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PSA Regulation Hub

This information was last updated Thursday 4 April 2024

 

PSA has prepared this information to support pharmacists using the best and most up-to-date information available.

 

PSA members can contact the Pharmacist-to-Pharmacist Advice Line for practice guidance and support, including navigating regulatory queries and concerns on:
1300 369 772 (business hours AEST)

 

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

Medicine shortages: Therapeutic substitution (updated 06 March 2024)

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: INSULIN DEGLUDEC / INSULIN ASPART (EXP. 5 JUNE 2024)

PBS subsidy: arrangements are in place for the substitutable (alternative) medicine under the insulin degludec and insulin aspart SSSI – refer to PBS website

 

Scarce medicine Substitutable (alternative) medicine Dose unit equivalence
Insulin degludec + insulin aspart
Injections, pre-filled pen
70 units-30 units per mL, 3mL
(Ryzodeg 70/30 Flextouch)		 Insulin degludec + insulin aspart
Injections, cartridges
70 units-30 units per mL, 3mL
(Ryzodeg 70/30 Penfill)		 One 3mL pre-filled pen (70 units-30 units per mL)
is equivalent to
one 3mL cartridge (70 units-30 units per mL)

Additional considerations for pharmacists:

  • When determining whether the substitution is appropriate for the patient consider, for example, their level of dexterity to load a cartridge into the delivery device (or that they will have access to a carer to assist). If the substitution is not appropriate, refer the patient back to the prescriber.
  • You must ensure patient/carer has, or is provided with, a suitable insulin delivery device for use with the Penfill cartridges. Any NovoPen device (NovoPen 4, NovoPen Echo or NovoPen 6) is suitable. Patients can access these devices for free through the NovoPen 6 Pharmacy Program.
  • Advise patient/carer on how to administer the substitutable medicine (cartridges), including how to use the insulin delivery system.
  • Advise the patient/carer of the number of dose units of the substitutable medicine that must be administered in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified in the above table.
  • Advise the patient/carer of the differences between the scarce medicine and the substitutable medicine.

 

Further information:

SSSI: CEFALEXIN (EXP. 30 APRIL 2024)

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

 

Scarce medicine

Substitutable (alternative) medicine

Note

Cefalexin 125 mg/5 mL

powder for oral liquid, 100 mL

  • Cefalexin Sandoz
  • Ibilex 125
  • Keflex

Cefalexin 250 mg/5 mL

powder for oral liquid, 100 mL

  • Cefalexin Sandoz
  • Ibilex 250
  • Keflex
  • Keforal

Cefalexin 250 mg capsule, 20

  • APO-Cephalexin
  • Ibilex 250
  • Keflex

250 mg of cefalexin is equivalent to:

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

Cefalexin 250 mg/5 mL

powder for oral liquid, 100 mL

  • Cefalexin Sandoz
  • Ibilex 250
  • Keflex
  • Keforal (s19A)

Cefalexin 125 mg/5 mL

powder for oral liquid, 100 mL

  • Cefalexin Sandoz
  • Ibilex 125
  • Keflex

Cefalexin 250 mg capsule, 20

  • APO-Cephalexin
  • Ibilex 250
  • Keflex

 

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;
  • only dispense capsules as the substitutable medicine where the prescribed dose of scarce medicine is divisible by 250 mg;
  • where capsules are to be dispensed as the substitutable medicine, ensure the patient is able to take a capsule dosage form; 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: FLUOXETINE (EXP. 31 MAY 2024)

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

 

Scarce medicine Substitutable (alternative) medicine Dose unit equivalence

Fluoxetine hydrochloride

20mg dispersible tablet

(Zactin)

Fluoxetine hydrochloride (as the only active ingredient) in capsule form (any brand) containing:

·     20mg

·     10mg

One tablet of scarce medicine (20mg dispersible tablet) is equivalent to:

·     one 20mg capsule of substitutable medicine

·     two 10mg capsules of substitutable medicine

Additional considerations for pharmacists:

 

The pharmacist must:

  • advise the patient, or person acting on behalf of 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
  • ensure that the patient is able to take the dosage form of the substitutable medicine
  • only substitute 10mg capsules of substitutable medicine for the scarce medicine where the prescribed dose of scarce medicine is less than 20mg fluoxetine hydrocholoride or is not a multiple of 20mg capsules.

