National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2021

Administered by Department of Health, Disability and Ageing

Legislation au F2021L01296 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. 2) Determination 2021

PB 108 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. 2) 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 Monodur 120 mg and Imdur 120 mg brands of the drug isosorbide mononitrate (tablet 120 mg (sustained release)) are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Isosorbide Mononitrate) Instrument 2021). The Amendment Determination specifies brands of isosorbide mononitrate tablet 60 mg (sustained release), including APO-Isosorbide Mononitrate, Duride, GenRx Isosorbide Mononitrate, ISOBIDE MR, Isomonit, Isosorbide AN, Imdur Durule and Monodur 60 mg, that can be supplied without a prescription in substitution for Monodur 120 mg and Imdur 120 mg.  

As a result, the Determination permits the supply by an approved pharmacist of a specified brand of isosorbide mononitrate tablet 60 mg (sustained release), where it 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 either Monodur 120 mg or Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release));
  • where it is not practicable to obtain a PBS prescription from a PBS prescriber for isosorbide mononitrate tablet 60 mg (sustained release) before the person needs the supply of the Monodur 120 mg or Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release));
  • 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 isosorbide mononitrate tablet 60 mg (sustained release). 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
  • isosorbide mononitrate tablet 60 mg (sustained release) is eligible for dispensing as a pharmaceutical benefit as outlined in this instrument.

In order for isosorbide mononitrate tablet 60 mg (sustained release) 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 isosorbide mononitrate tablet 60 mg (sustained release) dispensed would result in the patient receiving sufficient medicine to ensure an equivalent dosage regimen and duration to their prescription for Monodur 120 mg or Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release)); and
  • Advise the patient or their agent of the number of dose units of isosorbide mononitrate tablet 60 mg (sustained release) that must be taken by the patient in substitution for the prescribed dose of Monodur 120 mg or Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release)) (as appropriate).

 

The Amendment Determination commences on 18 September 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. 2) 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. 2) Determination 2021.

This section also provides that the instrument may be cited as PB 108 of 2021.

Section 2 Commencement

This section provides that the Amendment Determination commences on 18 September 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 one new item 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

5

Listed drug: Isosorbide mononitrate

Form: Tablet 120 mg (sustained release)

Manner of administration: Oral

Brand: either of the following:

(a) Imdur 120 mg

(b) Monodur 120 mg

Listed drug: Isosorbide mononitrate

Form: Tablet 60 mg (sustained release)

Manner of administration: Oral

Brand: any of the following:

(a) APO‑Isosorbide Mononitrate;

(b) Duride;

(c) GenRx Isosorbide Mononitrate;

(d) Imdur Durule;

(e) ISOBIDE MR;

(f) Isomonit;

(g) Isosorbide AN;

(h) Monodur 60 mg
 

 

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. 2) 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. 2) 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 Imdur 120 mg and Monodur 120 mg brands of the drug isosorbide mononitrate tablet 120 mg (sustained release) are currently subject to an SSSI (see the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Isosorbide Mononitrate) Instrument 2021).

The Amendment Determination specifies alternative brands of isosorbide mononitrate tablet 60 mg (sustained release) that can be supplied without a prescription in substitution for Imdur 120 mg or Monodur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release)) where the conditions in the Determination are met.

These include that the supply by an approved pharmacist of isosorbide mononitrate tablet 60 mg (sustained release) is in accordance with section 30EL of the Therapeutic Goods Act 1989 and it is supplied:

