Serious Scarcity Substitution Instruments (SSSIs)
Find out about current and lapsed Serious Scarcity Substitution Instruments (SSSIs). They allow community pharmacists to substitute medicines, without prior approval, in permitted circumstances.
Serious Scarcity Substitution Instruments (SSSIs) allow community pharmacists to substitute specific medicines without prior approval from the prescriber so long as the permitted circumstances within the SSSI are met.
Through an SSSI, patients can receive their medicines from their pharmacist without delay, ensuring treatments are not interrupted. It also relieves workload pressure on prescribers and pharmacists.
Current SSSIs
The following table displays all current SSSIs along with links to the alerts and the issued web statement for further information.
The legislative instrument remains in effect until the specified date, but it may be revoked before its end date if needed e.g. if the 'scarce medicine' is no longer scarce.
SSSIs are published on the TGA Safety alerts.
Pharmacists are encouraged to subscribe to the TGA Medicine shortages alert service, or social media channels for updates on new or revoked SSSIs.
See section Lapsed SSSIs for a table of lapsed or revoked SSSIs.
| Issue date | Alert | Scarce medicine(s) | Serious Scarcity Substitution Instrument (SSSI) | Duration of SSSI |
|---|---|---|---|---|
| 2024/12/16 | Discontinuation of Protaphane InnoLet insulin cartridges and approval of a substitute | PROTAPHANE INNOLET human insulin (rys) 100 IU/mL injection multidose cartridge, registration number 169633 | Federal Register of Legislation - Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Isophane Human) Instrument 2024 - external site | 16 December 2024 to 28 February 2026 |
| 2024/11/19 | Substitutions approved for HRT patch shortages |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol) Instrument 2024 - external site | 19 November 2024 – 31 January 2026 |
| 2024/09/27 | Substitution approved for Ryzodeg 70/30 FlexTouch shortage | RYZODEG 70/30 FLEXTOUCH 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Degludec and Insulin Aspart) Instrument 2024 - external site | 27 September 2024 to 31 March 2025 |
For Pharmacists - Dispensing the substitutable medicine
When you are unable to dispense a prescription for a Schedule 4 medicine (to the current Poisons Standard) because the supply of that medicine is unavailable, you should check if there is a current SSSI. This information can be found on the TGA's Medicine Shortages website.
You can only offer a substitutable medicine specified in the SSSI. You must also ensure all specified circumstances are met before you dispense the substitutable medicine.
Some of the general permitted circumstances for substitutions include, but are not limited to:
- The patient or carer has evidence of a valid prescription for the scarce medicine, unless otherwise permitted by law
- The pharmacist does not have access to the scarce medicine
- The prescriber has not indicated on the prescription for the scarce medicine that substitution is not permitted
- The pharmacist has exercised professional judgement and determined that the patient is suitable to receive the substitutable medicine
- The patient or carer has consented to receiving the substitutable medicine
- The total quantity of substitutable medicine supplied by the pharmacist must be equivalent to the quantity that would have been dispensed for the scarce medicine for the prescribed duration and dosage regimen
- The pharmacist makes a record of dispensing the substitutable medicine in substitution of the scarce medicine at the time of dispensing
- 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
If you believe the patient is not suitable to receive the substitutable medicine (for example, the patient has a history of hypersensitivity) you should not make the substitution and must refer the patient/carer back to their prescriber to discuss treatment options.
The substitutable medicine must be dispensed in compliance with the legislation relevant to the jurisdiction where the dispensing occurs.
FAQs - Pharmacists
SSSIs are consistently applied across all states and territories. If the SSSI is in force, it is valid in all jurisdictions.
No, a substitutable medicine cannot be dispensed if the prescriber has specified on the prescription that brand substitution is not permitted, e.g. the prescriber has ticked the 'brand substitution not permitted' box on the prescription form. This means pharmacists are not permitted to provide any substitutable or alternative medicine and patients must be referred back to the prescriber.
Yes, the pharmacist must have a process in place to inform the prescriber of the substitution as soon as possible after dispensing the medicine described in the SSSI.
Under certain circumstances, individual state/territory regulations authorise a pharmacist to dispense a medicine without a prescription, such as in an emergency or continued dispensing provisions. SSSIs will not affect these arrangements and can be used according to your state/territory medicines and poisons legislation. For example, if you are permitted to provide three days' worth of a medicine under an emergency provision, you can provide three days' worth of a substitutable medicine specified in the SSSI.
No, pharmacists are not permitted to dispense a substitutable medicine if the scarce medicine is in stock, or if the SSSI is no longer in force or has been revoked.
Electronic prescriptions are not fundamentally different from the paper scripts. Pharmacists are allowed to annotate a prescription electronically as part of a dispensing activity to display the annotation and the modification so that any dispensing pharmacist will see the original prescription. The annotation from other pharmacists and details of the last prescription dispensed are also shown. Further information is available on Electronic Prescribing - Frequently Asked Questions - external site
Yes, a pharmacist can dispense the substitutable medicine when the circumstances in the SSSI are met, including repeats. You should simply annotate the script, as usual.
- If the patient experiences a problem with a substitutable medicine, you should report this to the TGA. Make sure the report mentions the problem relates to an SSSI. Your report will contribute to the TGA's monitoring of the safety of the SSSI post-implementation.
- For adverse events, visit the Adverse Event Reporting portal to report - external site.
