Medicines and poisons recent updates

Bicillin L-A (benzathine benzylpenicillin) shortage

There is an ongoing national shortage of Pfizer Bicillin L-A (benzathine benzylpenicillin tetrahydrate) prefilled syringes (600,000 units per syringe and 1.2 million units per syringe) that is expected to continue into 2024.

Shortage of the Bicillin L-A 1.2 million unit syringe is expected to continue for several months into 2024 while the 600,000 unit syringe will likely remain in limited supply until November 2024.

Find out more, see Bicillin L-A (benzathine benzylpenicillin) shortage.

Public Health Emergency Order #25 (emergency access to Schedule 4 medicines for flood impacted patients)

Public Health Emergency Order #25 has been issued in response to the floods currently impacting Victoria. This Public Health Emergency Order authorises pharmacists to sell or supply a Schedule 4 medicine to a patient without a prescription in an emergency if the pharmacist considers it necessary to ensure continuity of treatment. The exact conditions that must be met prior to supply are contained in the Government Gazette notice. This Public Health Emergency Order will be in place until 10 February 2024.

Further details about this arrangement is provided in the document titled ‘Options available to pharmacists to supply Schedule 4 and Schedule 8 medicines in an emergency in Victoria’. The document also outlines options available for a pharmacist to supply a Schedule 8 medicine if a patient does not have a physical prescription, including supply off an electronic prescription, digital image of a paper prescription, or verbal instruction from a prescriber.

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.

Gazette Notice of decision

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 62 Friday 16 February 2024 is in force from 21 February 2024 to 20 August 2024 (inclusive), unless revoked earlier. This is an amendment and extension of the Order issued on 17 August 2023 (Gazette No. S 439).

The order is extended to authorise residential aged care facilities in Victoria to obtain, possess and supply the COVID-19 vaccine. The amended Order ceases to authorise health services defined as bodies corporate by operation of the Health Services Act 1988 to obtain, possess and supply the COVID-19 vaccine. Health services may obtain and possess the COVID-19 vaccine under a permit issued under section 19 of the Drugs, Poisons and Controlled Substances Act 1981.

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 2023, 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 2 Thursday 11 January 2024 (see pages 21-22) in force on 12 January 2024. 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 2023, 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 353). 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 2022, 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 2022, 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 2022, 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 2022, 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 2022, 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 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.

• Electronic prescriptions – Resources for Prescribers
• Electronic prescriptions – Resources for Pharmacists
• Electronic prescribing conformance register
• Criteria for electronic prescriptions 9 April 2020 (Victoria)

Training modules

• Electronic Prescribing in your practice
• Electronic Prescribing for Dispensers
• Introduction to Active Script Lists
• Digital Health for Specialists