  • to a person with a PBS prescription for Imdur 120 mg or Monodur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release));
  • where it is not practicable to obtain a PBS prescription from a PBS prescriber for isosorbide mononitrate tablet 60 mg (sustained release) before the person needs the supply of Imdur 120 mg or Monodur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release));
  • 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 isosorbide mononitrate tablet 60 mg (sustained release). 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
  • isosorbide mononitrate tablet 60 mg (sustained release) 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. 2) Determination 2021 was enacted to address the problem of drug shortages within the Pharmaceutical Benefits Scheme (PBS). Specifically, it responds to situations where certain medications are subject to severe supply issues, making it difficult for patients to obtain their prescribed treatments. The determination was made under subsection 89A(3) of the National Health Act 1953 by the Minister for Health, allowing for the substitution of specified pharmaceutical benefits without a prescription when certain conditions are met. This legislative instrument aims to ensure that patients maintain access to necessary medications by enabling pharmacists to substitute equivalent pharmaceutical benefits during shortages, thus facilitating the highest attainable standard of physical and mental health for Australians. The Amendment Determination complements the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021, allowing approved pharmacists to supply alternative brands of isosorbide mononitrate tablet 60 mg (sustained release) in substitution for Monodur 120 mg and Imdur 120 mg when these latter brands are subject to serious scarcity. This measure is intended to ensure continuity of care and access to essential medications, provided the pharmacist adheres to the conditions specified under the Determination and section 30EL of the Therapeutic Goods Act 1989. The Amendment Determination commenced on 18 September 2021, reinforcing the policy objective of maintaining the efficiency and effectiveness of the PBS in times of drug shortages.

Scope and Application

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2021 applies to approved pharmacists who are permitted to supply substitute pharmaceutical benefits under the Pharmaceutical Benefits Scheme (PBS) when the prescribed medicine is subject to a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI). Specifically, the Amendment Determination allows for the substitution of isosorbide mononitrate tablet 60 mg (sustained release) in place of Monodur 120 mg and Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release)) under certain conditions, namely where it is not practicable to obtain a PBS prescription for the substitute medicine, the pharmacist has provided cost information to the patient, and the substitute medicine is eligible for dispensing as a pharmaceutical benefit. The Amendment Determination is applicable nationally as it is a legislative instrument under the National Health Act 1953, which is a Commonwealth Act. There are no stated exclusions or exemptions in the Amendment Determination, however, it extends or restricts the application of the Determination through subordinate instruments. The Amendment Determination is compatible with human rights as it promotes the protection of human rights by ensuring continued access to medicines for patients.

Key Provisions

The National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Amendment (No. 2) Determination 2021 (Amendment Determination) primarily amends the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 (the Determination) to allow for new pharmaceutical benefits to be supplied without a prescription. This is subject to certain conditions specified in the Determination, including instances where there is a shortage of a particular medication, as indicated by a Therapeutic Goods Administration (TGA) Serious Scarcity Substitution Instrument (SSSI) (section 4). Specifically, the Amendment Determination specifies that certain brands of isosorbide mononitrate tablet 60 mg (sustained release) can be supplied without a prescription in substitution for Monodur 120 mg and Imdur 120 mg (isosorbide mononitrate tablet 120 mg (sustained release)), where it is not practicable to obtain a prescription and the patient has been informed of the costs involved (section 4). Under this Act, an approved pharmacist can supply a substitute pharmaceutical benefit when the pharmaceutical benefit prescribed for the patient is subject to a TGA SSSI (section 4). The pharmacist must ensure the patient receives a sufficient dosage regimen and duration by providing the correct number of dose units of the substitute medicine (section 4). Additionally, the pharmacist must inform the patient or their agent of the costs associated with the substitution, including whether the substitution is subsidised through the Pharmaceutical Benefits Scheme (PBS) or if it is a private prescription (section 4). Failure to comply with the requirements of the Determination may result in legal consequences. However, the Amendment Determination does not specify any particular offences, penalties, or civil/criminal consequences for breach. Nevertheless, any non-compliance with the provisions of the National Health Act 1953 or the Therapeutic Goods Act 1989 may result in penalties as prescribed by these respective Acts. For instance, under the Therapeutic Goods Act 1989, a person who contravenes certain provisions may be liable for civil penalties, including fines up to $222,200 for individuals and $1,111,000 for bodies corporate, or criminal penalties, including imprisonment for up to five years (section 41AA).

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