PBS subsidy arrangements for medicines subject to a Serious Scarcity Substitution Instrument
Page last updated: 18 December 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.
NOTE: The estradiol (brand: Estramon Germany) packs of 24 are not included in the estradiol SSSI.
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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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) |
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. |
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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 patch that releases estradiol 25 microgram/24 hours patch is equivalent to one patch that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 25 microgram/24 hours patch is equivalent to one patch that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to one patch that releases estradiol 50 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to one patch that releases estradiol 50 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 50 microgram/24 hours patch is equivalent to two patches that releases estradiol 25 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 75 microgram/24 hours patch is equivalent to two patches that releases estradiol 37.5 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to one patch that releases estradiol 100 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to one patch that releases estradiol 100 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch. 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. |
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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 patch that releases estradiol 100 microgram/24 hours patch is equivalent to two patches that releases estradiol 50 microgram/24 hours patch. 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. |
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Insulin isophane human 100 units/mL injection, 5 x 3 mL pen devices (PI, CMI) |
Insulin isophane human 100 units/mL injection, 5 x 3 mL cartridges (PI, CMI) |
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 3 mL (300 unit) cartridge of the substitutable medicine is equivalent to one 3 mL (300 unit) pre‑filled cartridge of the scarce medicine. |
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