1.1. Interim decision in relation to cetirizine

Interim decision:

For the reasons set out below, a delegate of the Secretary has, in relation to the proposed amendment, made an interim decision under regulation 42ZCZN not to amend the current Poisons Standard in relation to cetirizine.

Reasons for the interim decision (including findings on material questions of fact):

I agree with the committee's finding that the relevant matters of section 52E of the Therapeutic Goods Act 1989 are (a) 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; (c) the toxicity of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

In my view, the relevant parts of the SPF 2018 are the Scheduling Factors for Schedule 4 and 2.

Reasons for interim decision:

I have made a decision that the scheduling of cetirizine remains appropriate under Schedule 4 and Schedule 2 and below I have set out my reasons. Among other things, the information I have considered is that increasing the general sales level pack size may delay a person seeking advice in a pharmacy therefore best practice treatment may be similarly delayed.

I am not persuaded by the evidence, supplied by the Applicant, that there is a public health benefit of increasing the pack size for cetirizine for the treatment of seasonal allergic rhinitis at the general sales level. The arguments made by the Applicant in this respect focus on accessibility, consumer convenience and affordability, and I am not satisfied that these factors would result in a public health benefit which outweighs my concerns regarding delaying seeking advice from a health professional. To the extent that the Applicant has submitted that benefits arising from accessibility, consumer convenience and affordability should be considered in a more general sense (beyond any effect on public health) this is not relevant to the matters which I must consider under section 52E of the Therapeutic Goods Act 1989. Accordingly, I have not given any weight to these matters (except insofar as they related to public health), and they were not material to my decision.

I find that the claims that Australia is somewhat conservative in terms of the pack size available at the general sales level compared to similar overseas regulators appear to be correct. On balance I consider that there are other differences in the way medicines are regulated that may influence safety and access to health professional advice. While risks associated with the proposed unscheduled 20 days' supply pack of cetirizine may potentially be no different to permitting multiple buys of smaller sizes, I have given substantial weight to the concern that increasing the pack size could lengthen the time before a consumer seeks advice from a pharmacist or other health professional. Having considered the evidence, it is my view that the potential negative consequences on quality use of medicines and overall best practice treatment of seasonal allergic rhinitis outweigh the risks.

I have considered the compelling evidence that cetirizine is well tolerated. However, as with other second generation antihistamines, its sedation effects are dose-related and risks can increase when taken in combination with alcohol and any other medication that can cause memory impairment and affect psychomotor skills. In addition, I note that in contrast to many other second-generation antihistamines, cetirizine crosses the blood-brain barrier. Having regarded for the sedation potential of cetirizine my view is that the current Appendix K entry remains appropriate.

I also concur with the committee's reasons under each matter relating to section 52E.