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Summary of COVID-19 regulatory changes

This information was last updated Monday 20 March 2023

 

The tables below provide a summary of the arrangements available to support continuity of treatment (medicines) for patients during and beyond the COVID-19 pandemic.

 

PSA has prepared this information using the best and most up-to-date information that we have received. This is constantly changing. We are in constant contact the Australian Government and the state and territory governments and will update this information regularly.

 

This information is a guide and should not be used as a substitute or replacement for review of regulation and legislative instruments.

Digital image prescriptions ~ (26 October 2022)

Digital image prescriptions were the paperless transfer of prescriptions from a prescriber to a pharmacist to support telehealth consultations during COVID-19. This temporary measure was supported through existing territory regulation, temporary state regulatory amendments, public health emergency orders and a PBS Special Arrangement.

 

The PBS Special Arrangement ended on 31 March 2022 (except within hospitals), as did the legal authority to supply under temporary authorisations in all jurisdictions other than NSW.  In NSW this arrangement came to an end on 30 September 2022 (except within hospitals) This information remains available as prescriptions written prior to the expiry date of relevant orders, including where repeats are authorised, can continued to be supplied within these requirements until the prescription expires.

 

Prescriptions ineligible for supply as digital image prescriptions may be able to be supplied under other existing state and territory regulations – see phone/fax order by prescriber.

 

Digital image prescriptions are NOT examples of electronic prescriptions or electronic prescribing. Electronic prescribing information is available at PSA’s dedicated electronic prescriptions web page. Find out more at www.psa.org.au/ep

 

 

Transition arrangements

The Department of Health (Australian Government) has advised the following provisions for the end of the digital image prescription special arrangements from 31 March 2022:

Fact Sheet – National Health Plan: A guide for prescribers Arrangements for prescribing of medicines

Fact Sheet – National Health Plan: A Guide for Pharmacists Arrangements for prescriptions for supply of medicines

Why has the digital image prescribing initiative ended?

The implementation of this measure was only intended as an interim arrangement to support the community during COVID-19, which must now be ceased due to the associated increased risk of fraudulent behaviour.

 

Electronic prescribing has replaced the need for this temporary PBS measure. The Department of Health considers that electronic prescribing is now widely available nationally and will continue to support telehealth arrangements for the long term. Electronic prescribing, unlike digital image prescriptions, allows patients to receive their prescriptions electronically via email, SMS or mobile app, which they can send to their pharmacy to dispense their medicines.

 

The Department of Health advise most stakeholders now support the cessation of image-based prescribing in the community setting from 31 March 2022, noting the widespread access to electronic prescribing.

Digital image prescribing will be extended for hospitals. What will be captured by the term “hospitals”?

A “hospital” is an approved hospital authority as defined by section 94 of the National Health Act 1953, which is approved to supply pharmaceutical benefits to patients in or at that hospital whether private or public.

 

Limited image-based prescribing activities may continue for prescriptions written for hospital patients until 31 March 2023. A prescription written for a hospital patient can only be lawfully dispensed by a hospital pharmacy. This arrangement will only extend until 31 March 2023. The amendments limit the supply of pharmaceutical benefits to hospital settings, as defined by section 94 of the National Health Act 1953, which is an approved hospital authority who is approved to supply pharmaceutical benefits. This includes both public and private hospitals.

 

The changes to image-based prescribing remove the restriction on the supply of pharmaceutical benefits:
– For Schedule 4 Appendix D and Schedule 8 Medicines
– Under the National Health (Highly Specialised Drugs Program) Special Arrangement 2021 (HSD Special Arrangement)

Does the cessation of the arrangement in the community setting relate to the date of prescribing or date of dispensing?

The end date relates to the date of prescribing.

 

Transitional provisions that will recognise image-based prescriptions as legally valid if they have been prescribed before the end date of the Special Arrangement, but need to be dispensed after the end date.

Will the repeats for image-based prescriptions written and/or dispensed continue to be valid after 31 March 2022?

Prescriptions written before 31 March 2022 with existing repeats will continue to be honoured after 31 March 2022

Is digital image prescribing in NSW valid until 30 September 2022?

While the PBS Special Arrangement has ended, in NSW digital image prescriptions remained legal for the prescribing and supply of medicines until 30 September 2022. However, as these prescriptions were unable to be supplied as PBS prescriptions, in effect only non-PBS prescriptions can be supplied under this measure (except hospitals).

 

Prior to supplying PBS prescriptions from a fax, pharmacists should confirm with prescribers whether they intend to send the paper prescriptions under phone/fax arrangements.

Where can I find more information about transition arrangements?

The Department of Health (Australian Government) has updated relevant fact sheets and webpages that provide an overview of the amended image-based prescribing arrangement:

ACT

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – ACT regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. Ongoing under existing ACT legislation
Effective from 20 March 2020 N/A
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription is sent to the pharmacy according to Section 48 of National Health (Pharmaceutical Benefits) Regulations 2017
 For faxed prescriptions – The original written paper-prescription must be sent to the patient’s pharmacy within 24 hours of sending the faxed prescription
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
 (Refer to requirements under Commonwealth Special Arrangement)

 

June 2020 amendment to faxed prescription requirements

 

Sections 31A and 120A have been added to the Regulation to exempt the requirement to send or receive the original of a faxed prescription where the supply is made for a medicine in accordance with a Commonwealth special arrangement that requires prescribers to retain the original.

 

The Commonwealth Pharmaceutical Benefits Scheme (PBS) interim arrangements for telehealth consultations during COVID-19 are an example of where this applies.

