Today’s question is about drug packaging.  The question comes from New South Wales and a person working:

…  in the outdoor education industry specializing in leading high school students on multi-day hiking expeditions. Outdoor educators are provided with workplace first aid kits for these trips and as we are going out into the field those first aid kits contain over-the-counter medications such as paracetamol, ibuprofen, antihistamines, and anti-diarrhoeal medication. We are given (or denied) permission to administer these medications to the students via paperwork from their parents. 

I work across multiple schools and outdoor education companies and have observed that it is standard for medication to be stored in the expedition first aid kits in blister packs only, without the original cardboard packaging, to save space. I have raised this as an issue with managers in the past since without the original packaging there is no information about dosages and contraindications available. However, my concerns were dismissed. 

I was therefore very interested to hear during the recent training that this practice might in fact be illegal. My questions to you are: 

a)             whether this is indeed the case, and 

b)             where I can find this in the legislation so that I may refer to it the next time I am presented with a workplace first aid kit containing medication without its original packaging. 

Scheduled drugs

As I’ve indicated before no-one should be carrying and supplying scheduled drugs even those that can be bought over the counter.  The Therapeutic Goods (Poisons Standard—October 2024) Instrument 2024 (Cth) (‘the Standard’) tells us that schedule 2 drugs are Pharmacy medicines, that is:

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.

These drugs must only be supplied by ‘a pharmacist (or an assistant under the direction of a pharmacist) …)’ (cl 57), not from a person who bought the drugs from a pharmacy or licensed person.

Schedule 3 drugs are Pharmacist only medicines, that is:

Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

These drugs must only be supplied by ‘a pharmacist ….’ (cl 59) not from a person who bought the drugs from a pharmacist.

We can conduct a little thought experiment here.  I can go into a pharmacy and buy a pack of 100 paracetamol tablets – that is paracetamol listed under schedule 2.  But I couldn’t go and buy 10 packets and then start selling them. Clearly, I am not a pharmacist so cannot sell schedule 2 drugs.  If I cannot sell them, I also could not give them away. I would still be ‘supplying’ the drug, which includes ‘dispense and distribute’ and to ‘keep or have in possession for … dispensing or distribution’ (Poisons and Therapeutic Goods Act 1966 (NSW) s 4 definition of ‘supply’).  The Therapeutic Goods Act 1989 (Cth) s 3 further says that supply includes ‘administration to, or application in the treatment of, a person’.  If I cannot give away packets of 100, why can I give away two to a person who asks for them?  If I give the pills to someone, I am still ‘supplying’ the drug to them, and not in circumstances where they can ‘get advice from a pharmacist’ as I am not a pharmacist.

We can also look to the example of schedule 3 drugs in particular epipens and salbutamol inhalers. Regulation 18 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) says that schedule 3 drugs must not be supplied to a person unless the drugs are personally given by the pharmacist and giving the person the chance to seek advice about the medication. This rule, however, 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 …’ nor does it 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…

the person ‘has received training on the symptoms and first aid management of anaphylaxis…’  Appendix C to the Poisons and Therapeutic Goods Regulation 2008 (NSW) also provides that an appropriately trained person can possess those drugs for use in first aid.

If it was permissible to carry any schedule 3 drug in a first aid kit on the basis that you can buy it over the counter then those provisions would not be required. Clearly the Department and the Parliament accept that the purchase of, and carrying schedule 3 drugs for use in first aid is not generally permitted so specific exemptions are given for salbutamol and adrenaline.  The same argument would apply to schedule 2, without a specific exemption it cannot be permissible to carry schedule 2 drugs in order to supply them to a person without that person having the opportunity to ask a pharmacist about those drugs.

To be honest I don’t think any regulator would care if a person, when asked, said ‘I’ve got some paracetamol (or Imodium, or antihistamine), would you like one?’ to a friend or colleague who had a headache, diarrhoea or hay-fever.  But it’s different when you are holding yourself out as a practitioner of some sort and it’s different if you buy the drugs with the intended purpose of carrying them to hand out to people who you have not yet met.  That is, I see a difference where I have bought the drugs for my use and a friend or colleague asks for a paracetamol, from a case where I have bought them with the intention of – for the purpose of – supplying them to others.

Packaging

For the following discussion these definitions from the standard are relevant:

immediate container includes all forms of containers in which a poison is directly packed but does not include any such container intended for consumption or any immediate wrapper.

immediate wrapper means metal foil, plastic foil, waxed paper, or any other such material not intended for consumption, when used as the first wrapper for a dosage unit or dressing.

primary pack, in relation to a poison, means the pack in which the poison and its immediate container or immediate wrapper or measure pack are presented for supply.

If we’re talking about a box of paracetamol, the box is the ‘primary pack’ and the blister pack inside the box is the immediate wrapper.

