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Shortage of iodinated contrast media (contrast) diagnostic agents

20 June 2022

20 June 2022 Update:

  • To help reduce the impact of this shortage, the TGA has authorised the supply of multiple overseas-registered products under section 19A of the Therapeutic Goods Act 1989. For information on supply contact the following approval holders:
    • Guerbet Australia Pty Ltd on 02 8075 3007
    • Bayer Australia Pty Ltd on 1800 008 757
    • GE Healthcare Australia Pty Ltd on 1300 887 764
  • Information regarding the approval of overseas-registered product under section 19A of the Therapeutic Goods Act 1989 is published on the Database of section 19A approvals.

This statement has been developed in collaboration with the Royal Australian and New Zealand College of Radiologists

The Therapeutic Goods Administration (TGA) is aware of a global shortage of iodinated contrast media (contrast) diagnostic agents. The TGA recommends urgent conservation of stock until the shortage is resolved as current supply is very limited.

Non-ionic contrast agent is used to enhance imaging in a wide range of diagnostic procedures in adults and children.

GE Healthcare, the sponsor of Omnipaque (iohexol) and Visipaque (iodixanol), has notified the TGA of a shortage of multiple presentations of both these products due to reduced manufacturing capacity and freight delays caused by the recent unexpected COVID-19 lockdown in Shanghai, China.

GE Healthcare is the largest supplier of contrast media in Australia and expects to resume normal supply in mid-July 2022. Any updates to the return to supply date will be published on the Medicine Shortage Reports Database.

In the meantime, the TGA is working with a range of stakeholders to manage the shortage including working with sponsors who are investigating the import and supply of overseas registered non-ionic contrast media agents under section 19A of the Therapeutic Goods Act 1989.

The TGA has worked with the Royal Australian and New Zealand College of Radiologists (RANZCR) to develop general guidance to assist health professionals to conserve stock urgently (see 'Information for health professionals' section below).

Information for consumers

Iodinated contrast media (contrast) is regularly used to enhance computerised tomography (CT) and other imaging such as angiography, which supports diagnosis and ongoing treatment for a large number of conditions.

Information for consumers and health professionals about what contrast is and why it is used to enhance CT imaging is available from Inside Radiology, a website developed by RANZCR.

If you or someone you provide care for has been referred for a scan, your referring medical practitioner may ask you to defer imaging. If you have any concerns, please contact your referring medical practitioner.

Information for health professionals

Consider the current shortage of iodinated contrast media (contrast) diagnostic agents when referring patients for imaging.

Practices and hospitals can consider strategies such as:

  • Being judicious in the use of contrast for all modalities that use contrast
  • Using non-contrast CT when acceptable
  • Delaying non-urgent scans
  • Where possible using other modalities such as MRI or nuclear medicine
  • Coordinating between private practices and public hospitals to best serve patients in need of contrast CT scans
  • Develop plans for the management and treatment of patients without the level of diagnosis that they may be accustomed to.

RANZCR have published a statement to support health practitioners during this shortage. The statement contains information about:

  • how patients may be prioritised based on clinical need
  • strategies that radiology practices and hospitals may implement to conserve current supplies of contrast and manage patient care.

The RANCZR recommends that medical practitioners who are concerned about referring a patient for a CT or other imaging during this time should consult with a radiologist. The radiologist can provide advice on alternative imaging modalities or other strategies that could be used to diagnose clinical conditions.

In hospital settings, the Australasian College for Emergency Medicine encourages shared decision making and consultation with emergency department leadership to facilitate patient flow in consideration of the current shortage.

To help reduce the impact of this shortage, the TGA has authorised the supply of multiple overseas-registered product under section 19A of the Therapeutic Goods Act 1989. For information on supply, contact the following approval holders:

  • Guerbet Australia Pty Ltd on 02 8075 3007
  • Bayer Australia Pty Ltd on 1800 008 757
  • GE Healthcare Australia Pty Ltd on 1300 887 764

The TGA is also considering other applications of overseas-registered products for supply under Section 19A of the Therapeutic Goods Act 1989. Information regarding the approval of any overseas-registered products will be published on the Database of section 19A approvals.