 

This means that prescribers do not need to send the original of a faxed prescription to a pharmacist where it is prescribed during a telehealth consultation while the PBS special arrangements is in place. Pharmacists are also not obligated to receive the original in these circumstances
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Pharmacists may dispense and claim PBS items from a digital image of a prescription sent through by the prescriber (including S8 medicines, and S4 + Appendix D medicines as supported by existing ACT legislation) This includes for faxed prescriptions.
Legislative instrument/s
Relevant resources

NSW

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NSW regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. 30 September 2022
Effective from 20 March 2020 17 April 2020
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
  • The amendments to the NSW Poisons and Therapeutic Goods Regulation 2008 to enable supply based on a digital image of a prescription excludes medication chart prescriptions (Reg 36A)
  • Prescription to include a physical handwritten signature
  • Transmission of image of prescription to patient’s pharmacy from prescriber cannot be via text message
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats must be held in the pharmacy
  • Printed hardcopy of the image-based prescription must be printed and endorsed as per usual
  • Repeats must be retained and supplied at original dispensing pharmacy and may not be returned to the patient or transferred to another pharmacy
  • A pharmacist cannot forward an image-based prescription to another pharmacist for dispensing. If a pharmacist cannot dispense a medicine on an image-based prescription, inform the prescriber so that the prescriber can send the image-based prescription to another pharmacist
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Excludes:

Schedule 8 medicines and drug classes:

  • opioids
  • selected benzodiazepines (alprazolam, flunitrazepam)
  • psychostimulants (dexamfetamine, lisdexamfetamine, methylphenidate)
  • cannabis-based medicines

 

Schedule 4 Appendix D medicines and drug classes

  • anabolic steroids
  • barbiturates
  • benzodiazepines (except alprazolam, flunitrazepam)
  • erythropoietins
  • growth hormones
  • quetiapine
  • peptides
  • pregabalin
  • selective androgen receptor modulators
  • tramadol
  • zolpidem
  • zopiclone
Legislative instrument/s
Relevant resources

NT

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NT regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. Ended 31 March 2022, except for prescriptions prescribed and dispensed within hospitals.
Effective from 20 March 2020 20 March 2020
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
 (Refer to requirements under Commonwealth Special Arrangement)

 

  • All prescriptions must comply with ordinary rules that govern prescriptions in the NT
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
 (Refer to requirements under Commonwealth Special Arrangement)

 

  • By following the PBS processes, pharmacists will not be contravening NT law
  • Image based prescription cannot be sent to or from patients – they must be sent directly from the prescriber to the pharmacy
  • Pharmacists should be increasingly vigilant when processing prescriptions for ‘desirable medications’.
  • It is recommended that pharmacies develop a standard operating procedure for validating prescriptions and dealing with potential forgeries. All pharmacists (including locum pharmacists) should be briefed on these requirements
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 S8 and S4Ds medicines are excluded from the temporary PBS image based prescription measure
Legislative instrument/s Medicines, Poisons and Therapeutic Goods Act 2012
Relevant resources Pharmacy information notice – May 2020

QLD

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – QLD regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. when the Commonwealth Special Arrangement ends
Effective from 20 March 2020 26 March 2020 (retrospective)
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
 (Refer to requirements under Commonwealth Special Arrangement)

 

  • Digital Images of a prescription can only be sent to a pharmacy and must not be provided to patients
  • Before sending the digital copy of a diversion-risk medicine, the prescriber must take all reasonable steps to ensure the following details are written on the paper prescription the way in it is being sent; the place it is being sent and the date it is being sent. For example: ‘emailed to Pharmaceutical Pharmacy, Townsville on 1 January 2022’ on a paper prescription.
  • Original (paper) prescriptions for diversion-risk medicines must arrive at the pharmacy within 7 days (S4) or by end of next business day (S8) after the time the digital image prescription was sent.
  • Inform patients that only their nominated pharmacy can dispense repeats
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
 (Refer to requirements under Commonwealth Special Arrangement)

 

  • Record in the dispensing system when a supply has been made on a digital image prescription
  • Repeats are to be retained and supplied at the original dispensing pharmacy.
  • A pharmacist may not give a repeat supply on a faxed copy or digital image prescription where the initial dispensing occurred at another pharmacy
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Pharmacists may dispense and claim PBS items from a digital image of a prescription sent through by the prescriber (including S8s and restricted drugs, noting hardcopy requirements outlined above)
Legislative instrument/s
Relevant resources

SA

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – SA regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. 31 March 2022
Effective from 20 March 2020 27 March 2020
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
 (Refer to requirements under Commonwealth Special Arrangement) – see dot points at left

  • As outlined in the advice, a temporary exemption has been made to allow prescribers to give a prescription to a pharmacist using a digital image of the prescription instead of the original prescription
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
  • Ensure requirements under Poisons Regulations are met, including confirming person has an immediate need for the medicine and cannot obtain a prescription from a prescriber due to impact of pandemic
  • Repeats should be retained and supplied at original dispensing pharmacy
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 (Refer to requirements under Commonwealth Special Arrangement) – i.e. S8s and S4Ds cannot be supplied on a digital image of a prescription
Legislative instrument/s
Relevant resources

TAS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – TAS regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. 31 March 2022
Effective from 20 March 2020 15 April 2020
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
  • Must annotate prescription to state that it is a digital image of the prescription
  • Must record (in clinical system) that prescription was issued to a pharmacist as a digital image only
  • Must also record that digital image of the prescription has been sent directly to the pharmacy, noting the particulars of the pharmacy and method of transmission

 

More information in the fact sheet for prescribers
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
  • Recommended that pharmacists record in the dispensing system when they have made a supply based on the digital image of a prescription
  • Repeats must be retained and supplied at original dispensing pharmacy and may not be returned to the patient or transferred to another pharmacy
  • Same requirements apply for supply of S4 medicines on a digital image of a prescription sent from a prescriber in a hospital

 

Pharmacists can access additional information in the fact sheet
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Excludes (i.e. cannot be supplied on a digital image of a prescription) S8s and S4 declared restricted medicines as outlined in the Poisons (Declared Restricted Substances) Order 2017
Legislative instrument/s Poisons Regulations 2018
Relevant resources

VIC

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – VIC regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. 13 April 2022.
Exception: order extended for hospital pharmacy only until 13/10/22
Effective from 20 March 2020 7 April 2020
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original prescription.
  • Prescriber authorised under the Public Health Emergency Order include#:
    • registered medical practitioner
    • nurse practitioner
    • dentist
    • authorised midwife
    • authorised optometrist
    • authorised podiatrist

(#See Eligible medicines section below)

  • Must record that digital image of prescription was transmitted under the public health emergency order (PHEO #4)
  • Prescription must be signed by prescriber. Where operation of a telehealth service means this is not possible, prescribers may use a digital copy of their signature to sign the prescription.
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
 Must record that supply was made under the public health emergency order (PHEO #4)
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Excludes drugs of dependence (i.e. all S8 medicines, benzodiazepines anabolic steroids and phentermine

 

For clarity: tramadol, pregabalin, gabapentin, z-drugs, retinoids, reproductive medicines and S4 codeine preparations are not listed in Schedule 11 of the Act, and are therefore not ‘drugs of dependance’ excluded from PHEO#4.

