Due to the ongoing shortage of multiple strengths and presentations of oral liquid cefalexin medicines we have extended the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Instrument 2023 (SSSI). This instrument allows pharmacists to substitute different strengths of cefalexin oral liquid based on stock availability, using a patient’s existing prescription.
The current SSSI was due to expire on 31 October 2023 and has been extended by the Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefalexin) Amendment Instrument 2023 . The SSSI will remain in force until 30 April 2024 and continues to assist with timely access for patients using oral cefalexin syrups and suspensions.
- declares oral cefalexin syrups and suspensions as scarce medicines
- specifies the substitute medicine as per the substitution protocol provided in the table included in the SSSI
This SSSI allows a pharmacist to provide another cefalexin 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 cefalexin product.
The SSSI allows a pharmacist to offer to the patient or their carer:
- an alternative cefalexin syrup or suspension strength when the prescribed one is unavailable
- cefalexin 250 mg capsules if the prescribed syrup or suspension is unavailable, the patient can swallow capsules, and the dose is divisible by 250.
The SSSI is in force from 1 August 2023 until 30 April 2024. It may be extended if the shortage continues, or we may 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
The SSSI allows you to substitute the specified cefalexin 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 cefalexin.
Use your professional and clinical judgement to determine whether a patient is suitable for substitution. Some patients may not tolerate certain dosage forms and may only be able to take a liquid presentation. For those patients, if an oral solution is not available, refer them back to their prescriber to consider alternative treatment.
Consider how you obtain informed consent from the patient and make sure they understand the substitution. You may need to use educational resources, translation services, or engage a support from a carer or organisation such as the local Aboriginal Community Controlled Health Organisation (ACCHO).
A list of resources to help health professionals and consumers during the antibiotic shortages is available at our About the antibiotics shortage 2022-2023 page.
If providing a different strength of cefalexin oral liquid, consider how you will facilitate the patient or their carer being able to measure the required volume accurately. You may need to supply a measuring device.
You can use an overseas- registered cefalexin medicine approved under section 19A of the Therapeutic Goods Act 1989 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 a suitable cefalexin product is not available from your pharmacy so they can consider an alternative antibiotic if necessary.
You can choose the best way to communicate with the prescriber about the substitution. You can use email, fax, a letter, or phone call, at the time of the substitution or as soon as practicable after you have performed the substitution.
Many of the following actions are usual pharmacist practice but are included here for clarity as they must be followed to use the SSSI:
- Use clinical judgement to determine if a substitution is appropriate for the patient.
- 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 contains the same active ingredient but is a different strength
- 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 capsule presentations dispensed instead of a liquid presentation:
- confirm that the patient can take a capsule dosage form
- the prescribed dose must be divisible by 250 mg
- inform the patient about the differences between the products.
- Explain the total duration of the course of cefalexin to the patient or carer, including that there may be some medicine left over at the end of the course, so they clearly understand this information.
- Provide the patient or their carer 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 cefalexin 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.
When prescribing an oral liquid or suspension cefalexin, consider if a capsule dosage form can be prescribed instead to preserve liquids for paediatric patients and patients with swallowing difficulties.
Be alert to the potential that patients may be offered a substitute product by the pharmacist.
A pharmacist may supply a capsule presentation instead of a liquid presentation if the prescribed dose is divisible by 250 mg and they have confirmed that the patient is able to take capsules.
Patients will be advised to contact you if cefalexin is not available from their pharmacy. Please consider an alternative antibiotic if necessary.
A list of resources to help health professionals and consumers during the antibiotic shortages is available at our About the antibiotics shortage 2022-2023 page.
Information for patients
Talk to your prescribing doctor or pharmacist if you have any questions about this substitution.
The substitute medicine contains the same active ingredient as your prescribed medicine but may be in a different dosage form or contain a different strength of the active ingredient. The pharmacist will supply the correct total dose that has been prescribed by the doctor.
If you or someone in your care has been prescribed a liquid medicine and can’t take a capsule, let your pharmacist know.
You should take cefalexin for the number of days instructed by your doctor and pharmacist. This may result in some leftover medicine at the end of the course.
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, as well as other information, in the Consumer Medicine Information (CMI) leaflet, which is available from your pharmacist or on our Consumer Medicines Information page.
Information on how the substitute cefalexin 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 cefalexin. Please do not take any frustration or anger out on your pharmacist or doctor.
If you are unable to fill your cefalexin prescription, you should speak to your pharmacist or doctor about possible alternatives.
Medicine shortages occur for a range of reasons and sometimes cannot be prevented. We continue to actively monitor the supply of important medicines and is committed to assisting you in situations where your medicine supply may be disrupted.
Background information about antibiotic shortages
Cefalexin is a widely used antibiotic used to treat many different bacterial infections. The shortage of cefalexin products occurred due to manufacturing issues at a major supplier, which lead to unexpected increases in demand for alternative suppliers. Similar issues also affected the supply of a range of other antibiotics. For comprehensive information, go to our About the antibiotics shortage 2022-2023 page.