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This instrument declares that there is a serious scarcity across Australia of a specified medicine that contains the active ingredient warfarin sodium, and specifies the substitutable medicines that pharmacists are permitted to dispense in substitution in permitted circumstances.
Administered by: Health and Aged Care
Registered 16 Mar 2023
Tabling HistoryDate
Tabled HR20-Mar-2023
Tabled Senate21-Mar-2023
To be repealed 08 Aug 2023
Repealed by Self Repealing
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023

I, Nicholas Henderson, as delegate of the Minister for Health and Aged Care, make the following instrument.

Dated 16 March 2023

Nicholas Henderson

Acting First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health and Aged Care

 

 

 


Contents

1  Name........................................................................................................................................ 1

2  Commencement........................................................................................................................ 1

3  Authority.................................................................................................................................. 1

4  Definitions................................................................................................................................ 1

5  Declaration of a serious scarcity............................................................................................... 2

6  Substitution of scarce medicine by pharmacists........................................................................ 2

7  Period instrument in force........................................................................................................ 2

8  Repeals..................................................................................................................................... 2

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances                                                                                          3

Schedule 2—General permitted circumstances                                                          5

 


1  Name

                   This instrument is the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023.

2  Commencement

             (1)  Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

 

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1.  The whole of this instrument

17 March 2023.

17 March 2023

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

             (2)  Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3  Authority

                   This instrument is made under section 30EK of the Therapeutic Goods Act 1989.

4  Definitions

Note:          A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a)    medicine;

(b)    Register;

(c)    registered goods;

(d)    registration number.

                   In this instrument:

Act means the Therapeutic Goods Act 1989.

pharmacist has the same meaning as in subsection 30EK(6) of the Act.

prescriber means the person who:

                     (a)  is authorised under a law of a State or Territory to prescribe medicine; and

                     (b)  prescribed the scarce medicine for the patient.

registered medicine means a medicine that is included in the part of the Register for goods known as registered goods.

scarce medicine has the meaning given by section 5.

substitutable medicine has the meaning given by section 6.

tablet has the same meaning as in the Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.

Note:          TGO 101 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.

Declaration of a serious scarcity

                   For paragraph 30EK(1)(a) of the Act, a serious scarcity of the medicine specified in column 2 of each item in the table in Schedule 1 (the scarce medicine) across the whole of Australia is declared.

6  Substitution of scarce medicine by pharmacists

                   For paragraph 30EK(1)(b) of the Act, in relation to each item mentioned in the table in Schedule 1, each medicine specified in column 3 (the substitutable medicine) is permitted to be dispensed by a pharmacist in substitution for the scarce medicine specified in column 2, in the circumstances specified in:

                     (a)  column 5 of that item (the specific permitted circumstances); and

                     (b)  the table in Schedule 2 (the general permitted circumstances).

Note:          Substitution is only permitted where both the specific permitted circumstances and the general permitted circumstances exist.

7  Period instrument in force

                   This instrument remains in force until 7 August 2023.

8  Repeals

                   Unless repealed earlier, this instrument is repealed at the start of 8 August 2023.


 

Schedule 1—Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Note:       See sections 5 and 6.

Scarce medicine, substitutable medicine, dose unit equivalence and specific permitted circumstances

Column 1

Column 2

Column 3

Column 4

Column 5

Item

Scarce medicine

Substitutable medicine

Dose unit equivalence

Specific permitted circumstances

1

COUMADIN warfarin sodium 5 milligram tablet, registration number 42279

COUMADIN warfarin sodium 1 milligram tablet, registration number 42269

five tablets of substitutable medicine are equivalent to one tablet of scarce medicine

the pharmacist has:

(a) advised 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 in column 4; and

(b) ensured that the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine

2

COUMADIN warfarin sodium 5 milligram tablet, registration number 42279

COUMADIN warfarin sodium 2 milligram tablet, registration number 14937

two and a half tablets of substitutable medicine are equivalent to one tablet of scarce medicine

the pharmacist has:

(a) advised 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 in column 4; and

(b) where cutting of the tablet is required to obtain the correct dose of substitutable medicine—provided instructions to the patient, or person acting on behalf of the patient, for cutting the tablet; and

(c) ensured that the patient, or person acting on behalf of the patient, has access to information to support them in administering the substitutable medicine


 

Schedule 2—General permitted circumstances

Note:       See section 6.

General permitted circumstances

Column 1

Column 2

Item

Circumstances

1

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

2

the pharmacist does not have access to the scarce medicine

3

the prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted

4

the pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine

5

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

6

the patient, or person acting on behalf of the patient, has consented to receiving the substitutable medicine

7

the pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing

8

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