3 Interim decisions on a proposed amendment referred to the Advisory Committee on Medicines and Chemicals Scheduling in joint session (ACCS/ACMS #21, March 2019)
3.1 Interim decision in relation to paracetamol
Interim decision:
Pursuant to regulation 42ZCZN of the Regulations, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision to amend the current Poisons Standard in relation to paracetamol as follows:
Schedule 4 - Amend Entry
PARACETAMOL:
- when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;
- when combined with ibuprofen in a primary pack containing more than 30 dosage units;
- in slow release tablets or capsules containing more than 665 mg paracetamol;
- in non-slow release tablets or capsules containing more than 500 mg paracetamol;
- in individually wrapped powders or sachets of granules each containing more than 1000 mg paracetamol;
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in schedule 2;
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules except when included in Schedule 2;
- for injection;
- for the treatment of animals
Schedule 3
PARACETAMOL when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2.
Schedule 2
PARACETAMOL for therapeutic use:
- when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
- in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules; or
- in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
- in individually wrapped powders or sachets of granules enclosed in a primary pack containing more than 50 wrapped powders or sachets of granules intended only as a bulk medicine pack and labelled 'For dispensing only' and 'This pack is not to be supplied to a patient'; or
- in other preparations except:
- when included in Schedule 3 or 4; or
- in individually wrapped powders or sachets of granules each containing 1000 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:
- enclosed in a primary pack that contains not more than 10 such powders or sachets of granules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and
- not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
- 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:
- packed in blister or strip packaging or in a container with a child-resistant closure,
- in a primary pack containing not more than 20 tablets or capsules,
- compliant with the requirements of the Required Advisory Statements for Medicine Labels,
- not labelled for the treatment of children 6 years of age or less, and not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin
Index
PARACETAMOL
cross reference: ASPIRIN, IBUPROFEN, METOCLOPRAMIDE, SALICYLAMIDE, CAFFEINE
Schedule 4
Schedule 3
Schedule 2
Appendix F, Part 3
Appendix H
A new listing be created in Part 2 - Control on medicines and poisons, section 2.4 - child-resistant closures as follows:
Paracetamol included in Schedule 4, when packed and labelled for the treatment of animals
Nominal capacity: All sizes
Proposed date of effect of the proposed amendment: 1 October 2019
Reasons for the interim decision (including findings on material questions of fact):
I agree with the committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; and (e) the potential for abuse of a substance.
In my view, the relevant parts of the SPF, 2018 are the Scheduling Factors under Schedule 6 and 4.
Reasons for interim decision:
I have made the decision to schedule paracetamol for animal use in Schedule 4 of the Poisons Standard to allow it to be made available with a prescription from a veterinary practitioner. In making my decision I have had regard the Applicant's proposal for a Schedule 6 entry; the substance meets some of the criteria for Schedule 6 when used as intended, and I note that other concentrates for use in feed are Schedule 6. However, my view is that there is a moderate propensity for misuse, either accidentally carelessly or deliberately, making it unsuitable for a Schedule 6 classification. In my deliberations I have given substantial weight to the fact that the commercial animal product will contain large quantities of paracetamol, particularly in liquid form, and if the product is accidently ingested or deliberately misused there is potential for significant human toxicity, including delayed irreversible hepatotoxicity. I considered that if listed as a Schedule 6 substance, a commercial product could be supplied to anyone aged 16 or over from any wholesale or retail outlet without veterinary oversight and advice on the serious risk of harm to humans. I am not persuaded that strong label warnings, extensive safety directions and child-resistant packaging under a Schedule 6 classification are sufficient to mitigate the risks associated with potential misuse. I consider it a reasonable possibility that consumers may not be aware of how highly concentrated the commercial product is and that even a small dose could be lethal, especially for a child. In the absence of professional guidance I have found that the liquid form, as proposed, is unsuitable for Schedule 6. It is my view that on balance a Schedule 6 classification is unsuitable due to the risks associated with misuse and the safety concerns inherent in the highly concentrated nature of the commercial product.
I will now set out my reasons to have paracetamol for animal use under a Schedule 4 classification. Among other things I have considered, including the information presented above on potential harm to humans, I have taken into account the potential adverse consequences for animals. It is my view that veterinary intervention is warranted as the presence of fever in pigs may be an indication of disease that requires other control measures e.g. identification of causative factors. In particular, additional biosecurity measures to control any outbreak, and protection from additional risk to the herd as well as neighbouring populations may need to be implemented. I have not given any weight to the first aid instructions and safety directions to be listed in the FAISD Handbook and required to appear on the product label, as determined by the APVMA evaluator, in the Human Health Risk Assessment Technical Report provided by the Applicant, as these matters are considered under other legislation at the time of making my decision.
In relation to the separate matter of paracetamol for human use; having reviewed the current Poisons Standard I have decided that a future delegate initiated application is appropriate to restrict the volume of liquid paracetamol available for human use in Schedule 2.