New monitored medicines – pregabalin, gabapentin and tramadol
Following public consultation of the Regulatory Impact Statement to include pregabalin, gabapentin and tramadol in SafeScript, the proposed Regulations have now been made.
From 3 July 2023, pregabalin, gabapentin and tramadol will be monitored in SafeScript. Pharmacists and prescribers will be required to take all reasonable steps to check the records and information in SafeScript prior to supplying or prescribing pregabalin, gabapentin and tramadol for patients under their care.
Pregabalin, gabapentin and tramadol have been added to SafeScript in response to the growing evidence of their harms. Please refer to monitored medicines section for more information on why these three medicines have been included in SafeScript.
New emergency instructions
From 31 March 2023, new regulations enable a prescriber to transmit a digital image of an original prescription to a pharmacist to enable supply of a Schedule 4 or 8 medicine in an emergency. The new regulations implement a defined timeline (72 hours) for the prescriber to send the original paper prescription to the pharmacist after transmitting the digital image or following a verbal instruction to a pharmacist to instruct supply in an emergency.
Due to potential for postage delays it is not a legal requirement that the original paper prescription be received by the pharmacist within 72 hours.
Changed medicine regulatory requirements during COVID-19 pandemic
To facilitate the supply of medicines during the COVID-19 pandemic 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.
COVID-19 Vaccine – Authorisation – Distributors
PHEO #10 - Public Health Emergency Order: Authorisation for distribution - COVID-19 VACCINE. The Order in Gazette No. S 439 Thursday 17 August is in force from 21 August 2023 to 20 February 2024 (inclusive), unless revoked earlier. This is an amendment and extension of the Order issued on 7 July 2022 (Gazette 55 pp ).
The order is extended to authorise health services and residential aged care in Victoria to obtain, possess and supply the COVID-19 vaccine.
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 48 Saturday 11 February , in force on 11 February 2023, 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 August 2023 (inclusive) unless revoked earlier. This is an amendment and extension of the original Order issued on 11 August 2022 (Gazette No. S 397).
COVID-19 – Antiviral Medicines for Influenza – Authorisation – Residential Aged Care Facilities
PHEO #24 - Public Health Emergency Order: Authorisation for distribution - ANTIVIRAL MEDICINES for INFLUENZA Gazette No. G 28 Thursday 13 July (see page 1216) in force on 13 July 2023. 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.
The following Public Health Emergency Order expired on 21 August 2023 without extension
- PHEO #8 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE. The Order in Gazette No. S 55 Wednesday 15 February , pp. 1-5 was in force from 21 February 2023 to 20 August 2023 (inclusive), unless revoked earlier. This is an amendment and extension of the Order issued on 7 July 2022 (Gazette No. G ). This Order authorised 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.
The following Public Health Emergency Orders expired on 20 February 2023 without extension
- PHEO #9 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (students). The Order in Gazette No. S 353, Thursday 7 July , pp. 6-8 was in force from 21 August 2022 to 20 February 2023 (inclusive). This Order authorised 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.
- PHEO #11 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Aspen Medical). The Order in Gazette No. S 353 Thursday 7 July , pp. 11-12 was in force from 21 August 2022 to 20 February 2023 (inclusive), unless revoked earlier. This Order authorised 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.
- PHEO #12 - Public Health Emergency Order: Authorisation - COVID-19 VACCINE (Department of Defence). The Order in Gazette No. S 353, Thursday 7 July , pp. 13-14 was in force from 21 August 2022 to 20 February 2023 (inclusive). This Order authorised 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.
- PHEO #14 - Public Health Emergency Order: Authorisation for preparation and administration - COVID-19 VACCINE (surge workforce). The Order in Gazette No. S 353, Thursday 7 July , pp. 15-18 was in force from 21 August 2022 to 20 February 2023 (inclusive). This Order authorised 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.
- PHEO #15 - Public Health Emergency Order: Authorisation for administration - COVID-19 VACCINE (surge students). The Order in Gazette No. S 353, Thursday 7 July , pp. 19-21 was in force from 21 August 2022 to 20 February 2023 (inclusive). This Order authorised 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.
The following Public Health Emergency Order was revoked on 2 November 2022
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.
Note; The National Health (Continued Dispensing) Determination 2022 has 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.
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 .
PBS approved substitute benefits for specified SSSI: Medicine .
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 website for more information.
- Electronic prescriptions – Resources for
- Electronic prescriptions – Resources for
- Electronic prescribing conformance
- Criteria for electronic prescriptions 9 April 2020 (Victoria)
Training modules
Reviewed 12 September 2023