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Public notice of final decisions - ACMS#29, ACCS#27, Joint ACMS-ACCS#24, March 2020

Scheduling medicines and poisons

24 August 2020

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3.1.6 Fexofenadine

3 Final decisions on proposed amendments to the current Poisons Standard under regulation 42ZCZR

Note

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Deleted text is shown as red, smaller font, with a strikethrough.

3.1 Final decisions on proposed amendments referred to the Advisory Committee on Medicines Scheduling (ACMS #29, March 2020)

Final decision in relation to fexofenadine

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 fexofenadine as follows:

Schedule 4 - Amend Entry

FEXOFENADINE except:

  1. when included in Schedule 2;
  2. or in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 20 dosage units or less and not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 120 mg of fexofenadine;
  3. for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 5 dosage units or less and not more than 5 days' supply; and
    2. labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or
  4. for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:
    1. in a primary pack containing 20 dosage units or less and not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.

Schedule 2 - Amend Entry

FEXOFENADINE in preparations for oral use except in divided preparations:

  1. for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 20 dosage units or less and not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 120 mg of fexofenadine;
  2. for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when:
    1. in a primary pack containing 5 dosage units or less and not more than 5 days' supply; and
    2. labelled with a recommended daily dose not exceeding 180 mg of fexofenadine; or
  3. for the treatment of seasonal allergic rhinitis and children 6 years of age and over when:
    1. in a primary pack containing 20 dosage units or less and not more than 10 days' supply; and
    2. labelled with a recommended daily dose not exceeding 60 mg of fexofenadine.
Materials considered

In making this final decision, the Delegate considered the following material:

  • The application to amend the current Poisons Standard with respect to fexofenadine;
  • The four 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; (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 to amend the Schedule 2 and Schedule 4 entries for fexofenadine 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.

I have considered the public submission in opposition raising concern that broadening the availability of fexofenadine to the general sale level will reduce health professional consultation and may lead to inappropriate self-selection of products. In my view, seasonal allergic rhinitis is a common, easily identified condition that is appropriate for self-management where non-treatment can affect a patient's quality of life. Having considered that fexofenadine has an established safety profile and its limited propensity for overdose, as detailed in my reasons for my interim decision, I am satisfied that fexofenadine can be supplied at the general sales level, with reasonable safety, without any access to health professional advice.

Date of effect of the decision

1 October 2020

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