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

10 September 2021

Note

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This web publication constitutes a notice on an amendment 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). The notice publishes:

  • an amendment to the current Poisons Standard made by a delegate of the Secretary;
  • the reasons for this amendment; and
  • the date of effect of this amendment.

Amendment in relation to ivermectin

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 June 2021) to include an Appendix D listing for ivermectin as follows:

Appendix D, Item 10

  • 10. Poisons available only when prescribed or authorised for:
    • (1) an indication that is accepted by the Secretary of the Australian Government Department of Health in relation to the inclusion of ivermectin in tablet dosage form in the Australian Register of Therapeutic Goods (an approved indication); or

      Note: Approved indications are shown in the public summary of the Australian Register of Therapeutic Goods on the Therapeutic Goods Administration website at www.tga.gov.au.

    • (2) an indication that is not an approved indication, when the preparation is prescribed or authorised by 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 specialties or fields of specialty practices:
      • (a) dermatology;
      • (b) gastroenterology and hepatology;
      • (c) infectious diseases;
      • (d) paediatric gastroenterology and hepatology;
      • (e) paediatric infectious diseases; or
    • (3) use in a clinical trial that is approved by, or notified to, the Secretary of the Australian Government Department of Health under the Therapeutic Goods Act 1989.

IVERMECTIN in preparations for oral administration for human use.

Schedule 4

#IVERMECTIN:

  1. for human use; or
  2. for the treatment of mange in dogs

Index

Ivermectin

Schedule 7
Schedule 5
Schedule 4
Appendix D, Item 10

This amendment should be read in conjunction with the current Poisons Standard

Date of effect of the amendment

11 September 2021

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 paragraph (f), being any other matters that the Secretary considers necessary to protect public health;
  • the advice received from the Advisory Committee on Medicines Scheduling (ACMS#35 Out of Session Meeting) on 8 September 2021;
  • the Australian Health Ministers' Advisory Council's Scheduling Policy Framework (Version 1.0 January 2018); and
  • the Scheduling Handbook (Version 1.1, July 2019).

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

I have decided to amend the Poisons Standard by creating a new Appendix D listing for ivermectin. 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.

I have considered the concerns raised regarding the increase in off-label prescribing of oral ivermectin as a potential therapy for prophylaxis treatment of COVID-19. I note that ivermectin is not currently registered or approved for the prevention or treatment of COVID-19 in any member country of the Organisation for Economic Co-operation and Development ("OECD"). However, there has been a noticeable increase in the prescribing of oral ivermectin in Australia, which is believed to be for this purpose. Additionally, there has been significant increase in personal importation of ivermectin.

I have considered the advice provided by the Advisory Committee on Medicines Scheduling (ACMS) who share my serious concerns that there are significant public health risks associated with the prescribing of ivermectin for COVID-19. This includes the likelihood that people who have been prescribed the substance for this purpose may believe themselves to be protected from the disease and not get vaccinated or tested and seek appropriate medical care if they developed symptoms. This also poses the potential risk to the community through the spread of the disease as well as the risks to individuals using it for this purpose.

Oral ivermectin also has the potential to cause severe adverse events in persons, particularly when taken in high doses that have recently been described in social media and other sources for the prevention or treatment of COVID-19 infection. These include, for example, severe skin reactions accompanied by fever, chills and aching muscles, severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, worsening asthma and swelling of the face, legs, ankles and feet.

While oral ivermectin is generally well-tolerated at the recommended dose for the approved indications for which it is included in the Australian Register of Therapeutic Goods ("the Register"), there is insufficient data to support any higher doses. Currently, there is only one product containing oral ivermectin included in the Register. This is the prescription medicine, Stromectol ivermectin 3mg tablet blister pack (AUST R 181338), which is indicated for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis) and scabies.

The TGA has observed a significant increase in sales of this product in the last 24 months, with particular increase over the last two months that cannot be attributed to the approved indications alone. I am concerned that if action is not taken to address these concerns, it is possible that oral ivermectin will be in shortage in Australia for the treatment of the conditions for which it has been properly evaluated and approved in accordance with scientific data. Such a shortage may disproportionately impact vulnerable communities, including Aboriginal and Torres Strait Islander communities.

I note the Committee's unanimous advice that there is a need to urgently restrict prescribing of oral ivermectin through amendments to the scheduling in the Poisons Standard and that additional controls through Appendix D of the Poisons Standard is the most appropriate mechanism. My decision limits prescribing of oral ivermectin for indications that are not approved to the following specialists, if they believe it is appropriate for a particular patient; dermatologists, gastroenterologists and hepatologists, infectious diseases physicians, paediatric gastroenterologists and hepatologists, and paediatric infectious diseases physicians. This will allow for specialist prescribing for rare parasitic conditions that are not approved indications. General practitioners will only be able to prescribe ivermectin for TGA-approved conditions (indications) - that is, scabies and certain parasitic infections reflected in the Register.

My decision will not impact topical ivermectin products, which are approved for the treatment of rosacea, or veterinary products, including those mentioned in Schedule 5 and Schedule 7 of the current Poisons Standard. I am aware of overseas reports of people suffering severe adverse effects after using ivermectin products intended for animals. I note that communication and education activities as well as consultation with the Australian Veterinary Association and Veterinary Boards may be necessary to discourage such practices occurring in Australia.

My decision was not open to public consultation, given the seriousness of the circumstances, the risks to the community and the immediacy with which action needed to be taken. However, the ACMS (including state and territory representative members) was consulted in relation to the proposal and supported the amendment. Further, it was considered necessary to make the amendment urgently in order to support the Australian Government's response to the COVID-19 public health emergency.