National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 7) Determination 2023

Administered by Department of Health, Disability and Ageing

Legislation au F2023L01632 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. 7) Determination 2023

PB 126 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. 7) 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 fluoxetine in the manner of oral administration have been subject to shortages since November 2023. In response, the TGA has issued the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Instrument 2023, which allows pharmacists to supply a different form of oral fluoxetine at 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) (Fluoxetine) Instrument 2023. The Amendment Determination will specify that a different form of oral fluoxetine at the same dosage 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 assist Australians with timely access to medicine supply for patients.

The Amendment Determination permits the supply by an approved pharmacist of the specified substitute pharmaceutical benefit containing the drug fluoxetine 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 it is supplied:

  • to a person with a PBS prescription for the specified form of fluoxetine subject to serious shortages;
  • where it is not practicable to obtain a prescription from a PBS prescriber for the specified substitute pharmaceutical benefits before the person needs the supply of fluoxetine;
  • by the pharmacist having disclosed information about additional costs to the patient or their agent to 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 fluoxetine 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:

a)      ensure the patient is able to take the dosage form of the substitutable medicine; and

b)      advise the patient, or person acting on behalf of the patient, of the number of dose units of substitutable medicine that must be taken by the patient in substitution for the prescribed dose of scarce medicine, based on the dose unit equivalence specified.

The Amendment Determination commences on 11 December 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. 7) 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. 7) Determination 2023.

This section also provides that the Amendment Determination may be cited as PB 126 of 2023.

Section 2 Commencement

This section provides that the Amendment Determination commences on 11 December 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.

 

 

 

 

 

 

 

 

 

 

 

 

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. 7) 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. 7) 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 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 fluoxetine in the manner of oral administration are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Instrument 2023).

The Amendment Determination specifies that a different form of fluoxetine at the same strength 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 fluoxetine 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 medicine supply for patients that is considerate of changing availabilities of fluoxetine 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 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. 7) Determination 2023 is an amendment to the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021. Enacted under subsection 89A(3) of the National Health Act 1953, this determination aims to address the issue of medicine shortages by allowing approved pharmacists to supply substitute medicines without a prescription under specific conditions. This legislative instrument was introduced in response to ongoing shortages of certain pharmaceutical benefits, particularly fluoxetine, which has been subject to significant supply disruptions since November 2023. By enabling pharmacist substitution during shortages, the determination seeks to ensure patients have timely access to necessary medications, reducing the burden on healthcare professionals and maintaining the affordability of medicines through the Pharmaceutical Benefits Scheme (PBS). The policy objective of this amendment is to facilitate the substitution of prescribed medications with alternative forms during shortages, ensuring continuity of care and minimising disruptions to patients' health. The amendment allows for the supply of different forms of fluoxetine without a new prescription, provided certain conditions are met, including the disclosure of additional costs to the patient. This approach is intended to support the highest attainable standard of health by enabling patients to access their medications during periods of scarcity. The determination also reflects the advice of the Pharmaceutical Benefits Advisory Committee (PBAC), which endorsed the necessity of the substitution arrangement as a practical and necessary measure during the current shortage.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 7) Determination 2023 applies to approved pharmacists within the Pharmaceutical Benefits Scheme (PBS) and is made under subsection 89A(3) of the National Health Act 1953. This Amendment Determination specifies new pharmaceutical benefits that can be supplied without a prescription, particularly for the drug fluoxetine during periods of shortage, in line with the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Instrument 2023 issued by the Therapeutic Goods Administration (TGA). It allows for the substitution of different forms of fluoxetine at the same dosage without a new prescription under certain conditions, including the disclosure of additional costs to the patient. The Determination ensures that eligible patients can access their medication at PBS co-payment rates, thus supporting timely and equitable access to essential medicines during shortages. The Amendment Determination is effective from 11 December 2023. This legislative instrument is compatible with human rights as it supports the highest attainable standard of physical and mental health by facilitating continued access to necessary medications. By permitting pharmacist substitution of fluoxetine under specific conditions, it aims to mitigate the impact of shortages on patients and healthcare professionals, aligning with Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The Determination ensures that the substitution remains an affordable and practical alternative for patients, thereby promoting the progressive realisation of the right to health.

Key Provisions

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 7) Determination 2023 (Amendment Determination) modifies the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (Principal Determination) to enable the supply of new pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) without a prescription, provided certain conditions are met (Section 4). Specifically, it allows approved pharmacists to supply a substitute pharmaceutical benefit when the prescribed medicine is subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). In this case, the Amendment Determination specifies that a different form of oral fluoxetine at the same dosage can be supplied without a new prescription, in accordance with the SSSI issued by the TGA (Section 4). The Amendment Determination imposes specific obligations on approved pharmacists. It mandates that the substitution be carried out for patients who have a PBS prescription for the specified form of fluoxetine that is experiencing shortages (Section 4). Furthermore, the pharmacist must ensure that it is not practicable to obtain a new prescription from a PBS prescriber before the patient needs the supply of fluoxetine, and that the patient or their agent has been informed about any additional costs associated with the substitution, so they can make an informed decision (Section 4). The pharmacist must also ensure that the patient can take the dosage form of the substitutable medicine and advise the patient or their representative of the number of dose units of the substitutable medicine to be taken based on the dose unit equivalence specified (Section 4). There are no explicit offences or penalties detailed in the Amendment Determination for breaches of its provisions. However, it is important to note that any actions taken by pharmacists that do not comply with the requirements of the Therapeutic Goods Act 1989, including section 30EL, could potentially result in civil or criminal penalties under that Act. The Amendment Determination is a legislative instrument for the purposes of the Legislation Act 2003, and its provisions must be followed to ensure compliance with the legislative framework governing pharmaceutical benefits and pharmacist substitution during shortages.

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