 

#Pharmacists must confirm that a prescriber is authorised to prescribe the medicine as a pharmaceutical benefit
Legislative instrument/s
Relevant resources

WA

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – WA regulation
Effective to PBS special arrangement ended on 31 March 2022, except for prescriptions prescribed and dispensed within hospitals. Prescriptions written before 31 March 2022
Effective from 20 March 2020 N/A
Prescriber
  • Prescription must be written on or before 31 March 2022
  • Creates a paper prescription during telehealth consultation, signed as normal or using valid digital signature
  • Provides patient’s pharmacy with a digital image of the prescription via fax, email or text message
  • Must retain the (original) paper prescription (or a copy) for 2 years from date of prescription unless original.
 In WA, prior to 31 March 2022, prescribers were able to direct a pharmacist to supply a S4 or S8 medicine, in an emergency, including via a digital image (which is classified as ‘other electronic means’)

 

  • For S8s, prescriber must have been dispatched in 5 working days the (original) paper prescription by post or courier to the pharmacy which was sent the digital image
  • The (S8) prescription must have been marked by the prescriber to indicate confirmation of immediate request to supply on a digital image
Pharmacist
  • Can dispense and claim for the PBS item from the image
  • Must print out hardcopy of digital image prescription
  • Must retain the hardcopy for 2 years from date of supply
  • Repeats should be held in the pharmacy
  • Repeats must be retained at original dispensing pharmacy and may not be returned to the patient or transferred to another pharmacy
  • For S8s, pharmacist must keep copy of digital image or fax until original prescription is received – if it is not received within 10 working days of supply, the pharmacist must notify the Department of Health
Eligible medicines Excludes medicines in S8 and S4 + Appendix D in the Poisons Standard*

 

*Unless state and territory legislation allows supply via a digital image

 Pharmacists may dispense and claim PBS items from a digital image of a prescription written prior to 31 March 2022 sent through by the prescriber (including S8s, noting hardcopy requirements outlined above)
Legislative instrument/s
Relevant resources Fact sheet – digital image prescribing

Regulatory advice during COVID-19
Read full details on Digital image prescription here
Continued dispensing (updated 20 March 2023)

Continued dispensing is the supply of a standard quantity (usually 1 month’s supply) of an essential Prescription Only Medicines (S4) without a prescription in an emergency.

 

Prior to COVID-19, PBS Continued Dispensing was limited to oral contraceptives and statins. PBS Expanded Continued Dispensing and state/territory regulation have enabled supply of nearly all Prescription Only Medicines via this temporary measure during COVID-19; subject to professional and regulatory requirements.

 

These temporary PBS arrangements ended on 1 July 2022 and have been replaced by permanent measures. These permanent PBS Continued Dispensing measures, based of a list of medicine endorsed by PBAC in November 2021:

  • include a substantially larger formulary of medicines for stable chronic diseases than what was in place prior to 2019
  • do not include a large range of medicines able to be supplied under the temporary measures in place since early 2020.

 

Tasmania has announced it will allow non-PBS supply (private supply) of most Prescription Only Medicines under permanent regulation changes.

 

Temporary authorities during the acute phase of COVID-19 pandemic to supply full-pack quantities without a prescription where not covered by PBS Continued Dispensing has now lapsed in all jurisdictions.

 

ACT

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Legality to supply – ACT regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to Permanent (PBS Continued Dispensing)

Duration of public health emergency (where PBS Continued Dispensing does not apply)

 Permanent
Summary of conditions A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:

  • treatment is essential for well-being
  • the medicine has been previously prescribed and the person is in immediate need of it for continuing treatment
  • it is not practicable to obtain a prescription from an authorised prescriber (inc. phone/fax/electronic prescription)
 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months.
Eligible medicines and subsidy
  • Emergency supply via PBS Continued Dispensing enabled under the Regulation;
  • Emergency supply of S4 medicine without a prescription permitted under Standing Order where not captured by PBS Continued Dispensing for duration of public health emergency.

These measures only applies to Prescription Only Medicines (Schedule 4) which are not anabolic steroids, designated Appendix D medicines, benzodiazepines.

Controlled Drugs (Schedule 8) cannot be supplied without a prescription.

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022:

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Private supply – not exceed quantity in smallest generally available pack
  • Standard PBS maximum quantity
Record and communication Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information –

Last updated 20 December 2022 (ACT)

NSW

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Legality to supply – NSW regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to
  • Emergency supply of eligible PBS medicines via Continued Dispensing: Permanent
  • Emergency supply of medicines not eligible for PBS Continued Dispensing:  1 February 2023
 Permanent
Summary of conditions A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:

  • treatment is essential for well-being
  • the medicine has been previously prescribed and the person is in immediate need of it for continuing treatment
  • it is not practicable to obtain a prescription from an authorised prescriber

Emergency supply under this authority is permitted if patient has not received any such emergency supply of the medicine from any NSW pharmacy in previous 12 months

Pharmacist must promptly report supply to regular or most recent prescriber

 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months.
Eligible medicines and subsidy
  • Emergency supply of eligible PBS medicines via Continued Dispensing enabled through temporary authority and Regulation 45A.
  • Emergency supply of medicines not eligible for PBS Continued Dispensing is also permitted via temporary authority. Private pricing applies.

Temporary authority only applies to Prescription Only Medicines (Schedule 4) which are not Schedule 4D medicines. Controlled Drugs (Schedule 8) cannot be supplied without a prescription.

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022:

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Private supply – not exceed quantity in smallest available pack
  • Standard PBS maximum quantity
Record and communication Must record consistent with the requirements of temporary authority, including:

  • Note in the patient record that an attempt was made to contact the patient’s usual prescriber
  • Recorded consistent with requirements of a prescribed medicine

The pharmacist must report the supply to the patient’s usual or last known prescriber.

 Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information

Last updated 7 December 2022 (NSW)

NT

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Legality to supply – NT regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Legality to supply – NT regulation
Effective to As per Commonwealth instrument Permanent
Summary of conditions Commonwealth instrument automatically adopted – Continued Dispensing fully enabled under the Act (see also information sheet) The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months
Eligible medicines & subsidy
  • Limited to PBS-listed unrestricted S4 medicines
  • Excludes: Restricted S4 medicines, S8 medicines, privately funded S4s and S8s

Privately funded and non-PBS prescriptions are not permitted under this measure

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • Standard PBS maximum quantity
Record and communication Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information

Last updated 1 July 2022 (NT)

QLD

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Legality to supply – Queensland regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply n

 Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to Permanent (PBS Continued Dispensing)

Duration of public health emergency (where PBS Continued Dispensing does not apply)

 Permanent
Summary of conditions A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist reasonably believes:

  • the medicine has been previously prescribed and the person is in immediate need of it for essential continuing treatment and wellbeing
  • it is not practicable to obtain a prescription from an authorised prescriber to meet the need for the medicine
  • there is an immediate requirement to supply
 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months.
Eligible medicines & subsidy

These measures only applies to Prescription Only Medicines (Schedule 4).  Controlled Drugs (Schedule 8) cannot be supplied without a prescription.

Diversion-risk medicines may only be supplied under this measure where a decision not to supply the medicine could be life-threatening for the person.

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Private supply – not exceed quantity in smallest available pack
  • Standard PBS maximum quantity
Record and communication Supply must be recorded, including:

  • the supply event
  • any attempt(s) to contact the prescriber

The pharmacist must notify the authorised prescriber as soon as practicable, but no later than 7 days later

 Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’.
More information Updates and alerts – Queensland Health

Last updated 20 December 2022 (Queensland)

SA

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Legality to supply – South Australian regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to

PBS Continued Dispensing: Ongoing

 Permanent
Summary of conditions A Schedule 4 medicine may be supplied to a patient without a prescription if the pharmacist is satisfied:

  • person is being treated with the medicine
  • continued supply is essential to that person’s health
  • there is good reason for the person’s inability to produce a prescription.
 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months
Eligible medicines & subsidy
  • Emergency supply via PBS Continued Dispensing enabled through Regulation 21(2g) of the Controlled Substances (Poisons) Regulations 2011
  • Medicines not captured by PBS Continued Dispensing cannot be supplied, other than under the ‘3 day rule’ following the revocation of the public health emergency declaration.

Excludes:

  • Controlled Drugs (including opioids, some benzodiazepines and stimulants),
  • medicines restricted to specialist prescribing including those in Reg 19 of Poisons Regulations and Appendix D of Poisons Standard (these include certain fertility and cancer drugs and hydroxychloroquine)
 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Standard PBS maximum quantity
Record and communication
  • Must record the information required under the regulations for emergency supply of S4s
 Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information Regulation 21(2f) of the Controlled Substances (Poisons) Regulations 2011

Last updated 7 July 2022 (SA)

TAS

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Legality to supply – Tasmanian regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines. Only eligible restricted substances (see left column) can be supplied.
Effective to Ongoing Permanent
Summary of conditions An eligible restricted substance (see below) may be supplied to a patient without a prescription if:

 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months
Eligible medicines & subsidy Eligible restricted substances able to be supplied only include the following substances:

  • oral hormonal contraceptives; and
  • HMG-CoA Reductase Inhibitors

Name of substance must be listed in National Health (Continued Dispensing) Determination

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Standard PBS maximum quantity
Record and communication Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information Regulation 48: Poisons Regulations 2018

Note: Prior to 1 July 2022, PBS Continued Dispensing was enabled by an emergency order. This order issued by the Secretary in accordance with section 14 of the Public Health Act 1997 ceased to be in effect at when the Public Health Emergency Declaration expired at 12.01am on 1 July 2022.

Last updated 1 July 2022 (Tasmania)

VIC

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Legality to supply – Victorian regulation
These requirements must be met to supply as PBS Continued Dispensing or private supply 		Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to 22 December 2022 Permanent
Summary of conditions A Schedule 4 medicine may be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:

  • continuity of treatment is necessary
  • there is an immediate need for the medicine
  • it is impracticable for the patient to obtain a prescription for the medicine in time to meet therapeutic need
  • treatment has previously been prescribed for the patient
  • the patient or carer is aware of appropriate dose
 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months
Eligible medicines & subsidy

PHEO#2 only applies to Prescription Only Medicines (Schedule 4). Controlled Drugs (Schedule 8) cannot be supplied without a prescription.

 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Private supply – not exceed quantity in smallest commercially available pack
  • Standard PBS maximum quantity
Record and communication
  • Must record supply was made under the public health emergency order (PHEO #2)
  • Must record consistent with the requirements of other prescription medicines
 Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information
  • PHEO#22 has additionally been gazetted in response to the Victorian flood emergency

Last updated 19 October 2022 (Victoria)

WA

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  Legality to supply – WA regulation

These requirements must be met to supply as PBS Continued Dispensing or private supply

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to state requirements, to supply as PBS Continued Dispensing medicines
Effective to Permanent Permanent
Summary of conditions An Schedule 3 or Schedule 4 medicine listed in the Continued Dispensing determination may be supplied to a patient without a prescription if:

  • there is an immediate need for the medicine;
  • circumstances have prevented the patient from obtaining a valid prescription from their prescriber
  • the eligible medicine has been prescribed and supplied to the patient within the last 6 months
  • the patient’s condition is stable
  • the eligible medicine has not been supplied to the patient by any pharmacy under the authority of the SASA within the past 12 months.

 

 The National Health (Continued Dispensing) Determination 2022 allows eligible PBS medicine to be supplied to a patient without a prescription if:

  • usual prescriber is unable to be contacted and/or is unable to provide an electronic prescription*
  • medicine has been previously prescribed and therapy is continuous, stable and has been reviewed by the prescriber after initial prescribing*
  • medicine has been supplied to the patient as a PBS medicine in the previous 3 months*
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in previous 12 months
Eligible medicines & subsidy
  • Emergency supply via PBS Continued Dispensing enabled through SASA: Continued Dispensing
  • Standard quantities of medicines not supplied as PBS Continued Dispensing is not permitted. Emergency supply of S4 medicine without a prescription where not captured by PBS Continued Dispensing is limited to the 3-day rule (see ‘emergency supply – 3 day rule’ below).
 Medicines listed in Schedule 1 of the National Health (Continued Dispensing) Determination 2022.

