Doctors concerned by IV contrast shortages
COVID-19 lockdowns in China have exposed supply weaknesses with a hopeful reprieve next month.
COVID-19 lockdowns in China have exposed supply weaknesses with a hopeful reprieve next month.
The AMA has been discussing the ongoing shortages of iodinated contrast media (contrast) with the TGA. The shortage has been caused by COVID-19 lockdowns in Shanghai.
Last week both the TGA and the Royal Australian and New Zealand College of Radiologists published statements about the shortage, which it’s hoped will be resolved by mid-June.
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TGA statement: Shortage of iodinated contrast media (contrast) diagnostic agents
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RANZCR statement: RANZCR Statement on Iodinated Contrast Media Shortage
The shortage has affected the supply of other contrast in Australia. Earlier this week, Guerbet Australia lodged shortage notifications for Optiray (ioversol) products, with a shortage end date of 31 December 2022.
The AMA understands the TGA has been working with sponsors to equitably allocate stock and identify overseas-registered alternatives which can be permitted by the TGA under s19A of the Therapeutic Goods Act 1989. The TGA is working with sponsors and expediting regulatory applications to assist with the shortage.
The TGA has granted a temporary approval to Guerbet Australia to import and supply of Optiray (ioversol) from Canada and approval for a French product, Xenetix (iobitridol), is expected soon.
The AMA also understands a regulatory application to enable an additional Irish manufacturing site for Omnipaque is being reviewed.
The TGA has advised they are working with the International Freight Assistance Mechanism, Office of Supply Chain Resilience and Department of Infrastructure to prioritise deliveries into Australia.