1.1. Final decision in relation to cetirizine

1 Advisory Committee on Medicines Scheduling (ACMS #26) - Final decisions made pursuant to regulation 42ZCZR

1.1. Final decision in relation to cetirizine

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 not amend the current Poisons Standard in relation to cetirizine.

Date of effect of the decision

22 August 2019

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

I have made a final decision to confirm my interim decision to retain the Schedule 4 and Schedule 2 entries for cetirizine in the current Poisons Standard for the reasons set out in my interim decision and those referred to below. In making my final decision, I have taken into account the public submissions received before the second closing date in response to the call for further submissions published on 6 June 2019 under regulation 42ZCZP of the Regulations.

I have taken into account the critical argument in opposition of the interim decision that a change in pack size does not change the access to health professional advice. I consider the standard recommendations (such as the Therapeutic Guidelines series) relevant to this matter, which are that where allergic rhinitis is intermittent (i.e. less than 4 days per week or less than 4 consecutive weeks), and mild to moderate in nature, intranasal or oral antihistamines can be used alone or with intranasal corticosteroids. Intranasal corticosteroids are considered more effective where nasal obstructive symptoms are present. For patients with nasal congestion or more severe disease with sleep disturbance, impairment of daily activities and/or impairment of work or school performance, intranasal corticosteroids +/- oral/intranasal antihistamines are recommended. Having considered the standard treatment recommendations that, for more severe allergic rhinitis or nasal congestion other treatment may also be required, I confirm my interim decision that increasing the general sales level pack size may delay a person seeking advice in a pharmacy and may mean that best practice treatment is similarly delayed. My view is that in order for consumers to receive best practice, they need to talk to a pharmacist. A small pack size of cetirizine will encourage consumers to seek advice from a pharmacist more regularly than would be the case for a larger pack size.

The claims in the public submission that most consumers who purchase medicines in a general sales outlet are repeat purchasers, are familiar with the medicine and buy for convenience, are relevant. Among other things, I find that the provision of other information by pharmacist such as non-pharmacological and/or self-management advice such as avoidance of allergens, use of saline nasal sprays and direct steam inhalation plays an important role in managing the symptoms. In addition, I am of the view that lengthening the time before a consumer seeks advice is not in the interest of promoting public health.

I have taken into consideration the views expressed in the public submissions that Australia is lagging behind other nations with similar regulatory controls over medicines regarding pack sizes available at the general sales level. While the criticisms on pack size restrictions are generally correct, I find that the regulatory checkpoints underpinning supply overseas are not always equivalent. For example, although packs of up to 100 tablets are available outside pharmacies in Denmark, stores which sell medicines must be authorised by the Danish Medicines Agency and have to complete a number of e-learning modules before they can be authorised. In authorised stores, medicines must be stored behind the counter without customer self-selection in the same manner as Schedule 2 medicines must be stored in licensed country stores in Australia. For the reasons referred to be above, I have not given substantial weight to regulation of cetirizine in international markets.

I am not persuaded that removing the Appendix K entry is in the interest of protecting public health, particularly as the impetus for Appendix K was to reduce vehicle accidents. I accept that at 10 mg cetirizine does not usually cause drowsiness when taken at the recommended dose. In confirming my decision to retain the Appendix K entry, I have given substantial weight to the increased risk of sedation associated with cetirizine use in combination with alcohol and any other medication that can cause memory impairment or affect psychomotor skills.