PBS arrangements due to shortage of Zactin Tablet® (fluoxetine) dispersible tablets effective 1 February 2024
Page last updated: 2 February 2024
Due to the medicine shortage of fluoxetine (brand: Zactin Tablet), the department will be temporarily listing on the PBS an alternative brand, Fluoxetine 10 mg Capsules (Medreich, UK) from 1 February 2024.
The Therapeutic Goods Administration (TGA) has temporarily approved the supply of the Medreich brand under section 19A of the Therapeutic Goods Act 1989. Section 19A (s19A) of the Therapeutic Goods Act 1989 allows overseas-registered medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply. The Medreich brand of fluoxetine is registered in the UK.
Given the limited supply of Fluoxetine 10 mg Capsules, it will be listed as a PBS restricted benefit with the clinical criteria that it be prescribed only to patients who require the 10 mg dose either for their treatment regimen or to achieve their total recommended dose.
Changes to PBS Listing effective 1 February 2024:
Temporary s19A PBS listing of Fluoxetine Capsules 10 mg (Medreich, UK)
PBS listing from 1 February 2024
PBS restricted benefit – clinical criteria
Fluoxetine, Tablet, dispersible, 20 mg (as hydrochloride), Zactin Tablet
Pack of 28 tablets
Fluoxetine, Capsule 10 mg (Medreich) (S19A), Fluoxetine Capsules 10 mg (Medreich, UK)
Pack of 30 capsules
The listing has additional clinical criteria, ‘Patient must be receiving this drug under this restriction at a dose of 10 mg OR Patient must be receiving this drug under this restriction where a 10 mg strength is required to administer the total dose.’
Advice for prescribers from 1 February 2024:
- To receive Fluoxetine 10 mg Capsules as a PBS benefit, patients must be issued a new prescription dated on or after the PBS listing date of 1 February 2024.
- The listing has PBS restriction criteria, ‘Patient must be receiving this drug under this restriction at a dose of 10 mg OR Patient must be receiving this drug under this restriction where a 10 mg strength is required to administer the total dose.’
- Due to limited supply of Fluoxetine 10 mg Capsules, please consider writing separate prescriptions for fluoxetine 10 mg and fluoxetine 20 mg for patients requiring multiples of 10 mg dose.
Advice for dispensing from 1 February 2024:
- For prescriptions with a date of prescribing of 1 February 2024 onward, there are PBS subsidy arrangements for 20 mg dispersible tablets (Zactin Tablet) under the Serious Scarcity Substitution Instrument (SSSI) which will allow pharmacists to dispense the 20 mg and 10 mg capsule alternatives as needed without first being approved by the prescriber. Provided specific conditions in the SSSI are met, the 10 mg capsule can be dispensed for patients taking a dose of 10 mg OR a dose where a 10 mg strength is required to administer the total dose.
- For prescriptions written prior to 1 February 2024, patients must be issued a new prescription dated on or after the PBS listing date of 1 February 2024 in order to receive Fluoxetine 10 mg capsules as a PBS benefit.
- Information regarding maximum quantity packs can be found on the PBS website. Pharmacists should communicate any changes or substitutions to patients at the time of dispensing, ensuring that patients are fully informed and can make decisions about their medication in consultation with their prescriber.
- Repeat prescriptions are permitted at a maximum of 5 repeats.
Please visit the Therapeutic Goods Administration’s s19A approvals database for more information regarding Fluoxetine Capsules 10 mg (Medreich, UK).
For information pertaining to PBS listings, including medical and product information for fluoxetine, please visit the relevant PBS webpage.