THE TGA is informing pharmacists that due to the shortage of epilepsy medication, vigabatrin (Sabril), it has approved overseas-registered vigabatrin tablets under section 19A of the Therapeutic Goods Act 1989.
However, as the TGA is aware that supply of this stock is limited, it has also made a Serious Scarcity Substitution Instrument (SSSI), which allows pharmacists to dispense Sabril sachets to patients, with a prescription for Sabril tablets if the tablets are unavailable, and when pharmacist judges that it is appropriate.
The TGA reminds pharmacists that if Sabril tablets are not available but they have access to the Sabril sachets, they could use the SSSI.
The SSSI allows pharmacists to substitute vigabatrin (Sabril) oral sachets without prior approval from the prescriber, if the permitted circumstances of the SSSI are met.
The TGA says pharmacists should explain to the patient, and confirm they understand that one sachet of the powder (0.5g) of vigabatrin is equivalent as one tablet (500mg), and how to prepare and take the oral powder.
The prescriber should be notified of the substitution afterwards.
The above article was sent to subscribers in Pharmacy Daily's issue from 18 Sep 23
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