- Patients should also be referred to their prescriber for review and consideration of alternative treatments.
- The prescriber should be notified if there is a problem with a substitutable medicine that affects the patient.
No, due to complexities around dispensing and administration of medicines in RACF, SSSIs are currently not suitable in this context.
A pharmacist should supply a commercial product if one is available as outlined in the current Pharmacy Board of Australia Guidelines on compounding of medicines.
- A list of the substitute medicines that are eligible for PBS subsidy under an SSSI is available on the PBS website - external site.
- Frequently Asked Questions about PBS subsidy arrangements for PBS listed medicines subject to an SSSI can be accessed at PBS subsidy for medicines subject to a Serious Scarcity Substitution Instrument (PDF 188KB) - external site - (Word 35KB) - external site.
Lapsed SSSIs
The following table displays all SSSIs that have ended, and links to the alerts and web statements that were published about them.
| Issue date | Alert | Scarce medicine(s) | Serious Scarcity Substitution Instrument (SSSI) | Duration of SSSI |
|---|---|---|---|---|
| 2024/05/15 | Substitution approved for Orencia (abatacept) shortages | ORENCIA (abatacept) 125 mg single dose syringe subcutaneous injection ORENCIA (abatacept) 125 mg single dose ClickJect prefilled autoinjector | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2024 - external site | 15 May 2024 to 31 October 2024 |
| 2024/02/29 | Substitute approved for gliclazide 30 mg tablets | APO-GLICLAZIDE MR 30mg tablets blister pack (AUST R 151303) GLICLAZIDE MR VIATRIS gliclazide 30mg modified release tablet blister pack (AUST R 295541) PHARMACOR GLICLAZIDE MR gliclazide 30mg modified release tablet blister pack (AUST R 316934) | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Gliclazide) Instrument 2024 - external site | 29 February 2024 to 31 July 2024 |
| 2023/12/11 | Substitution approved for fluoxetine 20 mg dispersible tablets (Zactin Tabs) | ZACTIN TABS fluoxetine hydrochloride 20mg dispersible tablet blister pack (AUST R 90913) | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Instrument 2023 - external site and Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Fluoxetine) Amendment Instrument 2024 - external site | 11 December 2023 to 30 September 2024 |
| 2023/07/05 | Substitution allowed to address shortage of Ryzodeg 70/30 FlexTouch insulin | RYZODEG 70/30 FLEXTOUCH 70% insulin degludec (rys) / 30% insulin aspart (rys) 100 U/mL solution for injection cartridge (AUST R 280432) | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Degludec and Insulin Aspart) Instrument 2023 - external site | 6 July 2023 to 5 June 2024 |
| 2023/10/31 | Extension to oral cefalexin substitution instrument | A registered medicine that contains:
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023- external site - external site and Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023- external site - external site | 31 October 2023 to 30 April 2024 |
| 2023/09/07 | Substitute approved for vigabatrin (Sabril) shortage | SABRIL vigabatrin 500 mg tablet blister pack | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Vigabatrin) Instrument 2023 - external site | 12 September 2023 to 31 January 2024 |
| 2023/04/14 | Substitution allowed to address shortage of phenoxymethylpenicillin |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Phenoxymethylpenicillin) Instrument 2023 - external site | 17 April 2023 to 30 September 2023 |
| 2023/04/28 | Substitution allowed to address shortage of cefaclor |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefaclor) Instrument 2023 - external site | 1 May 2023 to 30 September 2023 |
| 2023/03/16 | Substitution instrument to address the shortage of COUMADIN warfarin 5mg tablets | COUMADIN warfarin sodium 5mg tablet (AUST R: 42279) | Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Warfarin) Instrument 2023 - external site | 17 March 2023 to 7 August 2023 |
| 2022/12/20 | Substitution allowed to address shortage of cefalexin | A registered medicine that contains:
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2022 - external site | 21 December 2022 to 31 July 2023 |
| 2021/09/17 | Substitution instrument to address shortage of Imdur Durules and Monodur Durules isosorbide mononitrate 120 mg modified release tablets |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Isosorbide Mononitrate) Instrument 2021 - external site | 18 September 2021 to 30 June 2023 |
| 2022/12/05 | Substitution allowed to address shortage of amoxicillin | A registered medicine that contains:
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Amoxicillin) Instrument 2022 - external site | 6 December 2022 to 31 May 2023 |
| 2022/02/09 | Substitution instrument to address shortage of Orencia abatacept |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Abatacept) Instrument 2022 - external site | 9 February 2022 to 30 June 2022 |
| 2021/08/12 | Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths) |
| Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Estradiol Valerate) Instrument 2021 - external site | 13 August 2021 to 1 May 2022 |
| 2021/08/06 | Tocilizumab (Actemra) Serious Scarcity Substitution Instrument |
| 7 August 2021 to 30 April 2022 |
Page history
Update to add SSSI for Protaphane InnoLet insulin cartridges.
Update to add HRT patches SSSI and transfer Zactin, Gliclazide and Abatacept to lapsed SSSI table.
Updated to add details of fluoxetine SSSI.
Update to add SSSI for Protaphane InnoLet insulin cartridges.
Update to add HRT patches SSSI and transfer Zactin, Gliclazide and Abatacept to lapsed SSSI table.
Updated to add details of fluoxetine SSSI.