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Summary of COVID-19 regulatory changes

This information was last updated Thursday 21 October 2021

 

The tables below provide a summary of the arrangements that are in place to enable pharmacists to support continuity of treatment (medicines) for patients during the COVID-19 pandemic.

 

PSA has prepared this information using the best and most up-to-date information that we have received. This is rapidly and 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 ~ (11 October 2021)

Digital image prescriptions are the paperless transfer of prescriptions from a prescriber to a pharmacist to support telehealth consultations during COVID-19.

 

This temporary measure is supported through existing territory regulation, temporary state regulatory amendments, public health emergency orders and a PBS Special Arrangement.  The PBS Special Arrangement was extended for a final time in September and will end on 31 December 2021.

 

By 31 December 2021, electronic prescribing will replace 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.

 

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

 

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.

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – ACT regulation
Effective to 31 December 2021 Ongoing under existing ACT legislation
Effective from 20 March 2020 N/A
Prescriber
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NSW regulation
Effective to 31 December 2021 30 September 2022
Effective from 20 March 2020 17 April 2020
Prescriber
  • 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 should 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NT regulation
Effective to 31 December 2021 Ongoing under existing NT legislation
Effective from 20 March 2020 N/A
Prescriber
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – QLD regulation
Effective to 31 December 2021 31 December 2021
Effective from 20 March 2020 26 March 2020 (retrospective)
Prescriber
  • 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
  • It is recommended that prescribers make a record on the prescription and in their clinical system, that a copy or digital image was sent to the pharmacy, noting the:
    • particulars of the pharmacy
    • method it was transmitted
  • Original (paper) prescriptions for controlled (Schedule 8) drugs, restricted drugs of dependency (benzodiazepines, codeine, phentermine) and anabolic steroids must still be sent to the pharmacy within 7 days of sending a digital image for dispensing
  • It is recommended that any paper prescriptions for these medicines that are sent to the pharmacy are marked, by the prescriber, to indicate that it is a ‘confirmation of a request to supply on a faxed copy or digital image prescription’
  • 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)

 

  • Pharmacists have an obligation to confirm the validity of all prescriptions sent as a digital image, and must take reasonable steps to confirm with the prescriber
  • Record in the dispensing system when a supply has been made on a faxed or digital image prescription
  • Repeats are to be retained and supplied at the original dispensing pharmacy. This includes any repeats on private prescriptions that were sent as digital image prescriptions
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – SA regulation
Effective to 31 December 2021 31 December 2021
Effective from 20 March 2020 27 March 2020
Prescriber
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – TAS regulation
Effective to 31 December 2021 31 December 2021
Effective from 20 March 2020 15 April 2020
Prescriber
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – VIC regulation
Effective to 31 December 2021 31 December 2021
Effective from 20 March 2020 7 April 2020
Prescriber
  • 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

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – WA regulation
Effective to 31 December 2021 31 December 2021
Effective from 20 March 2020 N/A
Prescriber
  • 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, prescribers continue to be 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 dispatch in 5 working days the (original) paper prescription by post or courier to the pharmacy which was sent the digital image
  • The (S8) prescription should be 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 sent through by the prescriber (including S8s, noting hardcopy requirements outlined above)
Legislative instrument/s
Relevant resources Information for pharmacists and prescribers
Continued dispensing (updated 27 Sep 2021)

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.

 

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.

 

Prior to COVID-19, PBS Continued Dispensing was limited to oral contraceptives and statins.

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – ACT regulation
Effective to 31 December 2021 Duration of declared emergency
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
  • Continued Dispensing fully enabled under the Regulation; see also the information sheet
  • Emergency supply of S4 medicine without a prescription permitted under Standing Order where not captured by Continued Dispensing
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: anabolic steroids, designated appendix D medicines, benzodiazepines, S8s
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than standard maximum quantity
  • non-PBS medicine – no more than quantity in smallest standard pack generally available
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record supply and label medicine –as outlined in the Standing Order and information sheet
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NSW regulation
Effective to 31 December 2021 31 December 2021
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
  • Continued Dispensing enabled through a temporary Authority
  • Emergency supply of S4 medicine without a prescription (outside of Continued Dispensing) is permitted if patient has not received any such emergency supply of the medicine from any pharmacy in previous 12 months
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: S4 + Appendix D medicines, S8s
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than standard maximum quantity
  • non-PBS medicine – no more than quantity in smallest standard pack generally available
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record supply – as outlined here
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – NT regulation
Effective to 31 December 2021 As per Commonwealth instrument
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
Commonwealth instrument automatically adopted – Continued Dispensing fully enabled under the Act (see also information sheet)
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
  • Limited to PBS-listed unrestricted S4 medicines
  • Excludes: Restricted S4 medicines, S8 medicines, privately funded S4s and S8s
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Privately funded and non-PBS prescriptions are not permitted under this measure

