News Archive > Consensus Guidelines for the Use of Anti-Coagulants During Heparin-Based Shortages

Consensus Guidelines for the Use of Anti-Coagulants During Heparin-Based Shortages

28 May 2008

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

Following the identification of a contaminant in international stocks of heparin, and the
recall from the Australian market of quantities of the low molecular weight heparin
product enoxaparin (Clexane®), the Therapeutic Goods Administration (TGA) and the
Department of Health and Ageing have been working to develop contingency plans to
mitigate the risk of potential future shortages of heparin-based products in Australia.

The Department, working with the Australian Health Protection Committee (AHPC), the
Committee of Presidents of Medical Colleges (CPMC) and the Australian Medical
Association (AMA), has developed a set of Consensus Guidelines for Australian
Clinicians for the use of anti-coagulants during heparin-based product shortages. These
Guidelines are intended to extend the availability of heparin based products by
prioritising their use according to clinical need, ensure there are no increases in
preventable morbidity and mortality, and facilitate national consistency in the utilisation of these products.

The Guidelines set out a staged approach, with the different stages determined by the
remaining availability of the various heparin-based products. Each stage provides
guidance for clinicians on the use of alternatives to Clexane and identifies those patients in whom the use of anticoagulants, and particularly Clexane, should be continued as a
priority.

As at 16 May 2008 the AHPC has determined that we are currently in Stage 1, in
which:
Greater than 6 weeks of uncontaminated Australian stocks of Clexane remain;
alternative heparin-based products such as dalteparin (Fragmin®), unfractionated
heparin (UFH) and fondaparinux (Arixtra®) are available, and are uncontaminated.

In Stage 1 clinicians should:

Avoid all usage of heparin based products which is not evidence-based, so long as a patient’s clinical condition is not compromised;

Use available enoxaparin (Clexane) and the alternative low molecular weight heparin dalteparin, where clinically indicated and according to the evidence;

For lower risk patients, consider using preventive strategies such as early
mobilisation, graduated compression stockings and mechanical calf stimulation, wherever possible, as long as a patient’s clinical condition is not compromised;

Consider substitution of low molecular weight heparin with alternatives such
as unfractionated heparin and/or warfarin, and/or other suitable anticoagulant therapies such as fondaparinux where the evidence suggests
no additional patient risk and as long as a patient’s clinical condition is not
compromised.

These guidelines have been endorsed by the Australian Medical Association, the
Committee of Presidents of Medical Colleges, and by all State and Territory Chief Health
Officers.

The TGA is continuing to explore all options to augment supply of the heparin products
for the Australian market. Your cooperation in implementing these guidelines, together
with the judicious use of available supplies, is required if Australia is to ensure that any
impact on clinical services can be minimised until normal heparin supply levels can once
again be restored.

Yours sincerely
Professor John Horvath AO, Chief Medical Officer
Dr Rohan Hammett, National Manager
Therapeutic Goods Administration
16 May 2008

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