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3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR
Note
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3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #31, June 2020)
3.1.5 Final decision in relation to ibuprofen
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to Ibuprofen as follows:
Schedule 2 - Amend Entry
IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:
- in liquid preparations when sold in the manufacturer's original pack containing 8 g or less of ibuprofen; or
- in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:
- as the only therapeutically active constituent (other than phenylephrine or when combined with an effervescent agent);
- packed in blister or strip packaging or in a container with a child-resistant closure;
- in a primary pack containing not more than 25 dosage units;
- 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 phenylephrine.
- in divided immediate release preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 12 dosage units, when labelled:
- not for the treatment of children under 12 years of age.
Materials considered
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to ibuprofen;
- The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Meeting of the Advisory Committee on Medicines Scheduling (ACMS #31);
- The eleven public submissions received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- Subsection 52E(1) of the Therapeutic Goods Act 1989, in particular (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; (e) the potential for abuse of a substance; and (f) any other matters considered necessary to protect public health;
- The Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
- The Scheduling handbook: Guidance for amending the Poisons Standard.
Reasons for the final decision (including findings on material questions of fact)
I have made a final decision to confirm my interim decision to amend the current Poisons Standard with respect to ibuprofen. My reasons for making the final decision are those set out in the interim decision. In making my final decision, I have taken into account the material detailed in the interim decision and the public submissions received before the second closing date in response to the call for further submissions published on 13 October 2020 under regulation 42ZCZP of the Regulations.
I have considered the public submission that opposes the amendment due to the risks of NSAIDs. I remain of the view that the net benefits of broadening the availability of immediate release ibuprofen with restrictions placed on age, dosage form and pack size, combined with warning labels, outweighs the potential risks associated with improper use.
I have considered the public submissions that oppose the confinement to immediate release ibuprofen, stating that modified release ibuprofen has an equivalent safety profile. Ibuprofen modified release was launched as Schedule 3 in November 2019 and as noted in my interim decision, has limited clinical experience in Australia. It is my view that this is a matter for a separate scheduling application. Therefore, I have not relied on the material in the public submissions in making my final decision.
Date of effect of the decision
1 February 2021