Following my post – Epipens in a Queensland workplace (September 18, 2019) I received two further questions that I will answer together, along with a further discussion on the legal regulation of these drugs.
The first question is
… I was wondering whether you might be able address the Australia-wide regulatory requirements for a PCBU to procure and store Epipens (Adrenaline) and Ventolin/Asmol (Salbutamol) as part of their First Aid resourcing. In the ACT for example we have the attached clause – but I am uncertain whether this allows PCBUs to routinely procure and store these medications? Do other states have similar clauses and do they mention stocking these medications in First Aid kits or First Aid rooms?
The clause referred to is the Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) cl 410 which says:
Part 9.2 Emergency supply and administration of adrenaline and salbutamol
410 Authorisations to supply and administer adrenaline and salbutamol—Act, s 26 (1) (b) and s 37 (1) (b)
(1) A person is authorised to do 1 or more of the following for someone else (the assisted person) who is in immediate need of adrenaline or salbutamol:
(a) supply authorised adrenaline or authorised salbutamol to the assisted person;
(b) supply authorised adrenaline or authorised salbutamol to someone else for immediate administration to the assisted person;
(c) administer authorised adrenaline or authorised salbutamol to the assisted person.
(2) In this section:
authorised adrenaline means adrenaline in a single use automatic injector delivering not more than 0.3mg adrenaline.
authorised salbutamol means salbutamol in, or for, a metered inhaler.
The second question is:
In relation to your post about Epipens in workplaces we work with a large portion of child care centres here in QLD. Some of these centres have purchased epipens ‘just in case” which I understand may not be okay. What about centres who have purchased an epipen as a secondary dosage to a child who attends who has anaphylaxis. There have been instances where a child suffering anaphylaxis has used their prescribed epipen but needs a second dosage before an ambulance arrives.
When we talk of scheduled medicines, drugs or poisons (the term used varies from jurisdiction to jurisdiction) we are talking about drugs listed in the Poisons Standard, a legislative instrument made under the Therapeutic Goods Act 1989 (Cth). The current version is the Standard for the Uniform Scheduling of Medicines and Poisons No. 24 also known as the Poisons Standard June 2019.
Although the Poisons Standard is an instrument made under Commonwealth law, it is state law that regulates how scheduled poisons are to be made available, used and stored. The essential thing to keep in mind is that items listed in the poisons standard are restricted. The level and type of restriction varies with the schedule, but all of the drugs are restricted. There are 10 schedules (though Schedule 1 is not used). In a medical/first aid context the relevant schedules are schedules 2, 3, 4 and 8. These are:
|Schedule 2.||Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.|
|Schedule 3.||Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.|
|Schedule 4.||Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.|
|Schedule 8.||Controlled Drug – Substances which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence.|
Adrenaline (found in epipens) and salbutamol (found in asthma inhalers) are both listed in Schedule 3. Adrenaline is also listed in Appendix H and is therefore a Schedule 3 Poison ‘Permitted to be Advertised’. Salbutamol when supplied ‘in metered aerosols or in dry powder formulations’ is listed in Appendix F. Drugs in Appendix F must carry one, or more, of 110 prescribed warnings. The prescribed warning for salbutamol is warning number 32 – that is the drug must be packaged with a label that says: ‘This preparation should be part of an overall treatment plan regularly assessed with your doctor’.
The first step in thinking about the restrictions that are going to apply to these drugs is to look at the title of the Schedule. Schedule 3 drugs are ‘Pharmacist Only Medicine’. They are ‘available to the public from a pharmacist without a prescription’ not ‘available to the public from someone who bought the drug from a pharmacist’. If you have a clinical need for the drug including if you are buying it as an agent for someone or as a carer for someone then you can buy it from a pharmacist and obtain professional advice. But if you supply the drug to someone else, that is if you carry it in your first aid kit and give it to someone who presents to you but who you have never met before, then they are not getting the drug from a pharmacist – and it’s a Pharmacist Only Medicine. One can infer, without reading further, that even though a person can buy a schedule 3 drug from a pharmacist, they cannot then go and give it out to someone else without an authority. And then you have to turn to state legislation to find what authorities there are.
I cannot do a complete jurisdiction by jurisdiction analysis but I’ll try to draw from legislation across the country in working out the next part of the answer.
