Back to list

UPDATE on Radiopharmaceutical Supply - Wednesday May 6, 2020 11:00hrs

Wednesday 06, May 2020

Update on Radiopharmaceutical Supply

Wednesday May 6, 2020 11:00hrs

 

The Working Group held their weekly Vcon yesterday afternoon with representatives from ANSTO, TGA, GMS and Dept of Health. Below is tabled the weekly update from Graham Morl & colleagues from ANSTO.

   

 

123I MIBG

  • New flight options are being explored to try to get product into Australia earlier. Flights are secure until end of May. Centres are being contacted to place orders fortnightly
  • Next shipment 14th May

131I MIBG

  • Agreement/contract sent to commercial partner. Awaiting response.

 

Logistics

  • New normal patterns seem to be stabilising after the first three weeks of change and turbulence but restrictions ate still placing considerable strain on ANSTO’s and GMS’ ability to deliver especially to regional areas.

 

Technetium

  • Little change, still facing  same core issues
  • Friday deliveries commence from this week
  • Still experiencing delays into Adelaide and Perth for other isotopes – may have to reschedule for Tuesday
  • Some regional areas facing delays (NSW and VIC) through Toll
  • Little more reduction across regional practices, dropped 20% activity across 5 or 6 of the sites

 

 

FDG

  • Significant discussion on scope and ability to obtain product and get it to sites such as Darwin in time to be viable
  • Discussions have occurred between the Working Group members and the Transport & Freight Taskforce (TFT)
  • TGA is also re writing legislation around compounding for Public hospitals
  • Liverpool Hospital have been provided TGA licence to manufacture & supply FDG. They are working with Qantas to send product around
  • Shipments going from Sydney to Darwin are sufficient at the moment
  • TAS is still struggling a bit, hope is that improvements in inbound flights per week begin soon
  • Hobart is doing okay but Launceston could do with some more support


Some specific issues related to manufacturing and logistics, such as a mandatory drop-off demanded by the airlines 2 hrs before the scheduled flight time (i.e., one half-life for F-18), have been escalated to the TFT to see if this can be reduced to 1 hour or less.


The TGA representative reported that the Therapeutic Goods Regulations related to Radiopharmaceuticals and associated compounds has been amended to allow for a wider range of manufacturing sites and for transport across state boundaries where previously there were restrictions. For further information, see Therapeutic Goods Amendment (Radiopharmaceuticals and Radiopharmaceutical Active Ingredients) Regulations 2020 which came into effect on 2 May 2020. An explanatory statement is also available. NB: These changes will only be in effect while the COVID-19 situation continues to disrupt normal business activities.


The Working Group will continue to meet with ANSTO on a weekly basis and provide updates, or more frequently if the situation changes.

AANMS                                                                        ANZSNM                                                          RAINS