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Source: Australian Department of Health

1 Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)

The NCEs listed below will be included in the new Poisons Standard that will come into effect on 1 February 2021.

Note

New text is shown as green, larger font, with a horizontal line above it.

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

1.1. Trifarotene

Recommendation

TRIFAROTENE

Index – New Entry

TRIFAROTENE

Schedule 4

Date of effect

1 February 2021

1.2. Cariprazine

Recommendation

Schedule 4 – New Entry

CARIPRAZINE

Index – New Entry

CARIPRAZINE

Schedule 4

Date of effect

1 February 2021

1.3 Bilastine

Recommendation

Schedule 4 – New Entry

BILASTINE

Index – New Entry

BILASTINE

Schedule 4

Index – Amend Entry

ANTIHISTAMINES cross reference: ASTEMIZOLE, AZELASTINE, BILASTINE, DESLORATADINE, FEXOFENADINE, LORATADINE, TERFENADINE, CETIRIZINE

Date of effect

1 February 2021

1.4. Filgotinib

Recommendation

Schedule 4 – New Entry

FILGOTINIB

Index – New Entry

FILGOTINIB

Schedule 4

Date of effect

1 February 2021

2 Amendments to the Poisons Standard in relation to Acitretin and SARS-CoV- (COVID-19) vaccine

2.1. Acitretin

Amendment

The Appendix D entry for acitretin will be amended in the new Poisons Standard that will come into effect on 1 February 2021:

Appendix D. Item 2 – Amend entry

2. Poisons available only from or on the prescription or order of a specialist physician or a dermatologist and for which the prescriber must, where the patient is a woman of child-bearing age:

  1. ensure that the possibility of pregnancy has been excluded prior to commencement of treatment; and
  2. If the drug is –
    1. acitretin or etretinate, advise the patient to avoid becoming pregnant during or for a period of 24 36 months after completion of treatment; or
    2. bexarotene, isotretinoin or thalidomide, advise the patient to avoid becoming pregnant during or for a period of 1 month after completion of treatment.

Date of effect

1 February 2021

Reasons for the amendment

I have decided to amend the Poisons Standard and change the Appendix D listing for acitretin.

The guidance in the Product Information for all eight acitretin products on the Australian Register of Therapeutic Goods (ARTG) has been updated to state ‘acitretin must not be used by patients who are pregnant or who intend to become pregnant during therapy or for 3 years after cessation of therapy’. This change was in response to the European Periodic Safety Update Reports and publications indicating a longer half-life of acitretin.[1],[2]

Currently, the Appendix D, Item 2 entry for acitretin (or etretinate) advises patients to avoid becoming pregnant for a period of 24 months after completion of treatment. To align with the Product information for these products, the advised period to avoid pregnancy after cessation of treatment has been amended to 36 months.

2.2. SARS-CoV-2 (COVID-19) vaccine

Amendment

A new Schedule 4 entry for the SARS-CoV-2 (COVID-19) vaccine will be included in the Poisons Standard commencing 1 February 2021. At present, the existing general entry relating to ‘VACCINES for human therapeutic use’ in Schedule 4 to the current Poisons Standard would apply to any proposed vaccine for SARS-CoV-2 (COVID-19). However, a specific entry will be included expressly mentioning ‘SARS-CoV-2 (COVID-19) vaccine’, consistent with the approach for other vaccines specified in Schedule 4 to the current Poisons Standard.

Schedule 4 – New Entry

SARS-COV-2 (COVID-19) VACCINE

Index – Amend Entry

SARS-COV-2 (COVID-19) VACCINE

Schedule 4

Date of effect

1 February 2021


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