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.

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.

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

How do I know if the substitution is allowed in my state or territory?

Can I dispense a substitutable medicine if the prescriber has specified on the prescription that brand substitution is not permitted?

Do I need to tell the prescriber about the substitution?

Can an SSSI be used for emergency supply?

Can I dispense the substitutable medicine if I have access to the scarce medicine?

How does the substitution work with electronic prescribing?

Can I dispense a substitutable medicine for repeat scripts?

What should I do if the patient experiences a problem with a substitutable medicine?

Can SSSIs be applied to the dispensing of medicines from medication charts in residential aged care facilities (RACF)?

Can I compound a scarce medicine if there is an SSSI in place?

Will substitutable medicines dispensed under an SSSI be subsidised through the PBS?

Lapsed SSSIs

The following table displays all SSSIs that have ended, and links to the alerts and web statements that were published about them.