  • includes Authority Required / Streamlined medicines
  • does not include authorities for increased quantities
  • excludes: Prescriber bag medicines and Controlled Drugs (Schedule 8)

Eligible medicines are subsidised by the PBS; usual co-payment applies. CTG applies for eligible patients.
Quantity
  • PBS medicine – not exceed standard PBS maximum quantity
  • Standard PBS maximum quantity
Record and communication
  • Supply must be recorded consistent with requirements of Medicines and Poisons Act 2014 and the Medicines and Poisons Regulations 2016
  • The pharmacist must notify the most recent prescriber of the eligible medicine for the patient that the supply has occurred
 Must record supply as outlined in National Health (Continued Dispensing) Determination 2022 and PSA Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists, including:

  • the information used to support the decision to supply
  • a statement the supply is an eligible PBS medicine
  • a statement that the conditions asterisked (*) above have been met

Must provide written communication to patient’s usual prescriber advising of Continued Dispensing supply in a ‘timely manner’
More information Note: Between March 2020 and June 2022, through a special authority linked to a declaration of public health emergency enabled PBS and non-PBS supply of most Schedule 4 medicines under this measure. This authority has now been revoked. The SASA has also been updated to align with the National Health (Continued Dispensing) Determination 2022. Non-PBS medicines are not subsidised under the PBS

Last updated 8 July 2022

Read full details on Expanded Continued Dispensing here
Medicine shortages: Therapeutic substitution (updated 20 March 2023)

 

Therapeutic substitution is the supply of alternative strengths, quantities or dose forms of a medicine by a pharmacist without prior approval from the prescriber. This is to ensure continuity of therapy during a verified national shortage of the prescribed medicine.

 

Supply of a substitutable (alternative) medicine by a community pharmacist must be in accordance with a specific Serious Scarcity Substitution Instrument (SSSI).

 

Current SSSIs

SSSI: WARFARIN - COUMADIN (EXP. 7 AUGUST 2023)

PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the warfarin SSSI – refer to PBS website

 

Scarce medicine Substitutable (alternative) medicine Dose unit equivalence
COUMADIN warfarin 5mg tablet COUMADIN warfarin 1mg tablet One tablet of scarce medicine is equivalent to FIVE tablets of substitutable (1mg) medicine
COUMADIN warfarin 5mg tablet COUMADIN warfarin 2mg tablet One tablet of scarce medicine is equivalent to TWO AND A HALF tablets of substitutable (2mg) medicine

 

Note: Pharmacists are only permitted to substitute with EITHER five Coumadin 1mg tablets OR two and a half Coumadin 2mg tablets – NOT a combination of 1mg and 2mg tablets.

 

Additional considerations for pharmacists:

Pharmacists are required to:

  • advise the patient of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table
  • for 2mg tablets only, as cutting of the tablet is required to obtain the correct dose of substitutable medicine—provide instructions to the patient on how to cut the tablet; and,
  • ensure the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.

 

Further information:

SSSI: cefalexin (Exp. 31 July 2023)

PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the amoxicillin SSSI – refer to PBS website.

 

 

 

Scarce medicine Substitutable (alternative) medicine Note
cefalexin 125 mg/5 mL (100 mL)
  • cefalexin 250 mg/5 mL (100 mL)
  • cefalexin 250 mg capsules

250 mg of cefalexin is equivalent to:

  • 5 mL of cefalexin 250 mg/5 mL suspension
  • 1 x 250 mg cefalexin capsule
cefalexin 250 mg/5 mL (100 mL)
  • cefalexin 125 mg/5 mL (100 mL)
  • cefalexin 250 mg capsules

250 mg of cefalexin is equivalent to:

  • 1 x 250 mg cefalexin capsule
  • 10 mL of cefalexin 125 mg/5 mL suspension
cefalexin 500 mg capsules
  • cefalexin 250 mg capsules

One 500 mg cefalexin capsule is equivalent to:

  • 2 x 250 mg capsules of cefalexin

Other substitutions without a new prescription are not permitted. For example, substitutions of 500mg capsules for oral suspensions – and vice versa – are not permitted.

 

Additional considerations for pharmacists:

Pharmacists are required to:

  • advise the patient of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table
  • ensure the correct dose of substitutable medicine is written in millilitres on the dispensing label (liquid formulations only)
  • if multiple bottles of substitutable medicine are dispensed—ensure the patient’s treatment course will be completed prior to the expiry of each bottle;
  • where cutting of the tablet is required to obtain the correct dose of substitutable medicine—provide instructions to the patient for cutting the tablet (tablets only); and,
  • ensure the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.

 

Further information:

  • Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (cefalexin) Instrument 2022 (Federal legislative instrument)

SSSI: AMOXICILLIN (Exp. 31 May 2023)

PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the amoxicillin SSSI – refer to PBS website.

 

 

 

Scarce medicine Substitutable (alternative) medicine Note
amoxicillin 100 mg/mL (20 mL)
  • amoxicillin 500 mg/5 mL (100 mL)
  • amoxicillin 125 mg/5 mL (100 mL)
  • amoxicillin 250 mg/5 mL (100 mL)

50 mg of amoxicillin is equivalent to:

(a) 0.5 mL of amoxicillin 500 mg/5 mL suspension;

(b) 2 mL of amoxicillin 125 mg/5 mL syrup or suspension;

(c)  1 mL of amoxicillin 250 mg/5 mL syrup or suspension
amoxicillin 500 mg /5 mL (100 mL)
  • amoxicillin 100 mg/1 mL (20 mL)
  • amoxicillin 125 mg/5 mL (100 mL)
  • amoxicillin 250 mg/5 mL (100 mL)

50 mg of amoxicillin is equivalent to:

(a) 0.5 mL of amoxicillin 100 mg/mL suspension;

(b) 2 mL of amoxicillin 125 mg/5 mL syrup or suspension;

