Department of Health

Regulatory requirements during COVID-19

Registered health practitioners play a vital role in treating and containing the novel coronavirus (COVID-19).

Medicines and Poisons Regulation recognises that during the pandemic you may have to adjust established procedures prior to prescribing and supplying medicines to patients, including applying for Schedule 8 permits and checking SafeScript.

During the pandemic health practitioners should take all reasonable steps to access SafeScript, as it is very effective in providing up-to-date and real time information about a patient’s prescribing and dispensing history.

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 2021to 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 2021to 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).

Order s55 DPCS Act Prohibiting sale or supply of poisons or controlled substances

Order - Restricting the sale, supply or use of Ivermectin Gazette G 42 21 October 2021 (PDF) page 2207 - to restrict unapproved uses to medical specialties or fields of specialty practices in a) dermatology; b) gastroenterology and hepatology; c) infectious diseases; d) paediatric gastroenterology and hepatology; and e) paediatric infectious diseases. The decision does not restrict treatment with Ivermectin for its approved uses to treat certain parasitic infections. It will not impede the conduct of registered clinical trials that are approved by, or notified to, the Secretary of the Australian Government Department of Health. The restriction commenced on 21 October 2021 and is in place for 12 weeks (until 13 January 2022) 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.

Electronic Prescribing

The Australian Government, in collaboration with States and Territories, is leading the introduction of electronic prescriptions. This initiative provides patients with a choice to receive either an electronic prescription or a paper prescription from their prescriber. The electronic prescribing national framework has been enabled in Victoria and Victorian law allows electronic prescriptions as a legal format for medicine supply.

Electronic prescriptions can be used for all Schedule 4 and Schedule 8 medicines, including drugs of dependence and medicines used for opioid replacement therapy.

No paper prescription or handwritten component is required for electronic prescriptions issued or dispensed using conformant software.

Visit the Australian Digital Health Agency Electronic Prescriptions website for more information.

Advice to authorised persons - refresher training during the coronavirus (COVID-19) pandemic

Medicines and Poisons Regulation has received feedback that not all components of refresher training required under Drugs and Poisons legislation can be provided in all instances due to the COVID-19 pandemic.

In response, Medicines and Poisons Regulation has issued the following advice regarding expectations and requirements for refresher training during the pandemic.

This advice applies to authorised persons required to complete refresher training stated in a Secretary Approval or Health Services Permit issued under Victoria Drugs and Poison legislation. A list of relevant authorised persons is included in the advice.

This advice does not apply to a person who has not previously completed all required training. The entire training must be completed before becoming an authorised person for the first time

Advice to authorised persons - refresher training during the coronavirus (COVID-19) pandemic

Note: Please consult the Australian Health Practitioner Regulation Agency (Ahpra) website for further information relating to continuing professional development for registered health professions during the coronavirus (COVID-19) pandemic.

Codeine - changes to patient access

For more information visit the Codeine Information Hub.

Access the codeine upscheduling factsheet

 

Reviewed 26 October 2021

Health.vic

Contact details

Postal address: Medicines and Poisons Regulation Department of Health GPO Box 4057 Melbourne VIC 3001

Medicines and Poisons Regulation Department of Health

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