TGA moves to address fluoxetine shortage

Matt Woodley

7/02/2024 4:44:15 PM

A temporary gap in availability has been addressed by listing an overseas alternative on the PBS.

Bunch of capsules
The shortage is expected to last until at least 29 February.

A shortage of fluoxetine 20 mg dispersible tablets (Zactin tabs) is expected to continue until at least the end of February, according to the Therapeutic Goods Administration (TGA).
To help manage the shortage, which sponsor Alphapharm said is related to manufacturing issues, the TGA has temporarily approved the supply of two overseas products, with Medreich fluoxetine 10 mg capsules (Link Medical Products) subsidised via the PBS.
‘These lower-strength capsule products can be used for patients taking a dose of less than 20 mg or a dose that cannot be made up using multiples of 20 mg,’ the regulator stated.
The TGA has also formed a Medicine Shortage Action Group (MSAG) made up of clinical experts in psychiatry, general practice and pharmacy to consider what effects the shortage may have on patients, prescribers and pharmacists.
The MSAG group gave the following advice:

  • Patients should be switched to fluoxetine 20 mg capsules, where possible
  • Where required, fluoxetine capsules may be opened and the contents dispersed. Advice about safely opening and dispersing the contents of fluoxetine capsule products can be found in the Society of Hospital Pharmacists (SHPA) guidelines
  • Patients with swallowing difficulties, dexterity issues, health conditions requiring enteral feeding or other conditions where the capsule dose form is not appropriate will require individualised advice regarding treatment options
  • In the event that a patient cannot receive their prescribed dose, referral to a prescriber would be required
Aside from creating an MSAG, the TGA has also made a Serious Scarcity Substitution Instrument (SSSI) that allows pharmacists to dispense the 20 mg and 10 mg capsule alternatives as needed without first being approved by the prescriber.
Information for prescribers
The TGA has advised doctors to keep the shortage in mind when prescribing to patients, particularly when starting new patients on the medicine, and also said they should switch patients to 20 mg capsules where possible.
Meanwhile, to receive the newly listed fluoxetine 10 mg capsules as a PBS benefit, patients must be issued a new prescription dated on or after 1 February 2024.
‘Due to the limited supply of overseas fluoxetine 10 mg capsule products, please consider the need for separate prescriptions for fluoxetine 10 mg and fluoxetine 20 mg for patients taking doses over 20 mg,’ the TGA stated.
Children and patients who take doses of fluoxetine less than 10 mg should be assessed for suitable alternative dosage forms.
While the shortage is only expected to continue until the end of the month, this date may change and prescribers have been advised to check the medicine shortage reports database for updates.
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