Update on Radiopharmaceutical Supply
Friday Mar 20, 2020 12:00hrs
The Working Group held a Vcon yesterday afternoon with ANSTO representatives.
ANSTO advised that the scheduled maintenance shutdown of the Mo99/Tc99m generator production line (Bld 23) that was planned for mid-April, when we would have been forced to import generators, has been postponed for the foreseeable future. This is due to uncertainty of supply from overseas with decreases in the number of flights arriving into Australia and the expected impact of COVID-19 on production line workforce. Likewise, the planned one month shutdown of the OPAL reactor in June is being reviewed and an update is likely next week.
The radiopharmaceutical supply chain is particularly vulnerable at this time, in Australia and globally. A single employee along a production chain testing positive or suspected to be positive could eliminate an entire team and halt production processes. Contraction of air transport services could also disrupt deliveries. There is a lack of predictability of these impacts and they potentially impact centralised radiopharmacies, PET tracer supply, imported radionuclides and ANSTO production.
ANSTO is taking pre-emptive measures to try and maintain domestic supply during this uncertain period. They are implementing a splitting of their workforce into two teams that do not overlap. Generator production will be impacted from next week with the usual 130 generators per week produced reduced to around 100. The total amount of Mo99 available will remain constant at this stage and a number of options exist for boosting supply including supplying generators with larger capacity for 2 weeks of operation is the best option. Metropolitan supply from the centralised radiopharmacies remains another strategy that can be implemented subject to the above mentioned risk of that pathway.
ANSTO are looking at local Lu177 requirements in anticipation that imports from Europe and elsewhere will be compromised. Radioiodine (I131) for thyroid treatments will remain available while the workforce is available. MIBG (I131 and I123) is problematic and ANSTO will be approaching larger radiopharmacies around Australia to see if they can assist in national supply.
The TGA representatives on the Vcon were also briefed that they may be required to communicate to their organisation and government if any legislated restrictions need to be reviewed in the current circumstances.
The Working Group plans to meet on a weekly basis and provide updates, or more frequently if the situation changes.
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