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

A staged response to a shortage of heparin based products

Guidelines to assist with contingency planning to manage the clinical implications of a shortage of heparin based products.

Page last updated: 16 July 2008

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

The AHPC group agrees that in the event of a shortage of heparin based products, there should be a staged clinical response to ensure maximum extension of availability of remaining stocks and that they are prioritised according to clinical need.

The TGA and the Department of Health and Ageing will keep the health community updated on stock availability and the need to move to and through the Stages outlined below. In addition, the Department has asked jurisdictions to advise it if any jurisdiction begins to experience shortages (ie Stage 2) so a national response can be implemented.

The AHPC group considers that as at 15 May 2008 we are in Stage 1. Conceptually, Stage 0 would indicate return to normal supply arrangements and national stock.

Stage 1

Forward supply of uncontaminated Australian low molecular weight heparin stocks greater than 6 weeks; alternative heparin-based products such as UFH and fondaparinux available, not contaminated.
  • Avoid all usage of heparin based products which are not evidence-based, so called ‘discretionary usage’. An example of ‘discretionary usage’ is anticoagulation in elective coronary angiography.
  • Use available low molecular weight heparin products such as enoxaparin (Clexane) and the alternative dalteparin (Fragmin), where clinically indicated and according to the evidence.
  • For lower risk patients, consider using VTE preventive strategies such as early mobilisation, GCSs and mechanical calf stimulation, wherever possible.
  • 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 disadvantage nor additional patient risk and there is no adverse impact on health service delivery, as discussed under Stage 2 below.

Stage 2

Forward supply of uncontaminated low molecular weight heparin stocks less than 6 weeks; alternative heparin-based products such as UFH and fondaparinux available, not contaminated.
  • Restrict usage of all heparin based products wherever possible to conserve stock for emergency and lifesaving indications. This will include postponing those elective surgical procedures which can be delayed safely and using alternatives for maintaining patency of intravascular catheters such as normal saline, where possible.

Note: Up to 15% of children in a tertiary facility receive heparin, most of which is in the form of flushes for critical line patency.

While available, use uncontaminated low molecular weight heparin products such as enoxaparin (Clexane) and dalteparin (Fragmin), according to the Prioritisation Schema outlined in Appendix 3.
  • For lower risk patients, use VTE preventive strategies such as early mobilisation, GCSs and mechanical calf stimulation wherever possible.
  • Consider substituting low molecular weight heparin products with unfractionated heparin and/or warfarin, and/or other suitable anticoagulant therapies such as fondaparinux where
possible, and according to the best available guidelines (Appendix 1 and 2). Substitution
should be according to the Prioritisation Schema outlined in Appendix 3. This will require assessment of any risk associated with the substitution, discussion with the patient and informed consent in some instances.

Low molecular weight heparin product substitution with alternative therapies will require health services planning to accommodate different treatment and testing regimens including planned anticoagulation for high risk surgery, to accommodate hospital admission where patients were previously managed as outpatients such as for treatment of VTE, and clinical training and vigilance around an anticipated different profile of adverse events associated with low molecular weight heparin substitutes. For example, many Australian doctors will have limited experience with unfractionated heparin usage and monitoring, in those clinical indications where LMWH is now the treatment of choice.

For patients needing anticoagulation in remote settings where testing is difficult, there are alternative regimens requiring minimal dose adjustment according to APTT outlined in the Appendices.
  • Where possible, clinically appropriate and safe, shift patients to warfarin, since the supply
of warfarin is not at risk. For example, elective hip and knee replacement surgery may be undertaken with planned anticoagulation using warfarin (rather than low molecular weight heparin) as is standard practice in North America.

Stage 3

Uncontaminated low molecular weight heparin remains unavailable; Australian stocks of low molecular weight heparin less than 2 weeks; alternative heparin-based products available but stock shortages developing.
  • Continue the above strategies of low molecular weight heparin products substitution with unfractionated heparin, fondaparinux and warfarin. Substitution should follow the Prioritisation Schema outlined in Appendix 3. Over time, availability of other heparin based products may become threatened as they are used across a broader range of indications and if world supply does not improve.
  • Continue to restrict elective surgery where anticoagulation with heparin based products essential, where possible.
  • Continue to use early mobilisation, GCSs in low risk patients and mechanical calf compression, where available.
If during Stage 3, the situation deteriorates with shortages of alternative products developing, the AHPC group will provide further advice to the Australian clinical community. The TGA will continue to closely monitor supply and provide updates on stock availability until the situation normalises.