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Prudent measures to conserve anti-coagulant medicines

12 June, 2008

Guidelines for clinicians on prudent measures to manage a potential shortage of anti-coagulant medicines containing the blood thinning agent, heparin, have been issued.

The Commonwealth chief medical officer, professor John Horvath, and the head of the Therapeutic Goods Administration, Dr Rohan Hammett, have released guidelines for clinicians on prudent measures to manage a potential shortage of anti-coagulant medicines containing the blood thinning agent, heparin.

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

This action followed testing of all heparin based products in Australia since March 2008 after the TGA became concerned about reports of several adverse reactions occurring in patients in the USA and Europe linked to another heparin based product found to have the same impurity.

While there have been no reports of adverse events in Australia associated with Clexane or any other heparin based products, the TGA decided to quarantine the affected batches of Clexane, as a precaution to protect patient safety.

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 TGA is exploring all options to secure supplies and clarify future product availability. 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.

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 AHPC agreed to implement the first stage of the guidelines on their release, based on their assessment of the current situation.

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

The guidelines are being distributed to the AMA, the Divisions of General Practice, the Pharmacy Guild, the Pharmaceutical Society of Australia, medical colleges, the Australian Private Hospital Association, and State and Territory Chief Health Officers and Chief Medical Officers.

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.