 

Note:

  • Prescribers are being advised to switch patients to fluoxetine 20mg capsules, where possible.
  • Patients with a prescription for Zactin Tabs will require a new prescription for the equivalent dose of fluoxetine capsules.
  • If the patient’s prescribed dose is less than 20mg or cannot be made up with multiples of 20mg, a new prescription for 10mg capsules (available through s19A but not subsidised on the PBS at present) will be required.
  • Fluoxetine capsules may be opened and the contents dispersed, if required.

 

Further information:

SSSI: GLICLAZIDE (EXP. 31 JULY 2024)

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

Scarce medicine

Substitutable (alternative) medicine

Dose equivalence

gliclazide 30mg tablets

gliclazide 60mg tablets

Half a tablet of the substitutable medicine is equivalent to one tablet of the scarce medicine

Additional considerations for pharmacists:

  • Ensure patient is aware of the requirement to cut the tablet in half to obtain the correct dose. Consider if your patient has the dexterity required to comfortably break the tablets. If substitution is not right for the patient, refer them back to their prescriber for review of their treatment.
  • To maintain the modified-release properties of the substitute product, tablets can be halved but not crushed or chewed.

Further information:

 SSSI for gliclazide MR 30 mg tablets

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:

Continued dispensing (updated 4 April 2024)

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.

ACT

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Legality to supply – ACT regulation

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) 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

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

  • 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 and label medicine similar to any 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 –

Last updated 4 April 2024 (ACT)

NSW

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Legality to supply – NSW regulation

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

A Schedule 4 medicine may be supplied to a patient without a prescription if the pharmacist:

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 Regulation 45A.
  • NSW regulation recognises medicines listed in the National Health (Continued Dispensing) Determination 2022
  • Regulation 45A 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 Standard PBS maximum quantity
Record and communication

Must record consistent with the requirements of Regulation 57, which includes:

  • standard recording requirements for medicines dispensed on prescription, and
  • the name and address of the authorised practitioner by whom it appears to the pharmacist that the substance was last prescribed

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 4 April 2024 (NSW)

NT

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Legality to supply – NT regulation

Eligibility to supply under the PBS – Commonwealth legislation

These requirements must be met, in addition to territory requirements, to supply as PBS Continued Dispensing medicine
Effective to Permanent Permanent
Summary of conditions Commonwealth instrument automatically adopted

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

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 Section 59A Supplying unrestricted Schedule 4 substance – continued dispensing (Medicines, Poisons and Therapeutic Goods Act 2012 – NT)

Last updated 4 April 2024 (NT)

QLD

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Legality to supply – Queensland regulation

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 A Schedule 4 medicine may be supplied to a patient without a prescription in accordance with a Continued Dispensing Determination (Commonwealth)

The National Health (Continued Dispensing) Determination 2022 allow 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 applies to Pharmacist Only Medicines (Schedule 3), Prescription Only Medicines (Schedule 4) and Controlled Drugs (Schedule 8) as listed in a 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

Supply must be recorded, including:

  • the supply event consistent with Section 160, similar to the recording requirements of other prescribed 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 Updates and alerts – Queensland Health

Last updated 4 April 2024 (Queensland)

SA

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Legality to supply – South Australian regulation

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

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(2)(g) of the Controlled Substances (Poisons) Regulations 2011

Last updated 4 April 2024 (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:

  • A valid prescription is unavailable
  • The usual prescriber is unable to be contacted or is unable to provide an electronic prescription
  • the patient has previously been supplied the medicine from a valid prescription
  • patient therapy is stable and they have been taking it regularly for an uninterrupted period, and the prescriber has reviewed stability since the commencement of the therapy
  • the last supply of the therapy was from a prescription
  • same medicine has not be supplied by Continued Dispensing in 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

Eligible restricted substances able to be supplied include the following substances:

  • Schedule 4 medicines (excluding restricted substances, known as Schedule 4D medicines described in Section 36 of the Poisons Act 1971).

