Community pharmacists are now able to substitute Actemra formulations without prior prescriber approval, due to serious shortages
Two tocilizumab (Actemra) formulations are now effectively interchangeable at the pharmacy level 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 Actemra 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.
Under the new Serious Scarcity Substitution Instrument (SSSI), community pharmacists can now dispense either product to a patient when one is available without prior approval to substitute from the prescriber.
The pharmacist is expected to notify the prescriber of the substitution soon after. Products can only be substituted in adults.
“Use your professional and clinical judgement to determine whether a patient is suitable for substitution and ensure the patient is fully informed and consents to the change,” said the TGA.
Community pharmacists should ensure the patient understands the differences between the products, it said.
“Both medicines are of the same strength and administered by subcutaneous injection, however the device to administer the medicine is different,” said the TGA.
“Patients usually get instructions on how to administer these medicines from their specialist. Due to limited supply, and to reduce burden in obtaining a new prescription, this SSSI allows the Actemra pre-filled syringe and the ACTPen autoinjector to be interchanged. However, the patient will need instructions on administration.
“Ensure the patient has received instructions or will receive instructions on administration from their specialist, their rheumatology nurse or General Practitioner as outlined in the Specific permitted circumstances.”
Pharmacists are asked to ensure patients are provided with the CMI and leaflets with links to instructional videos, which are available from the sponsor.
The SSSI is in force from 7 August 2021 until 31 December 2021, in all states and territories.
However the TGA said it may revoke it before its end date if the serious scarcity is resolved or safety concerns are identified.
Pharmacists who are having difficulty ordering Actemra products from their regular wholesalers have also been advised by the TGA to check other wholesalers for stock availability.