(c)  1 mL of amoxicillin 250 mg/5 mL syrup or suspension
amoxicillin 125 mg /mL (100 mL)
  • amoxicillin 500 mg/5 mL (100 mL)
  • amoxicillin 100 mg/1 mL (20 mL)
  • amoxicillin 250 mg/5 mL (100 mL)

50 mg of amoxicillin is equivalent to:

(a) 0.5 mL of amoxicillin 100 mg/mL suspension;

(b) 0.5 mL of amoxicillin 500 mg/5 mL suspension;

(c)  1 mL of amoxicillin 250 mg/5 mL syrup or suspension
amoxicillin 250 mg /5 mL (100 mL)
  • amoxicillin 500 mg/5 mL (100 mL)
  • amoxicillin 125 mg/5 mL (100 mL)
  • amoxicillin 100 mg/1 mL (20 mL)

50 mg of amoxicillin is equivalent to:

(a) 0.5 mL of amoxicillin 100 mg/mL suspension;

(b) 0.5 mL of amoxicillin 500 mg/5 mL suspension;

(c)  2 mL of amoxicillin 125 mg/5 mL syrup or suspension
amoxicillin 500 mg capsules
  • amoxicillin 250 mg capsules
  • amoxicillin 1000 mg tablets

one 500 mg amoxicillin capsule is equivalent to:

(a) two 250 mg amoxicillin capsules;

(b) half of a 1 gram amoxicillin tablet
amoxicillin 1000 mg tablets
  • amoxicillin 500 mg capsules
  • amoxicillin 250 mg capsule

one 1 gram amoxicillin tablet is equivalent to:

(a) four 250 mg amoxicillin capsules;

(b) two 500 mg amoxicillin capsules

Other substitutions without a new prescription are not permitted. Substitutions of solid dose forms (tablets/capsules) with liquid dose forms (suspensions) – and vice versa – are not permitted.

 

Additional considerations for pharmacists:

Pharmacists are required to:

  • advise the patient of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table
  • ensure the correct dose of substitutable medicine is written in millilitres on the dispensing label (liquid formulations only)
  • if multiple bottles of substitutable medicine are dispensed—ensure the patient’s treatment course will be completed prior to the expiry of each bottle;
  • where cutting of the tablet is required to obtain the correct dose of substitutable medicine—provide instructions to the patient for cutting the tablet (tablets only); and,
  • ensure the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.

 

Further information:

SSSI: isosorbide mononitrate (Exp. 30 June 2023)

PBS subsidy: arrangements are in place for the substitutable (alternative) medicines under the isosorbide mononitrate SSSI – refer to PBS website. If the required quantity of the substitutable medicine (60 mg) is more than the PBS maximum quantity, use the authority prescription number ‘00000246’ and disregard PBS Online warning (reason code 151).

 

Scarce medicine Substitutable (alternative) medicine Note
Isosorbide mononitrate 120 mg tablet (sustained release)

8273K

Imdur 120 mg

Monodur 120 mg

 Isosorbide mononitrate 60 mg tablet (sustained release)

1558B

APO-Isosorbide Mononitrate

Duride

GenRx Isosorbide Mononitrate

ISOBIDE MR

Isomonit

Isosorbide AN

Imdur Durule

Monodur 60 mg

 One tablet of the scarce medicine is equivalent to two tablets of the substitutable (alternative) medicine

 

Additional considerations for pharmacists:

  • The dose and total quantity of 60 mg tablets dispensed must be equivalent to the dosage regimen and duration originally prescribed for the 120 mg tablets.

 

Further information:

General requirements and information for pharmacists – dispensing according to a SSSI

  • Confirm there is evidence of a valid prescription for the scarce medicine for the patient.
  • Substitution can only be made under the SSSI if the pharmacist does not have access to the scarce medicine.
  • Confirm the prescriber has not indicated on the prescription for the scarce (original) medicine that substitution is not permitted.
  • Apply professional and clinical judgement to determine whether the patient is suitable to receive the substitutable (alternative) medicine.
  • If deemed suitable, ensure the patient is fully informed and has consented to receiving the substitutable medicine.
  • The total amount of substitutable medicine dispensed must provide for an equivalent treatment regimen (dosage and duration) as the scarce medicine.
  • A record of dispensing the substitutable medicine in substitution of the scarce medicine must be made at the time of dispensing.
  • The pharmacist must have, and follow, an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine.

 

Further general information:

Phone/fax order by prescriber

A phone/fax order is the communication of a prescription from a prescriber to a pharmacist via phone, fax or email (where permitted). The prescriber is then responsible for immediately dispatching the original hard-copy prescription to the supplying pharmacist.

 

Phone/fax orders, often referred to as ‘owing prescriptions’, must generally be reconciled (‘owing mark off’) before repeats can be issued or the item claimed through the PBS.

 

These permanent provisions existed within state/territory regulation, and within PBS regulation, prior to COVID-19. Compliance with the requirements of these provisions continues to be relevant during COVID-19 for prescriptions not prescribed as, or eligible for transmission as, digital image prescriptions (e.g. Controlled Drugs, original prescription intended to be sent to pharmacy etc.).

 

Phone/fax order requirements are not relevant when electronic prescriptions are issued as the legal copy of these prescriptions is accessed via prescription exchange services and downloaded directly into a pharmacy’s dispensing software.

