Metformin shortage extends


27699468 - tablet with the chemical formula of metformin

Metformin shortage substitution warning period extended to the end of the year 

The Therapeutic Goods Administration (TGA) has extended its Serious Shortage Substitution Notice for metformin modified-release 500 mg tablets until 31 December 2020.

The notice specifies substitutions that pharmacists may make for patients with a prescription for metformin modified-release 500 mg. It allows metformin modified-release 500 mg to be replaced with either immediate-release metformin 500 mg or metformin modified-release 1000 mg, depending on the prescribed dose.

The initial notice had applied until 31 July 2020.

The notice must be given effect under State or Territory law before pharmacists can supply according to the specified substitution, and the patient must consent to the substitution.

While the pharmacist does not require prior approval from the prescribing doctor, the TGA advises that they should “notify the prescriber of the substitution as soon as possible”. 

The initial notification of ongoing shortages for multiple brands of metformin modified-release 500 mg tablets (also known as extended-release or XR tablets) stated that they were “expected to continue until 5 June 2020 at the earliest”.

In its updated warning, issued on Monday 27 July, the TGA said that “some brands of metformin may be available during this period, but supply may not be sufficient to meet demand in Australia”.

The TGA has also granted section 19A approvals for overseas alternatives. These can be viewed here  

The TGA said that “if it becomes evident that supply has returned to a level that will meet expected demand…. [it] may lapse this Serious Shortage Substitution Notice prior to 31 December 2020”.

Pharmacy leaders had previously raised concerns about the complexity of the serious substitution process and the lack of PBS remuneration for .

The Metformin products listed on the medicine shortage database as being in short supply or unavailable are:

  • DIABEX XR 500 metformin hydrochloride 500mg extended release tablet blister pack – ARTG 98982
  • APO-METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack – ARTG 281211
  • BLOOMS THE CHEMIST METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack – ARTG 278176
  • CHEMMART METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack – ARTG 197405
  • DIAFORMIN XR metformin hydrochloride 500mg extended release tablet blister pack – ARTG 120868
  • METEX XR metformin hydrochloride 500 mg modified release tablet blister pack – ARTG 232661
  • TERRY WHITE CHEMISTS METFORMIN XR 500 metformin hydrochloride 500 mg modified release tablet blister pack – ARTG 278180

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