There are key concepts in the drugs legislation- they are
- Supply; and
This question started in Queensland, so I’ll start there. The Health (Drugs and Poisons) Regulation 1996 (Qld) uses the term ‘controlled drug’ to refer to drugs listed in schedule 8. A ‘restricted drug’ is listed in schedule 4. Drugs and poisons listed in the other schedules, ie schedules 2, 3, 5, 6, 7 and 9 are called a ‘poison’. Therefore, both salbutamol and adrenaline are included in the term ‘poison’.
possess, a … poison … includes—
(a) have custody or control of the drug, poison or other substance; and
(b) have an ability or right to obtain custody or control of the drug, poison or other substance.
supply … a poison, means give, or offer to give, a person 1 or more treatment doses of the drug or poison, to be taken by the person during a certain period.
administer … a poison means—
(a) give a person a single treatment dose of the drug or poison, to be taken by the person immediately…
If you buy an epipen or salbutamol inhaler from a pharmacist and put it in your first aid kit you possess that poison. If you give it to a person for them to use at some future time, then you have supplied a poison. If you give it to them for immediate use, or in the case of an epipen you physically use it to inject the person with adrenaline, or you connect an inhaler to a spacer and press the button as you instruct the patient to breath, then you have administered the poison.
Possession, supply and administration of a scheduled substance is prima facie unlawful. If we move jurisdiction and go to New South Wales we can look at the Poisons and Therapeutic Goods Regulation 2008 (NSW). Regulation 17 says:
A person who is not an authorised practitioner or a pharmacist may supply a Schedule 2 or 3 substance to another person if the supplier holds a licence or authority under Part 8 to supply the substance.
You might think that a first aider who has just completed a first aid course is unlikely to hold a licence or authority, but that may not be the case. When it comes to Schedule 3 drugs, r 18 says:
(1) A pharmacist must not supply a Schedule 3 substance to any person unless the pharmacist:
(a) personally hands the substance to the person, and
(b) gives the person an opportunity to seek advice as to the use of the substance, including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of the substance.
The regulation goes onto say
(3) This clause does not apply to the supply of salbutamol or terbutaline in metered aerosols for first aid purposes to a person who holds a current emergency asthma management certificate issued by an organisation approved by the Director-General for the purposes of this subclause…
(5) This clause does not apply to the supply of adrenaline for anaphylaxis first aid purposes if:
(a) 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
(b) the supply is to a person who 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 Director-General for the purposes of this paragraph.
Putting aside the problem that the Occupational Health and Safety Act 2000 has been repealed and replaced by the Work Health and Safety Act 2011 (NSW) and SafeWork, as the replacement to WorkCover, is not in the business of approving certificates you can see that if a person holds a certificate of competency approved by the Director General of Health then a pharmacist can sell them the drugs even though they are not intending to give them to a known individual ie they are for first aid. I cannot possibly say what organisations or certificates are approved by the Director-General.
Just because you can buy the drugs doesn’t mean you can use them. For that we look to appendix C clauses 12 and 13. They say:
12 ASTHMA FIRST AID
A person who holds a current emergency asthma management certificate issued by an organisation approved by the Director-General for the purposes of clause 18 (3) of this Regulation is authorised to possess and use salbutamol or terbutaline in metered aerosols if required in connection with the carrying out of first aid.
13 ANAPHYLAXIS FIRST AID
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 Director-General for the purposes of clause 18 (5) (b) (ii) of this Regulation.
So, in New South Wales, a person who has received training from an approved organisation can buy, possess and use salbutamol and adrenaline but a person who has not, cannot even though the drugs may be useful. If you want to carry those drugs in NSW you need to find out if the training organise was approved for the purposes of these clauses.
What if you don’t have that certificate? One of my correspondents referred to the Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) cl 410. That regulation (quoted above) says that in an emergency anyone can supply and/or administer salbutamol via an asthma puffer or adrenaline via an autoinjector (an epipen). That doesn’t give that person the right to buy the drugs, but to use them. So if they have the drugs for their own use they can give them to someone else in an emergency, or they can administer the patient’s own drugs.
The Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 36 says that it is an offence to possess a pharmacy only medicine that has been listed in the regulations, unless a person has authority. It turns out however that there are no pharmacy only medicines that have been listed, so in the ACT it is not an offence to possess salbutamol and adrenaline and to use them in an emergency. It is however an offence to supply these drugs or to issue a purchase order for them (ss 26 and 38).
The ACT has a number of ‘off the shelf’ licences that a person can apply for. One is a first aid kit licence. Each person authorised under the licence must be a nurse or a paramedic (Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) cl 611). A first aid kit allows the licences to issue a purchase order for the drugs listed in the licence and also allows anyone authorised under the licence to possess supply and administer the drugs listed in the licence. The licence conditions include schedule 2 and 3 drugs and then any specific drug listed in the licence (r 450). What follows is that for nurses and paramedics to be carrying schedule 2 and 3 drugs, and any other listed drug (ie schedule 4 and/or 8 drugs) they need a first aid kit licence.