 

May be subsidised under the PBS

ACT

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Legality to supply – ACT regulation
Prescriber requirements on issuing a phone/fax order
  • A prescription may be given by phone or fax
Requirement for prescriber to send paper prescription to the pharmacist June 2020 amendment to faxed prescription requirements

 

  • Faxed prescription – prescriber must send the original prescription to the pharmacist within 7 days (previously 24 hours)
  • Verbal prescription: a written prescription must be sent to the pharmacist within 24 hours
  • Faxed and verbal prescriptions – pharmacists must receive the original prescription within 14 days (previously 7 days) before notifying the Chief Health Officer about non-receipt of the original prescription
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
Legislative instrument S31 and S120 Medicines Poisons and Therapeutic Goods Regulation 2008
Relevant resources Telehealth prescribing fact sheet (ACT Health)

NSW

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Legality to supply – NSW regulation
Prescriber requirements on issuing a phone/fax order
  • A prescription may be given verbally, by phone, email or fax
Requirement for prescriber to send paper prescription to the pharmacist
  • Paper prescription must be sent to the pharmacist within 24 hours
  • Prescription must annotated it has been issued in confirmation of a direction under Clause 36 (Prescription Only Medicine) or Clause 81 (Controlled Drug)
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
  • If prescription not received in 7 days, pharmacist must report to Pharmaceutical Services
Legislative instrument Clauses 36, 44, 81 & 96 Poisons and Therapeutic Goods Regulation 2008 (NSW)
Relevant resources NSW Health Guide to poisons and therapeutic goods legislation for pharmacists

NT

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Legality to supply – NT regulation
Prescriber requirements on issuing a phone/fax order Verbal prescription:

  • A prescriber may verbally request supply of a medicine

 

Prescriptions, including faxed prescriptions, may be issued electronically in accordance with the Electronic Transactions Act (NT) 2020.
Requirement for prescriber to send paper prescription to the pharmacist
  • Prescription must be given to the pharmacist within 7 days
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
  • Pharmacist must not supply more than 7 days’ dose of prescription from a verbal request
  • If prescription not received in 7 days, pharmacist must report to CHO
Legislative instrument Section 19, 61, 97 Medicines Poisons and Therapeutic Goods Act 2012
Relevant resources Supplying without a prescription- Pharmacist fact sheet (NTG Department of Health)

QLD

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Legality to supply – QLD regulation
Prescriber requirements on issuing a phone/fax order Verbal prescriptions:

  • If a verbal prescription is dispensed or supplied, the prescriber must give the pharmacist a written prescription that confirms the oral prescription within 7 days (Schedule 4 medicines).
  • For Controlled Drugs (Schedule 8) the written prescription must be given as soon as practicable, but no later than the end of the next business day, after the oral prescription was given.

 

Faxed prescription:

  1. Prescriber may send a faxed or electronic copy of a prescription
  2. Before sending the digital copy of a diversion-risk medicine, the prescriber must take all reasonable steps to ensure the following details are written on the paper prescription the way in it is being sent; the place it is being sent and the date it is being sent. For example: ‘emailed to Pharmaceutical Pharmacy, Townsville on 1 January 2022’ on a paper prescription.
Requirement for prescriber to send paper prescription to the pharmacist
  • Paper prescription must be given within 7 days (Schedule 4), or as soon as practicable and no later than the end of the next business day (Schedule 8)
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
  • Pharmacist must provide a written report to the chief executive (Queensland Health) if the paper or electronic prescription does not arrive within 48 hours after required compliance period (i.e. 48 hours after 7 days for Schedule 4 medicines (9 days) or 48 hours after 5pm the next business day for Schedule 8 medicines).
Legislative instrument 84, 92, 227 Medicines and Poisons (Medicines) Regulation 2021
Relevant resources

SA

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Legality to supply – SA regulation
Prescriber requirements on issuing a phone/fax order Prescription via telephone or fax:

  • Prescription may be provided if prescriber satisfied there is good reason
  • Prescription must be immediately written, stating it is confirmation of the instruction

Emailed prescriptions are not provided for in SA under the Controlled Substances (Poisons) Regulations 2011 
Requirement for prescriber to send paper prescription to the pharmacist
  • Must be forwarded to pharmacist as soon as practicable, and for Controlled Drug (S8) no later than 24 hours
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
Legislative instrument Regulation 33 Controlled Substances (Poisons) Regulations 2011 (SA)
Relevant resources

TAS

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Legality to supply – TAS regulation
Prescriber requirements on issuing a phone/fax order Verbal prescription:

  • Must be impracticable to issue and deliver the prescription due to urgent circumstances
Requirement for prescriber to send paper prescription to the pharmacist
  • Prescriber must within 5 days send a prescription – which clearly states it confirms the instruction to supply
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
Legislative instrument Regulations 23 and 47 Poisons Regulations 2018 (Tas)
Relevant resources

VIC

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Legality to supply – VIC regulation
Prescriber requirements on issuing a phone/fax order A prescriber may issue a verbal instruction to supply a medicine an emergency.

 

Faxed prescriptions: Not valid for supply without a verbal instruction (Exception: medicines supplied under PHEO#4: see digital image prescription)
Requirement for prescriber to send paper prescription to the pharmacist
  • A written instruction, which indicates it confirms the verbal instruction previously given, is sent to the pharmacist as soon as practical
  • The instruction may be a chart, prescription or other written instruction
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
Legislative instrument 25, 47(1), 48 Drugs, Poisons and Controlled Substances Regulations 2017
Relevant resources

WA

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Legality to supply – WA regulation
Prescriber requirements on issuing a phone/fax order
  • Prescription may be provided in an emergency only
  • Prescription may be provided verbally, via telephone or other electronic means
Requirement for prescriber to send paper prescription to the pharmacist
  • Prescription must be prepared and sent to pharmacist within 24 hours
  • Prescription must be marked as confirming the emergency direction
Permitted medicines
  • All prescriptions; including Prescription Only Medicines (S4) and Controlled Drugs (S8)
Pharmacist obligations
  • Controlled Drug (S8): If prescription not received in 5 working days, pharmacist must report to the CEO
Legislative instrument Regulation 17 Medicines and Poisons Regulations 2016 (WA)
Relevant resources
Emergency supply – ‘3 day rule’

Emergency supply of medicines allows a pharmacist to initiate a small quantity supply (usually 3 days’) of a Prescription Only Medicine (S4) in an emergency without a prescription when it’s not possible to contact the patient’s prescriber. Under this arrangement there is no requirement for a follow up prescription.

 

Medicines supplied under what is commonly known in most jurisdictions as the ‘3-day rule’ are ineligible to be supplied under the PBS and can’t be changed into a full quantity dispensing at a later date on presentation of a prescription.

 

These permanent provisions existed within state/territory regulation prior to COVID-19. They may remain relevant during COVID-19 if Schedule 4 medicines are unable to be supplied under Expanded Continued Dispensing and other temporary expanded emergency supply provisions.

