Update on Radiopharmaceutical Supply
Wednesday Apr 8, 2020 17:00hrs
The Working Group held a Vcon yesterday afternoon with ANSTO representatives. The issues discussed were:
- Mo99-Tc99m generator supply - ANSTO have advised that they have implemented road transport for Victorian delivery and that this is working well so far. Some Queensland sites may experience a one day delay in delivery, arriving on Tuesday rather than Monday morning. ANSTO will continue to monitor available air and road transport options at this time when there are a very limited number of flights available;
- MIBG (123I) - this is currently being supplied from Japan on an ANA passenger flight. However, this flight will cease at the end of next week. ANSTO is investigating alternative transport methods included chartered flights and import/export delivery flights with AUSTRADE to continue to supply this radiopharmaceutical. This may mean that the frequency of supply is decreased (perhaps to once per month), however, it appears that an unlimited number of individual doses will be available on that batched delivery;
- MIBG (131I) - unrelated to Covid-19, ANSTO are unable to produce this at present. They are actively pursuing establishing a relationship with a private radiopharmacy to supply therapeutic doses. As with some other radiopharmaceuticals, the TGA will need to change or relax some regulations about GMP products and interstate transportation restrictions to allow this to be supplied and these talks are well advanced. This applies equally to some other radiopharmaceuticals such as PET agents;
- Maintenance shutdown - current working dates for necessary maintenance at ANSTO are:
OPAL (Mo99 production) – June 9 – 22 (abbreviated under circumstances)
ANM (Mo99 extraction) – June 15 – 18
Bld 23 (Mo99-Tc99m generator assembly) – late Nov
Contingencies are being put in place to ensure supply during these periods;
- Finally, there was some discussion about potential PET radiopharmaceutical supply vulnerabilities and backup from interstate. Currently this is not possible if GMP-certified product is produced in a public facility, but it is possible if produced in a private radiopharmacy. The TGA representative on the Working Group will assist in having this restriction relaxed to ensure that we can continue to be flexible with respect to supply.
The Working Group plans to meet with ANSTO on a weekly basis and provide updates, or more frequently if the situation changes.
AANMS ANZSNM RAINS