ANSTO announced today that it notified the Therapeutic Goods Administration (TGA) of an allegation by a member of its staff relating to quality assurance of one of its cyclotronproduced diagnostic radiopharmaceuticals, thallium 201. The TGA responded by initiating an audit of ANSTO’s radiopharmaceuticals production and quality control.
“ANSTO’s main priority is ensuring the qua lity of its radiopharmaceuticals, which contribute to the healthcare of the half a million Australians who receive nuclear medicine treatments each year,” said ANSTO Executive Director, Dr Ian Smith.
“On hearing the allegation, we did not hesitate in immediately initiating our own internal investigation,” continued Dr Smith. “The allegation related to the level of associated radioisotopes contained within thallium 201, a product used for the diagnostic imaging of patients who have heart problems.
“We also contacted the relevant regulator, the Therapeutic Goods Administration, as a priority. We sought its advice on how we should further determine the veracity of the allegation and ensure our medicines do meet the required standards.
“We worked closely with the Therapeutic Goods Administration as it conducted its own audit and we now await their final report.
“On the basis of our own investigation to date, there is no evidence that radiopharmaceuticals were distributed outside of product specifications.
“We want to reassure patients hearing this news that there is no reason to be concerned,” continued Dr Smith.
“The product in question is diagnostic, meaning that only very small amounts of the radiopharmaceutical are used. Also, radiopharmaceuticals pass through the body very quickly and do not have any significant health impact.”
Additional quality checks have been put in place to ensure any radiopharmaceuticals produced meet all relevant quality specifications. These additional checks will be reviewed by both the TGA and ANSTO.