Section 13(1) of the Standard says, ‘A poison must not be supplied unless it is labelled in accordance with this Division’.  The primary pack must contain words indicating the schedule the drug is listed in (s 16) along with the words ‘keep out of reach of children’ (s 18).  Other words must also be included depending on the type of poison, eg Schedule 8 poisons must have the words ‘possession without authority illegal’ (s 17) and there are other specific warnings for drugs that are a fire or burn hazards (s 19 and 20) etc.  The approved name and quantity, proportion or strength must also be listed (s 26).

Section 14 says (emphasis added):

Immediate wrapper

If a poison is enclosed in an immediate wrapper:

(a) the poison must be contained in a primary pack labelled in accordance with section 15; and

(b) the immediate wrapper must be conspicuously labelled with:

(i) the name of the manufacturer or distributor or the brand name or trade name used exclusively by the manufacturer or distributor for that poison; and

(ii) the approved name of the poison; and

(iii) a statement of the quantity, proportion or strength of the poison in accordance with section 34.

Paracetamol is listed in schedule 2 but not when it is (emphasis added):

… in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when:

 (A) packed in blister or strip packaging or in a container with a child‑resistant closure;

 (B) in a primary pack containing not more than 20 tablets or capsules;

 (C) compliant with the requirements of the required advisory statements for medicine labels;

 (D) not labelled for the treatment of children 6 years of age or less; and

 (E) not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

The required advisory statement is set out in Schedule 1, [191] of the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (Cth). It says the primary pack must have the following printed on it:

Adults: Keep to the recommended dose.  Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

Children and adolescents: Keep to the recommended dose.  Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

If an overdose is taken or suspected, ring the Poisons Information Centre (Australia 13 11 26, New Zealand 0800 764 766) or go to hospital straight away even if you feel well because of the risk of delayed, serious liver damage.

Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

Ibuprofen is also listed in schedule 2 but not when (emphasis added):

 (i) ibuprofen is the only therapeutically active constituent, other than phenylephrine or when combined with an effervescent agent; and

 (ii) packed in blister or strip packaging or in a container with a child-resistant closure; and

 (iii) in a primary pack containing not more than 25 dosage units; and

 (iv) compliant with the requirements of the required advisory statements for medicine labels; and

 (v) not labelled for the treatment of children 6 years or under; and

 (vi) if combined with phenylephrine—not labelled for the treatment of children under 12 years.

The required advisory statement is set out in Schedule 1, [130] of the Therapeutic Goods (Medicines Advisory Statements) Specification 2021 (Cth). It says the primary pack must have the following printed on it:

  • Do not use if you have a stomach ulcer.
  • Do not use if you have impaired kidney function.
  • Do not use if you have heart failure.
  • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
  • If you get an allergic reaction, stop taking and see your doctor immediately.
  • Unless a doctor has told you to, do not use if you have asthma.
  • Unless advised by your doctor or pharmacist, do not use with products containing ibuprofen, aspirin or other anti-inflammatory medicines or with medicines that you are taking regularly.
  • Do not use for more than a few days at a time unless a doctor has told you to.  Do not exceed the recommended dose.  Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.
  • Do not use if trying to become pregnant, or during the first 6 months of pregnancy, except on doctor’s advice.  Do not use at all during the last 3 months of pregnancy.
  • Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting.
  • Unless a doctor has told you to, do not use if you are aged 65 years or over.
  • Do not use in children 6 years of age or less.

Antihistamines and anti-diarrhoea drugs like Imodium are also schedule 2 medications.

Conclusion

A first aid kit should not contain scheduled drugs including sch 2 and 3 drugs unless the person in charge of the kit has a relevant authority.

It can contain paracetamol or ibuprofen when packed in accordance with the Standard to take them outside the schedule, ie in the case of paracetamol in a box of 20 or less, and for ibuprofen a box of 25 and provided the box carries the appropriate labels.  It follows that if they are not in their primary pack they are not being supplied in a way consistent with the Poisons Standard.  They must be in their primary package to confirm that they are not scheduled drugs and to demonstrate that all the warnings and dosage information are available to anyone who intends to use the drugs to administration the drugs to, or use them in the treatment of, a person. 

I would therefore agree that it is illegal for ‘standard for medication to be stored in the expedition first aid kits in blister packs only, without the original cardboard packaging’.

This blog is made possible with generous financial support from (in alphabetical order) the Australasian College of Paramedicine, the Australian Paramedics Association (NSW), the Australian Paramedics Association (Qld), 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.

This blog is a general discussion of legal principles only.  It is not legal advice. Do not rely on the information here to make decisions regarding your legal position or to make decisions that affect your legal rights or responsibilities. For advice on your particular circumstances always consult an admitted legal practitioner in your state or territory.