Changed medicine regulatory requirements for health practitioners during COVID-19 pandemic

To facilitate the supply of medicines during the COVID-19 pandemic and to reduce regulatory burden on prescribers and pharmacists the following public health emergency orders (PHEO) have come into effect. For further information about the public health emergency orders, prescribers and pharmacists should read the advice documents and gazette notices.

Emergency supply of medicines without a prescription

PHEO #2 - Public health emergency order amended General Gazette G 37 Thursday 16 September 2021 (Page 1943) for emergency supply without a prescription to people affected by COVID-19 until midnight 31 December 2021 unless revoked earlier. The Order PHEO #2 is the extension of the original Order issued on 26 March 2020 (Gazette No. S 158), again on 10 September 2020 (General Gazette Number G36) and again on 23 March 2021 (Gazette No. S 133).

Pharmacist supply on a digital image of an original paper prescription

PHEO #4 - Public health emergency order amended General Gazette G 37 Thursday 16 September 2021 (Pages 1944-1945) for supply on a digital image of an original paper prescription transmitted by the prescriber until midnight 31 December 2021 unless revoked earlier. This is the extension of the original Order issued on 11 May 2020 (Gazette No. S 229), again on 10 September 2020 (Gazette No. G36) and again on 23 March 2021 (Gazette No. S 133).

Covid-19 Vaccine - Authorisation - Classes of Workforce

PHEO #8 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE Gazette No. G 33 Thursday 19 August 2021, pp.1771-1775 in force on 21 August 2021, to authorise classes of persons to obtain, possess and use (including to administer) any SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which is a Schedule 4 Poison and any Schedule 3 Poison necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE under the conditions outlined in the Order until 20 February 2022 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 21 February 2021 (Gazette No. S 80).

PHEO #9 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (students) Gazette No. G 33 Thursday 19 August 202, pp.1776-1778 in force on 21 August 2021, to authorise classes of persons to obtain, possess and use (including to administer) any SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) under the conditions outlined in the Order until 20 February 2022 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 21 February 2021 (Gazette No. S 80).

PHEO #14 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE (surge workforce) Gazette No. S 476 Wednesday 1 September 2021 to authorise classes of persons to obtain, possess and use (including to administer) any SARS-CoV-2 (COVID-19) vaccine approved by the Therapeutic Goods Administration (COVID-19 VACCINE) under conditions outlined in the Order until 28 February 2022 (inclusive) unless revoked earlier.

PHEO #15 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (surge students) Gazette No. S 476 Wednesday 1 September 2021 to authorise classes of persons to obtain, possess and use (including to administer) any SARS-CoV-2 (COVID-19) vaccine approved by the Therapeutic Goods Administration (COVID-19 VACCINE) under conditions outlined in the Order until 28 February 2022 (inclusive) unless revoked earlier.

Covid-19 Vaccine - Authorisation - Distributors

PHEO #10 - Public Health Emergency Order: Authorisation for distribution - COVID-19 VACCINE Gazette No. G 33 Thursday 19 August 2021, pp.1778-1779 in force on 21 August 2021, to authorise classes of persons to obtain and distribute SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which is a Schedule 4 Poison and any Schedule 3 Poison necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE under the conditions outlined in the Order until 20 February 2022 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 21 February 2021 (Gazette No. S 80).

PHEO #12 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Department of Defence) Gazette No. G 33 Thursday 19 August 2021, pp. 1780-1781 - coming into force on 13 September 2021, to authorise Department of Defence to obtain, possess or supply SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which is a Schedule 4 Poison and any Schedule 3 Poison necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in this Order until 12 March 2022 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 13 March 2021 (Gazette No. S 118).

Covid-19 Vaccine - Authorisation - Aspen Medical User

PHEO #11 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Aspen Medical) Gazette No. G 33 Thursday 19 August 2021, pp.1779-1780 in force on 21 August 2021, to authorise Aspen Medical to obtain and possess SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which is a Schedule 4 Poison and any Schedule 3 Poison necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in this Order until 20 February 2022 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 21 February 2021 (Gazette No. S 80).

