Department of Health

Changed medicine regulatory requirements for health practitioners during floods

To facilitate the supply of medicines during the floods the following public health emergency order (PHEO) has 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 #22 - Public health emergency order issued Gazette S 570 Wednesday 2023 for emergency supply without a prescription to people affected by floods until 18 January 2023 unless revoked earlier.

PHEO#22 authorises a registered pharmacist to supply a Schedule 4 medicine to a patient for continued treatment without a prescription subject to the following conditions:

  • there is an immediate need for the medicine and it is impracticable for the patient to obtain a prescription in time to meet that need
  • treatment with the medicine has previously been provided for by a prescription issued, or a chart instruction written, for the patient by a prescriber
  • the patient, or an agent of the patient, or a person who has the care of the patient, or a person who is assisting in the care of the patient, is aware of the appropriate dose of that medicine for that patient

The quantity of the medicine supplied must not exceed:

  • for a medicine that is on the Pharmaceutical Benefits Scheme, the standard Pharmaceutical Benefits maximum quantity
  • for a medicine that is not on the Pharmaceutical Benefits Scheme, the quantity that is contained in the smallest commercially available pack

A pharmacist is required to make a record that supply was made under PHEO#22.

Advice to pharmacists utilising PHEO#22

PHEO#22 places an onus on a pharmacist to ensure that the Schedule 4 medicine has previously been prescribed for the patient and there is an immediate need for continued treatment. Options to confirm that the Schedule 4 medicine was previously prescribed for the patient may include prior records, dispensing labels on packaging and verbal or written medication history from the patient. Pharmacists should exercise their professional judgement to ensure supply is safe for the patient. There is no mandatory requirement for a pharmacist to supply a medicine under PHEO#22.

Alternative options

Medical practitioners and other suitably registered health practitioners may issue verbal instructions to a pharmacist to supply a Schedule 4 or a Schedule 8 medicine if, in the opinion of the practitioner, an emergency exists (Regulation 25 of the Drugs, Poisons and Controlled Substances Regulations 2017). The prescriber who issues verbal instructions must, as soon as practicable, send written confirmation (most commonly in the form of a prescription) to the pharmacist.

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 for emergency supply without a prescription to people affected by COVID-19 was revoked in the Victoria Government Gazette G 45 10 November 2022 page 4402.

The National Health (Continued Dispensing) Determination 2022 has now been adopted in Victoria. Pharmacists are authorised to supply Schedule 4 medicines in accordance with the Commonwealth Continued Dispensing Arrangement. The Minister for Health has approved a list of Schedule medicines that may be supplied under this arrangement - Victoria Government Gazette G 45 10 November 2022 pages 4397- 4401.

Pharmacist supply on a digital image of an original paper prescription (Hospital Use Only)

PHEO #4 - Public Health Emergency Order amended Gazette G 41 Thursday 13 October 2022 (for hospital use only for supply on a digital image of an original paper prescription transmitted by the prescriber until 31 March 2023 unless revoked earlier. This is an amendment and extension of the original Order issued on 11 May 2020 (Gazette No. S 229), again on 10 September 2020 (Gazette No. G36), again on 23 March 2021 (Gazette No. S 133), again on 16 September 2021 (General Gazette No. G37), again on 21 December 2021 (Gazette No. S 729), and again on 14 April 2022 (Gazette No. S 197).

National Health Plan – prescriptions via telehealth – a guide for pharmacists
National Health Plan – prescriptions via telehealth – a guide for prescribers
 

COVID-19 Vaccine – Authorisation – Preparation and Administration/Administration

PHEO #8 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE. The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 1-5 is in force from 21 February 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 1-5 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain, possess and use (including to prepare and administer) any SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which are Schedule 4 Poisons and any Schedule 3 Poisons necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in the Order. This is an amendment and extension of the Order issued on 21 August 2021 (Gazette No. G 33).

PHEO #9 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (students). The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 6-7 is in force from 21 February 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 6-8 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain, possess and use (including to prepare and administer) any SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) in accordance with the conditions outlined in the Order. This is an amendment and extension of the Order issued on 21 August 2021 (Gazette No. G 33).

