National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2023

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01047 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. 5) Determination 2023

PB 78 of 2023

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. 5) Determination 2023 (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).

The pharmaceutical benefits containing cefalexin in the manner of administration oral have been subject to ongoing shortages since October 2022. In response, the TGA has issued the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023, which allows pharmacists to supply different forms of oral cefalexin at equivalent doses 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 specified in the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023. The Amendment Determination specifies alternative strengths and brands of cefalexin that 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 antibiotic therapy.

The Amendment Determination also removes medicines from the Principal Determination that are no longer in shortage and are not covered by the TGA SSSI.

On 1 August 2023, SSSI arrangements for cefalexin which came into effect in 2022 will cease and be replaced by updated arrangements provided in the 2023 SSSI instrument. The Amendment Determination permits the supply by an approved pharmacist of any one of the specified substitute pharmaceutical benefits containing the drug cefalexin in the manner of administration oral in situations where the substitute benefit 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 any one of the specified forms of cefalexin subject to serious shortages;
  • where it is not practicable to obtain a prescription from a PBS prescriber for any one of the specified substitute pharmaceutical benefits before the person needs the supply of cefalexin;
  • by the pharmacist having disclosed information about additional costs to the patient or their agent so that they are able to make an informed decision before proceeding with the substitute supply; 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
  • the substitute pharmaceutical benefit containing cefalexin in the manner of administration oral is eligible for dispensing as a pharmaceutical benefit as outlined in this instrument.

In order for the specified substitute pharmaceutical benefits to be dispensed in accordance with section 30EL of the Therapeutic Goods Act 1989, among other things the pharmacist must:

 

  • ensure that the patient can take the substitutable medicine in a capsule dosage form;
  • only substitute the substitutable medicine for the scarce medicine where the prescribed dose of scarce medicine is divisible by 250 mg;
  • advise the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence.
  • ensure that the correct number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine is written on the dispensing label; and
  • ensure that the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine.

The Amendment Determination commences on 01 August 2023.

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 during the current shortage needing replacement as quickly as possible.

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. 5) Determination 2023

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. 5) Determination 2023.

This section also provides that the Amendment Determination may be cited as PB 78 of 2023.

Section 2 Commencement

This section provides that the Amendment Determination commences on 1 August 2023.

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. Item one provides for the repeal for the existing table to subsection 5(8) and substitutes with a new table, to include cefalexin and other medicines subject to a SSSI currently in force.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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. 5) Determination 2023

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. 5) Determination 2023 (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 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).

Select pharmaceutical benefits containing the drug cefalexin in the manner of administration oral are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023).

The Amendment Determination specifies that different forms of oral cefalexin at equivalent doses can be effectively substituted at the pharmacy level without the need to obtain a new prescription from the prescriber and that such supplies may be PBS subsidised 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 cefalexin 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 antibiotic therapy that is considerate of changing availabilities of cefalexin products. 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 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 their medicines while their supply is disrupted.

Conclusion

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

 

Nikolai Tsyganov

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health and Aged Care

Overview

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2023 was enacted to address ongoing shortages of specific pharmaceutical products, particularly oral cefalexin, under the Pharmaceutical Benefits Scheme (PBS). This legislative instrument amends the 2021 Principal Determination to allow the substitution of certain medicines without a prescription when they are subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). The primary objective is to ensure patients have timely access to essential medications, thereby reducing the burden on healthcare professionals and facilitating equitable access to necessary antibiotic therapies during periods of shortage. The determination is made under the authority of subsection 89A(3) of the National Health Act 1953, with the intention of aligning with the TGA's Serious Scarcity Substitution Instrument, particularly the Cefalexin Instrument 2023. This alignment allows pharmacists to supply alternative forms of cefalexin at equivalent doses without requiring a new prescription from the prescriber, provided that specific conditions are met. The conditions include ensuring the patient can take the substitutable medicine in a suitable dosage form, advising the patient of the correct dosage, and ensuring the correct information is provided on the dispensing label. This measure ensures that patients are not out of pocket for their medication and supports the broader goal of maintaining high standards of physical and mental health for Australians by ensuring continued access to necessary medicines.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2023 amends the existing National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 to specify new pharmaceutical benefits that may be supplied under the Pharmaceutical Benefits Scheme without a prescription, subject to certain conditions. This amendment responds to ongoing shortages of specific medicines, including oral cefalexin, by allowing approved pharmacists to supply substitute pharmaceutical benefits during the shortages. The Amendment Determination applies to approved pharmacists and patients in need of specific pharmaceutical benefits that are subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). The purpose of this amendment is to ensure that patients have timely access to essential medications at affordable rates, particularly during shortages of specific pharmaceutical products. It allows for the substitution of certain forms of oral cefalexin and other medicines, ensuring that patients can obtain their necessary medications without having to obtain a new prescription from their prescriber, subject to the conditions specified in the Principal Determination and the Therapeutic Goods Act 1989. The Amendment Determination is applicable across Australia, aligning with the provisions of the National Health Act 1953, and is effective from 1 August 2023. The Amendment Determination does not specify any exclusions or exemptions beyond those already outlined in the Principal Determination, and it extends the application of the Principal Determination by specifying new pharmaceutical benefits that can be supplied without a prescription during shortages. The amendment is made under subsection 89A(3) of the National Health Act 1953, and any further details or specific provisions are contained in the attached schedule of the Determination. The Amendment Determination is compatible with human rights, as it supports the right of everyone to the enjoyment of the highest attainable standard of physical and mental health by ensuring continued access to essential medications during shortages.

Key Provisions

The main operative sections of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 5) Determination 2023 (the Amendment Determination) specify new pharmaceutical benefits that can be supplied under the Pharmaceutical Benefits Scheme (PBS) without a prescription. This is in response to ongoing shortages of cefalexin, an antibiotic. Section 4 of the Amendment Determination provides that the new provisions apply to substitute pharmaceutical benefits containing cefalexin in the manner of administration oral. This allows approved pharmacists to supply alternative strengths and brands of cefalexin without a new prescription if certain conditions are met, including the supply being in accordance with section 30EL of the Therapeutic Goods Act 1989 (section 4(1)(a)-(c)). The Amendment Determination also removes medicines from the Principal Determination that are no longer in shortage and are not covered by a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI) (section 4(2)). The Amendment Determination imposes obligations and requirements on approved pharmacists when supplying substitute pharmaceutical benefits without a prescription. Pharmacists must ensure the patient can take the substitutable medicine in a capsule dosage form and that the prescribed dose of scarce medicine is divisible by 250 mg (section 4(1)(a)-(b)). The pharmacist must advise the patient of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence (section 4(1)(b)). The correct number of dose units must be written on the dispensing label and the patient must have access to information to support them in administering the substitutable medicine (section 4(1)(c)). The Amendment Determination does not explicitly state any offences, penalties, or consequences for breach. However, it is likely that any breach of the Therapeutic Goods Act 1989 or the National Health Act 1953 would result in civil or criminal penalties under those Acts. Under the Therapeutic Goods Act 1989, supplying therapeutic goods that do not comply with the Act may result in a fine of up to $22,200 for an individual or $111,000 for a body corporate, or imprisonment for up to two years, or both (section 32DA). Under the National Health Act 1953, contravening or failing to comply with the Act may result in a fine of up to $27,500 for an individual or $137,500 for a body corporate (section 12AA).

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Health Law
Pharmaceutical Law
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Licensing & Registration
Compliance Obligations
Consultation Requirements
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Substitution of Medicines
Serious Scarcity Substitution Instrument

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