PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument
Page last updated: 29 February 2024
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 an 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 an SSSI may be accessed at PBS subsidy for medicines subject to a Serious Scarcity Substitution Instrument (PDF 188KB) - (Word 35KB).
In addition to subsidising SSSIs to manage medicine shortages, the Department also works with sponsors of section 19A medicines to implement PBS subsidisation where possible. Further information is available at Section 19A products subsidised by the Pharmaceutical Benefits Scheme.
PBS Listed Scarce and Substitutable Medicines
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Scarce medicine(s) |
Substitutable medicine(s) |
Item codes for substitution where applicable |
Notes |
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For |
Use |
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Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one tablet of gliclazide MR 30 mg tablet is equivalent to half a tablet of gliclazide MR 60 mg tablet. If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance. |
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Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one fluoxetine 20 mg tablet is equivalent to two fluoxetine 10 mg capsules. If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance. If the required quantity is more than the listed maximum quantity, the authority prescription number '00000246' should be used. The PBS Online warning (reason code 151) can be disregarded in this circumstance. For substituting existing prescriptions of fluoxetine 20 mg tablets prescribed prior to 1 February 2024, a new prescription will be required. |
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Fluoxetine 20 mg tablet (PI, CMI) Zactin Tablet |
Fluoxetine 20 mg capsule (PI, CMI) Prozac 20 |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one fluoxetine 20 mg tablet is equivalent to one fluoxetine 20 mg capsule. If the substitutable medicine is an authority approved prescription, the PBS Online warnings (reason code 162 or 163) can be disregarded in this circumstance. |
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CEFALEXIN |
CEFALEXIN |
3320R |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that 250 mg of cefalexin is equivalent to 10 mL of cefalexin 125 mg/5 mL and 5 mL of cefalexin 250 mg/5 mL. |
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CEFALEXIN |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that 250 mg of cefalexin is equivalent to 10 mL of cefalexin 125 mg/5 mL and one capsule of cefalexin 250 mg. |
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CEFALEXIN |
CEFALEXIN |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that 250 mg of cefalexin is equivalent to 5 mL of cefalexin 250 mg/5 mL 100mL and 10mL of cefalexin 125 mg/5 mL 100mL. 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 this circumstance. |
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CEFALEXIN |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that 250 mg of cefalexin is equivalent to 5 mL of cefalexin 250 mg/5 mL 100mL and one capsule of cefalexin 250 mg. |
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INSULIN DEGLUDEC + INSULIN ASPART Injections, pre-filled pen, 70 units-30 units per mL, 3 mL, 5 (PI, CMI) |
INSULIN DEGLUDEC + INSULIN ASPART Injections, cartridges, 70 units-30 units per mL, 3 mL, 5 (PI, CMI) |
11417X |
11426J |
Supply must be in accordance with the TGA SSSI. The TGA's SSSI requires that the amount of substitutable medicine dispensed results in the patient receiving an equivalent dosage regimen to their prescription for scarce medicine. It is noted that one pre-filled pen, 70 units-30 units per mL, 3 mL is equivalent to one cartridge, 70 units-30 units per mL, 3 mL |
