Substitution allowed to address shortage of amoxicillin

The ADA has been notified of shortages of all strengths and presentations of oral amoxicillin medicines (capsules, tablets, and oral suspensions). 

To assist with timely access for patients that require amoxicillin, the TGA has made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Amoxicillin) Instrument 2022.  The SSSI allows pharmacists to substitute without prior approval from the prescriber so long as the permitted circumstances provided within the SSSI are met. Pharmacists will be required to use professional and clinical judgement to determine whether a patient is suitable for substitution, inform the patient or their carer of the substitution, and gain their consent to the change.

It means that, if Amoxicillin is prescribed and the specific strength and/or formulation on the script is unavailable, the pharmacist can legally dispense a different formulation or strength that still delivers the same overall Amoxicillin dose.  But please be aware that this does not empower the pharmacist to substitute a different antibiotic, not even Amoxicillin with clavulanic acid.
 
For more information about SSSIs, please see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).

The SSSI is in force from 06 December 2022 until 31 May 2023. The TGA may however, revoke this SSSI before its end date if the serious scarcity is resolved or safety concerns are identified. The SSSI is in effect in all states and territories. 

What you need to do

- Consider the current shortage when prescribing for your patients. Do not change your prescribing practice to second-line antibiotics without strong clinical indication for doing so. Always continue to follow best practice prescribing for antibiotics. 

- Be alert to the potential that patients may be offered a substitute product by the pharmacist and may contact you if amoxicillin is not available from their pharmacy. Please consider an alternative antibiotic if necessary. 

- Remember as an ADA member, you have free access to AusDi online to determine an alternate antibiotic or if in doubt contact the ADA’s Pharma Advice line or refer to the Therapeutic Guidelines Oral and Dental a copy of which you receive as a member. 

For further assistance, you can contact the ADA's PharmaAdvice service.