Office of Health Protection (OHP)

Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages

The Therapeutic Goods Administration (TGA), Australia's medicines regulator, recently recalled five batches of the widely used Clexane, a heparin product, on 22 April 2008 due to the detection of an impurity in the affected batches.

The worldwide nature of this contamination incident raises the prospect of a shortage of heparin-based products in Australia. At this stage it remains uncertain whether Australia will experience a shortage of heparin based products, and if a shortage occurs how long it might last.

Since the Australian recall the Australian Health Protection Committee (AHPC), augmented by representatives of the Committee of Presidents of Medical Colleges (CPMC) and the President of the Australian Medical Association (AMA), has been convened and has met regularly to monitor the supply situation and develop contingency plans to mitigate the risk of potential future shortages of heparin based products in Australia.

The Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin based product shortages (the guidelines) are a precaution, intended to extend the availability of heparin based products by prioritising their use according to clinical need, and facilitate national consistency in the utilisation of remaining supplies.

The guidelines set out a staged approach according to the availability of the different products. The first stage of the guidelines will be implemented on their release.The first stage advises doctors to consider prudent use of existing heparin based products including the use of clinically acceptable alternatives where there is no compromise of the quality of care. This stage does not advise the deferral of any procedures.

Together with the TGA, the AHPC is continuing to monitor the supply of heparin based products. On the basis of triggers outlined in the guidelines, the AHPC will provide advice to the Commonwealth Department of Health and Ageing if a move to a subsequent stage is required.

Online version of Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages

Printable version of Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages (PDF 135 KB)


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