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Notice of an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 - Hydroxychloroquine

3 April 2020

This web publication constitutes a notice on amendments to the current Poisons Standard made by a delegate of the Secretary pursuant to paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act). This notice publishes:

  • amendments to the current Poisons Standard made by a delegate of the Secretary;
  • the reasons for those amendments; and
  • the date of effect of those amendments.

1.1. Amendment in relation to hydroxychloroquine

Amendment

For the reasons set out below, a delegate of the Secretary of the Department of Health under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (the Act), has decided to exercise their power under that paragraph to amend the current Poisons Standard (the Poisons Standard February 2020) to amend the Appendix D listing for hydroxychloroquine as follows:

Appendix D, Item 8

8.

Poisons for which the initial treatment of a patient has been authorised by one of the following specialist health practitioners:

(1)

following the commencement of the Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 - a medical practitioner registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law, as a specialist in any of the following recognised specialties:

(a) dermatology;

(b) emergency medicine;

(c) intensive care medicine;

(d) paediatrics and child health;

(e) physician

(2)

following the commencement of the Poisons Standard Amendment (Hydroxychloroquine) Instrument 2020 - a dental practitioner registered under State or Territory legislation that forms part of the Health Practitioner Regulation National Law, as a specialist in the recognised specialty of oral medicine

HYDROXYCHLOROQUINE.

This amendment should be read in conjunction with the current Poisons Standard (https://www.legislation.gov.au/Details/F2020C00148).

Date of effect of the amendment

3 April 2020

Material considered

In relation to this amendment to the current Poisons Standard, the delegate considered the following:

  • paragraph 52D(2)(a) of the Therapeutic Goods Act 1989;
  • subsection 52E(1) of the Therapeutic Goods Act 1989, in particular in particular (f) any other matters that the Secretary considers necessary to protect public health;
  • the advice received from the state and territory health departments;
  • the advice received from the Oral Medicine Academy of Australasia;
  • the advice received from the Commonwealth Medical Officer;
  • the Australian Health Ministers' Advisory Council's Scheduling Policy Framework (SPF 2018); and
  • the Scheduling Handbook (V 1.1, July 2019).

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

I decided to amend the Poisons Standard by amending the Appendix D listing for hydroxychloroquine. In making this amendment I considered the matters in subsection section 52E(1) of the Therapeutic Goods Act 1989, including in particular paragraph 52E(1)(f) in relation to other matters that the Secretary considers necessary to protect public health.

This amendment will allow Australian Dental Board registered oral medicine specialists, who use hydroxychloroquine in their practice, to continue to initiate treatment using hydroxychloroquine in their patients.

In making this amendment, I considered that oral medicine specialists may be involved in the care and management of oral manifestations of certain autoimmune diseases requiring the use hydroxychloroquine.

I considered that inclusion of Australian Dental Board registered oral medicine specialists in the Appendix D, Part 8 listing for hydroxychloroquine in the Poisons Standard to be appropriate to ensure that these specialists can continue to access and initiate treatment with hydroxychloroquine.