Following my post Use of methoxyflurane in first aid (March 11, 2019) there have been comments, particularly on the facebook version of this page, with various comments and suggestions some of which are more and some less accurate, so I thought I would make a generic post.
Drugs and poisons are scheduled under the Therapeutic Goods Act 1989 (Cth). You can find the latest poisons standard (February 2019) here – https://www.legislation.gov.au/Details/F2019L00032. There are ten schedules. They are:
|Schedule 1.||This Schedule is intentionally blank.|
|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 5.||Caution – Substances with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label.|
|Schedule 6.||Poison – Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label.|
|Schedule 7.||Dangerous Poison – Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply.|
|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.|
|Schedule 9.||Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities.|
|Schedule 10 (previously Appendix C).||Substances of such danger to health as to warrant prohibition of sale, supply and use – Substances which are prohibited for the purpose or purposes listed for each poison.|
In a first aid context it is schedule 2, 3 and 4 drugs that are relevant. Schedule 8 drugs are sometimes carried by paramedics, nurses and doctors but will not be discussed here.
Relevant drugs are:
- Paracetamol which appears (depending on how its packaged and what it is mixed with) in schedules 2, 3 and 4 but for our purposes I will consider it a schedule 2 drug. Where it is in ‘tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent… [and] in a primary pack containing not more than 20 tablets or capsules…’ then it is not scheduled at all. And you can buy it at Coles or Woolworths;
- Salbutamol puffers and adrenaline packaged as an epipen which are schedule 3; and
- Methoxyflurane, schedule 4.
The Poisons Standard lists the drugs, but it does not govern who is allowed to possess them (ie have them in their possession); supply them (ie give them to someone else) or administer those drugs. That is a matter for state laws. Like all good Australian cooperative schemes, the laws should be uniform but there are differences.
It is an offence to possess, supply or administer any scheduled drug without an authority under relevant state poisons, therapeutic goods or medicines legislation (the name varies from jurisdiction to jurisdiction). Taking the Australian Capital Territory as an exemplar the relevant Act is the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT). Under that Act (s 11)(1):
(a) a pharmacy medicine [ie a schedule 2 medicine]; or
(b) a pharmacist only medicine [ie a schedule 3 medicine]; or
(c) a prescription only medicine [ie a schedule 4 medicine]; or
(d) a controlled medicine [ie a schedule 8 medicine].
The term ‘regulated substance’ includes a medicine as defined in s 11 (above) (see s 10). A person ‘deals’ with a medicine if they possess, supply or administer that medicine (s 19). There is further explanation of what possess, sell and supply mean in s 24.
It is an offence to supply (s 26), obtain (s 35), possess (s 36) or administer a medicine to another person without authority. There are exceptions to those rules. It is not an offence to possess a schedule 2 or 3 medicine unless it has been listed in the regulations for that purpose (s 36(a)(i)) and there are no relevant medicines listed. It is not an offence to administer to another person, or to self-administer, a schedule 2 or 3 medicine (ss 37(1)(a) and 37(2)(a)).
Putting aside the details one can say, as a general rule of thumb, that it is unlawful to possess, supply or administer a schedule 2, 3 or 4 medicine without authority. To quote from the Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT) r 10:
The Act requires that a person must not deal with a medicine in a particular way unless the person is authorised to deal with the medicine
The authorities can be found, generally, in one of three places –
- The Act;
- The Regulations; or
- An authority or licence issued by the relevant health licensing authority in the state or territory.
To stick with my exemplar of the ACT, as noted the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 37 says that there is no offence, so one can infer an authority, to administer or self-administer a schedule 2 or 3 drug. There are other exemptions in the Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT). Schedule 1 sets out the authority of various health practitioners. For example an ambulance officer employed by the Commonwealth, Territory or State may ‘within scope of employment, do any of the following: (a) obtain medicines; (b) possess medicines; (c) administer medicines.’ It is the employer that determines the ‘scope of employment’ so it is the employer who determines what drugs a paramedic can carry. A medical practitioner can:
… to the extent necessary to practise medicine and, if employed, within the scope of employment, do any of the following:
(a) issue purchase orders and requisitions for medicines;
(b) obtain medicines;
(c) possess medicines;
(d) administer medicines;
(e) prescribe medicines;
(f) supply medicines to patients during consultations;
(g) supply medicines for administration to patients to people authorised to administer them;
(h) supply medicines dispensed for patient to another health practitioner on patient’s transfer within institution;
(i) supply medicines dispensed for patient to patient on patient’s discharge from institution;
(j) supply medicines to patients during consultations if labelled in accordance with s 161.
Where medical practitioners are self-employed it is up to them to determine their scope of practice and what is required for their practice. In response to my earlier post it was said ‘No qualification (even degree Paramedics) gives an automatic authority or right to purchase, carry or supply/administer poisons or restricted substances’ but that’s not correct. Registration as a doctor (or dentist or vet) does give that right.
There are other exemptions under the regulations. For example, r 410 says
(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.
That regulation does not allow anyone to buy a salbutamol puffer or epipen but it does allow anyone to administer those drugs using their own or the patient’s or a bystander’s medication.
You are allowed to buy schedule 2 and 3 medicines for personal use (r 371) but buying them to put in a first aid kit would not be ‘personal use’.
Apart from the exemptions in the regulations and Act, the chief health officer can issue licences or authorities. The regulations provide for a number of standard form licences including a licence for ‘medicines for first-aid kits’. A first-aid kit licence can only be used to authorised registered nurses and paramedics to carry schedule 2, 3 and 4 drugs (rr 600 and 611). The chief health officer may however ‘issue a licence to a person to deal with a regulated substance or regulated therapeutic good even if the licence is not prescribed by regulation …’ (Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 78).