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – QLD regulation
Effective to 31 December 2021 Duration of declared public health emergency in relation to an infectious medical condition
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Restricted drugs (S4 medicines), other than those in the DTP Appendix 1
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than standard maximum quantity
  • non-PBS medicine – no more than quantity in smallest standard pack generally available
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
  • Must record each supply event
  • If medicine is non-PBS, must communicate with person’s treating doctor as soon as practicable, but no later than 7 days after supply event
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – SA regulation
Effective to 31 December 2021 Duration of declared public health emergency
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
  • Controlled Dispensing enabled through Regulations (see also Gazette and fact sheet)
  • Emergency supply of S4 medicine without a prescription permitted under the Regulations
  • Pharmacist must be satisfied “there is good reason for the person’s inability to produce a prescription for the drug”
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: S8s (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)
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than standard maximum quantity
  • non-PBS medicine – the quantity in smallest standard pack generally available
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record the information required under the regulations for emergency supply of S4s
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – TAS regulation
Effective to 31 December 2021
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
  • Continued Dispensing enabled through Regulations
  • Emergency supply of S4 medicine without a prescription also included in Regulations
  • Pharmacist must be satisfied, person has valid prescription but is unable to provide it or has previously had a valid prescription but is unable to be issued with new prescription, due to the emergency
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: psychotropic substances
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than PBS maximum quantity
  • non-PBS medicine – no more than the quantity in smallest pack generally available
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record and label in accordance with the Regulations
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – VIC regulation
Effective to 31 December 2021 31 December 2021
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
  • Controlled Dispensing enabled through public health emergency order (PHEO #2) – see also advice for pharmacists
  • Emergency supply of S4 medicine without a prescription also included in PHEO #2
  • Pharmacist must be satisfied patient or carer is aware of appropriate dose
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: S8s
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – not exceed standard PBS maximum quantity
  • non-PBS medicine – not exceed quantity in smallest commercially available pack
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record as outlined in the advice, including that supply was made under COVID-19 public health emergency order (PHEO #2)
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS

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Requirement for supply under PBS – Commonwealth legislation Legality to supply – WA regulation
Effective to 31 December 2021 Duration of declared Public Health State of Emergency
Summary of conditions An eligible PBS medicine may be supplied to a patient without a prescription if:

  • it is not practicable for patient to obtain a prescription
  • medicine has been previously prescribed and therapy is stable
  • continuity of treatment is necessary
  • same medicine has not been supplied by Continued Dispensing in the previous 12 months.
Eligible medicines
  • Are flagged through PBS Online
  • Includes Authority Required / Streamlined medicines (including increased quantities), S8s
  • Excludes: S100 Special Supply Arrangements and prescriber bag medicines
Excludes: S8s
Quantity Same quantity or number of units of the medicine that was supplied on the last prescription (including an increased quantity)
  • PBS medicine – no more than standard maximum PBS quantity
  • non-PBS medicine – no more than smallest standard pack size
Record and communication
  • Must record supply as outlined in PSA guidelines
  • Must provide written communication to patient’s most recent prescriber advising of Continued Dispensing supply within 24 hours
Must record as outlined in the advice and label as for any dispensed medicine
Subsidy Eligible medicines are subsidised by the PBS; usual copayment applies Non-PBS medicines are not subsidised under the PBS
Medicine shortages: Therapeutic substitution (updated 20 September 2021)

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).

 

SSSIs currently in force:

  • Tocilizumab (to 31 December 2021)
  • Estradiol (to 1 May 2022)
  • Isosorbide mononitrate (to 19 December 2022)

 

Shortage of multiple presentations of tocilizumab (Actemra) products has resulted due to global demand in response to the COVID-19 pandemic (to assist with off-label IV treatment of ventilated patients).

 

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

 

The SSSI for tocilizumab has been made to support access to the limited quantities for people in the community, principally to treat: rheumatoid arthritis, giant cell arthritis, systemic juvenile idiopathic arthritis, polyarticular idiopathic arthritis, cytokine release syndrome.

