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This instrument declares that there is a serious scarcity across Australia of specified medicines containing the active ingredient estradiol valerate, and specifies the substitutable medicines that pharmacists are permitted to dispense in substitution in permitted circumstances.
Administered by: Health
Registered 12 Aug 2021
Tabling HistoryDate
Tabled HR23-Aug-2021
Tabled Senate23-Aug-2021
To be ceased 01 May 2022
Ceased by Self Ceasing
Table of contents.

Commonwealth Coat of Arms of Australia

 

Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021

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

Dated 12 August 2021

Dr Jane Cook

First Assistant Secretary
Medicines Regulation Division
Health Products Regulation Group
Department of Health

 

 

 


Contents

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

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

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

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

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

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

7  Period instrument in force........................................................................................................ 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) (Estradiol Valerate) Instrument 2021.

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

The day after this instrument is registered.

 

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)    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.

scarce medicine has the meaning given by section 5.

substitutable medicine has the meaning given by section 6.

Declaration of 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, the 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 1 May 2022.


 

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

PROGYNOVA estradiol valerate 1 milligram tablet, registration number 10708

ESTROFEM estradiol (as hemihydrate) 1 milligram tablet, registration number 188520

one tablet of substitutable medicine is equivalent to one tablet of scarce medicine

the pharmacist has 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

2

PROGYNOVA estradiol valerate 1 milligram tablet, registration number 10708

ZUMENON estradiol (as hemihydrate) 2 milligram tablet, registration number 75888

one-half of a tablet of substitutable medicine is equivalent to one tablet of scarce medicine

the pharmacist has advised the patient, or person acting on behalf of the patient, of:

(a)  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 the substitutable medicine—the instructions for cutting the tablet

3

PROGYNOVA estradiol valerate 2 milligram tablet, registration number 323720

ESTROFEM estradiol (as hemihydrate) 2 milligram tablet, registration number 188521

one tablet of substitutable medicine is equivalent to one tablet of scarce medicine

the pharmacist has 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

4

PROGYNOVA estradiol valerate 2 milligram tablet, registration number 323720

ZUMENON estradiol (as hemihydrate) 2 milligram tablet, registration number 75888

one tablet of substitutable medicine is equivalent to one table of scarce medicine

the pharmacist has 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

 


 

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