Amoxicillin Serious Scarcity Substitution Instrument in force

These shortages are due to manufacturing issues at a major supplier leading to unexpected increases in demand for alternative suppliers.

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. Amoxicillin is a widely used antibiotic used to treat many different bacterial infections.

To assist with timely access for patients using amoxicillin, the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Amoxicillin) Instrument 2022. This SSSI:

·       declares most oral amoxicillin medicines as scarce medicines;

·       specifies the substitute medicine as per the substitution protocol provided in the table included in the SSSI;

·       does not declare 250mg capsules as scarce medicines because of the potential impact this would have on supply of the liquid formulations.

While amoxicillin products generally are in short supply, some have limited availability. This SSSI allows a pharmacist to dispense another amoxicillin product to a patient when one is available without prior approval to substitute from the prescriber. The pharmacist will then notify the prescriber of the substitution soon after and will include the correct instructions to the patient for the provided amoxicillin product.

The SSSI allows a pharmacist to offer to the patient or their carer:

·       an alternate amoxicillin syrup or suspension strength when the prescribed one is unavailable

·       amoxicillin 250mg capsules or 1 gram tablets if the prescribed 500mg capsules are unavailable

·       amoxicillin 250mg or 500mg capsules if the prescribed 1 gram tablets are unavailable.

The SSSI is in force from 6 December 2022 until 31 May 2023. You can read more here.