 

Scarce medicine Substitutable (alternative) medicine Note
Actemra (tocilizumab)

162 mg/0.9 ml solution for injection, pre-filled syringe

Actemra (tocilizumab)

162 mg/0.9 ml solution for injection, pre-filled pen, ACTPen autoinjector

One pre-filled syringe is equivalent to one pre-filled pen (autoinjector)
Actemra (tocilizumab)

162 mg/0.9 ml solution for injection, pre-filled pen, ACTPen autoinjector

Actemra (tocilizumab)

162 mg/0.9 ml solution for injection, pre-filled syringe

One pre-filled pen (autoinjector) is equivalent to one pre-filled syringe

 

Additional considerations for pharmacists:

  • The patient must be at least 18 years of age.
  • Ensure patient has received instructions or will receive instructions on administration from their specialist, rheumatology nurse or general practitioner.
  • Ensure patient has access to information to support them in administering the medicine such as the Consumer Medicines Information (CMI) leaflet. The sponsor’s self-administration instructional videos for patients can be accessed through QR codes contained in this leaflet.
  • Both Actemra subcutaneous injection pre-filled products have been specified as a scarce medicine as well as a substitutable (alternative) medicine – therefore they are effectively interchangeable.

 

Further information:

 

 

PBS subsidy: arrangements are in place for the substitutable (alternative) medicine Zumenon only under the estradiol SSSI – refer to PBS website.

 

Scarce medicine Substitutable (alternative) medicine Note
Progynova

(estradiol valerate)

1 milligram tablet

Estrofem

(estradiol hemihydrate)

1 milligram tablet

Dose unit equivalence is one to one
Zumenon

(estradiol hemihydrate)

2 milligram tablet

One tablet of Progynova is equivalent to half a tablet of Zumenon.

Patient may require instructions on cutting a tablet in half.

Note that advice may also be required regarding risk of harm from unintended exposure to estradiol.

Progynova

(estradiol valerate)

2 milligram tablet

Estrofem

(estradiol hemihydrate)

2 milligram tablet

Dose unit equivalence is one to one
Zumenon

(estradiol hemihydrate)

2 milligram tablet

Dose unit equivalence is one to one

 

Additional considerations for pharmacists:

  • When the equivalent dose of the substitutable medicine requires Zumenon 2mg tablets to be halved, pharmacists should confirm the patient’s ability to cut the tablets (or provide instructions).
  • Pharmacists are also reminded that APF25 recommends cautionary advisory labels 21 and A for estradiol tablets due to the potential risk of harm through unintended exposure. Advice should be provided, if relevant, to patients, carers and healthcare workers on how to avoid unintended exposure to estradiol. Use professional judgement on whether label A should be omitted if tablets need to be cut.

 

Further information:

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 that 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 you believe the patient is not suitable to receive the substitutable medicine, refer them back to their prescriber to discuss treatment options.
  • If deemed suitable, ensure patient is fully informed and consents to the change.
  • The total quantity of the substitutable medicine dispensed must be equivalent to the total dose and duration prescribed for the scarce medicine.
  • Make a record of the dispensing of the substitutable medicine at the time of dispensing.
  • Notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine.
  • SSSIs cannot be applied to the dispensing of medicines from medication charts in residential aged care facilities.
  • When dispensing according to a SSSI, the substitutable (alternative) medicine may not be subsidised by the PBS. Pharmacists must confirm arrangements in relation to each SSSI.

 

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

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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)

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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

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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)

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

  • Once a verbal prescription is issued, a paper prescription must be sent by fax or as an electronic copy within 24 hours

 

Faxed prescription:

  • Prescriber may send a faxed or electronic copy of a prescription
  • Prescriber must telephone the dispenser within 24 hours to confirm prescription details
Requirement for prescriber to send paper prescription to the pharmacist
  • Paper prescription must be sent by post or by hand or sent as an electronic prescription within 7 days
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 in 14 days
Legislative instrument 81, 81AA, 192, 192AA Health (Drugs and Poisons) Regulation 1996
Relevant resources

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

  • Prescription may be provided if prescriber satisfied there is good reason
  • Prescription must be immediately written, stating it is confirmation of the instruction
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
  • Exception: the prescriber has endorsed the faxed prescription with name and address of a single pharmacy at which the prescription may be dispensed.
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

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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

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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

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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

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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

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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
  • 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”
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

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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

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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 satisfied:

  1. an emergency exists
  2. the person seeking the medicine is under medical treatment requiring use of the medicine
  3. continuing treatment is essential to their wellbeing
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
  • Labelled with:
    1. name of the person being treated;
    2. name and address of pharmacy;
    3. date of sale;
    4. approved name, trade name, or the approved name of each drug present
    5. the words “EMERGENCY SUPPLY”, all capitalised, in a san-serif font
  • Supply must be recorded in an ‘emergency supply book’
Medicine excluded
  • Excludes Controlled Drugs (S8)
Other requirements of supply
Legislative instrument(s)
Relevant resources

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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

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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

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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

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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