PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument

Page last updated: 27 September 2021

Pharmacists can dispense substitutable medicines in place of prescribed medicines that are in shortage (scarce medicines) without prior approval from the prescriber in circumstances where the Therapeutic Goods Administration (TGA) has issued a Serious Scarcity Substitution Instrument (SSSI) in respect of that medicine.  PBS listed scarce medicines and the respective substitutable medicines that are eligible for PBS subsidy under these arrangements are listed below.

Information about the conditions and specified permitted circumstances that apply to a SSSI are published on the TGA website. Please note that all substitutions must be supplied in accordance with the TGA SSSI.

Section 5 of the National Health (Pharmaceutical Benefits) (Pharmacist Substitution of Medicines without Prescription during Shortages) Determination 2021 outlines the conditions that must be met for PBS subsidised supply.

Frequently Asked Questions about PBS subsidy arrangements for PBS listed medicines subject to a SSSI may be accessed at PBS subsidy for medicines subject to a Serious Scarcity Substitution Instrument (PDF 188KB) - (Word 35KB).

PBS Listed Scarce and Substitutable Medicines

Scarce medicine(s) Substitutable medicine(s) Item codes for substitution where applicable Notes
For Use

ESTRADIOL
estradiol valerate 1 mg tablet (PI, CMI)
Progynova

ESTRADIOL
estradiol 2 mg tablet (PI, CMI)
Zumenon

1663M

8274L

Supply must be in accordance with the TGA SSSI.

The TGA’s SSSI requires that the amount of Zumenon (estradiol) 2 mg dispensed results in the patient receiving an equivalent dosage regimen and duration to their prescription for Progynova (estradiol valerate) 1 mg

ESTRADIOL
estradiol valerate 2 mg tablet (PI, CMI)
Progynova

ESTRADIOL
estradiol 2 mg tablet (PI, CMI)
Zumenon

1664N

8274L

Supply must be in accordance with the TGA SSSI.

ISOSORBIDE MONONITRATE
Tablet 120 mg (sustained release) (PI, CMI)
Imdur 120 mg
Monodur 120 mg

ISOSORBIDE MONONITRATE
Tablet 60 mg (sustained release) (PI, CMI)
APO-Isosorbide Mononitrate
Duride
GenRx Isosorbide Mononitrate
Imdur Durule
ISOBIDE MR
Isomonit
Isosorbide AN
Monodur 60 mg

8273K

1558B

Supply must be in accordance with the TGA SSSI.

The TGA's SSSI requires that the amount of isosorbide mononitrate 60 mg dispensed results in the patient receiving an equivalent dosage regimen and duration to their prescription for isosorbide mononitrate 120 mg. If the required quantity is more than the maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151), can be disregarded in these circumstances.

TOCILIZUMAB
tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL syringes (PI, CMI)
Actemra Subcutaneous Injection

TOCILIZUMAB
tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (PI, CMI)
Actemra ACTPen

(syringe item codes)

(pen item codes)

Supply must be in accordance with the TGA SSSI.

Approved suppliers are asked to dispense against the item code for the substitute benefit with restriction criteria that is identical to that of the restriction criteria for the prescribed benefit, as provided in this table.

10954M

11567T

10951J

11565Q

11730J

11750K

11741Y

11725D

11720W

11742B

11748H

11734N

11721X

11722Y

11743C

11744D

12099T

12084B

12095N

12083Y

12086D

12090H

12102Y

12094M

12105D

12085C

TOCILIZUMAB
tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL pen devices (PI, CMI)
Actemra ACTPen

TOCILIZUMAB
tocilizumab 162 mg/0.9 mL injection, 4 x 0.9 mL syringes (PI, CMI)
Actemra Subcutaneous Injection

(pen item codes)

(syringe item codes)

Supply must be in accordance with the TGA SSSI.

Approved suppliers are asked to dispense against the item code for the substitute benefit with restriction criteria that is identical to that of the restriction criteria for the prescribed benefit, as provided in this table.

11567T

10954M

11565Q

10951J

11750K

11730J

11725D

11741Y

11742B

11720W

11734N

11748H

11722Y

11721X

11744D

11743C

12084B

12099T

12083Y

12095N

12090H

12086D

12094M

12102Y

12085C

12105D