Update on Radiopharmaceutical Supply
Wednesday May 27, 2020 17:00hrs
The Working Group has had an urgent Vcon this afternoon with representatives from ANSTO, TGA, GMS and Dept of Health.
On Tues morning May 26 there was a breakdown in a transport system for moving Mo99 around in Building 23 where the Mo99-Tc99m generators are assembled. The Working Group were given early warning of this yesterday by ANSTO. Upon inspection today, ANSTO has determined that the fault is relatively minor and accessible and anticipate that it will be repaired tomorrow and tested on Friday. Production of generators will begin again on Saturday at this stage if all goes according to plan. This area also contains the manufacturing and dispensing facilities for I131 capsules and Lu177.
The consequences of this are listed below:
- Only 8 of the 32 generators that should have been dispatched for use on Thursday were produced prior to the failure. These have been prioritised to regional centres and the centralised radiopharmacies in Melbourne and Adelaide. Therefore, 24 generators which should have been delivered on Thursday this week will be cancelled;
- Upon recommencing production according to the schedule above, 75 generators (ANSTO production capacity, up from 66 that would be manufactured in a normal run) will be manufactured over the weekend to be dispatched on Monday night, however, their delivery will be governed by the limited flight schedules at present apart from Sydney, Brisbane and Melbourne where road transport or more regular flights are available. Priority for these generators will be given to those sites that missed out on the 24 generators from this week. These should be available (transport permitting) for delivery on Tuesday;
- The weekly production of the 24 missing generators plus the 66 that would normally be made would provide 90 generators. However, only 75 will be dispatched early next week meaning there will be 15 generators not supplied to sites. Priority for the 75 generators will be assessed favouring regional centres and metropolitan radiopharmacies to maximise availability;
- Production of generators next week should see all back to normal supply by Friday, however, until then a “domino effect” will be evident due to the loss of 24 generators from the normal supply chain this week;
- Radioiodine supply will not be affected this week. ANSTO is holding stock until at least late June but this is finite and dependent on the number of orders received. GMS also has radioiodine capsules available at this time;
- Lu177 production is also affected but ANSTO will import from ITG (Germany) for the next two weeks to minimise the impact that any delay in re-establishing production in the cell could have.
The Working Group will continue to meet with ANSTO as required and provide updates.
AANMS ANZSNM RAINS