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ARSAC Newsletter 21.12.2018

ARSAC newsletter

Alternative products

 

The Committee has been made aware of supply issues with regard to 51-Chromium radiopharmaceuticals used primarily for GFR and Red Cell mass investigations.

Alternative 99mTc products have been approved by ARSAC for these indications:

99mTc -40-46

99m-Tc-DTPA

GFR

99mTc-48-111

99m-Tc-erythrocytes

Red Cell Volume

Practitioners and Employers should verify that they are licenced for these procedures in order to continue services.

If required, an Amendment should be submitted to Employer and Practitioner licences. Amendments due to supply issues will be processed as quickly as possible however please note that it may take up to 6 weeks. Timescales may be increased further if additional procedures are added to the application. 

There is no amendment form; https://www.gov.uk/government/publications/arsac-application-forms&source=gmail&ust=1547024204751000&usg=AFQjCNHP3EDYE3lPeZb87vKU6DVrsQyccA">the new licence application forms should continue to be used. Please ensure applications clearly state only the additional procedure(s) that has been applied for and that all information has been updated to include relevant training and experience and local governance requirements for the procedures.

Research studies that are using these techniques should also verify that they are authorised for alternative procedures. If required an https://www.gov.uk/guidance/how-and-when-to-submit-research-applications-to-arsac%23amendments-to-research-studies&source=gmail&ust=1547024204751000&usg=AFQjCNHHniS8jXvHExsxZ-Cbm4tfAfW_Bg">Amendment to the research study may need to be submitted. 

Considerations in changing techniques

When switching radiopharmaceuticals for a service the following should be considered prior to implementation:

  • The results obtained with both tracers may not be comparable for long term assessment or when used in research trials. 
  • Software used for calculations may need to be re-validated
  • There may be differences between GFR values calculated following administration of different preparations of 99mTc-DTPA. This needs to be taken into account when used across multicentre trials