The Therapeutic Goods Administration (TGA) has been notified of shortages of cefaclor oral liquid products Keflor and Ceclor. These shortages are due to an unexpected increase in demand. The current global shortage of antibiotics and long lead times for ingredients have significantly impacted supply.
Cefaclor is a type of antibiotic that belongs to a group of medicines called cephalosporins. It is used to treat bacterial infections that are sensitive to this ingredient, including respiratory tract infections, skin infections, acute otitis media, and acute sinusitis.
To assist with timely access for patients needing cefaclor oral liquid, we have approved overseas-registered cefaclor medicines. Pharmacists can ask about ordering these overseas-registered alternatives for you by contacting the approval holder listed in the section 19A approvals database.
We have also made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Cefaclor) Instrument 2023. This SSSI:
- declares both 125mg/5mL and 250mg/5mL cefaclor oral liquid strengths as scarce medicines
- declares as all cefaclor oral liquid strengths as substitutable medicines as per the substitution protocol provided in the table included in the SSSI.
While both strengths of cefaclor oral liquid are in shortage, local availability may vary.
The SSSI allows a pharmacist to provide another strength of cefaclor oral liquid 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 cefaclor product.
It is in force from 1 May 2023 until 30 September 2023. It may be extended if the shortage continues, or the TGA 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 cefaclor oral liquid 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 cefaclor.
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.
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 About the antibiotics shortage 2022-2023.
Some patients may not tolerate solid dosage forms and may only be able to take a liquid presentation. For those patients, if an oral liquid is not available, refer them back to their prescriber to consider alternative treatment. If providing a different strength of cefaclor 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 a cefaclor product 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.
Please advise patients to contact their prescriber if cefaclor is not available from your pharmacy so they can consider an alternative antibiotic if necessary.
Information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI can be found on the PBS website.
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 your 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 strength cefaclor oral liquid has been supplied due to the prescribed strength 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.
- 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.
- Consider how you explain to the patient or their carer the total duration of their course of cefaclor, and there may be some medicine leftover at the end of their 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 cefaclor oral liquid and suspension products when prescribing for your patients. However, continue to follow best practice prescribing for antibiotics.
When prescribing cefaclor oral liquid, consider if a solid dosage form could be prescribed instead. This will help to preserve liquids for paediatric patients and patients with swallowing difficulties.
Be alert to the potential that pharmacists may offer patients a different strength of cefaclor liquid to what was prescribed.
Patients will be advised to contact you if cefaclor 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 About the antibiotics shortage 2022-2023.
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 it is a different strength of the active ingredient. The pharmacist will supply the correct total dose as prescribed.
Cefaclor is used for many conditions, including respiratory tract infections, skin infections, acute otitis media, and acute sinusitis. Talk to your doctor, nurse, pharmacist, Aboriginal and Torres Strait Islander health worker or practitioner to make sure you get good medicine.
If you have been prescribed a liquid dosage form and are unable to take a capsule or tablet, advise your pharmacist.
You should take cefaclor for the number of days instructed by your doctor, pharmacist, nurse, or health worker. 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 the TGA website.
Information on how the substitute cefaclor 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 cefaclor.
If you are unable to fill your cefaclor 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.