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 Quantity supplied in accordance with previous prescription Standard PBS maximum quantity
Record and communication
  • Patient or agent must sign a declaration acknowledging they are being supplied with the medicine without a valid prescription,
  • Record the information used to support the decision to supplied the medicine through continued dispensing, including statements to the effect that:
    – conditions specified in regulation 48 have been met; and
    – the pharmacist is satisfied the Schedule 4 medicine was required to be supplied to the patient to facilitate continuity of treatment.
  • Inform the usual prescriber that the substance has been supplied (within 7 days)
  • Supply must be recorded consistent with requirements of Poisons Regulations 2018

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 4 April 2023 (Tasmania)

VIC

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Legality to supply – Victorian regulation

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 Regulation 57: Permanent Permanent
Summary of conditions

Medicines listed in National Health (Continued Dispensing) Determination 2022 (permanent)

Regulation 57 permits a Schedule 4 medicine to be supplied to a patient without a prescription in an emergency if the pharmacist is satisfied:

  • the sale or supply is necessary to ensure continuity of
    treatment
  • not been supplied to this patient under Regulation 57 in the previous 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 of eligible PBS medicines via Continued Dispensing permitted for medicines:

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 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

Last updated 27 March 2024 (Victoria)

WA

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  Legality to supply – WA regulation

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

A 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

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 current SASA has been updated to align with the National Health (Continued Dispensing) Determination 2022. Non-PBS medicines are not subsidised under the PBS

Last updated 4 April 2024

Background
  • 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 have now lapsed in all jurisdictions.
  • The National Health (Continued Dispensing – Emergency Measure) Determination 2023 (Instrument) (755 molecules) provided for temporary access under Continued Dispensing arrangements to a wider range of medicines than those available under the National Health (Continued Dispensing) Determination 2022 (150 molecules). This arrangement expired on 31 March 2024.
  • 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.
  • Tasmania has authorised  non-PBS supply (private supply) of most Prescription Only Medicines under permanent regulation changes.
Phone/fax order by prescriber (updated 7 June 2023)

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.

 

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.

As of 31 March 2023, a prescriber may now also send an emergency transmission of digital image to pharmacists (e.g. fax or email) if, in the opinion of the prescriber an emergency exists. Under this regulation:

  • the prescription must be transmitted directly to the pharmacist or pharmacy of the patient’s choice (i.e. not sent through the patient or a third party)
  • the prescriber must not send the digital image to more than one pharmacy or a person other than a pharmacist
  • the prescriber must send the original prescription to the pharmacist or pharmacy within 72 hours of transmitting the digital image.
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, 25A, 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 oral hormonal contraceptives: the patient has been treated by a prescriber with the medicine for a continuous period of a reasonable length; or
    (c) for other medicines: continuing the patient’s treatment with the medicine is urgent and essential for the patient’s well-being; and,
  • it is not practicable for the patient to obtain a prescription for the medicine before needing to continue treatment with the medicine; and,
  • for oral hormonal contraceptives: the patient has not been supplied the medicine without a prescription from the pharmacy at which the medicine is sought in the past 12 months.
Maximum quantity able to be supplied
  • 3 days treatment, or
  • for a prepack liquid, cream, ointment or aerosol – the minimum standard pack, or
  • for any oral contraceptive pill – any standard manufacturer’s pack (e.g. 1-month or 3-month packs)
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

Updated 2 January 2024 (QLD)

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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