National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025

Administered by Department of Health, Disability and Ageing

Legislation au F2025L01616 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025

PB  163 of 2025

Purpose

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.

The Principal Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).

Pharmaceutical benefits containing clonidine 150 micrograms in the manner of oral administration under the brand Catapres are anticipated to be in shortage from December 2025, with resolution expected by the end of March 2026. In response, the TGA is working on issuing the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025, which allows pharmacists to supply a different strength of clonidine tablets at an equivalent dose for the duration of the shortage, provided specified conditions are met.

The purpose of the Amendment Determination is to allow PBS subsidisation of the arrangements that will be specified in the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025. The Amendment Determination will specify that a different strength of clonidine tablets, at an equivalent dose, can be supplied without a new prescription, in accordance with the specifications and conditions outlined in the SSSI issued by the TGA. This minimises the burden on health care professionals and assists Australians with timely access to medicines.

The Amendment Determination permits the supply by an approved pharmacist of any one of the specified substitute pharmaceutical benefits containing the drug clonidine, in the manner of oral administration, in situations where the substitute benefit may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, and the following conditions are met:

  • the patient, or person acting on behalf of the patient, has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law;
  • the pharmacist does not have access to the scarce medicine;
  • the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted;
  • the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine;
  • the amount of substitutable medicine dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to that prescribed in relation to the scarce medicine;
  • the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine;
  • the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing; and
  • the pharmacist has an established procedure to notify the prescriber of the substitution at the time of, or as soon as practical after, dispensing the substitutable medicine.

 

In order for the specified substitute pharmaceutical benefits to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, the following specific permitted circumstances of substitution apply:

The pharmacist has advised the patient, or person acting on behalf of the patient, of:

  1.       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; and
  2.      where cutting of a tablet is required to obtain the correct dose of substitutable medicine, suitable instructions for cutting a tablet of the substitutable medicine; and
  3.       the differences between the scarce medicine and the substitutable medicine.

The Amendment Determination commences on 22 December 2025.

The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003.

A provision-by-provision description of the Amendment Determination is contained in the Attachment.

Consultation

The Amendment Determination reflects the intention of previous consultation.

In relation to the Amendment Determination, consultation was undertaken with the Chair and relevant expert members of the Pharmaceutical Benefits Advisory Committee (PBAC), an independent, expert advisory body that recommends medicines for listing on the PBS. Consultation with PBAC experts focused on specific advice about the appropriateness of PBS subsidisation for the Amendment Determination. The PBAC experts endorsed the proposed approach, as it was considered that the substitution arrangement is necessary, with limited other options available for patients needing replacement as quickly as possible during the current shortage.

It is noted the Therapeutic Goods Administration conducted consultation on the appropriateness of the substitutions and consultation on this Amendment Determination was limited to the appropriateness of a PBS subsidy for the substitute medicines. No further consultation was deemed necessary, as consultation with the PBAC Chair drew on the knowledge of relevant experts.


ATTACHMENT

 

Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025

Section 1 Name

This section provides that the name of the Amendment Determination is the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025

This section also provides that the Amendment Determination may be cited as PB  163 of 2025

Section 2 Commencement

This section provides that the Amendment Determination commences on 22 December 2025.

Section 3 Authority

This section provides that the Amendment Determination is made under subsection 89A(3) of the National Health Act 1953.

Section 4  Schedules

This section provides that each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

 

 

 

 

 

 

 

 

 

 

 

Statement of Compatibility with Human Rights

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025

This Disallowable legislative instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. 

Overview of the Disallowable Legislative Instrument

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to the conditions specified in the Principal Determination.

The Determination permits an approved pharmacist to supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is the subject of a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI).

The pharmaceutical benefits containing the drug clonidine in the manner of oral administration are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Clonidine) Instrument 2025).

The Amendment Determination specifies that a different strength of clonidine tablets at equivalent dose can be effectively substitutable at the pharmacy level without the need to obtain a new prescription from the prescriber at PBS subsidised prices for the duration of the TGA approval, where conditions in the Principal Determination are met and the supply is in accordance with section 30EL of the Therapeutic Goods Act 1989.

This means that eligible patients accessing a substitute pharmaceutical benefit containing clonidine under these arrangements will be paying PBS co-payment rates for the supply and will not be out of pocket. This minimises the burden of this shortage on health care professionals by reducing the need for interdisciplinary consultations, and assists Australians with timely and equitable access to clonidine products during periods of shortage. It further bolsters the intended public health outcome of the serious shortage intervention by ensuring the substitution remains an affordable and practical alternative for patients.

Human rights implications

The Amendment Determination engages Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Amendment Determination assists in the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme providing Australians with subsidised access to medicines. This is a positive and supportive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the scheme. By ensuring that patients have continued access to their medicines while their supply is disrupted, the Amendment Determination assists in the progressive realisation by all appropriate means, of the universal right to the enjoyment of the highest attainable standard of physical and mental health.

