Serious Scarcity Substitution Instruments (SSSIs)

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.

We make SSSIs for prescription-only medicines. This means a medicine that contains a Schedule 4 substance according to the current Poisons Standard. We can’t make an SSSI for a controlled drug containing a Schedule 8 substance, or for an over-the-counter medicine.

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.

For more information about SSSIs, go to: Substituting scarce medicines.

Current SSSIs

The following table displays all current SSSIs along with links to the Medicine shortage alerts on our website and the full SSSI documents for more information.

The legislative instrument remains in effect until the specified date, but it may be revoked before its end date if needed, for example if the 'scarce medicine' is no longer scarce.

Pharmacists are encouraged to subscribe to the TGA Medicine shortages alert service or social media channels for updates on SSSIs.

See the second table below for details of lapsed or revoked SSSIs: Lapsed SSSIs.

Information for pharmacists about dispensing the substitutable medicine

When you are unable to dispense a prescription for a Schedule 4 medicine (to the current Poisons Standard) because that medicine is unavailable, you should check if there is a current SSSI in the table above.

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.

SSSI availability in different states and territories

When the prescriber has specified that brand substitution is not permitted

Advising the prescriber about the substitution

Using an SSSI for emergency supply

If access to the scarce medicine is available

SSSIs and electronic prescribing

Dispensing a substitutable medicine for repeat scripts

Dispensing for residential aged care facilities

Compounding when there is an SSSI in place

SSSIs and the Pharmaceutical Benefits Scheme (PBS)

The following table displays all SSSIs that have ended.