National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01138 Not in force Legislative Instrument

Legislation content

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021

PB  95 of 2021

Authority

Subsection 89A(3) of the National Health Act 1953 (the Act) provides that the Minister may, by legislative instrument, determine the pharmaceutical benefits that may be supplied by an approved pharmacist without a prescription, and the conditions that must be satisfied when making a supply of those pharmaceutical benefits.

Purpose

The purpose of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (the Determination) to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme without a prescription, subject to the conditions specified in the 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 relating to the Prognyova brand of the drug estradiol (1 mg and 2 mg tablet forms) are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021). The Amendment Determination specifies an alternative brand of estradiol, Zumenon in a 2 mg tablet form (Zumenon (estradiol) 2 mg), that can be supplied without a prescription in substitution for Prognyova (estradiol valerate) 1 mg or 2 mg.  

As a result, the Determination permits the supply by an approved pharmacist of Zumenon (estradiol) 2 mg where Zumenon (estradiol) 2 mg may be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989 and it is supplied:

  • to a person with a PBS prescription for the Prognyova (estradiol valerate) 1mg or 2 mg;
  • where it is not practicable to obtain a PBS prescription from a PBS prescriber for Zumenon (estradiol) 2 mg before the person needs the supply of the Prognyova (estradiol valerate) 1 mg or 2 mg;
  • where the pharmacist has provided cost information to the patient or their agent so that they are able to make an informed decision before proceeding with the supply of Zumenon (estradiol) 2 mg. This includes the cost to the patient if the substitution is subsidised through the PBS and the cost to the patient if the substitution is a private prescription; and
  • Zumenon (estradiol) 2 mg is eligible for dispensing as a pharmaceutical benefit as outlined in this instrument.

In order for Zumenon (estradiol) 2 mg to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, among other things the pharmacist must:

  • Ensure that the amount of Zumenon (estradiol) 2 mg dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to their prescription for Progynova (estradiol valerate) 1 mg or 2 mg;
  • Advise the patient or their agent of the number of dose units of Zumenon (estradiol) 2 mg that must be taken by the patient in substitution for the prescribed dose of Prognyova (estradiol valerate) 1 mg or 2 mg (as appropriate); and
  • Where cutting of a tablet of Zumenon (estradiol) 2 mg is required to obtain the correct dose—instruct the patient on how to cut the tablet, as the Zumenon (estradiol) 2 mg tablet is unscored.

 

The Amendment Determination commences on 20 August 2021.

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.

 

 

 


ATTACHMENT

 

Details of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021

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. 1) Determination 2021.

This section also provides that the instrument may be cited as PB 95 of 2021.

Section 2 Commencement

This section provides that the Amendment Determination commences on 20 August 2021.

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.

Schedule 1 - Amendments

National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021

Item 1 – Subsection 5(8) (at the end of the table)

This item adds two new items to the table at subsection 5(8) of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021:

 

Column 2
Pharmaceutical benefit in shortage

 

Column 3

Approved substitute benefit

3

Listed drug: Estradiol,

Form: tablet containing estradiol valerate 1 mg

Manner of administarion: Oral

Brand: Progynova

Listed drug: Estradiol

Form:Tablet 2 mg

Manner of administration: Oral

Brand: Zumenon

4

Listed drug: Estradiol

Form: Tablet containing estradiol valerate 2 mg

Manner of administration: Oral

Brand: Progynova

Listed drug: Estradiol

Form: Tablet 2 mg

Manner of administration: Oral

Brand: Zumenon

 

Column 3 of this table sets out, for the purposes of subsection 89A(3) of the National Health Act 1953, the pharmaceutical benefits that may be supplied without a prescription where the conditions in the Determination are met.

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. 1) Determination 2021

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. 1) Determination 2021 (Amendment Determination) is to amend the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (the Determination) to specify two new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme without a prescription, subject to the conditions specified in the 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 relating to the Prognyova brand of the drug estradiol (1 mg and 2 mg tablet forms) are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021).

The Amendment Determination specifies an alternative brand of estradiol, Zumenon in a 2 mg tablet form (Zumenon (estradiol) 2 mg), that can be supplied without a prescription in substitution for Prognyova (estradiol valerate) 1 mg or 2 mg where the conditions in the Determination are met.  