Conclusion

The Amendment Determination is compatible with human rights, as it promotes the protection of human rights.

 

 

Rebecca Richardson

Assistant Secretary

PBS Listing, Pricing and Policy Branch

Technology Assessment and Access Division

Department of Health, Disability and Ageing

Overview

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025 was introduced to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021. This Amendment Determination was enacted by the Australian Government and aims to address the issue of medicine shortages by allowing pharmacist substitution of certain medicines without a prescription, subject to specific conditions. The primary objective of this legislation is to ensure that Australians have timely access to essential medicines during shortages by facilitating the substitution of pharmaceuticals, thereby reducing the burden on healthcare professionals and maintaining the affordability of essential treatments under the Pharmaceutical Benefits Scheme (PBS). This Amendment Determination specifically targets the anticipated shortage of clonidine 150 micrograms oral tablets, allowing approved pharmacists to supply a different strength of clonidine at an equivalent dose without a new prescription, provided certain conditions are met. This measure is intended to support the availability of necessary medications while mitigating the impact of shortages on patients and healthcare providers. By enabling the substitution of medicines under these conditions, the Amendment Determination promotes equitable access to healthcare and supports the progressive realisation of the right to the highest attainable standard of physical and mental health as recognised under international human rights instruments.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025 applies to approved pharmacists and patients in need of pharmaceutical benefits that are subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). Specifically, it allows pharmacists to supply a different strength of clonidine tablets at an equivalent dose without a new prescription under certain conditions, ensuring patients have continued access to essential medications during periods of shortage. This amendment extends to the Pharmaceutical Benefits Scheme (PBS) by enabling the subsidisation of the substitute pharmaceutical benefits, making them more affordable for patients. The Amendment Determination is subject to the conditions specified in the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 and is in accordance with section 30EL of the Therapeutic Goods Act 1989. The application of this determination is Commonwealth-wide, impacting all states and territories within Australia. The Amendment Determination does not specify any exclusions, exemptions, or thresholds beyond those outlined in the Principal Determination and the SSSI issued by the TGA. Any further extension or restriction of application is managed through subordinate instruments as necessary.

Key Provisions

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 4) Determination 2025 (Amendment Determination) amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to allow the supply of certain pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) without a prescription, subject to certain conditions. This amendment is particularly relevant to medicines containing clonidine, which are expected to be in short supply from December 2025. Specifically, the Amendment Determination allows approved pharmacists to supply a different strength of clonidine tablets at an equivalent dose without requiring a new prescription, provided certain conditions are met (s. 4). These conditions include having evidence of a valid prescription for the scarce medicine, the pharmacist not having access to the scarce medicine, and the prescriber not indicating that substitution is not permitted. Furthermore, the pharmacist must exercise professional judgment to determine the patient's suitability for the substitute medicine, ensure the patient receives an equivalent dosage regimen, and obtain the patient's consent. The pharmacist must also record the substitution and notify the prescriber of the substitution (s. 4). The pharmacist must inform the patient about the number of dose units to be taken, instructions for cutting the tablet if necessary, and differences between the scarce medicine and the substitutable medicine (s. 4). The Amendment Determination imposes specific obligations on both pharmacists and patients. Pharmacists must ensure they meet all the conditions stipulated in the Principal Determination before supplying the substitute medicine. This includes verifying the patient's prescription, ensuring the pharmacist does not have access to the scarce medicine, and confirming that the prescriber has not explicitly prohibited substitution. Pharmacists must also exercise professional judgment to assess the patient's suitability for the substitute medicine, ensure the patient receives an adequate dosage, and obtain explicit consent from the patient. Additionally, pharmacists are required to record the substitution and notify the prescriber promptly (s. 4). Patients, on the other hand, must provide evidence of a valid prescription for the scarce medicine unless otherwise permitted by law. They must also consent to receiving the substitute medicine and be informed about the number of dose units to be taken, instructions for cutting the tablet if necessary, and differences between the scarce medicine and the substitutable medicine (s. 4). Failure to comply with the conditions set out in the Amendment Determination may result in civil or criminal consequences. While the Amendment Determination does not specify explicit penalties for non-compliance, breaches of the conditions could potentially lead to actions under the Therapeutic Goods Act 1989 or other relevant legislation. Pharmacists found to be in breach of their obligations may face disciplinary action from professional bodies or legal repercussions under health and safety laws. Patients who do not comply with the requirements, such as failing to provide a valid prescription or consent, may face difficulties in accessing necessary medications during shortages. The overarching intent of the Amendment Determination is to ensure that the substitution of medicines remains a viable and regulated process that prioritises patient health and safety (s. 4).

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.