E-News Sept02

Improving the Safe Use of Anticoagulant Therapy

The UK National Patient Safety Agency (NPSA) has recently published a Risk Assessment of Anticoagulation Therapy, a Detailed Risk Assessment Grid and has worked with the British Society of Haematology and other stakeholders to develop a set of Recommendations to improve the safety of patients being treated with anticoagulants. As part of these recommendations a Set of Work Competences have also been developed.

You need to register and then take the following menu options: Communities, Discussion Groups, Medication Safety, and 'Anticoagulants (e.g. Warfarin and Heparin products)' from the list of discussion issues.

A wide stakeholder consultation is being undertaken on these recommendations. The NPSA would like to receive your comments and suggestions concerning their draft recommendations by 31st March 2006.

Of note, one of the recommendations states, "There is evidence that using computer dosing software for decision support and audit can improve practice."

The report also states that there is a wide variation in the supply and dosing methods used for warfarin tablets, and this leads to complexity and confusion for patients, carers and healthcare professionals. It makes recommendations on the tablet size, 'same' dose each day, and dose change increments. Also that doses must always be expressed as mg and not as numbers of tablets!

Even you do not operate in England and Wales the material available will be great value and interest to all anticoagulation providers around the world.

The NPSA plans to issue final recommendations to improve the safe use of anticoagulant therapy to the NHS in England and Wales later in 2006.

AstraZeneca Decides to Withdraw Exanta

AstraZeneca has recently announced that the company has decided to withdraw the anticoagulant ExantaT (melagatran / ximelagatran) from the market and terminate its development. AstraZeneca estimates that approximately 400 patients are currently being prescribed the drug for short-term prevention of venous thromboembolism (VTE) following orthopaedic surgery (O.S.). Two ongoing Exanta clinical trials will be discontinued and Exanta-treated patients switched to other treatments.

The withdrawal of Exanta has been triggered by new patient safety data (an adverse event report of serious liver injury) in the EXTEND clinical trial. The trial examines use of Exanta in extended VTE prophylaxis in OS up to 35 days post-operatively, and so involves a longer duration of therapy than currently approved for marketing. Liver findings have previously been observed during clinical trials of chronic use as referred to in the prescribing information. This new patient report indicates a potential risk of severe liver injury, with an observation of rapid onset of signs and symptoms in the weeks following the end of the 35 days treatment.

This specific observation has not previously been made in relation to Exanta and indicates that regular liver function monitoring may not mitigate the possible risk. While there is no evidence of a risk of liver injury with approved use up to 11 days, any unapproved use beyond 11 days is a concern.

Therefore, in the interests of patient safety, AstraZeneca is taking the precautionary measure of withdrawing Exanta. AstraZeneca has informed regulatory authorities of its decision to withdraw Exanta and is now communicating with all prescribers and healthcare professionals to advise them that no new patients should be started on Exanta.

Syd Stewart

Managing Director

End of Newsletter

“Dawn AC is an easy to use, adaptable, powerful, and comprehensive PC based Anticoagulation Software System. It covers the complete oral anticoagulation life cycle with Induction and Maintenance Modules “

“Lancet Nov 7th 1998, Multi-centred Randomised Trial using Dawn AC shows computer aided dosage leads to INR control 20 to 30% better than medical experts”