactic reaction, anyone can administer any drug that is prescribed for them (Poisons and Therapeutic Goods Act 1966 (NSW) s 10(c1); Poisons and Therapeutic Goods Regulation 2008 (NSW) r 59(1)(a)). If the drug is in a box with their name etc on it then anyone can administer that; whether they are trained in first aid or not (see Helping with another person’s drugs (September 19, 2019)). If the label is ‘quite old’ then the issue would be whether the drugs were within date, not the age of the label.

With respect to question (2), if a person was having an anaphylactic reaction and someone could provide an adrenaline auto-injector I would not expect the first aider to identify the dosage; I think if they could identify it as an adrenaline auto-injector they would reasonably assume that they are entitled to use it. They would be justified in using it by the common law of necessity. They would also be protected by the ‘good Samaritan’ provisions in the Civil Liability Act 2002 (NSW). The contents of the anaphylaxis action plan would be legally irrelevant.

With respect to question 3 if a person has had a dosage administered but requires another dosage a first aider would be justified in using whatever auto-injector he or she could access. The law will not say ‘let the person die because you couldn’t find a 300µg autoinjector. The test is what is reasonably necessary and in the patient’s best interests. If the drug has been prescribed for the patient and the patient has two 500µg auto-injectors then of course the second one can be used for the reason given above. It is no offence to assist a person with the administration of any drug that has been prescribed for them.

Conclusion

In short if a first-aider who has received training that meets the requirements set out in cl 13, wants to go to a chemist to buy an auto-injector to put in their first aid kit, they can buy and carry a 300µg autoinjector. If a person was suffering from anapylaxis and in need of adrenaline, a trained first aider could use a 500µg autoinjector if that is what was accessible and certainly if had been prescribed for the patient.

This blog is made possible with generous financial support from the Australasian College of Paramedicine, the Australian Paramedics Association (NSW), Natural Hazards Research Australia, NSW Rural Fire Service Association and the NSW SES Volunteers Association. I am responsible for the content in this post including any errors or omissions. Any opinions expressed are mine, and do not necessarily reflect the opinion or understanding of the donors.