PHEO #14 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE (surge workforce). The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 14-16 is in force from 1 March 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 15-18 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain, possess and use (including to prepare and administer) any SARS-CoV-2 (COVID-19) vaccine approved by the Therapeutic Goods Administration (COVID-19 VACCINE) in accordance with the conditions outlined in the Order. This is an amendment and extension of the original Order issued on 1 September 2021 (Gazette No. S 476).

PHEO #15 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (surge students). The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 17-19 in force from 1 March 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 19-21 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain, possess and use (including to prepare and administer) any SARS-CoV-2 (COVID-19) vaccine approved by the Therapeutic Goods Administration (COVID-19 VACCINE) in accordance with the conditions outlined in the Order. This is an amendment and extension of the original Order issued on 1 September 2021 (Gazette No. S 476).

PHEO #16 – Public Health Emergency Order: Authorisation for preparation and administration – COVID-19 VACCINE (Limited Scope COVID-19 Vaccinator). The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 22-24 is in force from 7 July 2022 to 6 January 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain, possess and use (including to prepare and administer) any SARS-CoV-2 (COVID-19) vaccine approved by the Therapeutic Goods Administration (COVID-19 VACCINE) in accordance with conditions outlined in the Order. This is an amendment and extension of the original Order issued on 7 January 2022 (Gazette No. S 6).

COVID-19 Vaccine – Authorisation – Distributors

PHEO #10 - Public Health Emergency Order: Authorisation for distribution - COVID-19 VACCINE. The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 8-9 is in force from 21 February 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 9-10 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises classes of persons to obtain and distribute SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which are Schedule 4 Poisons and any Schedule 3 Poisons necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in the Order. This is an amendment and extension of the Order issued on 21 August 2021 (Gazette No. G 33).

PHEO #12 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Department of Defence). The Order in Gazette No. S 77 Thursday 17 February 2022, pp. 12-13 is in force from 13 March 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353, Thursday 7 July 2022, pp. 13-14 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises Department of Defence to obtain, possess or supply SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which are Schedule 4 Poisons and any Schedule 3 Poisons necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in this Order. This is an amendment and extension of the Order issued on 13 September 2021 (Gazette No. G 33).

COVID-19 Antiviral Medicines – Authorisation – Residential Aged Care Facilities

PHEO #17 - Public Health Emergency Order: Authorisation for distribution - COVID-19 ANTIVIRAL MEDICINES Gazette No. S 397 Thursday 11 August 2022, in force on 11 August 2022, to authorise classes of persons (Residential Aged Care Facilities) to obtain and possess or supply SARS-CoV-2 (COVID-19) ANTIVIRAL MEDICINES approved by the Therapeutic Goods Administration when under the conditions outlined in the Order until 10 February 2023 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 9 February 2022 (Gazette No. S 363).

COVID-19 Vaccine – Authorisation – Aspen Medical User

PHEO #11 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Aspen Medical). The Order in Gazette No. S 77 Thursday 17 February 2022, pp.10-11 is in force from 21 February 2022 to 20 August 2022 (inclusive), unless revoked earlier. The Order in Gazette No. S 353 Thursday 7 July 2022, pp. 11-12 is in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorises Aspen Medical to obtain and possess SARS-CoV-2 (COVID-19) VACCINE approved by the Therapeutic Goods Administration (COVID-19 VACCINE) which are Schedule 4 Poisons and any Schedule 3 Poisons necessary for the treatment of anaphylactic reactions to the COVID-19 VACCINE in accordance with the conditions outlined in this Order. This is an amendment and extension of the original Order issued on 21 August 2021 (Gazette No. G 33).

COVID-19 – Antiviral Medicines for Influenza – Authorisation – Residential Aged Care Facilities 

PHEO #23 - Public Health Emergency Order: Authorisation for distribution - ANTIVIRAL MEDICINES for INFLUENZA Gazette No. S 624 Thursday 3 November 2022 in force on 3 November 2022. This Order authorises classes of persons (Residential Aged Care Facilities) to obtain and possess or supply Schedule 4 poisons entered in the Australian Register of Therapeutic Goods and indicated for the treatment of influenza, under the conditions outlined in the Order for a period of six months unless revoked earlier.

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.

Training modules

Reviewed 01 December 2022

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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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