 

Not subsidised under the PBS

ACT

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Legality to supply – ACT regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied:

  1. treatment is ongoing and essential to person’s health or wellbeing
  2. medicine has been previously prescribed for that person’s treatment
  3. person is in immediate need to the medicine to continue the treatment
  4. because of an emergency, it is not practicable for the person to obtain a prescription from a prescriber
Maximum quantity able to be supplied
  • 3 days treatment or, if not possible due to dose form, smallest manufacturer’s pack
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
Medicine excluded
  • Excludes Controlled Drugs (S8)
Other requirements of supply Pharmacist must send notification to ordinary prescriber in writing within 24 hours
Legislative instrument(s) S251 – S254 Medicines Poisons and Therapeutic Goods Regulation 2008
Relevant resources

NSW

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Legality to supply – NSW regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied:

  1. treatment is ongoing and essential to person’s health or wellbeing
  2. medicine has been previously prescribed for that person’s treatment
  3. person is in immediate need to the medicine to continue the treatment
  4. in the circumstances, it is not practicable for the person to obtain a prescription from a prescriber
Maximum quantity able to be supplied
  • 7 days treatment or, if not possible due to dose form, smallest standard pack
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
  • Labelled with the words “EMERGENCY SUPPLY”
Medicine excluded
  • Excludes S4D and Controlled Drugs (S8)
Other requirements of supply
Legislative instrument(s) Clauses 7, 45, Appendix A Poisons and Therapeutic Goods Regulation 2008 (NSW)
Relevant resources

Last updated 7 December 2022 (NSW)

NT

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Legality to supply – NT regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied:

  1. supply justified because of urgent circumstances
  2. medicine has previously been supplied on prescription
  3. if supplying to a third-party (agent), the agent gives the name and number of the authorised prescriber, and produces proof of their identity
Maximum quantity able to be supplied
  • 7 days’ supply at the daily dose or, the smallest primary pack packaged and labelled by the manufacturer
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
Medicine excluded
  • Excludes S4D (restricted Schedule 4 substances) and Controlled Drugs (S8)
Other requirements of supply
Legislative instrument(s)
Relevant resources

QLD

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Legality to supply – QLD regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist reasonably satisfied:

  • the medicine has been previously prescribed to the patient; and
  • (a) for diversion-risk medicines: failure to sell the medicine could be life-threatening for the patient; or
    (b) for other medicines: continuing the patient’s treatment with the medicine is urgent and essential for the patient’s well-being
  • it is not practicable for the patient to obtain a prescription for the medicine before needing to continue treatment with the medicine.
Maximum quantity able to be supplied
  • 3 days treatment or,
  • for a prepack liquid, cream, ointment or aerosol – the minimum standard pack
Labelling and recording requirements Labeling requirements:

  • name of the person for whom it was dispensed

  • the approved name of the substance and/or its proprietary name (including strength and form of the substance) and quantity of medicine supplied

  • adequate directions for use;

  • if the substance is intended for external use only, the word “POISON”, or the words “FOR EXTERNAL USE ONLY”, in red on a white background;

  • all other standard requirements of dispensing labels (e.g. pharmacy details, KEEP OUT OF REACH OF CHILDREN etc.)

 

Recording:

  • As required for labeling (above), plus: for diversion-risk medicines, a reason why the pharmacist is supplying the medicine.
Medicine excluded
  • Excludes Controlled Drugs (S8)
Other requirements of supply
Legislative instrument(s)
Relevant resources

SA

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Legality to supply – SA regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied:

  1. there is good reason for person’s inability to produce a prescription
  2. the person is being medically treated with the medicine
  3. continuing treatment is essential to their health
Maximum quantity able to be supplied
  • 3 days treatment or, if not possible due to dose form – the minimum standard pack
Labelling and recording requirements
  • Recorded as a dispensed medicine, including directions given for the safe and proper use of the medicine
Medicine excluded
  • Excludes Controlled Drugs (S8) and Schedule 4 medicines in Reg 19(1) of the regulations (e.g. clomiphene, isotretinoin, thalidomide etc.)
Other requirements of supply
Legislative instrument(s)
Relevant resources

TAS

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Legality to supply – TAS regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied, on reasonable grounds:

  1. patient is undergoing medical treatment which requires that medicine
  2. continuation of the treatment is essential to their wellbeing
  3. it is not practicable for the patient to obtain a prescription for the medicine before medicine needed
Maximum quantity able to be supplied
  • 3 days treatment or, if not possible due to dose form, smallest standard pack
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
  • Labelled with the words “EMERGENCY SUPPLY”
  • Records at pharmacy must include supply made under Regulation 53 and reason for emergency supply
Medicine excluded
  • Excludes specified psychotropic substances, S4D medicines and Controlled Drugs (S8)
Other requirements of supply
Legislative instrument(s)
Relevant resources

VIC

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Legality to supply – VIC regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied:

  1. supply necessary to ensure continuity of treatment
  2. immediate need for medicine exists and it is impracticable to obtain a prescription
  3. medicine has previously been prescribed for the person
  4. patient or their agent is aware of the appropriate dose of the medicine
  5. supply does not continue an emergency supply by the pharmacist supplying the medicine
Maximum quantity able to be supplied
  • 3 days treatment or, if not possible due to dose form, smallest commercially available pack
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
Medicine excluded
  • Excludes Controlled Drugs (S8).
Other requirements of supply
Legislative instrument(s)
Relevant resources

WA

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Legality to supply – WA regulation
Conditions which must be met to supply Prescription Only Medicine in an emergency without a prescription. Pharmacist satisfied on reasonable grounds:

  1. person is under regular treatment with the medicine
  2. it is not practical to obtain a prescription to allows for uninterrupted treatment
  3. interruption to treatment likely to cause harm
Maximum quantity able to be supplied
  • 3 days’ treatment
  • If a non-divisible pack (e.g. eye drops); one standard pack can be supplied*
Labelling and recording requirements
  • Labelled and recorded as a dispensed medicine
Medicine excluded
  • Excludes Controlled Drugs (S8)
Other requirements of supply Regulation 29 Medicines and Poisons Regulations 2016 (WA)*

* information regarding non-divisible packs drawn from WA Health fact sheet
Legislative instrument(s)
Relevant resources

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