What one can infer is that an individual could, arguable, buy an epipen or a asthma puffer to put in their first aid in the ACT, but an employer – a PCBU – could not as they could not issue a purchase order nor supply the drug to their staff first aiders. Remember they are ‘pharmacy only medicines’ – to be supplied by a pharmacist not someone who bought them from a pharmacist. Further a pharmacist may refuse to supply the drugs to someone who does not have a clinical need as that is inconsistent with the scheduling provisions but does not appear to be specifically dealt with in the Act or regulations.
Where does one find authorities? That’s problematic because in each jurisdiction the health authorities can issue licences to individuals or organisations and they are not generally available. If you have done training with an approved organisation or are employed by or volunteer with an organisation that organisation may have an authority that allows you to possess, supply and administer those drugs.
There are some authorities in the regulations. My second correspondent said ‘we work with a large portion of childcare centres here in QLD. Some of these centres have purchased epipens ‘just in case” which I understand may not be okay’. But remember in that original post (Epipens in a Queensland workplace (September 18, 2019)) I listed who can buy epipens and that included Queensland Education and Care (ie child care) services and educational institutions. So they have an authority. And if a person buys an epipen for a named child with a known allergy, then they are buying as that child’s agent and can get the necessary pharmacist’s advice.
Ventolin puffers and epipens are now standard first aid equipment but they remain restricted. They are schedule 3 drugs. Although you can buy them from a pharmacist you cannot simply buy them to put them in your first aid kit ‘just in case’. Advice to NSW pharmacists from NSW Health confirms that ‘A pharmacy may only supply scheduled medicines to patients of that pharmacist for their personal treatment’ and must ‘personally hand the medicine to the customer and give him (or her) the opportunity to seek advice about its use, including dose and possible toxicity of the medicine.’
A person with first aid qualifications cannot simply stock up these drugs because it’s a good idea, they need an authority. An authority may be found in the regulations in your state or territory (as in Queensland for child care centres or educational institutions). If that’s the case you can see it by looking at the regulations. But authorities or licences can also be issued by health authorities and they may be issued to individuals, to organisations, to people who hold an approved certificate or position and may be issued to licensees and then allow them to authorise their staff or volunteers. Those sorts of authorities are not generally publicly available so it’s not possible for me to say who can actually carry and use what drugs. If you want to carry and use scheduled drugs you need to make sure that you, or the organisation you work or volunteer for, has that authority.
Having said that, it is unlikely that any drug authority would actually care that a person qualified in first aid has an epipen or salbutamol puffer in their kit. They may be concerned if however an organisation – like an event health services organisation – is putting teams in the field with scheduled drugs without appropriate authorities, licences and quality controls.
To answer my correspondents’ questions
… I was wondering whether you might be able address the Australia-wide regulatory requirements for a PCBU to procure and store Epipens (Adrenaline) and Ventolin/Asmol (Salbutamol) as part of their First Aid resourcing.
No I can’t really do an Australia wide overview but in answering this question I’ve referred to legislation in Queensland, NSW and the ACT to show that the principles are the same. Salbutamol and adrenaline are scheduled drugs so anyone needs an authority to possess, supply and administer those drugs.
In the ACT for example we have the attached clause [Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) cl 410] – but I am uncertain whether this allows PCBUs to routinely procure and store these medications?
No it does not allow a PCBUs to routinely procure and store these medications.
Do other states have similar clauses and do they mention stocking these medications in First Aid kits or First Aid rooms?
Yes and some states specifically mention stocking various drugs in first aid kits or rooms, but you have to look at the regulations in each state. AS noted Queensland educational authorities can use adrenaline and ‘A person who has completed an asthma management course approved by the Department of Health is authorised to administer S3 salbutamol…’ (Health (Drugs and Poisons) Regulation 1996 (Qld) r 256B; see also Queensland Department of Health Fact Sheet: Use of blue/grey reliever medication to provide asthma first aid at schools, workplaces and community events (January 2015)).
In relation to your post about Epipens in workplaces we work with a large portion of child care centres here in QLD. Some of these centres have purchased epipens ‘just in case” which I understand may not be okay.
It’s OK approved Queensland Education and Care (ie child care) services and educational institutions to buy and use epipens (Health (Drugs and Poisons) Regulation 1996 (Qld) r 277(8)).
What about centres who have purchased an epipen as a secondary dosage to a child who attends who has anaphylaxis. There have been instances where a child suffering anaphylaxis has used their prescribed epipen but needs a second dosage before an ambulance arrives.
As I said in my earlier post about epipens in Queensland (emphasis added):
A person who has a clinical need for adrenaline eg they have been diagnosed with anaphylaxis or care for someone who has, can buy it from a pharmacist without further authority (r 277(1)(b)).
For further discussion including some detailed analysis of specific questions relating to particular jurisdictions, see https://emergencylaw.wordpress.com/page/2/?s=scheduled+drugs