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 #29, March 2020)
Final decision in relation to flurbiprofen
Final decision
Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision, with a minor editorial change to the wording, and amend the current Poisons Standard in relation to flurbiprofen as follows:
Schedule 4 - Amend Entry
FLURBIPROFEN except when included in or expressly excluded from Schedule 2.
Schedule 2 - Amend Entry
FLURBIPROFEN in preparations for topical oral use when:
- in divided preparations containing 10 mg or less of flurbiprofen per dosage unit except when:
- in a primary pack containing not more than 16 dosage units; and
- labelled only for the treatment of adults and children over 12 years.
- in undivided preparations containing 0.25 percent or less or 10 mg or less per dose of flurbiprofen.
Materials considered
In making this final decision, the Delegate considered the following material:
- The application to amend the current Poisons Standard with respect to flurbiprofen;
- The five public submissions received in response to the pre-meeting consultation under regulation 42ZCZK of the Regulations;
- The advice received from the Advisory Committee on Medicines Scheduling (ACMS #29);
- The one public submission received in response to the interim decision consultation under regulation 42ZCZP of the Regulations;
- Section 52E of the Therapeutic Goods Act 1989, in particular (a) the risks and benefits of the use of a substance; (a) the risks and benefits of the use of a substance; (b) the purpose for which a substance is to be used and the and extent of use of a substance; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance;
- 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, with a minor editorial change to the wording, to amend the Schedule 2 and Schedule 4 entries for flurbiprofen in the current Poison Standard. 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 submission received before the second closing date in response to the call for further submissions published on 10 June 2020 under regulation 42ZCZP of the Regulations.
Flurbiprofen lozenges are typically used to treat the inflammation and pain associated with a sore throat. I have considered the public submission in opposition, which claims that making flurbiprofen-containing products accessible outside of the pharmacy setting presents a greater risk of COVID-19 spread on the basis that it may delay consumer access to COVID-19 testing and health professional advice. I have not found, and the submitter has not provided, any compelling evidence to substantiate these claims or to establish that there is a net risk to public health in down-scheduling flurbiprofen as proposed in my interim decision.
Date of effect of the decision
1 October 2020