TGA warns of shortages of 18 antibiotics


The TGA has revealed that 18 antibiotics are subject to supply shortages, and the agency is rolling out measures to enable patients and prescribers to access alternative products, where necessary.

The regulator said Australia was experiencing shortages of antibiotics including amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim.

The shortages were caused by manufacturing issues or an unexpected increase in demand and did not appear to be localised particular to any regions of Australia.

Where patients are unable to access particular agents or brands, the TGA said pharmacists may be able a different brand, or doctor could prescribe a different strength or medicine with similar spectrum of activity.

And when suitable Australian-registered alternatives are not available, the TGA has taken action to approve overseas-registered alternatives under s19A of the Therapeutic Goods Act 1989.

In a Medicines Shortage Alert published on 11 January, the TGA said Serious Scarcity Substitution Instruments (SSSIs) had been issued to assist with the shortage of oral amoxicillin and cefalexin products.

“Each SSSI allows a pharmacist to dispense a substitute product containing the same active ingredient when the prescribed product is unavailable, without prior approval from the prescriber, under certain conditions.

This means a pharmacist can dispense a different strength or form of amoxicillin or cefalexin if the antibiotic prescribed is unavailable, the TGA said.

In its advisory statement, the TGA said alternative Australian-registered products are available for some antibiotics that were affected by shortages, including amoxicillin capsules and tablets; azithromycin injection; cefaclor tablets; cefalexin capsules; doxycycline capsules; erythromycin capsules; flucloxacillin capsules; metronidazole tablets; nitrofurantoin capsules; procaine benzylpenicillin syringe; rifampicin capsules; cefotaxime injection; roxithromycin tablets; minocycline tablets; linezolid tablets and daptomycin injection.

Overseas-registered alternative products have also been approved for:

  • Amoxicillin capsules and suspension
  • Amoxicillin/Clavulanic acid tablets and suspension
  • Cefalexin capsules
  • Metronidazole tablets and suspension
  • Phenoxymethylpenicillin tablets
  • Sulfamethoxazole/trimethoprim injection and tablets
  • Trimethoprim tablets.

In the longer term, the TGA said it was working with industry, pharmaceutical wholesalers and pharmacies to manage inventory and supply to enable fair distribution of stock in Australia, and to bring forward or increase future orders for products and coordinating planning on supply of critical medicines.

“Whilst many of the shortages are expected to resolve in the next few months, we are aware of ongoing global constraints for some products which will see their shortages extend until the end of 2023,” it said.

Meanwhile, the AMA has called for a national plan to address the ‘intolerable’ shortages of some common antibiotics such as amoxicillin.

“It may be a combination of securing supply chains, national stockpiles, and potentially the capability in Australia, of manufacturing some of these medications,” he told the ABC.

According to the TGA Medicine Shortage Reports Database, the following antibiotics are listed as subject to critical shortages:

  • Ampicillin
    IBIMICYN ampicillin 500mg (as sodium) powder for injection vial
    Expected supply: 15 Mar 2023
    Availability: Limited
    Availability Management action: Another strength is available.
  • Cefotaxime sodium
    DBL CEFOTAXIME SODIUM for injection 1g vial
    Expected supply: 28 Feb 2023
    Availability: Limited Availability
  • Phenoxymethylpenicillin benzathine
    CILICAINE V phenoxymethylpenicillin (as benzathine) 150mg/5mL oral liquid, suspension bottle
    Expected supply: 30 Apr 2023
    Availability: Emergency Supply Only
    Management action: Sponsor is working to expedite the next shipment.
  • Phenoxymethylpenicillin potassium
    ASPECILLIN VK phenoxymethylpenicillin 250mg (as potassium) tablet bottle
    Expected supply: 28 Feb 2023
    Availability: Unavailable
    Management action: An unregistered product has been approved for supply under Section 19A
  • Phenoxymethylpenicillin potassium
    ASPECILLIN VK phenoxymethylpenicillin 250mg (as potassium) tablet bottle
    Expected supply: 28 Feb 2023
    Availability: Unavailable
    Management action: An unregistered product has been approved for supply under Section 19A
  • Phenoxymethylpenicillin potassium
    PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250mg/5ml powder for oral liquid bottle
    Expected supply: 28 Feb 2023
    Availability: Unavailable
    Management action: Sponsor is working to expedite the next shipment.
  • Rifampicin
    RIMYCIN 300 rifampicin 300 mg capsule bottle
    Expected supply: 03 Feb 2023
    Availability: Unavailable
    Management action: Alternative generic products are available
  • Sulfamethoxazole
    Trimethoprim
    DBL SULFAMETHOXAZOLE 400 mg and TRIMETHOPRIM 80 mg/5 mL concentrated injection ampoule
    Expected supply: 10 Mar 2023
    Availability: Unavailable
  • Voriconazole
    VORCON voriconazole 200 mg powder for injection vial
    Expected supply: 31 Dec 2022
    Availability: Unavailable
    Management action: Alternative generic products are available.
  • Voriconazole
    VORICONAZOLE WOCKHARDT voriconazole 200 mg powder for injection vial
    Expected supply: 31 Mar 2023
    Availability: Unavailable
    Management action: Alternative generic products are available.

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