Pharmaceutical company Sanofi-Aventis notified the Therapeutic Goods Administration (TGA) in August 2023 about a shortage of the tablet form of their vigabatrin product, Sabril. A global recall will affect supply until at least the end of October 2023, but the shortage may continue until the end of the year.
We recognise the importance of continuous supply of this medicine to people living with epilepsy who are prescribed vigabatrin.
Although the oral 0.5 g powder sachet form of Sabril was also recalled, Sanofi-Aventis has advised that there should be enough unaffected sachets available to cover patients’ needs until the tablets are available again.
For more information about the background to the product recall and the shortage, go to the medicine shortage alert published on 8 August 2023. This alert also includes guidelines for use of the sachets in place of the tablets for patients, clinicians and pharmacists.
We have approved overseas-registered vigabatrin (Sabril) tablets under section 19A of the Therapeutic Goods Act 1989 (Act). However, we are aware that supply of this stock is extremely limited.
We have also made a Serious Scarcity Substitution Instrument (SSSI) that allows pharmacists to dispense Sabril sachets to patients with a prescription for Sabril tablets if the tablets are unavailable and when the pharmacist judges that it is appropriate.
For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).
Information for pharmacists
If Australian Sabril tablets are unavailable, you can dispense the overseas-registered vigabatrin (Sabril) tablets approved under section 19A of the Act if they are available. Because they have the same name, strength, quantity and sponsor as the Australian Sabril, these approved vigabatrin tablets are PBS subsidised. You can find information about the Pharmaceutical Benefits Scheme (PBS) subsidy of medicines approved under section 19A on the PBS website.
If Sabril tablets are not available but you have access to the Sabril sachets, you could use the SSSI. The SSSI allows you to substitute vigabatrin (Sabril) oral sachets without prior approval from the prescriber if the permitted circumstances of the SSSI are met. See both the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2) of the SSSI.
You can find information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI on the PBS website.
When using the SSSI, you should do the following:
- Use your clinical judgement to determine if a substitution is appropriate for the patient.
- Give the patient the equivalent quantity of sachets to the number of tablets they were prescribed, as required by the SSSI, and include the correct instructions for the substitute product.
- Explain to the patient or their carer and confirm they understand that one sachet of the powder will give them the same dose (0.5 g) of vigabatrin as one tablet (500 mg), and how to prepare and take the oral powder.
- Use educational resources, translation services, or engage the support of a carer or organisation such as the local Aboriginal Community Controlled Health Organisation (ACCHO), to explain the substitution, if needed, or refer the patient to their prescriber.
- Provide the patient or their carer with information about the medicine, such as the Consumer Medicines Information (CMI) leaflet, if needed.
- Notify the prescriber of the substitution afterwards.
Information for prescribers
Keep in mind that there is a shortage of vigabatrin (Sabril) tablets when prescribing for your patients, particularly when starting new patients on the medicine.
With an SSSI in place, the pharmacist may:
- give your patient vigabatrin sachets in place of tablets, or they may refer the patient to you to review their needs
- give your patient instructions about how to prepare and take the oral powder, or they may ask the patient to contact you for guidance
- ask your patient to contact you if the pharmacy does not have tablets or sachets in stock.
Information for patients
If you have a prescription for Sabril tablets and they are unavailable, your pharmacist may offer you the sachets instead. Talk to your prescribing doctor or pharmacist if you have any questions about this substitution.
If you are receiving sachets in place of tablets, the pharmacist will:
- explain that one Sabril sachet contains the same amount of vigabatrin as one Sabril tablet
- supply you with the same number of sachets as the number of tablets you have been prescribed by your doctor
- explain how to prepare the sachet (dissolve the powder in half a glass of water, juice or soft drink − it will dissolve easily and has no taste or smell)
- tell you to drink the solution immediately (or if any remains, to throw it away within 24 hours).
In some situations, the pharmacist may ask you to see your GP or specialist for instructions about taking the sachets.
Please keep in mind that excipients (inactive ingredients, including sweeteners, flavours, and colours) vary between brands and formulations of medicines, so you should tell your pharmacist if you are allergic or intolerant to certain ingredients. You can 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 Consumer Medicines Information page of our website.
Information on how the substitute medicine is subsidised on the Pharmaceutical Benefits Scheme (PBS) can be found on the PBS website.
If you are unable to fill your Sabril prescription, you should speak to your doctor about possible alternatives.
Medicine shortages happen for a range of reasons and sometimes cannot be prevented. We continue to monitor the supply of important medicines and are committed to helping you when your medicine supply may be affected by a shortage.