Influenza Vaccine - Authorisation - Ambulance Victoria Staff Vaccination

PHEO #13 - Public health emergency order Gazette No. S 334 Friday 25 June 2021 to authorise registered paramedics employed by Ambulance Victoria who have successfully completed a program of study approved by the Chief Health Officer to administer the 2021 influenza vaccine to Ambulance Victoria operational staff members until midnight 1 October 2021, unless earlier revoked.

Medicine Shortages

Serious Shortage Medicine Substitution Notices

The Therapeutic Goods Act 1989 enables community pharmacists to supply an alternative medicine where there is a serious shortage of the medicine written on the prescription.

The Commonwealth Minister for Health can make a legislative instrument to:

  • declare that there is a serious scarcity of specified medicine (the scarce medicine) across the whole or a specified part or parts of Australia; and
  • specify the medicine (the substitutable medicine) that pharmacists are permitted to dispense in substitution for the scarce medicine and specify the circumstances in which that substitution is permitted.

Serious Scarcity Substitution Instruments (SSSI) are published by the Therapeutic Goods Administration. They allow pharmacists to dispense the substitutable medicine under described conditions, even if dispensing is not enabled under state or territory legislation.

Substitutable medicines for a scarce medicine will be Schedule 4 poisons only and usually:

  • Tablets/capsules of lower or higher strength
  • Other dose forms containing the same active ingredient (for example, a capsule instead of a tablet, or a syrup or suspension).
  • Where a fixed-dose combination may not be available but the two or three medicines that make up the combination are these medicines can be dispensed individually.
  • Dispensing of an immediate-release form in lieu of a sustained/extended-release version and vice versa
  • The same active ingredient, but with a different salt.

SSSI are time-limited but may be extended or revoked.

The pharmacist may supply in accordance with the SSSI without obtaining prior approval from the prescriber as long as the permitted circumstances within the SSSI are met.

SSSI and the Pharmaceutical Benefits Scheme

Approved pharmacists can dispense PBS listed approved substitute benefits in place of prescribed pharmaceutical benefits in shortage without prior approval from the prescriber in circumstances where the Therapeutic Goods Administration has issued a SSSI in respect of that medicine.

SSSI and the Drugs, Poisons and Controlled Substances Regulations 2017

SSSI apply where there is a prescription and in other circumstances where supply is lawful under the Drugs, Poisons and Controlled Substances Regulations 2017, such as emergency supply made in the absence of a prescription (Regulations 47(1)(e) and 47(1)(f) ) and supply on a medication chart instruction (Regulations 47(1)(c) and 47(1)(d)).

SSSI are consistent with the existing provisions of the Drugs Poisons and Controlled Substances Regulations 2017, which make it an offence to supply Schedule 4 and Schedule 8 poisons, on prescriptions, contrary to prescribers' written intentions (regulations 50 and 51) other than in exceptional circumstances (regulation 53), which would include unavailability or a prescribed medicine.

Note: Regulation 68 requires a pharmacist, who varies from the instructions of a prescription without the consent of the prescriber, to:

  • inform the prescriber as soon as practicable after the supply; and
  • make a record (i.e. in connection with the corresponding dispensing record) to confirm that the exceptional circumstances existed in relation to that supply

A summary on the application of regulations 50, 51, 53 and 68 is found in the Medicines and Poisons Regulation document for Pharmacists Dispensing medicines.

Current SSSI are published by the Therapeutic Goods Administration.

PBS approved substitute benefits for specified SSSI: Medicine shortages.

Medicines and poisons phone line inactive

The Department of Health and Human Services (DHHS) is working around the clock with health services, the Commonwealth and international agencies to respond to the outbreak of coronavirus disease (COVID-19) and to keep the Victorian community safe.

The Medicines and Poisons Branch (MPR) is contributing to the DHHS response. To enable this the MPR phone line will not be operating for the immediate term.

If you have issues registering with SafeScript or logging in SafeScript, please contact SafeScript technical support on 1800 723 379.

If your query relates to drugs and poisons legislative controls in Victoria, please refer to the Licences and permits to possess (& possibly supply) scheduled substances page. Online forms are available at this location.

If your query relates to an urgent matter for a licence or permit application for an entity to purchase medicines or if you are reporting concerns about possible contraventions of drugs and poisons legislation please email dpcs@dhhs.vic.gov.au. We will respond to your query earliest convenience.

Commonly used online forms

For a full list of online forms, please visit the Online Forms - Medicines and Poisons Regulation web page.