Substitution allowed to address shortage of amoxicillin
The Therapeutic Goods Administration (TGA) has been notified of shortages of all strengths and presentations of oral amoxicillin medicines (capsules, tablets and oral suspensions). These shortages are due to manufacturing issues at a major supplier leading to unexpected increases in demand for alternative suppliers.
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 provide another amoxicillin medicine, when the prescribed medicine is unavailable, without prior approval 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 alternative 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. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. This SSSI is in effect in all states and territories.
For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).
Information for pharmacists - Information for prescribers - Information for patients
Information for pharmacists
The SSSI allows you to substitute the specified amoxicillin products without prior approval from the prescriber so long as the permitted circumstances provided within the SSSI are met. See both the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI for amoxicillin.
Use your 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.
You can use an amoxicillin medicine approved under section 19A of the Act as a substitute for a scarce medicine. More information on these products is available on the Section 19A approvals database.
Information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI can be found on the PBS website.
Please advise patients to contact their prescriber if amoxicillin is not available from your pharmacy so they can consider an alternative antibiotic if necessary.
- Calculate and provide the correct dose to the patient or their carer.
- Explain to the patient or their carer and confirm their understanding that:
- A different product has been supplied due to the prescribed product being unavailable.
- Each medicine is the same active ingredient but are different strengths.
- If the patient takes the medicine as directed by the pharmacist, the patient will receive the same dose they were prescribed.
- For liquid preparations:
- Calculate the correct volume required to provide the prescribed dose.
- Include the correct dose, written in millilitres, on the dispensing label.
- If multiple bottles are being dispensed, manage the reconstitution and supply of the bottles so that the treatment course will finish prior to the expiry of reconstituted bottles.
- For tablet or capsule presentations:
- Calculate the number of tablets or capsules required to provide the prescribed dose.
- Include the correct dose on the dispensing label.
- Inform the patient about the differences between the products and that each medicine has the same active ingredient but are different strengths.
- Provide the patient with information to support them in administering these medicines such as the Consumer Medicines Information (CMI) leaflet, if required.
Information for prescribers
Consider the current shortage of amoxicillin when prescribing for your patients but continue to follow best practice prescribing for antibiotics. Do not change your prescribing practice to second-line antibiotics without strong clinical indications for doing so.
Be alert to the potential that patients may be offered a substitute product by the pharmacist.
Patients are advised to contact you if amoxicillin is not available from their pharmacy. Please consider an alternative antibiotic if necessary.
Information for patients
Talk to your prescribing doctor or pharmacist if you have any questions about this substitution.
The substitute medicines contain a different strength of the same active ingredient that your doctor prescribed, the pharmacist will supply the correct total dose as prescribed.
Each medicine is the same active ingredient but are different strengths. If you take the medicine as directed by your pharmacist, you will receive the same dose that was prescribed to you.
Excipients (inactive ingredients, including sweeteners, flavours, and colours) vary between brands. Let your pharmacist know if you are allergic or intolerant to certain ingredients. You can also find information about excipients in the Consumer Medicine Information (CMI) leaflet, which is available from your pharmacist or on the TGA website.
Ask your pharmacist for information to support you in taking these medicines. Your pharmacist may provide you with both the Consumer Medicines Information (CMI) leaflet and information from the sponsor of these medicines.
Information on how the substitute amoxicillin medicines are subsidised on the Pharmaceutical Benefits Scheme (PBS) can be found on the PBS website.
Please keep in mind that health professionals at the medical practices and pharmacies you visit want the best possible health outcomes for everyone, but they do not control the availability of amoxicillin. Please do not take any frustration or anger out on your pharmacist or doctor.
If you are unable to fill your amoxicillin prescription, you should speak to your pharmacist or doctor about possible alternatives.
Medicine disruptions occur for a range of reasons and sometimes shortages cannot be prevented. The TGA continues to actively monitor the supply of important medicines and is committed to assisting you in situations where your medicine supply may be disrupted.