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Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS/ACCS/Joint ACMS-ACCS meetings, March 2020

Scheduling of chemicals and poisons

10 June 2020

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1.7. Fexofenadine

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

1.7. Interim decision in relation to fexofenadine

Note

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Interim decision

Pursuant to regulation 42ZCZN of the Regulations, a Delegate of the Secretary has, in relation to the proposed amendment to broaden the availability of fexofenadine, made an interim decision to 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.
Proposed date of effect of the proposed amendment

1 October 2020

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

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

Summary of ACMS advice/recommendations to the Delegate

The Committee recommended that the scheduling of fexofenadine in Schedule 2 and Schedule 4 be amended in the Poisons Standard 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 ageand 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.

The Committee also recommended an implementation date of 1 October 2020.

Members agreed that the relevant matters under Section 52E(1) of the Therapeutic Goods Act 1989 included (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 reasons for the advice included:

  1. the risks and benefits of the use of a substance
    • The benefits of broadening the availability of fexofenadine for general sale to 180mg tablets (5 days supply) for people aged over 12 years outweighs potential risks of improper use.
  2. the purposes for which a substance is to be used and the extent of use of a substance
    • Seasonal allergic rhinitis is a common, easily identified condition that is appropriate for self-management where non-treatment can affect a sufferer's quality of life.
    • Second generation non-sedating anti-histamine approved for relief of seasonal allergic rhinitis.
  3. the toxicity of a substance
    • Established safety profile with low risk of sedation.
    • No significant increase in risk with increased dose from 120mg/day to 180mg/day.
    • The safety profile is well defined fexofenadine is substantially safe for use.
    • Lack of sedative effect, low abuse potential, wide therapeutic index, well-established toxicity profile, not associated with significant ECG abnormalities.
  4. the dosage, formulation, labelling, packaging and presentation of a substance
    • Tablets and liquids are available. Liquid formulations are intended for use in children under 6 and the scheduling of this formulation should remain unchanged.
    • Recommend in divided preparations only.
  5. the potential for abuse of a substance
    • NIL
  6. any other matters that the Secretary considers necessary to protect public health
    • NIL

Reasons for interim decision

I have made an interim decision to amend the Schedule 2 and Schedule 4 entries for fexofenadine in the Poison Standard. The reasons for my decision are set out below.

It is my view that the net benefits of broadening the availability of fexofenadine to general sale in 180mg tablets (5 day supply) for people aged over 12 years outweighs the potential risks associated with improper use. In coming to this decision, I considered that fexofenadine has an established safety profile with no evidence of greater risk associated with increased dose from 120mg to 180mg. I am satisfied that the dose and safety of fexofenadine in children aged 6-12 for the treatment of seasonal allergic rhinitis is well established. I have considered that the evidence establishes that fexofenadine-containing products have limited propensity for overdose.

Based on my reading of the data I have identified that the main risk to public health associated with down-scheduling to the general sales level is the potential for dosing errors in liquid formulations intended for children less than 6 years of age. I have made a decision to restrict the dosage form to "divided preparations" to ensure that liquid formulations remain scheduled to mitigate the risk of misuse in children.

I am satisfied that fexofenadine can be supplied at the general sales level, with reasonable safety, without any access to health professional advice. It is my view that the criteria for 'reasonable safety' as set out in the Scheduling Handbook are satisfied. Taking the mitigating factors for liquid formulations into consideration, I find that fexofenadine can be supplied at the general sales level, with reasonable safety, without any access to health professional advice.

I agree with the Committee's finding that the relevant provisions of section 52E of the Therapeutic Goods Act 1989 are (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.

Implementation date

I have decided the appropriate implementation date is 1 October 2020.

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