What follows is:
- It is illegal to deal wth scheduled drugs without an authority, so no-one should be putting scheduled drugs in their first aid kit without knowing what that authority is.
- Just because you can buy schedule 2 and 3 drugs from a pharmacist without a prescription does not mean you can carry those drugs to supply to someone else as you see fit. A schedule 3 drug, for example, is a drug ‘which should be available to the public from a pharmacist’ not ‘available to the public from someone who bought the drug from a pharmacist’.
- The authority may be found in the relevant Act, its regulations, or an authority issued by the relevant health regulating agency in your state or territory.
- The most common authority will be some form or licence issued to an agency – whether that is an employer or an agency for which you volunteer – that will say appropriately endorsed or authorised employees or members can carry and use the approved drugs. The authority is unlikely to be personal in which case you can only carry and use those drugs in the course of your duties.
- Some authorities do come with a qualification. A doctor by virtue of being a registered medical practitioner can carry and supply scheduled drugs. To return to my post Use of methoxyflurane in first aid (March 11, 2019) it was the case that a person who, in NSW, had held a WorkCover approved occupational first aid certificate could administer methoxyflurane and nitrous oxide. Equally it is the case, in New South Wales, that ‘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.’
My problem in answering questions on authorities is that I cannot access the authorities. These are not generally publicly available (though I can now see where they have been issued in NSW, even though one can’t see the details – see NSW Ministry of Health Licences To Supply Poisons and/or Restricted Substances and Licences to Manufacture or Supply Drugs of Addiction by Wholesale (8 March 2019).
It remains the case that it is unlawful to obtain, possess, supply or administer a schedule 2, 3 or 4 medicine without authority. It follows that if a first aider is not sure of where that authority comes from, they should not be carrying those drugs in their first aid kit. If they are provided in kits supplied by the employer or organisation for which you volunteer you may have some confidence that they have the right authority, and even if they do not have the right authority that will be an issue for them more so than for the volunteer or employee.
No-one should be carrying schedule 4 drugs in their kit without a clear understanding of their authority.
Schedule 2 and 3 drugs should not be carried but it may be the case that no regulator is going to be too concerned about a trained first aider carrying salbutamol or an epipen but strictly speaking it is probably illegal. It is not illegal in the ACT to possess those drugs (r 36) or to administer them in an emergency (r 410) but a pharmacist may refuse to sell them if they are not for personal use.
Thanks for the information. Just to be clear, to have methoxyflurane, Panadol, EpiPen and Ventolin on site, a relevant license will be required?
Where do you get this license in NSW?
And can I confirm the law is stated in Poisons and Therapeutic Goods Regulation 2008 (NSW)?
It would seem that when doing first aid training there is a lack of communication about the requirement of such licenses. The only reason I have started to research is I did a refresher in provide pain management, and it was mentioned about the employer requiring a license for methoxyflurane. But I have never being aware of a license required for methoxyflurane or an EpiPen, Ventolin and Panadol.
Any a path you can send me down to get the correct information will be helpful.
Also – can you please confirm what training is required for buying, possessing and administering methoxyflurane? A couple of training center’s have said we need a Occupational first aider on our staff. Is this correct? If it is can it just be one person in the company who does it and the others who use the methoxyflurane are trained in first aid and provide pain management only?
Or does anyone who is going to be using it have to complete the training?
Again there is lack of information out there. And the pre requisite for the provide pain management is provide first aid. Should it not be Occupational first aid as the pre requisite if the are legalities involved in purchasing S4 medications?
Any legislation you can point me to will be appreciated.
Thanks in advance.
This is not the place for legal advice so if you are planning to obtain and supply these drugs you need to consult with the relevant health department and if further advice is required, contact a solicitor in your jurisdiction.
In NSW a licence is required for methoxyflurane – it is a schedule 4 drug – but see Use of methoxyflurane in first aid (March 11, 2019) https://australianemergencylaw.com/2019/03/11/use-of-methoxyflurane-in-first-aid/.
Panadol where it is packaged in a form that you can buy at a supermarket is not a scheduled drug (see Non-scheduled drugs (July 27, 2022) https://australianemergencylaw.com/2022/07/27/non-scheduled-drugs/.
In NSW the Poisons and Therapeutic Goods Regulation 2008 (NSW) Appendix C says:
In other words in NSW the ‘licence’ for an epi-pen or Ventolin is in the regulation providing the training has been approved.
Where a licence is required they are issued by NSW Health – see https://www.health.nsw.gov.au/Hospitals/privatehealth/Pages/app-forms-licences-ptga.aspx
The relevant law is in the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). Having said that depending on any individual circumstances other laws may also be relevant including the Work Health and Safety Act 2011 (NSW) and the Health Practitioner Regulation National Law. As I say this is not a place for legal advice so I cannot say what legislation will apply in any particular case or circumstance.
I cannot confirm what training is required for buying, possessing and administering methoxyflurane. Cl 9 of Appendix C of the Poisons and Therapeutic Goods Regulation says
But that is out-of-date – see Use of methoxyflurane in first aid (March 11, 2019) https://australianemergencylaw.com/2019/03/11/use-of-methoxyflurane-in-first-aid/. If that clause still applied it would require anyone who is going to carry and use the drug to hold the relevant certificate.
A safework inspector has guided me to the pharmaceutical services at the NSW Health department.