These include that the supply by an approved pharmacist of Zumenon (estradiol) 2 mg is in accordance with section 30EL of the Therapeutic Goods Act 1989 and it is supplied:

  • to a person with a PBS prescription for the Prognyova (estradiol valerate) 1mg or 2 mg;
  • where it is not practicable to obtain a PBS prescription from a PBS prescriber for Zumenon (estradiol) 2 mg before the person needs the supply of the Prognyova (estradiol valerate) 1 mg or 2 mg;
  • where the pharmacist has provided cost information to the patient or their agent so that they are able to make an informed decision before proceeding with the supply of Zumenon (estradiol) 2 mg. This includes the cost to the patient if the substitution is subsidised through the PBS and the cost to the patient if the substitution is a private prescription; and
  • Zumenon (estradiol) 2 mg is eligible for dispensing as a pharmaceutical benefit as outlined in this instrument.

 

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 Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with providing subsidised access for people 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. 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 by ensuring that patients have continued access to medicines.

Conclusion

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

Nikolai Tsyganov

Acting Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

Overview

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021 was enacted to address issues arising from the shortage of specific pharmaceutical products, particularly in the context of the Pharmaceutical Benefits Scheme (PBS). This determination was introduced to amend the existing National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 to include new pharmaceutical benefits that can be supplied without a prescription, subject to specific conditions. The enactment body was the Minister of Health under the authority provided by subsection 89A(3) of the National Health Act 1953. The policy objective of this amendment is to ensure continued access to necessary medications during shortages by enabling pharmacists to substitute prescribed drugs with alternative brands when required. This amendment responds to the practical challenges posed by drug shortages, particularly those subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). By specifying new pharmaceutical benefits that can be supplied without a prescription under the PBS, the amendment aims to maintain patient access to essential medicines. The conditions for such substitutions include ensuring that the patient receives the correct dosage, providing cost information to the patient, and ensuring the substituted drug is eligible for PBS benefits. The determination commences on 20 August 2021, and it reflects the intention of previous consultations to improve the efficiency and effectiveness of the PBS during times of drug scarcity.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021 applies to the substitution of pharmaceutical benefits during shortages, specifically targeting the substitution of estradiol medications under the Pharmaceutical Benefits Scheme (PBS). The Amendment Determination amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 to allow for the supply of Zumenon (estradiol) 2 mg as an alternative to Progynova (estradiol valerate) 1 mg or 2 mg by an approved pharmacist, provided the conditions set out in the Determination are met. This includes instances where it is not practicable to obtain a PBS prescription for Zumenon (estradiol) 2 mg before the patient requires the Progynova (estradiol valerate) 1 mg or 2 mg. The Amendment Determination ensures that patients have continued access to essential medications during shortages, facilitating the substitution process under strict guidelines to maintain patient safety and informed decision-making. This legislation operates on a national level in accordance with the National Health Act 1953 and is effective from 20 August 2021.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 1) Determination 2021 (Amendment Determination) are detailed in Sections 1 through 4. Section 1 identifies the name and citation of the Amendment Determination, which is referred to as PB 95 of 2021. Section 2 specifies the commencement date of the Amendment Determination, which is 20 August 2021. Section 3 outlines the authority under which the Amendment Determination is made, namely subsection 89A(3) of the National Health Act 1953. Finally, Section 4 describes how the Amendment Determination amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 by specifying new pharmaceutical benefits that may be supplied without a prescription. The Amendment Determination imposes specific obligations and requirements on parties involved in the Pharmaceutical Benefits Scheme (PBS). Approved pharmacists are permitted to supply certain pharmaceutical benefits without a prescription under defined conditions. For instance, pharmacists can supply Zumenon (estradiol) 2 mg without a prescription in substitution for Prognyova (estradiol valerate) 1 mg or 2 mg, provided that the substitution is permissible under the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021 and specific conditions are met. These conditions include ensuring the patient receives sufficient medication, advising the patient of the dose, and providing cost information to the patient before the substitution. The pharmacist must also ensure that the substituted medication is eligible for dispensing under the PBS and that the patient has a PBS prescription for the original medication or it is not practicable to obtain a prescription before the supply is needed. The Amendment Determination does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches of its provisions. However, any actions by pharmacists or other entities that do not comply with the conditions specified in the Determination or other relevant legislation, such as the Therapeutic Goods Act 1989, may result in penalties under those statutes. For instance, supplying a pharmaceutical benefit without meeting the requirements could potentially lead to sanctions under the Therapeutic Goods Act, which includes civil and criminal penalties. The exact penalties would depend on the specific breach and the applicable provisions of the Therapeutic Goods Act and any other relevant legislation.

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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.