Shortage woes

Doctor on the phone

Wholesaler portals will likely show zero stock quantity for both Actemra ACTPen autoinjector and pre-filled syringe, even if they are available, said TGA

The TGA has provided pharmacists with instructions to assist with ordering and substituting tocilizumab (Actemra) products during the current shortage.

Two Actemra formulations are now effectively interchangeable at the pharmacy level, without prior contact with the prescriber, after the TGA declared them to be “scarce and substitutable medicines”:

  • ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled syringe (AUST R: 234034)
  • ACTEMRA tocilizumab (rch) 162 mg/0.9 mL solution for injection pre-filled pen, ACTPen Autoinjector (AUST R: 296808)

Both products are in short supply due to global demand in response to the COVID-19 pandemic, following its recommendation by the World Health Organization as treatment for patients seriously ill COVID-19.

This shortage is expected to continue until early 2022.

Pharmacists should ensure the patient understands the differences between the products when substituting, and are expected to notify the prescriber of the substitution soon afterwards.

“Supply of Actemra ACTPen autoinjector and pre-filled syringe will fluctuate during the shortage. Wholesaler portals will likely show zero stock quantity for both medicines, even if they are available,” said the TGA.

It advised pharmacists to call their usual wholesaler directly for availability of both devices and confirm how to order stock.

If the wholesaler does not have stock, “ask when the next allocation is arriving,” the TGA said. Pharmacists can see full instructions here.

The Serious Scarcity Substitution Instrument (SSSI) for tocilizumab is in force from 7 August 2021 until 31 December 2021, in all states and territories.

The TGA said it may revoke it before its end date if the serious scarcity is resolved or safety concerns are identified.

Both Actemra formulations dispensed under the SSSI are covered by PBS subsidy arrangements.

Meanwhile availability is “extremely limited” of Actemra vials for infusion (IV). Pharmacists should refer patients on IV tocilizumab for infusion to their prescriber for further guidance on managing treatment during the shortage, said the TGA.

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